GEARING UP FOR AAHRPP A Presentation for IRB Members April 2011 - - PowerPoint PPT Presentation
GEARING UP FOR AAHRPP A Presentation for IRB Members April 2011 Beverley Esparza, CIP Assistant Director, Human Research Protections 1 Learning Objectives April 2011 Considerations During IRB Review Conflict of interest
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Beverley Esparza, CIP Assistant Director, Human Research Protections
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The Reviewer Checklist contains not only the elements for IRB approval and required elements of informed consent but also considerations required by the regulations and AAHRPP.
Full Committee determinations are documented in the minutes however AAHRPP wants to see additional protocol specific documentation – like determinations for pregnant women, fetuses, neonates, prisoners and children.
Our Reviewer Checklist & Supplemental Reviewer Checklists helps us address this requirement! Therefore, please ensure that you have checked off all the applicable boxes in the Checklist(s), including your signature!
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When modifications affect one or more regulatory criteria, the IRB must assess- has the approval criteria been met?
Are there new findings that might relate to the participants willingness to continue participation? Has this information been provided to subj ects?
The modification checklist addresses these issues.
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At the time of continuing review, the IRB is provided with a summary of unanticipated problems involving risks to participants or others, for consideration.
The Reviewer Checklist Also Asks:
Do we need verification from other sources that no changes have occurred? (e.g. the sponsor)
If there were changes or new findings that might relate to the subj ect’ s willingness to continue to participate and if the information was / will be provided to subj ects.
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Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the IRB-approved documents; and (b) the characteristics of the subj ect population being studied;
At least possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or problem may have been caused by the procedures involved in the research); and
Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Always consider whether the notification of current participants is necessary when such information might relate to the participant’s willingness to continue in the research.
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Refer to the GREEN laminated sheet.
Researchers must j ustify in writing when non-random subj ect selection occurs in research involving prisoners.
Appendix C addresses this requirement.
For DHHS funded research involving prisoners, the research must not start until OHRP has approved the research.
*Remember: California Penal Code 3502 prohibits biomedical research involving
biomedical research studies. Biomedical research is defined by CA law as, “research relating to or involving biological, medical or physical science.”
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Refer to the BLUE laminated sheet.
The consent process cannot be waived or altered for research involving neonates of uncertain viability.
If the IRB determines 45 CFR 46.404 or 45 CFR 46.405 (research categories # 1 or # 2 on the blue laminated sheet), the IRB must also determine whether permission from both parents is required or if it is acceptable for only one parent to sign the consent.
The S upplemental Reviewer Checklist addresses this requirement.
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Regulatory Criteria When Using Short Forms
S hort Forms: The informed consent documentation requirements [21 CFR 50.27] permit the use of either a written consent document that embodies the elements of informed consent or a "short form" stating that the elements of informed consent have been presented orally to the subj ect.
When a short form consent document is to be used [21 CFR 50.27(b)(2)], the IRB should review and approve the written summary of the full information to be presented orally to the subj ects.
A witness is required to attest to the adequacy of the consent process and to the subj ect's voluntary consent. Therefore, the witness must be present during the entire consent interview, not just for signing the documents.
The subj ect or the subj ect's legally authorized representative must sign and date the short form.
The witness must sign both the short form and a copy of the summary, and the person actually obtaining the consent must sign a copy of the summary.
The subj ect or the representative must be given a copy of the summary as well as a copy of the short form.
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For a waiver of the consent process or a waiver of written consent, refer to the applicable S upplemental Reviewer Checklists.
S upplemental Reviewer Checklist “ O” refers to the regulatory criteria for a waiver of consent (or alteration).
S upplemental Reviewer Checklist “ P” refers to the regulatory criteria for a waiver of documented consent. “ P” will prompt the IRB to consider if an Information S heet is
heet must be reviewed and approved by the IRB.
S upplemental Reviewer Checklists address DHHS criteria, whether FDA regulations apply & if it is acceptable to waive parental permission.
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HRP S taff draft and finalize the minutes of a convened IRB meeting.
Minutes reflect attendance, including when votes increase and decrease based on those who left the meeting.
Minutes reflect the names of IRB members who left the meeting due to a conflict of interest along with the fact that a conflict of interest was the reason for the absence.
Minutes document substantive issues and discussions.
Minutes document the rationale for significant risk and non-significant risk device determinations as required by the regulations.
Minutes document the j ustification of deletion or substantive modification
DHHS approved sample consent document. The IRB Reviewer Checklist prompts the IRB to address this issue, as applicable.
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IMPORTANT: The IRB makes the final determination whether the interest and its management, if any, allows for the research to be approved.
The convened IRB receives a report monthly informing of the COIOC evaluation and management plans.
If the study/ e-MOD / e-CPA is reviewed at subcommittee, the IRB Chair reviews the COI report and signs off on the approval of the COIOC evaluation and management plans.
If the study / e-MOD / e-CPA is reviewed at a convened meeting, the IRB reviews the COI report and signs off on the approval of the COIOC evaluation and management plans.
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Each committee member (now including IRB “ C” ) must review and sign a “ Conflict of Interest (COI) Disclosure Form for IRB Members” at the initial IRB committee member orientation and annually thereafter.
Each committee member must indicate on the IRB Reviewer checklist whether or not they have a conflicting interest.
Also, those members who have a conflict of interest must inform the IRB Administrator before the Committee meeting or at the beginning of the meeting.
At the beginning of each convened IRB meeting the IRB Chair or designee will ask the members if anyone has a conflicting interest with any of the research protocols on the agenda.
Refer to the purple laminated sheet!
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IRB committee members with a conflicting interest may not participate in any portion of the review of research activities except to provide information requested by the IRB and must absent themselves from the meeting during the IRB’ s deliberative discussion and vote on the affected research.
IRB members who review Expedited level research in subcommittee must also absent themselves from the review and any deliberative discussion and vote on the affected research.
This includes the review of unanticipated problems involving risks to participants or others, as well as the review of potential non-compliance matters.
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IRB Members should understand where to find additional information about investigational devices and when an IDE is needed: IDE Regulations-IRB Member Page
S R device=Investigational Device Exemption (IDE) required
When the IRB reviews research involving an investigational device without an IDE, the IRB will determine:
No IDE needed= Exempt from 21 CFR 812
NS R= abbreviated requirements apply
Notation in Reviewer Checklist
HRP S taff record determination in the IRB minutes
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Appendix K- how will device be used? Who has access to the device?
Investigator’ s assurance: assure administration and control
Controlling devices- is the Lead Researcher’ s plan to use the device appropriate with qualified personnel and for the appropriate indication?
UCI policy and procedure for controlling investigational devices
Sample Investigational Device Accountability Log on website- must be uploaded / used if researcher does not submit their
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ONLY when the patient has a life-threatening or severely debilitating disease or condition; and
There are no standard or generally recognized alternative treatment
condition; and
The patient’ s condition requires immediate intervention before review at a convened meeting of the IRB is possible to avoid maj or irreversible morbidity or death.
S ingle use of investigational drug or device allowed: Check website – has this drug / device already been used?
Per FDA regulations, Emergency Use may only be granted one (1) time per institution for one (1) patient under the three (3) conditions listed above. If any of the above three (3) conditions do not apply, or if there is a desire to use the test article again on the same or different patient, an IRB Application must be submitted for review and approval by a convened IRB.
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Is research: all regulatory criteria to be considered
Review the Notification Form- this must be submitted
When an emergency use of an unapproved drug in a life threatening situation occurs and consent is possible, researchers should use the UCI Emergency Use Consent Form.
Chair must review 5 day follow up report and exception to the requirement to obtain informed consent (if applicable)
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Mechanism: EQUIP= Education and Quality Improvement Program
Requirement by AAHRPP to maximize compliance with the regulations for social science and non-school of medicine research
Through EQUIP, HRP staff conduct periodic study monitoring and educational outreach in an effort to ensure that human subj ect research activities are conducted in accordance with regulations, laws and institutional policies regarding the protection of human subj ects.
EQUIP primarily focuses on research conducted on the Irvine campus and reviews all levels of research; exempt, expedited and full committee (greater than minimal risk research).
IRB can require monitoring / observation of the consent process through EQUIP.
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