Yale University Institutional Review Boards
100 CH.10 IRB Renewal Regulatory Review Checklist
Protocol #
Principal Investigator:
Date Submitted:
Reapproval w/ amend? YES
Review Date:
Staff reviewer_________
Approval Expiration Date: _______________
NO
If yes, see change section
Full Comm. Meeting Date: _____________ Expedited Review category:
General Information
PI Affiliation and Title:
Note: Is special permission required to serve as PI?
YES
NO
Human Subject Protection Training?
YES
NO
HIPAA Training?
YES
NO
YES
NO
Faculty Advisor:
Names of those requiring HSPT or HIPAA Training:
Signatures received?
NA
Conflict Of Interest completed?
YES
NO
If No, who? _________________________
Transactional Review __________________ SFI ________________________________
IP _________________
No Protocol Related COI
Disclosure in Consent?
YES
NO
NA
Funding Source Active?
YES
NO
Source(s)________________________________
Expiration date(s)_______________________ _
(If DoD, Dept of Defense, DARPA, Dept of the Army, Navy or Air Force, DoD Supplement form is required)
Sponsor protocol version # and date**: _______________________________________
C/M/grant number for federal funding:
Are all active grants congruent?
YES
NO
Study Status
No enrollment to date
Active open to Enrollment
Enrollment progressing as planned
Is enrollment within target range (N) for the study? YES
NO
Slower than planned, which will require study extension or reduction of planned number of subjects
Enrollment closed
Date enrollment closed:
Participants still completing research interventions
Follow up only (describe nature of follow-up)
Data analysis only
Secondary Data Analysis only
Still in proposal stage
100 CH.10 – renewal Review
Comments:
IND** or IDE**
YES
NO NA
Number: _____________ Name:______________________ Holder:*__________________
*If holder is PI, has the FDA requested changes? If so, we must obtain a copy of the request.**
Required for INDs and IDEs: Investigator’s Brochure: Version/Date:_________________________
Noncompliance, Adverse Events , Deviations and Unanticipated Problems
Have any noncompliance, serious, unanticipated adverse events or unanticipated problems, deviations or increased
frequency of these events been reported?
YES
NO
Are they on file?
YES
NO
(Describe the issue and action taken, if any)
Has the protocol lapsed?
YES
NO
(If so, complete lapsed procedure.)
Should any reports on file be considered by the full Committee?
YES
NO
(If so, confer with Chair)
Is there a valid Certificate of Confidentiality?
Needs one?
If Yes, Expiration Date (_____________)
YES
YES
NO
NO
N/A
Approval Criteria (45 CFR 46.111)
Since the last review has anything occurred or is there any new information which may affect the risk/benefit ratio, either
from the literature or from the Principal Investigator’s findings?
YES
NO
If yes, please explain:
Research Design remains sound
YES
NO
(No new information that affects study hypothesis or risk/benefit assessment or acceptability of continuing study)
Risks to subjects are minimized
YES
NO
(Risks are well described; risks are reasonable in relation to potential benefits to subjects, or to the importance of
knowledge that may result from the research)
Risk assessment:
Study qualifies as minimal risk
Study is greater than minimal risk
Potential for direct benefit? YES
NO
Subject selection remains equitable
YES
NO
(Inclusion/exclusion criteria are appropriate; recruitment methods and materials are appropriate; rationale for number
of subjects is justified; screening procedures are acceptable)
Choose all that apply:
Children* permission of one parent sufficient? YES
Decisionally impaired*
Economically Disadvantaged
Employees*
Females of childbearing potential(biomedical studies)
Fetal material, placenta, or dead fetus
** Cite in letter/minutes
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NO
Non-English Speaking Is a translator
needed? YES
NO
Pregnant women and/or fetuses*
Prisoners*
Students*, Psychology Pool
Wards of the state
100 CH.10 – renewal Review
If vulnerable populations - are appropriate provisions made?
YES
NO
Recommended findings citing DHHS regulations and FDA regulations: **:_____________
If no, explain:
Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
Does the consent process/form continue to be appropriate and adequate for the research? YES
NO
Consent continues to be obtained.
Consent waived under 45 CFR 46.116(d). Not applicable to FDA research. All four criteria must be met: (1) The
research involves no more than minimal risk to the subjects; (2) The waiver or alteration will not adversely affect the rights
and welfare of the subjects; (3) The research could not practicably be carried out without the waiver or alteration; and (4)
Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Informed consent will be appropriately documented.
Standard written consent form will be used.
Short form consent will be used.
Qualifies for waiver of documentation of consent under (45 CFR 46.117(c)(1) or (2)). Either criterion may be used.
Does not waive the consent process. A HIPAA waiver is still required if applicable. Not applicable to FDA research.
The consent document is the only record linking participant to research and the principal risk of the
research is potential harm resulting from breach of confidentiality. If so, the participant must be asked
whether s/he wants documentation linking him/her with the research and the participant’s wishes will govern.
The research presents no more than minimal risk and involves no procedures for which written consent is
normally required outside the research context.
Information sheet will be used (no signature required)
The research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants.
(Data and Safety Monitoring Plan is appropriate to level of risk; Data security plan is appropriate- this does not need to
be one of the “formal” plans if study is minimal risk)
YES
NO
There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
N/A Examples – anonymous data
YES
NO
NA
Consent Form(s): Indicate number of forms submitted. If reapproval, check file history for number of forms previously
submitted. Note discrepancy.
___Adult (__Cases __Controls) ___Parental Permission ___Adolescent Assent ___Child Assent
___Non-English ___Compound Authorization ___ Information Sheet ___Other:________________________
Consent Requirements
Yes
Exculpatory language is excluded
Includes statement that the study involves research
The purpose and duration of participation for the study is described
Procedures/experimental procedures are adequately described
Risks and Anticipated benefits adequately described
Description of alternative procedures or treatments
Confidentiality provisions for identified data described
** Cite in letter/minutes
Page 3 of 6
No
n/a
Comments/Concerns
100 CH.10 – renewal Review
Consent Requirements
Yes
No
n/a
Comments/Concerns
Yes
No
n/a
Comments/Concerns
Yes
No
n/a
Comments/Concerns
Description of compensation for injury, if any, if greater than minimal
risk
Description of availability of and information on how to obtain medical
treatment, if any, if greater than minimal risk, including who to contact
for research related injury
Contact for questions about the research and rights as research participant
research (including a local contact for international studies)
Statement that participation is voluntary and that they may withdraw
participation at anytime
Statement that refusal to participate will not lead to penalty or loss of
benefits
Other Consent Considerations as applicable
If the study involves the psychology subject pool, statement on other
options to meet course requirements and pool contact information.
FDA ClinicalTrials.gov language
GINA language in the consent form
Explanation of CoC protections
Statement regarding potential for currently unforeseeable risks
Circumstances where participation could be terminated by PI
Potential costs to participants
Consequences of withdrawal and any requirements for orderly
withdrawal
Provision of significant new findings
Number of participant to be enrolled.
Option that the sample or data be destroyed when they withdraw their
participation from the study, if a subject withdraws his/her participation.
Explanation that the samples or data will be anonymized and that sample
or data destruction is not possible, if a subject withdraws his/her
participation.
Explanation about future banking and whether the subject can opt out of
the future banking and still participate in the main study.
A plan to re-contact minors providing assent for biological samples/data
when they reach the age of majority.
HIPAA Authorization Requirements
List specific types of PHI that may be used or disclosed
Description of foreseeable research uses and disclosures of PHI
Identity or class of persons that are authorized to request use of or
disclose the PHI?
Identity or class of persons from whom the investigator may request PHI
use or disclosure?
Statement that the information may be redisclosed if individuals aren’t
covered by HIPAA
Statement of when the request for use or disclosure of his/her PHI will
expire
Statement of when PHI or other identifiable research materials will be
destroyed, or not
Statement of right to revoke authorization and exceptions to the right to
revoke
** Cite in letter/minutes
Page 4 of 6
100 CH.10 – renewal Review
Changes
Yes
PI
Check COI information.
Personnel
Check HRPP and HIPAA training. Check
Yale affiliation.
No
Comments
COI: YES
NO
Names of those requiring HSPT or HIPAA
training:
Funding Source
Does it need congruency review?
Congruency done: YES
NO
NA
Expiration date of
grant:__________________________
Population
Is new population appropriate and does it
now include a new vulnerable group?
If so, which one(s)?
Vulnerable group: YES
NO
If Yes, findings: ____________
Location
Note: If country is Iran, Cuba, North Korea, Sudan,
Syria, or Burma/Myanmar, advise PI to contact Don
Deyo from G&C and copy Don and Jan on email to
PI** (See http://www.treasury.gov/resourcecenter/sanctions/Programs/Pages/Programs.aspx)
Are these locations considered ‘engaged’
in research? If so, has the other IRB
approval been submitted? If not, remind
Investigator in approval/SMR letter that
this would be required prior to initiation of
study activities at those locations.
Embargoed country: YES
NO
Site IRB approval received: YES
NO
Collaborators/Affiliates
Note new collaborator(s) affiliate(s), confirm
appropriate FWA status.
Risk Assessment
If the amendment changes the risk
assessment, note the new risk
determination.
New risk assessment:
Revised DSMP: YES
NO
NA
Has the data and safety monitoring plan
been modified accordingly (if risk is
increased)?
Note: for changes to greater than
minimal risk, In Case of Injury section
in the application and consent
document(s) may be required.
Protocol procedures/
Protocol Updated: YES
Has the protocol been updated?
Measures, questions, interview prompts,
focus group prompts, etc.
Do the new questions change the assessment of
risk for the study?: YES
NO
Consent form(s)/RAF/Waiver
RAF/Waiver
If yes, have all changes been incorporated?
Changes incorporated: YES
NO
If there are subjects already enrolled, is reconsent recommended to inform previouslyenrolled subjects of new information (risks,
etc.)?
Reconsent necessary: YES
NO
** Cite in letter/minutes
Page 5 of 6
NO
Consent
100 CH.10 – renewal Review
Will re-consent be achieved verbally or via
consent addendum? Consent waiver
required for verbal re-consent.
Does the amendment require changes to
the RAF or waiver?
Consent addendum: YES
Certificate of Confidentiality
Does the amendment require a CoC?
YES
NO
NO
**All asterisked items that relate to this protocol MUST be mentioned in the letter and meeting minutes (if full
Committee). Check all that apply:
Conflict of Interest
Human Subject Protections or HIPAA Training
Sponsor Protocol/Version/Date
Grant Congruency (grant number and title)
Vulnerable Population findings (also include FDA minors findings if applicable)
External IRB approvals (or letters of support if applicable)
International research site on embargoed list
IND/IDE number or exemption granted
FDA correspondence required or received/acknowledged
Other Committee approvals
Deception
Third-party subjects
Risk Assessment
Waiver of Informed Consent or Waiver of Signed Consent (indicate if the waiver is for pre-screening
activities, recruitment, and/ or the entire study)
Waiver of HIPAA research authorization (distinguish between pre-screening waiver vs. recruitment waiver:
waiver should be appropriately requested in the IRB application.).
Amendment
REQUIRED Coeus data entry at approval action:
Risk Level
CONFIRMATION of Required Coeus data entry after approval action (check all that apply and make necessary
updates):
Billable
Personnel updates Area(s) of Research Funding Source(s)
Special Review Categories (e.g., congruency, C-o-C, consent and/or HIPAA waivers, external IRB or other
Committee approvals, prisoner category, etc.)
NOTES/COMMENTS:
** Cite in letter/minutes
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