IRB REVIEWER FORM

STUDY AMENDMENT CERTIFICATION FORM

HRPP Document Number 064

SECTION 1: STUDY TITLE:

Reviewer: XXXXXXXX /

Meeting Date: XXXXXXXX

/

Study Number: Pro0000

Principal Investigator and Study Coordinator

/ Amendment Number and Date
XXXXXX /

XXXXXX

SECTION 2: TYPE OF REVIEW Full IRB Review Expedited Review

SECTION 3: TYPE OF AMENDMENT (check all that apply)

Consent form change Personnel change Protocol Change Other

If other, please specify/describe:

SECTION 4A: STUDY INFORMATION – PERSONNEL CHANGE REQUEST

If the Study Amendment Request does not involve a Personnel Change Request, move to the next section of the Amendment Review Form.

Does this amendment involve a change in study personnel? Yes No

Does this amendment request a change in the Principal Investigator? Yes No

SECTION 4B: STUDY INFORMATION – PROTOCOL CHANGE REQUEST

If the Study Amendment Request does not involve a Protocol Change Request, move to the next section of the Amendment Review Form.

Was appropriate protocol amendment documentation provided by the investigator? Yes No

Are the proposed changes appropriately explained? Yes No

Is the rationale for the changes explained? Yes No N/A

Do you believe the changes are:

Minor (minor modifications or changes do not include any procedures that involve more than minimal risk and the modification or change falls into categories (1)-(7) of research that could be reviewed by using the expedited procedure) Yes No

Substantive Yes No

Does the Study Amendment Request require review at a convened meeting of the IRB? Yes No

SECTION 4C: STUDY INFORMATION – CONSENT FORM CHANGES

If the Study Amendment Request does not involve a Consent Form Change Request, move to the next section of the Amendment Review Form.

Regulations

45 CFR 46.404/21 CFR 50.51 - Research that involves no more than minimal risk

45 CFR 46.405/21 CFR 50.52 - Research that involves greater than minimal risk but also presents the prospect of direct benefit to individual subjects

45 CFR 46.406/21 CFR 50.53 - Research that involves greater than minimal risk and no prospect of direct benefit to the individual subjects, but is likely to yield generalizable knowledge about the subject’s disorder or condition

45 CFR 46.407/21 CFR 50.54 - Research not otherwise approvable that represents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

Does the proposed amendment affect the informed consent? Yes No

If Yes, has a copy of the currently approved consent form been submitted with the

Appropriate changes made? Yes No

If No, what additional changes are needed to the consent form?

If Yes, are the consent form changes ready for approval? Yes No

Do the following Subject Protections (Respect/Autonomy) Remain Acceptable in Light of this Amendment?

§  Inclusion and Exclusion criteria remain appropriate. Yes No

§  The selection of subjects continues to be equitable-considering the purpose

and setting of the research and whether the results benefit the community

being studied. Yes No

§  Special protections remain in place for vulnerable subjects. Yes No N/A

§  The consent process remains free of coercion and undue influence-

which includes consideration of subject recruitment and enrollment procedures

and payment for participation. Yes No

§  The informed consent form remains clearly written and does not contain

any exculpatory language. Yes No

§  All risks to subjects are clearly and accurately identified and considered

(i.e. use of placebo, wash out periods). Yes No N/A

§  The consent process remains acceptable. Yes No

§  There continues to be adequate provisions to protect the privacy

interests of participants? Yes No N/A

§  There continue to be adequate provisions to maintain the confidentiality of data. Yes No

§  The consent form contains the eight required elements of informed consent

and any of the six additional elements as appropriate. Yes No

§  Overall safety plan and monitoring remains adequate and appropriate. Yes No

§  Does the frequency of review remain appropriate? Yes No

SECTION 4D: RISK/BENEFIT ANALYSIS:

§  The risks to subjects remain reasonable in relation to the anticipated benefits

and/or the significance of the knowledge that may reasonably be expected to

result from the research. Yes No

§  In the opinion of the reviewer does this Amendment increase the degree of

risk in this study? Yes No

§  Risks to participants were minimized by using procedures that were consistent

with sound research design and did not unnecessarily expose participants to risk. Yes No

§  Risks to participants were minimized, whenever appropriate, by using procedures

already being performed on the participant for diagnostic or treatment purposes. Yes No

§  Risks to others (i.e. relatives, friends) are accurately identified and considered. Yes No N/A

§  Do enrolled subjects need to be informed about protocol changes or any

significant new findings that may impact their willingness to continue to take

part in research study? Yes No

THINKING POINTS

Additional considerations for review of modifications to previously approved research

·  If information has arisen that might affect the willingness of participants to continue to take part in the research, will it be provided to those participants?

·  The IRB evaluated whether the management of information that is relevant to the protection of participants is adequate?

SECTION 5: MODIFICATIONS ARE REQUIRED TO: (please check below and attach marked

documents or list modifications)

Consent form(s)

Protocol

Protocol Summary

Advertisements

Waiver

Submission Application

Other (please list):

REVIEWER RECOMMENDATION:

Motion: Approve Approve with Changes Disapprove Defer

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Page 1 of 3 Revised Version January 30, 2012