Cede Review - PDF document

1 SOP: Cede Review NUMBER DATE AUTH
SOP: Cede Review NUMBER DATE AUTHOR APPROVED BY PAGE 08505/15/20S. SewardsA. Tahmassianof PURPOSE 1.1This procedure establishes the process to determine whether reliance is appropriate between institutions that each hold a ederalide ssurance (FWA) and set forth the steps to designate Harvard University Area(HUA), FWA00004387as either the Reviewing or Relying Institution. 1.2 serve as either the Reviewing or Relying institution for MultiSite Studyor cooperative non exemptHuman Researchor is otherwise triggered by the Designated Reviewer. 1.3This process ends when HUAhas been designated as either the Reviewingor Relying Institution or the study is otherwise ineligible or inappropriate for reliance. REVISIONS FROM PREVIOUS VERSION 2.1See POLICY3.1The HUA Human Research Protection Plan (HRP101) details the criteria for reviewing for or relying on other institutions/organizations. 3.2The institution may leverage the SMARTIRBagreement, the OHRP Authorization Agreement template or create a local Authorization Agreement to establish reliance. RESPONSIBILITIES4.1IRB Staff carryout these procedures. PROCEDURE WHEN HARVARD UNIVERSITY AREASERVES AS THE REVIEWING 5.1When a request for reliance is received, the Designated Reviewerwill notify the IRB Staff Reliance Administratorthrough the Ancillary Reviewprocess 5.1.1If the request involves the Harvard Master Agreement, the Designated Reviewerwill also notify the HLC Reliance Administrator. 5.2he IRB Staff Reliance Administrator 5.2.1etermine eligibility for HUAto serve as the Reviewing Institution, i.e., HUAis engaged in nonexempt human subjects research. 5.2.2When applicable, advise the PI to “Create New Study” in ESTR, and submit necessary supporting documentation. A modification may be submitted if this request occursafter initial review/approval. 5.2.3Ensure that each relying institution has an active FWA. 5.2.4 Authorization Agreement (IAA) using “TEMPLATEHUAIAA Template(HR509)”. 5.2.4.1Email draft IAA to the relying institution’s contact(s) for review and signature. 5.2.4.2When appropriate, obtain signature from the Harvard University Area Institutional Official / Organizational Officialor their designee. 5.2.4.3When the HUA IAA Templateis not used, ensure that the template 5.2.5If request involves SMARTIRBparticipating institution, advise PI to submit a reliance requestin the SMARTIRBsystem. 5.2.6If the request involves the Harvard Master Agreement, a separate reliance agreement is not needed.

2 SOP: Cede Review NUMBER DATE AU
SOP: Cede Review NUMBER DATE AUTHOR APPROVED BY PAGE 08505/15/20S. SewardsA. Tahmassianof 5.2.7If proposed relying IRB fails to respond after 60 days, the request may be discarded. If so,notify the Designated Reviewer. 5.2.8Obtain documentation of local context requirements through relying institution.5.2.8.1For determining who is responsible for meeting the additional requirements of the NIH Genomic Data Sharing Policy, see the Harvard University Policy and Procedures for Human Genomic Data Sharing documenthttps://vpr.harvard.edu/files/ovprtest/files/harvard_gds_policy_and_procedures_6_24_19.pdf ). 5.2.9reate a Site SmartForm in ESTRby competing theAdd/Manage Participating Sitesactivity on the main study workspace. All necessary documentationis included in SITE SmartFormregarding the cede, e.g., fullyexecuted IAA or SMARTIRB reliance request, local context requirements. 5.2.10Place acopy of the fullyexecuted IAA or SMARTIRBreliance requestin the Reliance folder in SharePoint 5.2.11Update the Reliance spreadsheet5.2.12When the study is closed, notify the relying site(s). 5.3Note. Only IAAs are placed in the Site SmartForm. Individual Investigator Agreements (IIAs) should be uploaded to the ESTR Study SmartFormsection Study Team Members, item 2. Please refer to the HUA Administrative Manualfor more information pertaining to the IIA documentation process. 5.4Designated Reviewerto complete review as per SOPHUA NonCommittee Review Conduct (HRP032) 5.5Designated Revieweris to add the following text tothe Correspondence Letterunder the heading “Harvard Special Determinations”: IAA with insert institution name her&#x-1.8;&#x 000;e PROCEDURE WHEN HARVARD UNIVERSITY AREA SERVES AS THE RELYING INSTITUTION (e.g., participating site)6.1IRB Staff Reliance Administratorwill:6.1.1Determine eligibility for Harvard University Areato serve as the Relying Institution (see“Institutional Review Board” section of HRPP PlanHRP101). 6.1.1.1If the request involves the Harvard Master Agreement, the Designated Reviewerwill notify the HLC Reliance Administratorvia the Ancillary Reviewprocess. 6.1.2When applicable, advise the PI to create an External IRB Submission” in ESTR 6.1.3Ensure that the reviewing institution has an active FWA. 6.1.4If the request does not involve SMARTIRBparticipating institution, execute an IRB Authorization Agreement (IAA) using “TEMPLATEHUA IAA Template (HRP509)”. 6.1.4.1Email draft IAA to the relying institution’s contact(s) for r

3 eview and signature. 6.1.4.2When appropr
eview and signature. 6.1.4.2When appropriate, obtain signature from the Harvard University Area IO/OOor their designee. 6.1.5If request involves a SMARTIRBparticipating institution, advise PI to submit areliance request in the SMARTIRBsystem. 6.1.6If the request involves the Harvard Master Agreement, a separate reliance agreement is not needed. 6.1.7If proposed reviewing IRB fails to respond after 60 days, the request may be discarded. If so, notify the Designated Reviewer. 6.1.8Conduct local context review using “WORKSHEET HUA HUA Harvard Policies (HRP309)” SOP: Cede Review NUMBER DATE AUTHOR APPROVED BY PAGE 08505/15/20S. SewardsA. Tahmassianof 6.1.8.1For determining who is responsible for meeting the additional requirements of the NIH Genomic Data Sharing Policy, see the Harvard University Policy and Procedures for Human Genomic Data Sharing document https://vpr.harvard.edu/files/ovprtest/files/harvard_gds_policy_and_procedures_6_24_19.pdf ). 6.1.9Provide Designated Reviewerwith the necessary documentation, e.g., fullyexecuted IAA or SMARTIRBreliance request, local context review. 6.1.10Place acopy of the fullyexecuted IAA or SMARTIRBreliance requestin the Reliance folder in SharePoint 6.1.11Update the Reliance spreadsheet. 6.2Designated Reviewerto complete review as per SOPHUA NonCommittee Review Conduct (HRP032)including indicating thereviewing IRBs risk level determination. CRITERIA FOR ENTERING INTO A RELIANCE AGREEMENT WITH INDEMNIFICATION 7.1If the study is determined to be greater than minimal risk and the reliance agreement includes an indemnification agreement, the Harvard School/Department should have sufficient insurance in place prior to entering into the reliance agreement. 7.2Should there be any question in regard to the indemnification language, contact the IO/OO 7.3Documentation of this insurance should be included in the ESTRStudy SmartForm. MATERIALS8.1TEMPLATEHUA IAA Template (HRP509)8.2WORKSHEET HUA HUA Harvard Policies (HRP309)8.3SOPHUA NonCommittee ReviewConduct (HRP8.4HUA Human Research Protection Plan(HRP101) 8.5Harvard Master Agreement REFERENCES9.1NIH Policy on the Use of a Single Institutional Review Board for MultiSite Research, http://osp.od.nih.gov/sites/default/files/NIH_sIRB_Policy_Multi_site_Research_UPDATED2016.pdf 9.245 CFR 46.1149.3ample text for an nstitution with a deralwide ssurance (FWA) to rely on the IRB/IEC of another institution https://www.hhs.gov/ohrp/registerirbsobtainfwas/forms/irbuthorization agreement/index.htm