IRBMED: Ceding IRB Review to an External IRB
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1 : Ceding IRB Review to an External IRB Angela Faber, BS, CIP Senior Associate Regulatory Analyst, Seminar Series April 10, 2018
2 TERMINOLOGY For the purposes of this presentation: IRB of Record External IRB Reviewing IRB Central IRB Ceding IRB Relying IRB Not covered in this presentation Agreements, SMART IRB, IREx (IRB Exchange). Contact for assistance. 2
3 Required Submissions Why, when there is another IRB of record? Tracking of PI/Institutional activities related to U-M patients/subjects External IRB review is limited to IRB regulatory requirements Local context/informed consent Obligation to verify training Obligation to consider Conflicts of Interest Verify that local policies will be followed Ancillary reviews 3
4 TYPES OF EXTERNAL IRBs Commercial IRBs Advarra, Quorum, Western IRB, etc. Industry-sponsored, multisite clinical trials sirb for NIH-sponsored trial Consortium research Outside Institution IRBs Universities, hospitals, etc. sirb for NIH-sponsored trial Consortium research Other collaborative research NCI-CIRB NCI-sponsored clinical trials 4
5 Ceded Study Submissions Initial Reviews Amendments Continuing Reviews Adverse Event (ADV) and ORIO Reports Need IRB of Record approval letters before acknowledgement. Exceptions: Certain ADV/ORIOs and study team updates if the Informed Consent Form is not affected. 5
6 Working with Central (External) IRBs Guidance on the overall process Direct contact information for specific commercial IRBs Guidance regarding what to submit to at initial review and afterwards 6
7 Intake Process for Ceding IRB Review Commercial IRB If a Master Reliance Agreement is in place - complete only the ceding application Advarra (formerly Chesapeake/Schulman) Quorum Western IRB (WIRB) Consortium If a Master Reliance Agreement is place complete only the ceding application XYZ Net Others Complete an Intake Form (found on the website to be updated by 4/13) SMART IRB participant Any other academic partner 7
8 Ceding Application: Initial Reviews In eresearch, Section Requesting review by non-um IRB All appropriate ancillary reviews are still required will acknowledge that external IRB will be the IRB of Record Generally, considers the following for a ceded submission: Institutional risk Conflicts of interest Institutional policies Whether project meets criteria for ceding 8
9 Ceding Application: Initial Reviews Items confirmed by : PEERRS training for U-M study personnel Current CV s (within 2 years) Appropriate Informed Consent/Assent Forms IRB approval for the study from the external IRB Institutional Cover Page (Advarra (formerly Chesapeake/Schulman), Quorum, etc.) Approved consent documents should be posted as correspondence by the study team after receiving approval from the IRB of Record. 9
10 Ceding Application: Initial Reviews Must have the following before beginning researchrelated activities: acknowledgement External IRB approval Required U-M ancillary approvals 10
11 Ceding Application: Amendments When to submit: Any changes to the study that impact U-M ancillary committees: Research Pharmacy (IDS or Investigational Drug Service): Changes in dosing, addition of medication, prescribers RDRC/SHUR (Radioactive Drug Research Committee/Subcommittee on the Human Use of Radioisotopes): Changes in radiation dosing CRAO (Clinical Research Calendar Review & Analysis Office): Billing calendar updates, changes that impact subject injury language in consent COI (Conflict of Interest): Addition or removal of study team members 11
12 Ceding Application: Amendments What to submit: Revised or new documents that prompt submitting an amendment External IRB approval letter 12
13 Ceding Application: Continuing Reviews Submit prior to expiration date Include current External IRB Approval Letter If terminating (closing) the study, include the External IRB letter reflecting termination of the study. 13
14 Ceding Application: Reporting Requirements Report events involving local subjects to *: Serious Adverse Events related to the research per guidance Unanticipated Problems Protocol deviations that may represent a systematic problem requiring local evaluation by to determine that sufficient local resources are available for the safe conduct of the study Reports of Continuing and/or Serious Non-Compliance Study holds or suspensions that are not built into the study design from External IRB or Sponsor (e.g. interim analysis or enrollment completion need not be reported) *May require dual reporting to and External IRB 14
15 Common Mistakes to Avoid IRB approval letter from external IRB missing from application Uploading the incorrect version of the Informed Consent Document CV older than 2 years COI management plan not followed 15
16 New Challenges and Responsibilities Tracking multiple different IRB procedures for AE/ORIO reporting Use of different consent templates and needing familiarity with each of them for discussions with subjects Remembering to submit necessary amendments to 16
17 Questions? 17
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