ELEMENT II.2.G.
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: (D) R equiring current participants to re-consent to
(a) Policies and procedures define the problems participation.
researchers have to report to the IRB or EC and the (E) Modification of the continuing review schedule.
time frame for reporting. (F) Monitoring of the research.
(i) The list of problems that need reporting includes: (G) Monitoring of the consent process.
(A) Internal adverse events that are unexpected, (H) Referral to other organizational entities.
(viii) Policies and procedures describe the reporting of
involve new or increased risks, and are related
to the research. problems determined to represent unanticipated
(B) E xternal adverse events that are unanticipated problems involving risks to participants or others,
problems involving risks to participants or others. including the distribution of the report to:
(C) C hanges made to the research without prior IRB (A) Specific organizational officials.
or EC approval in order to eliminate apparent (B) R egulatory agencies, when the research is
immediate harm.
(D) O ther unanticipated information that is related overseen by those agencies, and they require
to the research and indicates that participants or separate reporting.
others might be at increased risk of harm. (C) T he maximum time allowed between the
(ii) Policies and procedures define unanticipated recognition of a reportable event and fulfilling
problems involving risks to participants or others. reporting requirements.
(iii) Policies and procedures describe: (2) When following DHHS regulations:
(A) The review of problems reported by researchers. (a) Policies and procedures include a requirement that
(B) T he determination of whether each reported the report of unanticipated problems involving risks
problem is an unanticipated problem involving to participants or others be sent to OHRP, when the
risks to participants or others. research is covered by DHHS regulations.
(iv) Policies and procedures describe the review pro- (i) W hen research is not covered by DHHS regula-
cess of unanticipated problems involving no more tions, written materials specify that reports of unan-
than minimal risks to participants or others. ticipated problems involving risks to participants or
(v) P olicies and procedures describe the convened others are not to be reported to OHRP.
IRB’s or EC’s review of unanticipated problems (3) When following FDA regulations:
involving more than minimal risks to participants or (a) Policies and procedures include a requirement that
others, including: the report of unanticipated problems involving risks
(A) If a primary reviewer system is used, documents to participants or others be sent to the FDA, when the
distributed to primary reviewers. research is FDA-regulated.
(B) Documents distributed to all IRB or EC members. (i) W hen research is not covered by FDA regulations,
(vi) Policies and procedures indicate the IRB or EC written materials specify that reports of unanticipat-
is required to consider the following range of ed problems involving risks to participants or others
actions: are not to be reported to FDA.
(A) Suspension of IRB approval the research. (4) When following VA requirements:
(B) Termination of IRB approval the research. (a) Policies and procedures indicate the terms “unan-
(C) N otification of current participants when such ticipated” and “unexpected” refer to an event or
information might relate to participants’ willing- problem in VA research that is new or greater than
ness to continue to take part in the research. previously known in terms of nature, severity, or
(vii) P olicies and procedures indicate that, in addition frequency, given the procedures described in proto-
to the required actions, the IRB or EC optionally col-related documents and the characteristics of the
may consider the following possible actions: study population.
(A) Modification of the protocol. (b) F or unanticipated problems involving risks to partici-
(B) M odification of the information disclosed during pants or others, members of the VA research com-
the consent process. munity are required to ensure that all unanticipated
(C) P roviding additional information to past partici- problems involving risks to participants or others in
pants. research are reported promptly to the IRB.
Element II.2.G. 151
ELEMENT II.2.G.
REQUIRED WRITTEN MATERIALS
(c) F or serious unanticipated problems involving risks to (ii) IRB review of serious unanticipated problems and
participants or others, within five business days of be- unanticipated serious adverse events.
coming aware of any serious unanticipated problem
involving risks to participants or others in VA research, (e) P olicies and procedures indicate that within five
members of the VA research community are required business days after a report of a serious unanticipat-
to ensure that the problem has been reported in ed problem involving risks to participants or others,
writing to the IRB. Serious unanticipated problems or of a local unanticipated serious adverse event, the
involving risks to participants or others include: convened IRB or a qualified IRB member-reviewer
must determine and document whether the reported
(i) I nterruptions of participant enrollments or other incident was serious and unanticipated and related
research activities due to concerns about the safety, to the research.
rights, or welfare of human research participants,
research staff, or others. (i) “ Related” means the event or problem may rea-
sonably be regarded as caused by, or probably
(ii) Any work-related injury to personnel involved in hu- caused by, the research.
man research, or any research-related injury to any
other person, that requires more than minor medical (ii) If the convened IRB or the IRB reviewer determines
intervention (i.e., basic first aid), requires extended that the problem or event was serious, unanticipat-
surveillance of the affected individuals, or leads to ed, and related to the research, the IRB chair or
serious complications or death. designee must report in writing the unanticipated
problem or event within five business days after the
(iii) A ny VA National Pharmacy Benefits Management determination to:
(PBM) Bulletins or Communications (sometimes
referred to as PBM Safety Alerts) relevant to one (A) Facility director.
or more of the VA facility’s research projects. (B) Associate chief of staff for research.
(C) The Research and Development Committee.
(iv) Any data monitoring committee, data and safety (f) T he facility director must report the problem or event
monitoring board or data and safety monitoring
committee report describing a safety problem. to the appropriate Office of Research Oversight re-
search officer within five business days after receiving
(v) A ny sponsor analysis describing a safety problem such notification.
for which action at the VA facility might be warrant- (g) If the convened IRB or the IRB reviewer determines
ed. that the problem or event was serious, unanticipated,
and related to the research, a simultaneous determi-
(vi) Any unanticipated problem involving substantive nation is required regarding the need for any action
harm, or a genuine risk of substantive harm, to the (e.g., suspension of activities; notification of partici-
safety, rights, or welfare of human research partici- pants) necessary to prevent an immediate hazard to
pants, research staff, or others. participants in accordance with VA regulations.
(i) A ll determinations of the IRB reviewer (regardless
(vii) A ny problem reflecting a deficiency that substan-
tively compromises the effectiveness of the VA of outcome) must be reported to the IRB at its next
facility’s HRPP. convened meeting.
(ii) If it was determined that the problem or event is
(d) Local unanticipated serious adverse events. serious, unanticipated, and related to the research,
(i) P olicies and procedures indicate that within five the convened IRB must determine and document
whether a protocol or consent document modifica-
business days of becoming aware of any local tion is warranted.
(i.e., occurring in the reporting individual’s own (iii) I f the convened IRB determines that a protocol or
facility) unanticipated serious adverse events in VA consent document modification is warranted, the
research, members of the VA research community IRB must also determine and document:
are required to ensure that the serious adverse event (iv) Whether previously enrolled participants must be
has been reported in writing to the IRB. notified of the modification.
(A) This requirement is in addition to other applica- (v) W hen such notification must take place and how
such notification must be documented.
ble reporting requirements (e.g., reporting to the
sponsor under FDA regulations).
(B) T he unfounded classification of a serious ad-
verse event as “anticipated” constitutes serious
non-compliance.
Element II.2.G. 152
ELEMENT II.2.G.
REQUIRED WRITTEN MATERIALS
(h) Policies and procedures include a requirement that (6) When following the ICH-GCP (E6) guideline:
the report of unanticipated problems involving risks to (a) Policies and procedures define the problems re-
participants or others be sent to:
searchers have to report to the IRB or EC to include:
(i) T he Office of Research and Development, if (i) N ew information that may affect adversely the safe-
VA-funded.
ty of the participants or the conduct of the clinical
(ii) The Regional Office of Research Oversight. trial.
(iii) T he VA Privacy Office, when the report involves (ii) Any changes significantly affecting the conduct of
the clinical trial or increasing the risk to participants.
unauthorized use, loss, or disclosure of individually
identifiable patient information.
(iv) The VHA Information Security Officer when the
report involves violations of VA information security
requirements.
(i) I RBs of academic affiliates and the IRB of record
for VA facilities must also follow these requirements
when reviewing VA research.
(5) When following DoD requirements:
(a) Any unanticipated problems involving risks to partici-
pants or others for any DoD-supported research must
be promptly (within 30 days) reported to the DoD
human research protection officer.
OUTCOMES
• The IRB or EC evaluates each reported problem to
determine whether it is an unanticipated problem
involving risks to participants or others.
• The IRB or EC reviews problems that are unanticipated
problems involving more than minimal risks to partici-
pants or others.
• The IRB or EC or an organizational official reports
unanticipated problems involving risks to participants
or others to appropriate organizational officials and
applicable regulatory agencies.
Element II.2.G. 153
ELEMENT II.2.H.
The IRB or EC has and follows written policies and procedures for suspending or terminating IRB or
EC approval of research, if warranted, and for reporting these actions, when appropriate.
ELEMENT II.2.H.
ELEMENT II.2.H. The IRB or EC has and follows written policies and procedures for suspending or terminating
IRB or EC approval of research, if warranted, and for reporting these actions, when appro-
priate.
COMMENTARY
The IRB or EC must have the authority to suspend or Sometimes organizations use the term “administrative hold”
terminate its approval of research that is not being con- or “voluntary hold” to describe a temporary halt of IRB
ducted in accordance with the laws, regulations, codes, approval. An administrative hold directed by the IRB is a
and guidance or the IRB’s or EC’s requirements. The IRB suspension and must be classified and reported as such.
or EC should have policies and procedures to suspend This includes a suspension of enrollment alone. An adminis-
or terminate approval of research, taking into account the trative hold cannot be used to extend IRB approval beyond
rights and welfare of current participants. Written materials the expiration date of a protocol without IRB approval of
should indicate that authority to suspend or terminate IRB continuing review.
or EC approval is retained, regardless of whether research
was approved by the convened IRB, or through the expe- See AAHRPP Tip Sheet 14
dited procedure, or through limited IRB review or is exempt. See AAHRPP Tip Sheet 15
The IRB or EC retains the ability to suspend or terminate See AAHRPP Tip Sheet 21
research even when continuing IRB or EC review is not re-
quired. These policies and procedures should also describe
the organization’s process for reporting terminations and
suspensions of IRB or EC approval.
REGULATORY AND GUIDANCE REFERENCES • V A: 38 CFR 16.103(b)(5)(ii), 38 CFR 16.113, What
to Report to ORO: ACTION, Memorandum dated
• DHHS: 45 CFR 46.103(b)(5)(ii), 45 CFR 46.113, 9/08/05, VHA Handbook 1058.01, VHA Handbook
OHRP Guidance on Reporting Incidents to OHRP 1200.05, 11, 14, 42
• FDA: 21 CFR 56.108(b)(3), 21 CFR 56.113, FDA • ICH-GCP: 4.12.1, 4.12.2, 4.12.3
Information Sheets: Continuing Review After Study
Approval
• D oD: Instruction 3216.02 4.b.4
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: (A) Is not being conducted in accordance with the
(a) Policies and procedures define the process for IRB’s or EC’s requirements.
suspending or terminating IRB or EC approval of (B) H as been associated with unexpected serious
research. harm to participants.
(i) Policies define:
(A) Suspension of IRB approval. (iii) P olicies and procedures describe who is authorized
(B) Termination of IRB approval. to suspend or terminate research.
(ii) Policies and procedures indicate that the IRB or
(iv) Policies and procedures describe who can suspend
EC can suspend or terminate approval of research or terminate IRB approval on an urgent basis.
that:
(v) P olicies and procedures have suspensions and ter-
minations by someone other than the convened IRB
Element II.2.H. 155
ELEMENT II.2.H.
REQUIRED WRITTEN MATERIALS
reported to and reviewed by the convened IRB. (c) Reporting of terminations or suspensions of research.
(vi) When study approval is suspended or terminated, (i) A ny termination or suspension of research (e.g., by
policies and procedures have the IRB or EC or the the IRB or other research review committee, or by
person ordering the suspension or termination: the associate chief of staff for research or other VA
(A) Consider actions to protect the rights and facility official) related to concerns about the safety,
rights, or welfare of human research participants,
welfare of currently enrolled participants. research Staff, or others must be reported in writing
(B) C onsider whether procedures for withdrawal within five business days after the termination or
suspension occurs to:
of enrolled participants take into account their (A) Facility director.
rights and welfare (e.g., making arrangements (B) Associate chief of staff for research.
for medical care outside of a research study, (C) Research and Development Committee.
transfer to another researcher, and continuation (D) IRB.
in the research under independent monitoring). (E) Other relevant research review committee.
(C) C onsider informing current participants of the (ii) The facility director must report the termination or
termination or suspension. suspension to the appropriate Office of Research
(D) H ave any adverse events or outcomes reported Oversight research officer within five business days
to the IRB or EC. after receiving such notification.
(vii) P olicies and procedures describe the prompt (iii) P olicies and procedures describe the prompt
reporting of suspensions and terminations of IRB reporting of suspensions and terminations of IRB or
or EC approval. EC approval to:
(viii) The maximum time allowed between the recogni- (A) The Office of Research and Development, if
tion of a reportable event and fulfilling reporting
requirements. VA-funded.
(ix) The distribution of the report to: (B) The Regional Office of Research Oversight.
(A) Specific organizational officials. (C) T he Privacy Office, when the report involves un-
(B) R egulatory agencies when the research is
overseen by to those agencies, and they require authorized use, loss, or disclosure of individually
reporting. identifiable patient information.
(2) When following DHHS regulations: (D) T he Information Security Officer when the
(a) Policies and procedures describe the prompt report- report involves violations of information security
ing of suspensions and terminations of IRB or EC requirements.
approval to OHRP. (iv) IRBs of academic affiliates that are the IRB of
(3) When following FDA regulations: record for a VA facility must also follow these
(a) Policies and procedures describe the prompt report- requirements when reviewing VA research.
ing of suspensions and terminations of IRB or EC (5) When following DoD requirements:
approval to FDA. (a) Any suspension or termination of DoD-supported
(4) When following VA requirements: research is promptly (within 30 days) reported to
(a) Policies and procedures include the following defini- the DoD human research protection officer.
tions, procedures and timeframes:
(b) T he research and development committee and facili-
ty director have the authority to suspend or terminate
their approval of research.
OUTCOMES • The IRB or EC or organizational official reports sus-
pensions and terminations of approval of research to
• The IRB or EC suspends or terminates approval of appropriate organizational officials and applicable
research in its policies and procedures. regulatory agencies.
• W hen the IRB or EC suspends or terminates approval
of research, the rights and welfare of enrolled partici-
pants are protected.
Element II.2.H. 156
ELEMENT II.2.I.
The IRB or EC has and follows policies and procedures for managing multi-site research by defining
the responsibilities of participating sites that are relevant to the protection of research participants,
such as reporting of unanticipated problems or interim results.
ELEMENT II.2.I.
ELEMENT II.2.I. The IRB or EC has and follows policies and procedures for managing multi-site research by
defining the responsibilities of participating sites that are relevant to the protection of re-
search participants, such as reporting of unanticipated problems or interim results.
COMMENTARY
This Element applies when the IRB or EC reviews research
where the researcher under the oversight of the HRPP is
responsible for the overall conduct of the study. That is, the
researcher is the lead researcher of a multi-site study or
provides study-wide services such as for data coordination.
In such cases, policies and procedures should describe the
steps the IRB or EC follows to communicate among the sites
involved in the multi-site study on issues other than IRB or
EC review. Such communications might include reporting of
unanticipated problems, protocol modifications, and interim
results.
See AAHRPP Tip Sheet 1
REGULATORY AND GUIDANCE REFERENCES
• V A: VHA Handbook 1200.05, 9; VHA Handbook
1200.01
• DoD: Instruction 3216.02 2 (3) (b); SECNAVINST
3900.39D 6f
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: the IRB or EC evaluate whether the management
(a) Policies and procedures describe oversight of of information that is relevant to the protection of
participants is adequate.
research where the researcher is responsible for the (2) When following VA requirements:
overall conduct of the study (for example, serving as (a) Policies and procedures indicate that for a VA multi-
the lead researcher of a multi-site study) site study, not only the principal researcher, but also
(i) P olicies and procedures have applications include all local site researchers, must obtain written approv-
als from the relevant local VA facilities’ IRBs of record
information about the management of information and all other local committees, subcommittees, and
that is relevant to the protection of participants, such other approvals according to the respective applica-
as: ble local, VA and other federal requirements.
(A) Unanticipated problems involving risks to partici- (i) R esearch cannot be initiated at any given site until
the local researcher has obtained written notifica-
pants or others. tion that the research can be initiated from the local
(B) Interim results. associate chief of staff for research and development.
(C) Protocol modifications.
(ii) When the researcher is the lead researcher of
a multi-site study, policies and procedures have
Element II.2.I. 158
ELEMENT II.2.I.
REQUIRED WRITTEN MATERIALS
(ii) Policies and procedures include a definition of
collaborative research.
(iii) Policies and procedures indicate that collaboration
is encouraged when non-VA researchers have a
substantial role in the design, conduct, or analysis
of research.
(iv) Policies and procedures indicate that collaborative
research may not be undertaken without a signed
agreement that addresses the responsibilities of
each party, including ownership of data and re-
use of data for other research.
(3) When following DoD requirements:
(a) When conducting multi-site research, policies and
procedures indicate that a formal agreement be-
tween organizations is required to specify the roles
and responsibilities of each party.
OUTCOMES
• T here is communication among the IRBs of sites
participating in a multi-site study.
Element II.2.I. 159
STANDARD II-3
The IRB or EC approves each research protocol or plan according to criteria based on applicable
laws, regulations, codes, and guidance.
STANDARD II-3
STANDARD II-3 The IRB or EC approves each research protocol or plan according to criteria based
on applicable laws, regulations, codes, and guidance.
ELEMENT II.3.A. The IRB or EC has and follows written policies and procedures for identifying and analyzing
risks and identifying measures to minimize such risks. The analysis of risk includes a deter-
mination that the risks to participants are reasonable in relation to the potential benefits to
participants and to society.
COMMENTARY
Minimization of risks In all research, the IRB or EC should evaluate the impor-
A criterion for approval of research is that risks to partici- tance of the knowledge that is likely to result from the
pants are minimized by using procedures that are consis- research.
tent with sound research design and do not unnecessarily
expose participants to risk, and whenever appropriate, by Resources
using procedures already being performed on the par- The IRB or EC should evaluate each research study to en-
ticipants for diagnostic or treatment purposes. The IRB or sure that it has the resources necessary to protect research
EC should evaluate whether research submitted for review participants. Such resources include staffing and personnel,
satisfies this criterion. IRB or EC members should understand in terms of availability, number, expertise, and experience;
how to apply this criterion. They should recognize risks psychological, social, or medical services, including
whose probability or magnitude can be reduced by using counseling or social support services that may be required
procedures that are consistent with sound research design because of research participation; psychological, social, or
and that do not unnecessarily expose participants to risk. medical monitoring, ancillary care, equipment needed to
If the research context involves procedures already being protect participants, and resources for participant communi-
performed for diagnostic or treatment purposes, the IRB or cation, such as language translation services.
EC should recognize risks whose probability or magnitude
can be reduced by using those procedures. If the research An organization, such as an independent review board,
context does not involve such procedures, this strategy for that does not provide all necessary resources should eval-
minimizing risks is not applicable. uate the resources of the local site. This might be accom-
plished by a case-by-case review of resources at each
Risk-potential benefit analysis site. For example, an IRB can evaluate the adequacy of
Another criterion for approval of research is that risks to resources based on a description of facilities and personnel
participants are reasonable in relation to potential benefits, provided by the researcher. The precise resources required
if any, to participants, and the importance of the knowledge are protocol specific.
that may reasonably be expected to result. The IRB or EC
should evaluate whether research submitted for review See AAHRPP Tip Sheet 1
satisfies this criterion. The IRB or EC should be able to rec- See AAHRPP Tip Sheet 20
ognize the likelihood and magnitude of harms and benefits,
and understand the importance of the knowledge reason- Standard II-3 161
ably expected to result. The IRB or EC should be cognizant
of the range of harms, including physical, social, economic,
psychological, and legal harm. The IRB or EC should also
be cognizant of the range of benefits. Direct benefits to
participants can take the form of therapy, education, infor-
mation, resources, or empowerment.
STANDARD II-3
REGULATORY AND GUIDANCE REFERENCES • V A: 38 CFR 16.111(a)(1), 38 CFR 16.111(a)(2), VHA
Handbook 1200.05, 17, 22
• DHHS: 45 CFR 46.111(a)(1), 45 CFR 46.111(a)(2),
45 CFR 46.111(a)(6) • D oD: Instruction 3216.02 6.b
• FDA: 21 CFR 56.111(a)(1), 21 CFR 56.111(a)(2), 21 • I CH-GCP: 2.2, 2.3, 3.13,4.2.1, 4.2.2, 4.2.3
CFR 56.111(a)(6)
REQUIRED WRITTEN MATERIALS
(1) Essential requirements for IRB or EC review: (V) A vailability of medical or psychosocial resourc-
(a) Policies and procedures describe the process for es that participants may need as a consequence
of the research.
identifying and analyzing risks, and identifying mea-
sures to minimize risks. (2) When following DoD requirements:
(i) A pplications include information allowing the IRB or (a) The definition of the minimal risk based on the phrase
EC to conduct an analysis of the risks and potential “ordinarily encountered in daily life or during the
benefits, such as: performance of routine physical or physiological
(A) The purposes of the research. examinations or tests” must not be interpreted to
(B) The scientific or scholarly rationale. include the inherent risks certain categories of human
(C) The procedures to be performed. subjects face in their everyday life. For example, the
(D) A description of the procedures being per- risks imposed in research involving human subjects
focused on a special population should not be
formed already for diagnostic or treatment evaluated against the inherent risks encountered in
purposes. their work environment (e.g., emergency responder,
(E) The risks and potential benefits of the research to pilot, soldier in a combat zone) or having a medical
participants. condition (e.g., frequent medical tests or constant
(ii) In order to approve research, policies and proce- pain).
dures have the IRB or EC determine that:
(A) Risks to participants are minimized by using pro-
cedures that are consistent with sound research
design and that do not unnecessarily expose
participants to risk.
(B) R isks to participants are minimized, when ap-
propriate, by using procedures already being
performed on the participants for diagnostic or
treatment purposes.
(C) R isks to participants are reasonable in relation-
ship to the potential benefits, if any, to partic-
ipants, and the importance of the knowledge
that may be expected to result.
(D) R esearch studies have the resources necessary
to protect participants:
(I) Adequate time for the researchers to conduct
and complete the research.
(II) Adequate number of qualified staff.
(III) Adequate facilities.
(IV) A ccess to a population that will allow recruit-
ment of the necessary number of participants.
Standard II-3 162
STANDARD II-3
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
OUTCOMES
• I RB or EC members approve research according to
the criteria of approval pertaining to risks and potential
benefits.
• W hen considering risks, the IRB or EC considers physi-
cal, psychological, social, economic, and legal risks.
• When considering benefits, the IRB or EC considers
direct benefits, if any, to participants and the impor-
tance of the knowledge likely to result from the
research.
• Research studies have the resources necessary to
protect participants.
Standard II-3 163
ELEMENT II.3.B.
The IRB or EC has and follows written policies and procedures for reviewing the plans for data and
safety monitoring, when applicable, and determines that the data and safety monitoring plan
provides adequate protection for participants.
ELEMENT II.3.B.
ELEMENT II.3.B. The IRB or EC has and follows written policies and procedures for reviewing the plans for
data and safety monitoring, when applicable, and determines that the data and safety
monitoring plan provides adequate protection for participants.
COMMENTARY
A criterion for approval of research is that when appropri- IRB or EC members should understand the range of possi-
ate, the research protocol or plan makes adequate provi- ble options for monitoring and that monitoring might occur
sions for monitoring the data to ensure the safety of par- at specific points in time, after a specific number of partici-
ticipants. The IRB or EC should evaluate whether research pants have been enrolled, or upon recognition of harm. IRB
submitted for review satisfies this criterion. or EC members should understand that monitoring might
be conducted by the researcher, the sponsor (e.g., medical
For clinical research involving no more than minimal risk and monitor, safety monitoring committee), or by an indepen-
for most behavioral and social science research (because dent monitoring board.
most involves no more than minimal risk), provisions for data
and safety monitoring are not needed to protect partici- See AAHRPP Tip Sheet 1
pants. IRB or EC members should have criteria for determin- See AAHRPP Tip Sheet 6
ing when such monitoring is necessary. See AAHRPP Tip Sheet 20
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 46.111(a)(6) • D oD: Instruction 3216.02 8; SECNAVINST
3900.39D, para. 6c
• FDA: 21 CFR 56.111(a)(6)
• ICH-GCP: 5.1.6
• VA: 38 CFR 16.111(a)(6), VHA Handbook 1200.05,
10, 17, 22
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: (B) H ow the safety information will be collected
(a) Policies and procedures describe when the IRB or (e.g., with case report forms, at study visits, by
telephone calls with participants).
EC considers provisions for monitoring data to ensure
the safety of participants to be appropriate. (C) T he frequency of data collection, including
(i) W hen the IRB or EC considers provisions for moni- when safety data collection starts.
toring data to ensure the safety of participants to be (D) T he frequency or periodicity of review of cumu-
appropriate, policies and procedures have appli- lative safety data.
cations include descriptions of such provisions.
(ii) I n order to approve research in which the IRB or EC (E) The plan might include establishing a data mon-
considers provisions for monitoring data to ensure itoring committee and a plan for reporting data
the safety of participants to be appropriate, poli- monitoring committee findings to the IRB and the
cies and procedures have the IRB or EC determine sponsor.
that the research plan makes adequate provisions.
The IRB might consider provisions such as: (F) F or studies that do not have or are not required
(A) What safety information will be collected, to have a data monitoring committee and are
blinded, have multiple sites, enter vulnerable
including serious adverse events. populations, or employ high-risk interventions,
the IRB or EC needs to carefully review the
Element II.3.B. 165
ELEMENT II.3.B.
REQUIRED WRITTEN MATERIALS
data and safety monitoring plan and determine (v) T he IRB or HRPP official must communicate with
whether a data monitoring committee is needed. research monitors to confirm their duties, authorities,
(G) If not using a data monitoring committee, and and responsibilities.
if applicable, statistical tests for analyzing the
safety data to determine whether harm is occur- (vi) The duties of the research monitor are determined
ring. on the basis of specific risks or concerns about the
(H) Provisions for the oversight of safety data (e.g., research.
by a data monitoring committee).
(I) Conditions that trigger an immediate suspension (vii) M ay perform oversight functions (e.g., observe
of the research, if applicable. recruitment, enrollment procedures, and the
(2) When following DoD requirements: consent process, oversee study interventions and
(a) Policies and procedures have the IRB or EC consider interactions, review monitoring plans and unantic-
the appointment of a research monitor: ipated problems involving risks to participants or
(i) R equired for research involve greater than mini- others, oversee data matching, data collection,
mal risk, although the IRB or EC or organizational and analysis).
official can require this for a portion of the research
or studies involving no more than minimal risk, if (viii) May discuss the research protocol with research-
appropriate. ers, interview human subjects, and consult with
(ii) The research monitor is appointed by name and others outside of the study.
must be independent of the team conducting the
research. (ix) R eport observations and findings to the IRB or a
(iii) T here may be more than one research monitor designated official.
(e.g., if different skills or experience are needed).
(iv) The monitor may be an ombudsman or a member (b) The research monitor has the authority to:
of the data safety monitoring board. The IRB must (i) Stop a research study in progress.
approve a written summary of the monitors’ duties, (ii) Remove individuals from study.
authorities, and responsibilities. (iii) T ake any steps to protect the safety and well-being
of participants until the IRB or EC can assess.
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
OUTCOMES
• IRB or EC members articulate when provisions for data
and safety monitoring are required.
• IRB or EC members determine that research protocols
or plans include adequate provisions for monitoring the
data to provide for the safety of participants.
Element II.3.B. 166
ELEMENT II.3.C.
The IRB or EC has and follows written policies and procedures to evaluate the equitable
selection of participants.
ELEMENT II.3.C.
ELEMENT II.3.C. The IRB or EC has and follows written policies and procedures to evaluate the equitable
selection of participants.
COMMENTARY
A criterion for approval of research is that selection of par- provided to reimburse participants for their time, effort, or
ticipants is equitable. The IRB or EC should evaluate wheth- other expenses. Recruitment methods, advertisements, or
er research submitted for review satisfies this criterion. IRB or payment arrangements that are misleading, inaccurate,
EC members should understand how to apply this criterion. exculpatory, coercive, or unduly influential violate ethical
In evaluating this criterion, IRB or EC members should requirements for consent. Therefore, the IRB or EC should
consider both the selection (inclusion and exclusion) criteria review proposed recruitment processes and advertising
and the proposed plans for recruitment of participants. IRB materials to judge whether they fulfill the requirements for
mmbers should evaluate whether selection criteria and consent.
recruitment practices meet this criterion.
Payment arrangements can place participants at risk of
Recruitment methods, including advertisements, and partic- coercion or undue influence or cause inequitable selec-
ipant payment arrangements affect the equitable selection tion. Two situations should be examined: finder’s fees and
of participants and an appropriate consent process. recruitment bonuses. A finder’s fee or referral is a payment
from the researcher or sponsor to a person who refers a
A research study might have fair selection criteria, but use prospective participant. Recruitment bonuses are payments
recruitment methods or payment arrangements that lead from the sponsor to a researcher or organization based
to inequitable selection. For example, recruitment meth- on the rate or timing of recruitment. For example, a sponsor
ods, advertisements, or payment arrangements that target might contract to pay the researcher or organization a fixed
economically disadvantaged participants can lead to fee for each participant but promise an additional payment
unfair selection of participants despite reasonable selection if more than a certain number of participants are enrolled in
criteria. Therefore, the IRB or EC should evaluate whether the first week or if the site has the highest enrollment at the
recruitment processes, advertisements, and payment end of the month. Policies and procedures should describe
arrangements affect the equitable selection of participants. acceptable and unacceptable payment arrangements
among the sponsor, organization, researcher, and those
Recruitment methods, advertising materials, and payment referring research participants.
arrangements also represent a part of the consent process.
Recruitment methods and advertisements are the beginning See AAHRPP Tip Sheet 1
of the consent negotiations; payments for participation are See AAHRPP Tip Sheet 20
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 17.92, 45 CFR 46.111(a)(3), 45 CFR • VA: 38 CFR 16.111(a)(3), 38 CFR 16.116, 38 CFR
46.116, OHRP Guidance on Written Institutional 17.45, VHA Handbook 1200.05, 5, 58, 59
Review Board (IRB) Procedures
• D oD: Instruction 3216.02 11., Dual Compensation
• FDA: 21 CFR 56.111(a)(3), 21 CFR 50.20, 21 CFR Act, 24 U.S.C 301, DoD 3216.2, para. 4.4.4; SEC-
56.111(a)(3), FDA Information Sheets: Frequently NAVINST 3900.39D, para. 6a(6)
Asked Questions: Informed Consent Document Con-
tent, Frequently Asked Questions: IRB organization, A • DOJ: 28 CFR 512.11(4,5)
Guide to Informed Consent, Recruiting Study Subjects,
Payment to Research Subjects • ICH-GCP: 3.1.8
Element II.3.C. 168
ELEMENT II.3.C.
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: need to determine their eligibility and interest, such
(a) Policies and procedures describe the process to as:
(A) The name and address of the researcher or
evaluate the equitable selection of participants.
(i) A pplications include information that allows the IRB research facility.
(B) T he purpose of the research or the condition
or EC to determine whether selection of participants
will be equitable, such as: under study.
(A) The purposes of the research. (C) I n summary form, the criteria that will be used to
(B) T he setting in which the research will be con-
determine eligibility for the study.
ducted. (D) A brief list of benefits to participants, if any.
(C) W hether prospective participants will be vulner- (E) The time or other commitment required of the
able to coercion or undue influence. participants.
(D) The selection (inclusion/exclusion) criteria. (F) T he location of the research and the person or
(E) Participant recruitment and enrollment proce-
office to contact for further information.
dures. (vii) A pplications include the amount and schedule of
(F) T he amount and timing of payments to partici-
all payments.
pants. (viii) Policies and procedures have the IRB or EC
(ii) In order to approve research, policies and proce-
review payments to determine that:
dures have the IRB or EC determine that selection (A) The amount of payment and the proposed
of participants is equitable.
(iii) I n making an assessment about whether selection method and timing of disbursement neither is
of participants is equitable, policies and proce- coercive nor presents undue influence.
dures have the IRB or EC take into account: (B) C redit for payment accrues as the study pro-
(A) The purposes of the research. gresses and not be contingent upon the partici-
(B) T he setting in which the research will be pant completing the entire study.
(C) A ny amount paid as a bonus for completion is
conducted. reasonable and not so large as to unduly in-
(C) W hether prospective participants will be vulner- duce participants to stay in the study when they
would otherwise have withdrawn.
able to coercion or undue influence. (D) A ll information concerning payment, including
(D) The selection (inclusion/exclusion) criteria. the amount and schedule of payments, is set
(E) Participant recruitment and enrollment proce- forth in the consent document.
(ix) P olicies and procedures describe acceptable
dures. and unacceptable payment arrangements for
(F) The influence of payments to participants. the sponsor, organization, researcher, and those
(iv) Policies and procedures have the IRB or EC referring research participants.
(x) P olicies and procedures on payment arrangements
review: address the acceptability of payments in exchange
(A) The information contained in the advertisement. for referrals of prospective participants (“finder’s
(B) The mode of its communication. fees” or “referral fees”).
(C) The final copy of printed advertisements. (xi) P olicies and procedures on payment arrangements
(D) The final audio or video taped advertisements. address payments designed to accelerate recruit-
(v) P olicies and procedures have the IRB or EC review ment that are tied to the rate or timing of enrollment
(“bonus payments”).
advertising to ensure that advertisements do not: (2) When following FDA regulations:
(A) State or imply a certainty of favorable outcome (a) Policies and procedures have the IRB or EC review
advertising to ensure that advertisements do not:
or other benefits beyond what is outlined in the (i) M ake claims, either explicitly or implicitly, about the
consent document and the protocol. drug, biologic, or device under investigation that
(B) Include exculpatory language. are inconsistent with FDA labeling.
(C) E mphasize the payment or the amount to be (ii) Use terms, such as “new treatment,” “new medica-
paid, by such means as larger or bold type. tion,” or “new drug,” without explaining that the test
(D) P romise “free treatment” when the intent is only
to say participants will not be charged for taking
part in the investigation.
(vi) Policies and procedures have advertisements
limited to the information prospective participants
Element II.3.C. 169
ELEMENT II.3.C.
REQUIRED WRITTEN MATERIALS
article is investigational. (iv) When recruitment occurs in a group setting, the
(iii) A llow compensation for participation in a trial IRB shall appoint an ombudsman.
offered by a sponsor to include a coupon good (b) W hen research involves U.S. military personnel,
for a discount on the purchase price of the product policies and procedures require limitations on dual
once it has been approved for marketing. compensation:
(3) When following VA requirements:
(a) Policies and procedures have the IRB consider the (i) P rohibit an individual from receiving pay of com-
relevance of the research to the mission of VA and pensation for research during duty hours.
the Veteran population it serves.
(b) P olicies and procedures have the protocol and (ii) An individual may be compensated for research if
related materials justify the inclusion of non-Veterans. the participant is involved in the research when not
Non-veterans may be enrolled in VA-approved on duty.
research studies, including the provision of outpatient
or hospital care for research participants, only when (iii) F ederal employees while on duty and non-Federal
there are insufficient veterans available to complete persons may be compensated for blood draws for
the study or when the researcher can present a research up to $50 for each blood draw.
compelling argument to the IRB for the inclusion of
non-veterans (e.g., survey of VA employees; study of (iv) Non-Federal persons may be compensated for
active duty military; study involving veterans’ family research participating other than blood draws
members), and the research is relevant to the care of in a reasonable amount as approved by the IRB
veterans or active duty military personnel. according to local prevailing rates and the nature
(c) To improve veterans’ access to non-VA research, of the research.
advertisements for research not conducted at a VA
facility may be posted, provided facility director en- (5) When following DOJ requirements:
sures there is a formal process to review and approve (a) Policies and procedures indicate that for research
recruiting documents, flyers, and advertisements prior
to being posted or distributed. conducted within the Bureau of Prisons:
(i) A VA facility may not use Facebook as a method of (b) The selection of participants within any one organi-
advertising non-VA studies.
(4) When following DoD requirements: zation must be equitable.
(a) When research involves U.S. military personnel, pol- (c) I ncentives may not be offered to help persuade
icies and procedures include additional protections
for military research participants to minimize undue inmate participants to participate. However, soft
influence. Superiors of service members (e.g., unit drinks and snacks to be consumed at the test setting
officers, senior NCOs, and equivalent civilians): may be offered.
(i) A re not permitted to influence the decision of their (d) R easonable accommodations such as nominal mon-
subordinates. etary recompense for time and effort may be offered
(ii) May not be present at the time of recruitment. to non-confined research participants who are both:
(iii) H ave a separate opportunity to participate, when (i) No longer in Bureau of Prisons custody.
applicable. (ii) Participating in authorized research being
conducted by Bureau employees or contractors.
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
Element II.3.C. 170
ELEMENT II.3.C.
OUTCOMES
• IRB or EC members determine that selection of partici- • Provide prospective participants with sufficient
pants is equitable. opportunity to consider whether to participate.
• IRB or EC members determine that advertisements: • M inimize the possibility of coercion or undue
• P rovide prospective participants with sufficient influence of participants.
opportunity to consider whether to participate. • B ased on the timing or rate of participant enrollment
• Do not include any exculpatory language through (often known as bonus payments or finder’s fees),
are prohibited unless they are judged not to interfere
which the participant or the legally authorized repre- with providing prospective participants with sufficient
sentative is made to waive or appear to waive any of opportunity to consider whether to participate and
the participant’s legal rights, or releases or appears do not increase the possibility of coercion or undue
to release the researcher, the sponsor, or the institu- influence on researchers or participants.
tion, or its agents from liability for negligence.
• IRB or EC members determine that payment
arrangements:
Element II.3.C. 171
ELEMENT II.3.D.
The IRB or EC has and follows written policies and procedures to evaluate the proposed
arrangements for protecting the privacy interests of research participants, when appropriate,
during their involvement in the research.
ELEMENT II.3.D.
ELEMENT II.3.D. The IRB or EC has and follows written policies and procedures to evaluate the proposed
arrangements for protecting the privacy interests of research participants, when appropri-
ate, during their involvement in the research.
COMMENTARY
A criterion for approval of research is that there are ade- What is private depends on the individual and can vary
quate provisions to protect the privacy interests of partici- according to gender, ethnicity, age, socio-economic class,
pants. The IRB or EC should evaluate whether research education, ability level, social or verbal skill, health status,
submitted for review satisfies this criterion. IRB or EC legal status, nationality, intelligence, personality, and the
members should understand how to apply this criterion. individual’s relationship to the researcher. For example,
protecting the privacy interests of a young child might
Privacy refers to persons and their interest in controlling the mean having a parent present at a session with a
access of others to themselves. (Confidentiality refers to the researcher. Protecting the privacy interests of a teenager
agreement between the researcher and participant on how might mean having a parent absent.
data will be managed and used.) For example, based on
their privacy interests, people want to control: IRB members should understand the concept of privacy
The time and place where they give information. and how it differs from confidentiality. IRB or EC members
The nature of the information they give. should know strategies to protect privacy interests relating to
The nature of the experiences that are given to them. contact with prospective participants and access to private
Who receives and can use the information. information.
For example, persons might not want to be seen entering See AAHRPP Tip Sheet 1
a place that might stigmatize them, such as a pregnancy See AAHRPP Tip Sheet 5
counseling center that is clearly identified as such by signs See AAHRPP Tip Sheet 20
on the front of the building.
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 46.111(a)(7)
• FDA: 21 CFR 56.111(a)(7)
• VA: 38 CFR 16.111(a)(7), VHA Handbook 1200.05,
10, 12, 17
REQUIRED WRITTEN MATERIALS
(1) Essential requirements:
(a) Applications include a description of provisions to
protect the privacy interests of participants.
(b) I n order to approve research, policies and proce-
dures have the IRB or EC determine that the research
protocol or plan contains adequate provisions to
protect the privacy interests of participants.
Element II.3.D. 173
ELEMENT II.3.D.
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
OUTCOMES
• I RB or EC members understand the concept of privacy.
• IRB or EC members determine that the research proto-
col or plan contains adequate provisions to protect
the privacy interests of participants.
Element II.3.D. 174
ELEMENT II.3.E.
The IRB or EC has and follows written policies and procedures to evaluate proposed arrangements
for maintaining the confidentiality of identifiable data, when appropriate, preliminary to the
research, during the research, and after the conclusion of the research.
ELEMENT II.3.E.
ELEMENT II.3.E. The IRB or EC has and follows written policies and procedures to evaluate proposed
arrangements for maintaining the confidentiality of identifiable data, when appropriate,
preliminary to the research, during the research, and after the conclusion of the research.
COMMENTARY
A criterion for approval of research is that there are ade- The confidentiality protections include information obtained
quate provisions to maintain the confidentiality of identifi- preliminary to research; for example, information collected
able data. The IRB or EC should evaluate whether research from personal records to determine potential sample size,
submitted for review satisfies this criterion. IRB or EC mem- as well as the maintenance of the confidentiality of informa-
bers should understand how to apply this criterion. tion after the study has ended, when identifiable information
is maintained.
Confidentiality refers to maintenance of the researcher’s
agreement with the participant about how the participant’s See AAHRPP Tip Sheet 1
identifiable private information will be handled, managed, See AAHRPP Tip Sheet 4
and disseminated. IRB or EC members should understand See AAHRPP Tip Sheet 20
the concept of confidentiality and how it differs from priva-
cy. IRB or EC members should be knowledgeable about
strategies to maintain confidentiality of identifiable data, in-
cluding controls on storage, handling, and sharing of data.
When appropriate, the IRB or EC should also know how
certificates of confidentiality can be used to maintain the
confidentiality of identifiable data. When appropriate, the
IRB or EC should also be aware of other standard methods
to protect confidentiality, such as inter-file linkage, error
inoculation, top coding, bracketing, and data brokering.
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 46.111(a)(7) • D OJ: 28 CFR 22, 28 CFR 512.11,12,13,15
• FDA: 21 CFR 56.111(a)(7) • I CH-GCP: 2.11
• VA: 38 CFR 16.111(a)(7), VHA Handbook 1200.05, • NIH Policy for Issuing Certificates of Confidentiality
10, 12, 17, 38 (Effective October 1, 2017), and NIH Certificate of
• DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April Confidentiality FAQs
21, 2016), DOE Notice 443.1 (January 21, 2016),
and their accompanying Contractor Requirements
Documents (CRDs)
Element II.3.E. 176
ELEMENT II.3.E.
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: any such information, document, or biospecimen
(a) Applications include a description of provisions to that contains identifiable, sensitive information about
the individual and that was created or compiled
maintain the confidentiality of data. for purposes of the research, unless such disclosure
(i) I n order to approve research policies and pro- or use is made with the consent of the individual to
whom the information, document, or biospecimen
cedures have the IRB or EC determine that, when pertains; or
appropriate, the research protocol or plan contains (ii) May not disclose or provide to any other person
adequate provisions to maintain the confidentiality not connected with the research the name of such
of data. an individual or any information, document, or
(2) When following DHHS regulations: biospecimen that contains identifiable, sensitive
(a) W ritten materials specify that research is automatical- information about such an individual and that was
ly covered by a certificate of confidentiality whenev- created or compiled for purposes of the research.
er the study is funded in whole or in part by the NIH (iii) May disclose information only when:
and involves identifiable, sensitive information. (A) Required by Federal, State, or local laws (e.g.,
(b) Written materials define “identifiable sensitive infor-
mation.” as required by the Federal Food, Drug, and
(c) E xamples of research automatically covered by a Cosmetic Act, or state laws requiring the re-
certificate of confidentiality include: porting of communicable diseases to State and
(i) B iomedical, behavioral, clinical or other research, local health departments), excluding instances
including exempt research, except where the of disclosure in any Federal, State, or local civil,
information obtained is recorded in such a manner criminal, administrative, legislative, or other
that human participants cannot be identified or the proceeding.
identity of the human subjects cannot readily be (B) N ecessary for the medical treatment of the
ascertained, directly or through identifiers linked to individual to whom the information, document,
the subjects. or biospecimen pertains and made with the
(ii) The collection or use of biospecimens that are consent of such individual;
identifiable to an individual or for which there is (C) M ade with the consent of the individual to
at least a very small risk that some combination of whom the information, document, or biospeci-
the biospecimen, a request for the biospecimen, men pertains; or
and other available data sources could be used to (D) M ade for the purposes of other scientific
deduce the identity of an individual. research that is in compliance with applicable
(iii) The generation of individual level, human genomic Federal regulations governing the protection of
data from biospecimens, or the use of such data, human subjects in research.
regardless of whether the data is recorded in such (f) W ritten materials require that when research is cov-
a manner that human subjects can be identified or ered by a certificate of confidentiality, researchers
the identity of the human subjects can readily be must inform participants (for example, in the consent
ascertained. document) of the protections and limitations of certifi-
(iv) Any other research that involves information about cates of confidentiality.
an individual for which there is at least a very small (i) F or studies that were previously issued a Certificate,
risk, as determined by current scientific practices and notified participants of the protections provided
or statistical methods, that some combination of by that Certificate, NIH does not expect partici-
the information, a request for the information, and pants to be notified that the protections afforded
other available data sources could be used to by the Certificate have changed, although IRBs
deduce the identity of an individual. may determine whether it is appropriate to inform
(d) Researchers may also apply for a certificate of confi- participants.
dentiality for non-federally funded research. (ii) If part of the study cohort was recruited prior to
(e) W ritten materials specify that when research is cov- issuance of the Certificate, but are no longer
ered by a certificate of confidentiality, researchers: activity participating in the study, NIH does not
(i) M ay not disclose or provide, in any Federal, State, expect participants consented prior to the change
or local civil, criminal, administrative, legislative, or in authority, or prior to the issuance of a Certificate,
other proceeding, the name of such individual or
Element II.3.E. 177
ELEMENT II.3.E.
REQUIRED WRITTEN MATERIALS
to be notified that the protections afforded by the individual cannot be admitted as evidence or used
Certificate have changed, or that participants who for any purpose in any action, suit, or other judicial,
were previously consented to be re-contacted to administrative, or legislative proceeding without the
be informed of the Certificate, although IRBs may written consent of the individual to whom the data
determine whether it is appropriate to inform partic- pertain.
ipants. (c) Except for computerized data records maintained
(g) Written materials require that researchers conducting at an official U.S. Department of Justice site, records
NIH-supported research covered by a certificate of that contain non-disclosable information directly
confidentiality must ensure that if identifiable, sensitive traceable to a specific person may not be stored in,
information is provided to other researchers or orga- or introduced into, an electronic retrieval system.
nizations, regardless of whether or not the research (d) If the researcher is conducting a study of special
is federally funded, the other researcher or organiza- interest to the Office of Research and Evaluation
tion must comply with applicable requirements when (ORE) but the study is not a joint project involving
research is covered by a certificate of confidentiality. ORE, the researcher may be asked to provide ORE
(3) When following DOE requirements: with the computerized research data, not identifiable
(a) Written materials require the IRB or EC to review to individual participants, accompanied by detailed
and ensure that research protocols submitted to the documentation. These arrangements must be nego-
IRB for review comply with the DOE requirements for tiated prior to the beginning of the data collection
protecting personally identifiable information (PII). phase of the project.
(4) When following DOJ requirements: (5) W hen following VA requirements where
(a) Written materials indicate that for National Institute of research involves a certificate of confidentiality:
Justice (NIJ)-funded research: (a) For studies that do not involve a medical intervention,
(i) A ll projects are required to have a privacy certifi- no annotation may be made in the medical record.
cate approved by the NIJ human subjects protec- (b) For studies involving a medical intervention, a prog-
tion officer. ress note in the medical record should be made, indi-
(ii) All researchers and research staff are required to cating the individual has been enrolled in a research
sign employee confidentiality statements, which are study, any details that would impact clinical care, and
maintained by the responsible researcher. the name and contact information of the researcher
(b) Written materials indicate that for research conduct- conducting the study.
ed with the Bureau of Prisons:
(i) A non-employee of the Bureau may receive records
in a form not individually identifiable when advance
adequate written assurance that the record will be
used solely as a statistical research or reporting
record is provided to the agency.
(ii) Except as noted in the consent statement to the
participant, the researcher must not provide
research information that identifies a participant to
any person without that participant’s prior written
consent to release the information. For example,
research information identifiable to a particular
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
Element II.3.E. 178
ELEMENT II.3.E.
OUTCOMES
• IRB or EC members understand the concept of
confidentiality.
• IRB or EC members determine that, when appropriate,
the research protocol or plan contains adequate provi-
sions to maintain the confidentiality of identifiable data
in accordance with agreements between researchers
and participants.
Element II.3.E. 179
ELEMENT II.3.F.
The IRB or EC has and follows written policies and procedures to evaluate the consent process
and to require that the researcher appropriately document the consent process.
ELEMENT II.3.F.
ELEMENT II.3.F. The IRB or EC has and follows written policies and procedures to evaluate the consent
process and to require that the researcher appropriately document the consent process.
COMMENTARY
To approve research, the IRB or EC has to determine that not simply a consent document. Instead, the IRB or EC
the consent process meets these criteria for approval of should know the nature and circumstances of the consent
research: process, such as who will conduct the consent interview,
the timing of obtaining consent, and any waiting period be-
The researcher obtains the legally effective consent of tween informing the participant and obtaining consent, and
based on this information determine whether the criteria for
the participant or the participant’s legally authorized approval of research are met.
representative.
The consent process provides sufficient opportunity for Another criterion for approval of research is that research-
the participant or the participant’s legally authorized ers inform prospective participants of required disclosures.
representative to consider whether to participate. The IRB or EC should evaluate whether research submitted
The consent process minimizes the possibility of coer- for review satisfies this criterion. This cannot be accom-
cion or undue influence. plished solely by evaluation of a written consent document,
The consent discussion is in language understandable because the consent document does not reflect all the
to the participant or the representative. information communicated to the participant during the
The consent discussion is free of exculpatory language consent process. Therefore, the IRB or EC should evaluate
through which the participant or the legally authorized the information that will be communicated to the participant
representative is made to waive or appear to waive during the consent process, and determine which informa-
any of the participant’s legal rights. tion will be disclosed.
Documentation of consent contains all applicable
basic and additional elements of disclosure (See Table When reviewing research, the IRB or EC should evaluate
II.3.F.), and meets requirements in law and regulation, whether the consent process will be documented using a
either with a long-form consent document, or a short- consent document.
form consent document, or a broad consent document.
The IRB or EC should evaluate whether a research study See AAHRPP Tip Sheet 1
satisfies these criteria. This cannot be accomplished solely See AAHRPP Tip Sheet 11
by evaluating a written consent document, since the consent See AAHRPP Tip Sheet 19
process is an ongoing discussion that should be culturally See AAHRPP Tip Sheet 20
and linguistically appropriate to the study population, and
REGULATORY AND GUIDANCE REFERENCES CFR 50.25(b), 21 CFR 50.27(a), 21 CFR 50.27(b), 21
CFR 56.111(a)(5), FDA Information Sheets: A Guide
• DHHS: 45 CFR 46.109(b), 45 CFR 46.109(e), 45 to Informed Consent, Frequently Asked Questions:
CFR 46.111(a)(4), 45 CFR 46.116, 45 CFR 46.117, Informed Consent Document Content, Recruiting Study
OHRP Guidance on Exculpatory Language in In- Subjects, IRB Procedures, FDA Information Sheets:
formed Consent, OHRP Guidance on Obtaining and Frequently Asked Questions: Informed Consent Pro-
Documenting Informed Consent of Subjects Who Do cess, Data Retention When Subjects Withdraw from
Not Speak English FDA-Regulated Clinical Trials
• FDA: 21 CFR 50.20, 21 CFR 56.109(b), 21 CFR Element II.3.F. 181
56.109(f), 21 CFR 56.111(a)(4), 21 CFR 50.25(a), 21
ELEMENT II.3.F.
REGULATORY AND GUIDANCE REFERENCES
• VA: 38 CFR 46.111(a)(4), 38 CFR 16.116, 38 CFR • ICH-GCP: 2.9, 3.1.5, 3.1.9, 4.3.4, 4.8.1-4.8.9, 4.8.11
16.117, VHA Handbook 1200.05, 9, 30, 31, 32,
33, 55, VHA Handbook 1200.12, VHA Handbook • DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April
1907.01 21, 2016), DOE Notice 443.1 (January 21, 2016),
and their accompanying Contractor Requirements
• DOD: Instruction 3216.2, para. 5.3.4; SECNAVINST Documents (CRDs)
3900.39D, para. 6a(5)
• DOJ: 28 CFR 512.16
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: participant or the representative.
(a) Policies and procedures describe the evaluation of (E) The information being communicated to the par-
the consent process: ticipant or the representative during the consent
(i) A pplications include a description of the consent process will not include exculpatory language
through which the participant or the legally
process including: authorized representative is made to waive or
(A) The person who will conduct the consent inter- appear to waive any of the participant’s legal
rights.
view. (iii) I n order to approve research, policies and proce-
(B) T he person who will provide consent or permis- dures have the IRB or EC determine that in seeking
consent, the required disclosures (See Table II.3.F.)
sion. will be provided to each participant or a legally
(C) A ny waiting period between informing the pro- authorized representative in accordance with legal
and regulatory requirements. (See Tip Sheet 1:
spective participant and obtaining consent. Criteria for Approval)
(D) S teps taken to minimize the possibility of coer- (iv) Policies and procedures have the IRB or EC con-
sider whether additional disclosures (See Table
cion or undue influence. II.3.F.) are required for inclusion in the consent
(E) The language used by those obtaining consent. process.
(F) T he language understood by the prospective (v) P olicies and procedures have the IRB or EC deter-
mine that the consent process will be documented
participant or the legally authorized representa- according to legal and regulatory requirements,
tive. or equivalent protections.
(G) The information to be communicated to the pro- (2) When following DHHS regulations:
spective participant or the legally authorized (a) Written materials have the IRB or EC determine:
representative. (i) T he required and appropriate additional elements
(ii) In order to approve research, policies and proce- of disclosure are included in the consent process.
dures have the IRB or EC determine: (ii) To allow use of the long form of consent documen-
(A) The researcher will obtain the legally effective tation, policies and procedures have the IRB or EC
consent of the participant or the participant’s determine that:
legally authorized representative. (A) The consent document embodies the basic and
(B) T he circumstances of the consent process pro- required additional elements of disclosure.
vide the prospective participant or the legally (B) T he participant or the participant’s legally
authorized representative sufficient opportunity authorized representative will sign the consent
to consider whether to participate. document.
(C) T he circumstances of the consent process
minimize the possibility of coercion or undue Element II.3.F. 182
influence.
(D) T he individuals communicating information to the
participant or the legally authorized representa-
tive during the consent process will provide that
information in language understandable to the
ELEMENT II.3.F.
REQUIRED WRITTEN MATERIALS
(C) A copy of the consent document will be given to (iv) The participant or the participant’s legally autho-
the person signing the consent document. rized representative will sign and date the consent
document.
(D) T he researcher will give either the participant or
the representative adequate opportunity to read (v) T he researcher will give either the participant or
the consent document before it is signed. the legally authorized representative adequate
opportunity to read the consent document before it
(b) T o allow the use of the short form of consent docu- is signed.
mentation, policies and procedures have the IRB or
EC determine that: (c) S hort-form Consent When Following FDA Regula-
tions
(i) T he consent document states that the elements of
disclosure required by regulations have been pre- (i) T o allow the use of the short form of consent docu-
sented orally to the participant or the participant’s mentation when following FDA regulations, policies
legally authorized representative. and procedures have the IRB or EC determine that:
(ii) A written summary embodies the basic and re- (A) The consent document states that the elements
quired additional elements of disclosure. of disclosure (See Table II.3.F.1.) required by
regulations have been presented orally to the
(iii) There will be a witness to the oral presentation. participant or the participant’s legally autho-
(iv) For participants who do not speak English, the rized representative.
witness is conversant in both English and the lan- (I) A written summary embodies the basic and
guage of the participant. appropriate additional elements of disclosure.
(v) T he participant or the participant’s legally autho-
rized representative will sign the consent document. (II) There will be a witness to the oral presenta-
(vi) The witness will sign both the short form and a tion.
copy of the summary.
(vii) T he person actually obtaining consent will sign a (III) For participants who do not speak English, the
copy of the summary. witness is conversant in both English and the
(viii) A copy of the signed short form will be given to language of the participant.
the participant or the legally authorized represen-
tative. (IV) T he participant or the participant’s legally
(ix) A copy of the signed summary will be given to authorized representative will sign the consent
the participant or the legally authorized represen- document.
tative.
(3) When following FDA regulations: (V) T he witness will sign both the short form and a
(a) Policies and procedures have the IRB or EC deter- copy of the summary.
mine that the required and appropriate additional
elements of disclosure are included in the consent (VI) T he person actually obtaining consent will
process. sign a copy of the summary.
(b) Policies and procedures have the IRB or EC deter-
mine that: (VII) A copy of the signed short form will be given
(i) T he consent document embodies the basic and to the participant or the legally authorized
required additional elements of disclosure. representative.
(ii) There is a statement noting the possibility that the
FDA may inspect the records that will be provided (VIII) A copy of the signed summary will be given
to each participant. to the participant or the legally authorized
(iii) T here is a statement that a description of the representative.
clinical trial will be available on http://www.clini-
caltrials.gov as required by U.S. law. The website (d) With regard to data retention when participants with-
will not include information that can identify the draw from a clinical trial, policies and procedures
participant. At most the website will include a have the IRB or EC:
summary of the results. The participant can reach
the website at any time. (i) W hen a participant withdraws from a study, the
data collected on the participant to the point of
withdrawal remains part of the study database and
may not be removed. The consent document can-
not give the participant the option of having data
removed.
(ii) A researcher may ask a participant who is with-
drawing whether the participant wishes to provide
continued follow-up and further data collection
Element II.3.F. 183
ELEMENT II.3.F.
REQUIRED WRITTEN MATERIALS
subsequent to their withdrawal from the interven- (5) When following DoD requirements:
tional portion of the study. Under this circumstance, (a) Policies and procedures have the IRB or EC deter-
the discussion with the participant distinguishes
between study-related interventions and continued mine that the disclosure for research-related injury
follow-up of associated clinical outcome informa- follow the requirements of the DoD component.
tion, such as medical course or laboratory results (b) C onsent documents must include additional DoD ele-
obtained through non-invasive chart review, and ments of disclosure. (See Table II.3.F.)
address the maintenance of privacy and confiden- (6) When following DOE requirements:
tiality of the participant's information. (a) When the research is classified, the IRB must de-
(iii) T he researcher must obtain the participant’s termine if participants need access to classified
consent for this limited participation in the study information to make a valid consent decision.
(assuming such a situation was not described in the (b) Consent documents must include additional DOE
original consent document). The IRB or EC must elements of disclosure. (See Table II.3.F.1.)
approve the consent document. (7) When following DOJ requirements:
(iv) If a participant withdraws from the interventional (a) Policies and procedures indicate that for National
portion of a study and does not consent to con- Institute of Justice-funded research:
tinued follow-up of associated clinical outcome (i) U nder a privacy certificate, researchers and re-
information, the researcher must not access for pur-
poses related to the study the participant's medical search staff do not have to report child abuse unless
record or other confidential records requiring the participant signs another consent document to
the participant's consent. However, a researcher allow child abuse reporting.
may review study data related to the participant (b) C onsent documents must include additional DOJ
collected prior to the participant's withdrawal from elements of disclosure. (See Table II.3.F.)
the study, and may consult public records, such as (8) When following the ICH-GCP (E6) guideline:
those establishing survival status. (a) Consent documents must include additional ICH-
(4) When following VA requirements: GCP (E6) elements of disclosure. (See Table II.3.F.)
(a) The consent document must include all required (b) P olicies and procedures on documentation of the
disclosures, but does not need to use a specific tem- consent process include:
plate. (i) P rior to a participant’s participation in the trial, the
(b) T he consent document must be signed and dated by written consent document should be signed and
the participant or legally authorized representative, personally dated by the participant or by the partic-
and by the person obtaining consent. The IRB may ipant's legally acceptable representative.
waive the requirement for the signature of the person (ii) Prior to a participant’s participation in the trial, the
obtaining consent when there is no physical contact written consent document should be signed and
with the participant (e.g., where the only contact with personally dated by the person who conducted the
the participant is through telephone or mail). informed consent discussion.
(c) T he consent document must indicate the date of IRB (iii) I f a participant is unable to read or if a legally
approval, but the date does not need to appear on acceptable representative is unable to read, an
each page of the consent document. impartial witness should be present during the
(d) Consent may be obtained and documented elec- entire informed consent discussion.
tronically so long as there are appropriate authen- (A) After the written consent document and any oth-
tication controls to provide assurance the consent
is rendered by the appropriate individual, and the er written information to be provided to partici-
participant dates the consent, or software provides pants is read and explained to the participant or
the current date when signed. the participant’s legally acceptable representa-
(e) C onsent to take a photograph, video, or audio tive, and after the participant or the participant’s
recording for research cannot be waived by the IRB. legally acceptable representative has orally
(f) C onsent documents must include additional VA ele- consented to the participant’s participation in
ments of disclosure. (See Table II.3.F.) the trial and, if capable of doing so, has signed
and personally dated the consent document,
the witness should sign and personally date the
consent document.
Element II.3.F. 184
ELEMENT II.3.F.
REQUIRED WRITTEN MATERIALS
(B) B y signing the consent document, the witness at- Short-form Consent
tests that the information in the consent document • To allow the use of the short form of consent documen-
and any other written information was accu-
rately explained to, and apparently understood tation, policies and procedures have the IRB or EC
by, the participant or the participant's legally determine that:
acceptable representative, and that consent was • T he consent document states that the basic and
freely given by the participant or the partici-
pant’s legally acceptable representative. appropriate additional elements of disclosure (See
Table II.3.F.1.) have been presented orally to the
(C) P rior to participation in the trial, the participant participant or the participant’s legally authorized
or the participant's legally acceptable represen- representative, including required disclosures when
tative should receive a copy of the signed and the research involves private identifiable information
dated written consent document and any other or identifiable biospecimens. (See Tip Sheet 1: Crite-
written information provided to the participants. ria for Approval)
• A written summary embodies the basic and appro-
When following the revised Common Rule when it priate additional elements of disclosure. (See Table
goes into effect: II.3.F.)
• Written materials have the IRB or EC determine: • There will be a witness to the oral presentation.
• T he required and appropriate additional elements of • For participants who do not speak English, the wit-
ness is conversant in both English and the language
disclosure are included in the consent process. of the participant.
• The consent document begins with a concise and • The participant or the participant’s legally authorized
representative will sign the consent document.
focused presentation of key information that is most • The witness will sign both the short form and a copy
likely to assist a prospective participant or legally au- of the summary.
thorized representative in understanding the reasons • The person actually obtaining consent will sign a
why one might or might not want to participate in the copy of the summary.
research. • A copy of the signed short form will be given to the
• Written materials define for researchers what the participant or the legally authorized representative.
• A copy of the signed summary will be given to the
organization considers “key information”. participant or the legally authorized representative.
• W ritten materials specify what the organization Broad consent
• To allow use of broad consent, policies and procedures
considers a “concise” presentation of key informa- have the IRB or EC determine that:
tion. • The study is limited to the storage, maintenance,
• T he consent process and documentation as a whole and secondary research use of identifiable private
presents information in sufficient detail, and facilitates information and identifiable biospecimens (collected
the prospective participant’s or legally authorized for either research studies other than the proposed
representative’s understanding. research, or non-research purposes).
Long form of consent documentation • The study has undergone limited IRB review and
• To allow use of the long form of consent documen- meets requirements for exempt Category 7 or
tation, policies and procedures have the IRB or EC Category 8. (See Elements II.2.A. and II.2.C.)
determine that: • Researchers must provide all required disclosures for
• T he consent document embodies the basic and ap- broad consent to each participant or participant’s
propriate additional elements of disclosure, including legally authorized representative. (See Table II.3.F.1.)
required disclosures when the research involves • If there is a change made for research purposes in
private identifiable information or identifiable biospe- the way the identifiable private information or identi-
cimens. (See Tip Sheet 1: Criteria for Approval) fiable biospecimens are stored or maintained, there
• The participant or the participant’s legally authorized are adequate provisions to protect the privacy of
representative will sign the consent document. subjects and to maintain the confidentiality of data.
• A copy of the consent document will be given to the
person signing the consent document.
• The researcher will give either the participant or the
representative adequate opportunity to read the
consent document before it is signed.
Element II.3.F. 185
ELEMENT II.3.F.
REQUIRED WRITTEN MATERIALS
Posting of clinical trial consent form
• W ritten materials must describe the process for posting
one IRB-approved consent form for each clinical trial
conducted or supported by a Federal department
or agency on a website specified by the US Federal
government.
• W ritten materials specify the person or role responsible
for posting the consent form.
• The consent form must be posted on the website after
the clinical trial is closed to recruitment, but no later than
60 days after the last study visit by any participant, as
required by the protocol.
• Written materials must describe the process to request
from the Federal funding agency an exception to the
requirement to post the consent document, and the
process to redact confidential commercial information
from the consent form.
COMMON TYPES OF MATERIALS THAT MAY BE USED TO MEET THE ELEMENT
• Application form
• Reviewer checklist
• Consent template
OUTCOMES
• U nless waived, IRB or EC members determine that the
consent process will seek the legally effective consent
of participants or their legally authorized representa-
tives.
• IRB or EC members determine that the required and
additional elements of disclosure, when appropriate,
are included in the consent process.
• IRB or EC members determine that the consent process
will be documented as required.
Element II.3.F. 186
TABLE II.3.F.1.
Elements of Consent Disclosure
TABLE II.3.F.1. ELEMENTS OF CONSENT DISCLOSURE
BASIC ELEMENTS OF CONSENT DISCLOSURE FOR LONG FORM AND SHORT FORM CONSENT DOCS
• A statement that the study involves research. • An explanation of whom to contact for answers to perti-
• An explanation of the purposes of the research. nent questions about the research.
• A n explanation of the expected duration of the partici-
• An explanation of whom to contact for answers to perti-
pant’s participation. nent questions about the research participants’ rights.
• A description of the procedures to be followed.
• I dentification of any procedures that are experimental. • A n explanation of whom to contact in the event of a
research-related injury to the participant. (May not be
(May be omitted if there are none.) omitted just because the research involves no more
• A description of any reasonably foreseeable risks or than minimal risk.)
discomforts to the participant. (May be omitted if there • Contact information for the research team for questions,
are none.) concerns, or complaints. (Element III.1.G.)
• A description of any benefits to the participant or to
others, which may reasonably be expected from the • Contact information for someone independent of the
research. (May be omitted if there are none.) research team for problems, concerns, questions, informa-
• A disclosure of appropriate alternative procedures or tion, or input. (Element I.4.A.)
courses of treatment, if any, that might be advantageous
to the participant. (May be omitted if there are none.) • A statement that participation is voluntary.
• A statement describing the extent, if any, to which • A statement that refusal to participate will involve no pen-
confidentiality of records identifying the participant will
be maintained. (May be omitted if confidentiality will alty or loss of benefits to which the participant is otherwise
not be maintained.) entitled.
• A n explanation as to whether compensation is available • I f research involves the collection of identifiable informa-
if injury occurs. (May be omitted if the research involves tion or identifiable biospecimens, an explanation of
no more than minimal risk.) potential future use. (May be omitted if the research
• I f compensation is available when injury occurs, an ex- does not involve collection of identifiable information or
planation as to what it consists of or where further infor- identifiable biospecimens):
mation may be obtained. (May be omitted if the research o A statement that identifiers might be removed from the
involves no more than minimal risk.)
• A n explanation as to whether any medical treatments are identifiable private information or identifiable biospe-
available if injury occurs. (May be omitted if the research cimens and that, after such removal, the information or
involves no more than minimal risk.) biospecimens could be used for future research studies
• I f medical treatments are available when injury occurs, or distributed to another researcher for future research
an explanation as to what it consists of or where further studies without additional informed consent from the
information may be obtained. (May be omitted if the participant or legally authorized representative, if this
research involves no more than minimal risk.) might be possible; or
o A statement that the participant’s information or
specimens collected as part of the research, even
if identifiers are removed, will not be used or
distributed for future research studies.
ADDITIONAL ELEMENTS OF DISCLOSURE • A statement that significant new findings developed
during the course of the research which may relate to the
• A statement that the particular treatment or procedure may participant’s willingness to continue participation will be
involve risks to the participant, which are currently unfore- provided to the participant.
seeable.
• The approximate number of participants involved in the
• A statement that if the participant is or becomes pregnant, study.
the particular treatment or procedure may involve risks to
the embryo or fetus, which are currently unforeseeable. • A statement that the participant’s biospecimens (even
if identifiers are removed) may be used for commercial
• Anticipated circumstances under which the participant’s profit and whether the participant will or will not share in
participation may be terminated by the investigator with- this commercial profit.
out regard to the participant’s consent.
• Any additional costs to the participant that may result from
participation in the research.
Table II.3.F.1. 188
TABLE II.3.F.1. ELEMENTS OF CONSENT DISCLOSURE
ADDITIONAL ELEMENTS OF DISCLOSURE (continued)
• The amount and schedule of all payments. • A statement regarding whether clinically relevant research
• T he consequences of a participant’s decision to withdraw results, including individual research results, will be dis-
closed to the participant, and if so, under what conditions.
from the research.
• P rocedures for orderly termination of participation by the • For research involving biospecimens, a statement specify-
ing whether the research will (if known) or might include
participant. whole genome sequencing.
ADDITIONAL REQUIREMENTS FOR FDA-REGULATED RESEARCH
• A statement that the results of the research will be posted • A statement that notes the possibility that the Food and
on clinicaltrials.gov. Drug Administration may inspect the records.
ADDITIONAL REQUIREMENTS WHEN FOLLOWING THE ICH-GCP (E6) GUIDELINE
• The approval or favorable opinion by the IRB. • A statement that the monitors, the auditors, the IRB, and
• The probability for random assignment to each treatment. the regulatory authorities will be granted direct access to
• The participant's responsibilities. the participant's original medical records for verification
• W hen applicable, the reasonably foreseeable risks or of clinical trial procedures and data, without violating the
confidentiality of the participant, to the extent permitted by
inconveniences to an embryo, fetus, or nursing infant. the applicable laws and regulations and that, by signing
• T he important potential benefits and risks of the alternative a written informed consent form, the participant or the
participant's legally authorized representative is authoriz-
procedures or courses of treatment that may be available ing such access.
to the participant.
• W hen there is no intended clinical benefit to the partici- • If the results of the trial are published, the participant’s
pant, the participant should be made aware of this. identity will remain confidential.
ADDITIONAL REQUIREMENTS FOR DOD RESEARCH
• A statement that the DoD or a DoD organization is • A statement that representatives of the DoD are
funding the study. authorized to review research records
ADDITIONAL REQUIREMENTS FOR DOE RESEARCH
• The identity of the sponsoring agency, unless the sponsor • When research is classified, consent documents must
requests that it not be done, because doing so could state the project is classified, and what it means for the
compromise intelligence sources or methods; the research purposes of the research project
involves no more than minimal risk to participants; and
the IRB determines that by not disclosing the identity, the When research is sponsored by the Bureau of Prisoners,
investigators will not adversely affect the participants. consent documents must disclose:
• The identity of the researchers.
ADDITIONAL REQUIREMENTS FOR DOJ RESEARCH • Anticipated uses of the results of the research.
When research is funded by the National Institutes of
Justice, the consent document must disclose:
• The name(s) of the funding agency(ies).
Table II.3.F.1. 189
TABLE II.3.F.1. ELEMENTS OF CONSENT DISCLOSURE
ADDITIONAL REQUIREMENTS FOR DOJ RESEARCH (continued)
• T he extent to which confidentiality of records identifying • A statement that participation is completely voluntary
the subject will be maintained. For studies sponsored by and that the participant may withdraw consent and end
NIJ the subject should be informed that private, identifi- participation in the project at any time without penalty or
able information will be kept confidential and will only prejudice (the inmate will be returned to regular assign-
be used for research and statistical purposes. If, due to ment or activity by staff as soon as practicable).
sample size or some unique feature, the identity of the
individual cannot be maintained, the participants need to • A statement regarding the confidentiality of the research
be explicitly notified. If the researcher intends to disclose information and exceptions to any guarantees of confi-
any information, the participant needs to be explicitly dentiality required by federal or state law. For example,
informed what information would be disclosed, under a researcher may not guarantee confidentiality when the
what circumstances, and to whom. The participant must participant indicates intent to commit future criminal
be informed of any risks that might result from this disclo- conduct or harm himself or herself or someone else, or,
sure and must explicitly provide written consent prior to if the participant is an inmate, indicates intent to leave
participating in the research. the facility without authorization.
• A statement that participation in the research project will
have no effect on the inmate participant's release date
or parole eligibility.
ADDITIONAL REQUIREMENTS FOR VA RESEARCH • A statement that informs VA research subjects that they
or their insurance will not be charged for any costs
• A statement that in the event of a research-related injury related to the research.
the VA has to provide necessary medical treatment to a
participant injured by participation. • A statement that a veteran-participant will not be required
to pay for care received as a participant in a VA research
• Any payments the participant is to receive for participating project except in accordance with federal law and that
in the study. certain veterans were required to pay co-payments for
medical care and services provided by VA.
• A ny real or apparent conflict of interest by the researchers
where the research will be performed. • Consent for research must describe any photographs,
video, or audio recordings obtained for research
• A statement that VA will provide treatment for research purposes; how they will be used, and whether they will
related injury in accordance with applicable federal be disclosed outside the VA.
regulations.
BROAD CONSENT FOR THE STORAGE, MAINTENANCE, AND SECONDARY USE OF IDENTIFIABLE
PRIVATE INFORMATION AND IDENTIFIABLE BIOSPECIMENS
When following DHHS regulations, written materials should include the following requirements for broad consent when
the revised Common Rule goes into effect.
• A statement that the study involves research. • The types of organizations or researchers that might
• A description of any reasonably foreseeable risks or conduct research with the identifiable private information
or identifiable biospecimens.
discomforts to the participant. (May be omitted if there
are none.) • The period of time that the identifiable private information
• A description of any benefits to the participant or to or identifiable biospecimens may be stored and
others which may reasonably be expected from the maintained (which period of time could be indefinite).
research. (May be omitted if there are none.)
• The time that the identifiable private information or
identifiable biospecimens may be used for research
purposes (which period could be indefinite).
Table II.3.F.1. 190
TABLE II.3.F.1. ELEMENTS OF CONSENT DISCLOSURE
BROAD CONSENT FOR THE STORAGE, MAINTENANCE, AND SECONDARY USE OF IDENTIFIABLE
PRIVATE INFORMATION AND IDENTIFIABLE BIOSPECIMENS (continued)
• A statement describing the extent, if any, to which con- • Unless the participant or legally authorized representative
fidentiality of records identifying the participant will be will be provided details about the specific research
maintained. (May be omitted if confidentiality will not be studies, a statement that they will not be informed of the
maintained.) details of any specific research studies that might be
conducted using the participant’s identifiable private
• A statement that participation is voluntary. information or identifiable biospecimens, including the
• A statement that refusal to participate will involve no pen- purposes of the research, and that they might not have
chosen to consent to some of those specific research
alty or loss of benefits to which the participant is otherwise studies.
entitled.
• A statement that the participant may discontinue partic- • Unless it is known that clinically relevant research results,
ipation at any time without penalty or loss of benefits to including individual research results, will be disclosed to
which the participant is otherwise entitled. the participant in all circumstances, a statement that such
• A statement that the participant’s biospecimens (even results might not be disclosed to the participant.
if identifiers are removed) may be used for commercial
profit and whether the participant will or will not share in • For research involving biospecimens, a statement
this commercial profit. specifying whether the research will (if known) or might
• I nformation about future use of private identifiable infor- include whole genome sequencing.
mation or identifiable biospecimens:
o A statement that identifiers might be removed from • An explanation of whom to contact for answers to perti-
nent questions about the research participant’s rights.
the identifiable private information or identifiable
biospecimens and that, after such removal, the • A n explanation of whom to contact for answers to
information or biospecimens could be used for future questions about storage and use of the participant’s
research studies or distributed to another researcher identifiable information or biospecimens.
for future research studies without additional informed
consent from the participant or legally authorized • An explanation of whom to contact in the event of a
representative, if this might be possible; or research-related injury to the participant. (May not be
o A statement that the participant’s information or omitted just because the research involves no more than
specimens collected as part of the research, even minimal risk.)
if identifiers are removed, will not be used or
distributed for future research studies. • C ontact information for the research team for questions,
• A general description of the types of research that may concerns, or complaints. (Element III.1.G.)
be conducted with the identifiable private information or
identifiable biospecimens, such that a reasonable person • Contact information for someone independent of the
would expect the broad consent would permit the types research team for problems, concerns, questions,
of research conducted. information, or input. (Element I.4.A.)
• A description of the identifiable private information or
identifiable biospecimens that might be used in the
research.
• W hether sharing of identifiable private information or
identifiable biospecimens might occur.
Table II.3.F.1. 191
ELEMENT II.3.G.
The IRB or EC has and follows written policies and procedures for approving waivers or
alterations of the consent process and waivers of consent documentation.
ELEMENT II.3.G.
ELEMENT II.3.G. The IRB or EC has and follows written policies and procedures for approving waivers or
alterations of the consent process and waivers of consent documentation.
COMMENTARY
Waiver or alteration of the consent process Waiver of consent documentation
In certain situations, the IRB or EC may waive or alter the In certain situations, the IRB or EC may waive the require-
consent process in accordance with laws, regulations, ment to document the consent process. When the IRB or EC
codes, and guidance. approves a waiver of the requirement to document the con-
sent process, records should document the protocol-specif-
When an IRB or EC waives the requirement to obtain ic reasons justifying the waiver. An IRB or EC might require
consent, it waives the entire requirement for consent, both that a written statement describing the research be provided
the attributes of the consent process and the elements of to participants, such as a copy of a consent document that
disclosure. When an IRB or EC alters the consent process, might be used if the participant requests written documenta-
consent is still obtained, but the consent process or elements tion of the consent process.
of disclosure differ from what is generally required. When
the IRB or EC approves a waiver or alteration of the con- See AAHRPP Tip Sheet 1
sent process, records should document why the IRB or EC See AAHRPP Tip Sheet 19
judged that each criterion was met for the specific protocol See AAHRPP Tip Sheet 20
being reviewed.
IRBs or ECs sometimes use the terms “passive consent,”
“deferred consent,” or “implied consent” to describe con-
sent processes that do not follow one or more requirements
for the consent process. Each of these cases represents a
waiver or alteration in the consent process. Research that
proposes these consent procedures cannot be approved
unless the IRB or EC approves a waiver or alteration of the
consent process.
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 46.116(c), 45 CFR 46.116(d), 45 • DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April
CFR 46.117(c), OHRP Guidance on Informed Con- 21, 2016), DOE Notice 443.1 (January 21, 2016),
sent Legally Effective and Prospectively Obtained and their accompanying Contractor Requirements
Documents (CRDs)
• FDA: 21 CFR 56.109(c)(1), 21 CFR 56.109(d), IRB
Waiver or Alteration of Informed Consent for Clinical • ED: 343 CFR 99
Investigations Involving No More Than Minimal Risk
to Human Subjects (July 2017)
• VA: 38 CFR 16.116(c), 38 CFR 16.116(d), 38 CFR
16.117(c), VHA Handbook 1200.05, 34
• DOD: Instruction 3216.02 9. (2.1.1), 10 USC
980(a,b)
Element II.3.G. 193
ELEMENT II.3.G.
REQUIRED WRITTEN MATERIALS
(1) Essential requirements: (ii) When granting waivers of the requirement to ob-
(a) Policies and procedures describe the process for tain written documentation of the consent process,
policies and procedures have the IRB EC consider
waivers and alternations of the consent process and requiring the researcher to provide participants with
documentation of consent: a written statement regarding the research.
(i) P olicies and procedures allow the IRB or EC to
(4) When following VA requirements:
waive or alter the consent process by determining (a) Policies and procedures require the IRB to document
that the criteria for waivers or alterations are met.
(ii) Policies and procedures allow the IRB or EC to the reason when it waives the requirement to obtain
waive parental permission by determining that the written documentation of the consent process.
criteria for waivers or alterations are met. (5) When following DoD requirements:
(iii) P olicies and procedures allow the IRB or EC to (a) When research supported by DoD-appropriated
waive the requirement for written documentation of funds involves experimental subjects as defined in
the consent process by determining that the criteria DODI 3216.02, consent must be obtained in ad-
for waivers are met. vance, unless waived.
(iv) Policies and procedures have the IRB or EC docu- (i) T he Assistant Secretary for Defense for Research
ment its findings justifying the waiver or alteration.
(2) When following DHHS regulations: and Engineering may waive the requirements for
(a) Policies and procedures allow the IRB or EC to waive consent when all of the following are met:
or alter the consent process by determining that the (A) The research is necessary to advance the de-
regulatory criteria for waivers or alterations of the
consent process are met. (See Table II.3.G.1.) velopment of a medical product for the Military
(b) W ritten materials allow the IRB or EC to waive the Services.
requirement to document the consent process by (B) T he research may directly benefit the individual
determining that the regulatory criteria for waivers experimental subject.
are met. (See Table II.3.G.1.) (C) T he research is conducted in compliance with
(i) W hen the IRB or EC considers waiving the require- all other applicable laws and regulations.
ment to obtain written documentation of the consent (ii) For classified research, waivers of consent are
process, policies and procedures have the IRB or prohibited.
EC review a written description of the information (b) I f the research participant does not meet the defini-
that will be provided to participants. tion of “experimental subject” as defined in DODI
(ii) W hen granting waivers of the requirement to obtain 3216.02, policies and procedures allow the IRB or
written documentation of the consent process, pol- EC to waive the consent process.
icies and procedures have the IRB or EC consider (6) When following ED requirements:
requiring the researcher to provide participants with (a) Policies and procedures include a process to comply
a written statement regarding the research. with the Family Educational Rights and Privacy Act
(3) When following FDA regulations: (FERPA). This process may occur outside the IRB or
(a) Policies and procedures allow the IRB or EC to waive EC.
or alter the consent process by determining that the (b) FERPA applies when researchers obtain student
regulatory criteria for waivers or alterations of the records or personal education information from an
consent process are met. (See Table II.3.G.2.) education program as defined as any program
(b) P olicies and procedures allow the IRB or EC to waive principally engaged in the provision of education, in-
the requirement to document the consent process by cluding, but not limited to, early childhood education,
determining that the regulatory criteria for waivers elementary and secondary education, postsecond-
are met. (See Table II.3.G.2.) ary education, special education, job training, career
(i) W hen the IRB or EC considers waiving the require- and technical education, and adult education.
ment to obtain written documentation of the consent (c) The organization has in policies and procedures, a
process, policies and procedures have the IRB or process to grant exceptions to parental or student
EC review a written description of the information consent to release student records for research. This
that will be provided to participants. responsibility may be delegated to the IRB or EC,
another individual, or component of the organization
(e.g., a FERPA committee).
Element II.3.G. 194
ELEMENT II.3.G.
REQUIRED WRITTEN MATERIALS birth and mother’s maiden name.
(iii) B iometric records, including one or more mea-
(d) A n educational agency or institution may disclose
personally identifiable information from an education surable biological or behavioral characteristics
record of a student without consent if the disclosure that can be used for automated recognition of an
is part of an agreement between organizations or individual, including fingerprints, retina and iris
researchers conducting studies for, or on behalf of, patterns, voiceprints, DNA sequence, facial char-
educational agencies or institutions to: acteristics, and handwriting.
(iv) Other information that, alone or in combination, is
(i) Develop, validate, or administer predictive tests. linked or linkable to a specific student that would
(ii) Administer student aid programs. allow a reasonable person in the school communi-
(iii) Improve instruction. ty, who does not have personal knowledge of the
(e) A school district or postsecondary institution that relevant circumstances, to identify the student with
reasonable certainty.
uses this exception is required to enter into a written (7) When following DOE requirements:
agreement with the organization or researcher con- (a) Policies and procedures specify that when conduct-
ducting the research that specifies: ing classified research the IRB may not grant a waiv-
(i) The determination of the exception. er of the consent process or waiver of documentation
(ii) The purpose, scope, and duration of the study. of consent.
(iii) The information to be disclosed.
(iv) That information from education records may only When following the revised Common Rule when it
goes into effect:
be used to meet the purposes of the study stated in • If the participants or LAR are members of a distinct cul-
the written agreement and must contain the current
requirements in U.S. Department of Education tural group or community in which signing forms is not
regulations on redisclosure and destruction of the norm, documentation of consent may be waived if
information. the research presents no more than minimal risk of harm
(v) T hat the study will be conducted in a manner that to the participants, and provided there is an appropri-
does not permit personal identification of parents ate alternative mechanism for documenting consent
and students by anyone other than representatives was obtained.
of the organization with legitimate interests. • If a broad consent procedure is used:
(vi) That the organization is required to destroy or • A n IRB may not omit or alter any of the required
return all personally identifiable information when
no longer needed for the purposes of the study. elements of disclosure, and when appropriate, any of
(vii) T he time period during which the organization the additional elements of disclosure.
must either destroy or return the information. • If a study requests broad consent for the storage,
(f) E ducation records may be released without consent maintenance, and secondary research use of identifi-
under FERPA if all personally identifiable information able private information or identifiable biospecimens,
has been removed including: and refused to consent, an IRB or EC cannot waive
(i) S tudent’s name and other direct personal identifi- consent for the storage, maintenance, or secondary
ers, such as the student’s social security number or research use of the identifiable private information or
student number. identifiable biospecimens.
(ii) Indirect identifiers, such as the name of the student’s
parent or other family members; the student’s or
family’s address, and personal characteristics or
other information that would make the student’s
identity easily traceable; and date and place of
OUTCOMES
• IRB or EC members waive the requirement to document
the consent process according to criteria for waivers.
Element II.3.G. 195
TABLE II.3.G.1
Waivers and Alterations of Consent Under US DHHS Regulations
TABLE II.3.G.1. WAIVERS AND ALTERATIONS OF CONSENT UNDER US DHHS REGULATIONS
WAIVER OF THE CONSENT PROCESS—PUBLIC DEMONSTRATION PROJECT
• The research is conducted by or subject to the approval of state or local government officials.
• The research or demonstration protocol is designed to study, evaluate, or otherwise examine:
• Public benefit or service programs.
• Procedures for obtaining benefits or services under those programs.
• Possible changes in or alternatives to those programs or procedures.
• Possible changes in methods or levels of payment for benefits or services under those programs.
• The research cannot practicably be carried out without the waiver or alteration.
• The research is not regulated by the US FDA
WAIVER OR ALTERNATION OF CONSENT PROCESS—OBTAINING CONSENT NOT PRACTICABLE
• The research involves no more than minimal risk to the participants.
• The waiver or alteration will not adversely affect the rights and welfare of the participants.
• The research cannot practicably be carried out without the waiver or alteration.
• When appropriate, the participants will be provided with additional pertinent information after participation.
WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—MINIMAL RISK
• The research presents no more than minimal risk of harm to participants.
• T he research involves no procedures for which written document of the consent process is normally required outside of
the research context.
• The oral or written information provided to participants includes all required and appropriate additional elements of
consent disclosure.
• The IRB or EC has determined whether the researcher should provide participants with a written statement regarding the
research.
(Also applies to research regulated by the US FDA; See Table II.3.G.2.)
WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—BASED ON HARM
• The only record linking the participant and the research will be the consent document.
• The principal risk will be potential harm resulting from a breach of confidentiality.
• E ach participant will be asked whether the participant wants documentation linking the participant with the research,
and the participant’s wishes will govern.
• The oral or written information provided to participants includes all required and appropriate additional elements of
consent disclosure.
• The IRB or EC has determined whether the participant should be provided written information.
SEE ELEMENT II.4.C. PLANNED EMERGENCY RESEARCH
Table II.3.G.1. 197
TABLE II.3.G.2. WAIVERS AND ALTERATIONS OF CONSENT UNDER US DHHS REGULATIONS
WAIVER OR ALTERNATION OF CONSENT PROCESS – OBTAINING CONSENT NOT PRACTICABLE
• The clinical investigation involves no more than minimal risk to the participants.
• The waiver or alteration will not adversely affect the rights and welfare of the participants.
• The clinical investigation cannot practicably be carried out without the waiver or alteration.
• When appropriate, the participants will be provided with additional pertinent information after participation.
WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—MINIMAL RISK
• The clinical investigation presents no more than minimal risk of harm to participants.
• The research involves no procedures for which written document of the consent process is normally required outside of
the research context.
• T he oral or written information provided to participants includes all required and appropriate additional elements of
consent disclosure.
• The IRB or EC has determined whether the participant should be provided written information.
SEE ELEMENT II.4.C. PLANNED EMERGENCY RESEARCH
Table II.3.G.2. 198
STANDARD II-4
The IRB or EC provides additional protections for individuals who are vulnerable to coercion
or undue influence and participate in research.
STANDARD II-4
STANDARD II-4 The IRB or EC provides additional protections for individuals who are vulnerable to coercion
or undue influence and participate in research.
ELEMENT II.4.A. The IRB or EC has and follows written policies and procedures for determining the risks to
prospective participants who are vulnerable to coercion or undue influence and ensuring
that additional protections are provided as required by applicable laws, regulations, codes,
and guidance.
COMMENTARY
The IRB or EC should evaluate research to judge whether In research involving no more than minimal risk and vulner-
the research involves participants who are vulnerable to able populations, the IRB or EC may decide that existing
coercion or undue influence. When some or all of the protections are sufficient and no additional protections are
participants are likely to be vulnerable, the IRB or EC warranted. Conversely, sometimes when research involves
should ensure that additional safeguards are included in the no more than minimal risk, additional protections for vulner-
research design to protect the rights and welfare of these able populations might be appropriate.
participants. If the IRB or EC reviews research that involves If additional protections for vulnerable populations are not
children; pregnant women, fetuses, or neonates; prisoners; required under laws, regulations, codes, and guidance,
or adults who lack the ability to consent, or the IRB or EC then policies and procedures should describe equivalent
regularly reviews research that involves other vulnerable protections. Equivalent protections ensure safeguards are
individuals (for example, students, employees, or economi- in place to protect vulnerable populations, while allowing
cally or educationally disadvantaged persons, or homeless flexibility in review.
persons), the IRB or EC should have written policies and
procedures regarding additional protections for these See AAHRPP Tip Sheet 1
categories. See AAHRPP Tip Sheet 11
See AAHRPP Tip Sheet 18
It is impractical to have specific policies for every vulnera- See AAHRPP Tip Sheet 20
ble population that might be involved in research. Therefore,
when a research study involves vulnerable populations not
otherwise covered by specific policies and procedures,
policies and procedures should describe in general the
steps followed by the IRB or EC to evaluate such research
to determine the need for additional protections.
REGULATORY AND GUIDANCE REFERENCES
• DHHS: 45 CFR 46.111(b), 45 CFR 46 Subpart B, Epidemiologic Research Involving Prisoners as Sub-
45 CFR 46 Subpart C, 45 CFR 46 Subpart D, 45 jects (Federal Register, Vol. 68, No. 119, pp. 36929-
CFR 46.111(b), 45 CFR 46.205, OHRP Guidance on 36931, Friday, June 20, 2003)
Special Protections for Children as Research Subjects,
OHRP Guidance on the Involvement of Prisoners in • F DA: 21 CFR 50.3, 21 CFR 50 Subpart D, 21 CFR
Research, May 23, 2003, 45 CFR 46 Waiver of the 56.111(b), 21 CFR 56.111(c)
Applicability of Certain Provisions of Department of
Health and Human Services Regulations for Protec- • V A: 38 CFR 16.111(b), VHA Directive 2001-028,
tion of Human Research Subjects for Department of VHA Handbook 1200.05, 36, 45, 46, 47, 48, 49
Health and Human Services Conducted or Supported
Standard II-4 200
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AAHRPP Evaluation Instrument (2018-10-15)
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