Institutional Review Board (IRB)
CONTINUING REVIEW FORM
IRB Meeting Date:
IRB Reviewer:
Principal Investigator:
IRB #:
Study Summary (45 CFR 46.111 determinations):
Recruitment process:
Detail any changes that have occurred since the last continuing review.
Is the recruitment process adequately detailed in the original protocol?
Yes
No
(If no, please request protocol revision from PI, and obtain adequate information to make necessary granting of
HIPAA waivers and waiver of informed consent, etc.)
If changes have occurred, do they fall within the scope of previously granted HIPAA waivers or waivers of consent?
Yes
No
Is selection of subjects equitable? (In making this assessment the IRB should take into account the purposes of the
research and the setting in which the research will be conducted and should be particularly cognizant of the special
problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons.)
Yes
No
If some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged
persons, have additional safeguards have been included in the study to protect the rights and welfare of these
subjects?
Yes
No
N/A, subject population to be enrolled is not considered vulnerable as described above.
If yes, describe:
Are these safeguards adequately detailed in the protocol?
Yes
No
If no to either question above, state necessary required changes to protocol:
Are these safeguards still adequate in light of changes or new information since the last continuing
review?
Yes
No
Is the payment plan adequately detailed in the protocol?
Is there an ICF for this study?
Yes
No
Yes
No
N/A
N/A (Study Closed to Enrollment)
Is the consent process adequately described in the protocol (who conducts consent interview, when, where,
etc.)?
Yes
No
Have there been any changes to this process since the last continuing review?
If Yes, describe:
Yes
No
Does the consent process remain adequate in light of changes and new information since the last continuing
review?
Yes
No
Will subjects who are not competent to provide consent be enrolled?
03/07/12
Yes
No
Describe process by which competence is determined and by whom:
Describe process by which legally authorized representative is determined and how and when
permission from legally authorized representative documented:
Is this process adequately described in the protocol?
Yes
No
Have there been any non-English speaking subjects enrolled in this research study?
Yes
No
If no, why:
If yes, and a short form was used, were more than 5 short forms in the same language used in the study
in a twelve (12) month period?
Yes
No
N/A (short form not used)
If non-English speaking subjects have been, or will be, enrolled in the study is the plan to enroll nonEnglish speaking subjects adequately detailed in the protocol or Site-Specific Appendix?
Yes
No
Describe changes to risk(s) or benefit(s) to subjects identified since the last continuing review:
Are risks to subjects are minimized? (By using procedures which are consistent with sound research design and
which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.) This determination should both reflect the
adequacy of the original determination and any changes or new information since the last continuing review.
Yes
No
If yes, have these procedures been adequately detailed in the protocol?
Yes
No
If no, state necessary required changes to protocol:
Are risks to subjects reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result? (In evaluating risks and benefits, the IRB should consider
only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies
subjects would receive even if not participating in the research). The IRB should not consider possible long-range
effects of applying knowledge gained in the research (for example, the possible effects of the research on public
policy) as among those research risks that fall within the purview of its responsibility.) This determination should
both reflect the adequacy of the original determination and any changes or new information since the last
continuing review.
Yes
No
If yes, describe how:
If no, state necessary required changes to protocol:
Status since last Continuing Review:
No enrollment to date
Enrolling subjects
Closed to enrollment
Number of subjects enrolled since last Continuing Review:
Number of subjects enrolled to date
Number of subjects being followed (if applicable):
Number of withdrawals during the past year:
03/07/12
Reason(s) for withdrawal
Any problems in prior year?
Yes
No
If yes, describe:
Any changes to protocol:
Yes
No
If yes, describe:
Are the informed consent form(s) (ICF) complete?
Yes
No
If no, describe:
Does the study involve human genetic testing?
Yes
If yes, is it adequately addressed in the ICF?
Will this study be posted on www.clinicaltrials.gov?
No
Yes
Yes
No
No
If YES, please check the box at the end of the statement to confirm that the following statement appears in the
ICF(s) unaltered, per federal regulation: “A description of this clinical trial will be available on http://www.Clinical
Trials.gov, as required by US Law. This Web site will not include information that can identify you. At most, the
Web site will include a summary of the results. You can search this web site at any time.”
Is a witness’ signature needed in the ICF?
Yes
No
Funding:
Please note: Typically research sponsored by a pharmaceutical company involves a contract; grants are provided by
federal bodies (e.g., NIH), as well as private entities (e.g., National Kidney Foundation).
Is there a grant for this study, either federal or private?
Yes
No
Is the research proposed in the protocol within the scope of the grant? In particular, if the study has been amended
since the last continuing review, are all of the changes still within the scope of the current grant?
Yes
No
N/A
Health Insurance Portability and Accountability Act (HIPAA):
Is HIPAA applicable?
Yes
No
N/A (Study Closed to Enrollment)
Was HIPAA documentation included for review?
Yes
No
N/A
Type of HIPAA documentation (e.g., ICF/RAF combination document, separate RAF, waiver):
If a separate RAF was submitted, should revisions be made to the RAF?
Yes
No
N/A
Please note: If a Research Authorization Form (RAF) was not included for review, then no changes are being made to the form at this time.
If HIPAA does apply, and the RAF language is included in the ICF, the questions below must be completed.
At CR, it is optional for the PI to incorporate the HIPAA research authorization form (RAF) information into the
ICF; the PI may create a combined document or keep a separate ICF and RAF.
If 1 combination document is used, the ICF must contain each of the following elements; please indicate if they
are present:
03/07/12
USE/DISCLOSURE INFORMATION:
a. A specific and meaningful description of PHI to be used or disclosed is stated.
Yes
No
b. Name(s) or other specific identification of person(s) or class of persons authorized to make the requested use
or disclosure is stated.
Yes
No
c. The name(s) or other specific identification of the person(s) or class of persons to who may use the PHI or to
whom the PHI may be disclosure is stated.
Yes
No
d. The PHI to be used or disclosed is the minimum necessary to conduct the research.
Yes
No
e. A description of each purpose of the requested use or disclosure is stated. (This element must be study
specific. It cannot be for future, unspecified research.)
Yes
No
AUTHORIZATION PARAMETERS:
f. Authorization expiration date or event is stated (e.g., end of the research study or none).
Yes
No
g. A statement that the subject may revoke the authorization in writing and either (1) the exceptions to the right
to revoke and a description of how the individual may revoke Authorization or (2) reference to the relevant
section(s) of the Tufts Notice of Privacy Practices.
Yes
No
h. A statement about the covered entity’s ability or inability to condition treatment, payment, enrollment, or
eligibility for benefits on the authorization, including research-related treatment, and, if applicable,
consequences of refusing to sign the authorization.
Yes
No
i.
A statement that the PHI may be re-disclosed by the recipient and no longer protected by the Privacy Rule.
Yes
No
Comments:
Additional Findings:
Does an IND/IDE currently apply to this research?
Yes
No
Have there been changes (e.g., FDA approval of drug, identification of new risks) since the last continuing review that
would change the need for an IND/IDE?
Yes
No
If yes, explain:
Reviewer Comments:
ACTION RECOMMENDED:
APPROVE
MODIFICATION REQUIRED
DEFER
Are the changes/clarifications:
Substantive and to be reviewed by the convened IRB?
Not substantive and may be reviewed and approved via expedited review procedures?
Reviewer’s Signature: ___________________________________
03/07/12
Date: _________________