Institutional Review Board

IRB FAQ

Education and Training FAQ

  • What training is required?
    • All Key Personnel are required to complete the CITI basic human subjects training. For additional information including registration information, visit the Human Subjects Research Education (CITI) page.
    • Effective January 1, 2015, all Montefiore, Einstein and PAGNY employees who participate in clinical research (including faculty investigators) must have certification of completion of GCP training in order to submit a protocol to the IRB for review and approval – and reapproval.
     
  • What is involved in taking the on-line CITI GCP course?
    Log into your existing CITI account, click “Add Course or Update Learner Groups”, choose “Yes” to question #3, scroll to the end and click “Submit”. Under your course list on the Main Menu, you’ll now have a “GCP” course available, consisting of 14 modules.
  • If I have completed the required Human Subjects Research training CITI program, will that be sufficient to satisfy the GCP requirement?
    No. Human Subjects Research training is a separate module that provides “basic training” regarding the ethical aspects of clinical research. If your project involves the treatment or study of human subjects as described above, you will need this additional GCP certification.
  • What will happen to my IRB submission if one member of the project’s key personnel isn’t yet GCP qualified (or hasn’t submitted documentation yet)?
    Your submission will be rejected by iRIS due to education failure. You will need to remedy the situation, withdraw the submission, then resubmit.
  • How often will I be required to re-certify for GCP?
    Every 5 years, as for the Human Subjects Research module.
  • What GCP courses/programs satisfy the new requirement?
    • Collaborative Institutional Training Initiative (CITI);
    • Academy of Physicians In Clinical Research (APCR);
    • FDA Investigator Course;
    • TransCelerate Biopharm Course;
    • National Institute of Allergy and Infectious Disease (NIAID) Program;
    • GCP courses offered by ACRP or SOCRA.
     
  • How do I get credit for a GCP course I've already taken?
    Submit your completion certificate or other documentation to Carmen Garcia or fax to 718-430-8714. Reminder: We receive automatic notification from CITI if you have taken the GCP course while affiliated with Einstein.
  • What other training is available?
    The Einstein IRB offers seminars on a variety of topics.

Consent FAQ

  • What are the requirements for translated consents for participants who only understand Spanish?
    • Subjects must always be presented with a consent in a language they understand.
    • The IRB (generally) requires that researchers proactively obtain Spanish translations of their consents for direct benefit studies that plan to enroll 5+ subjects.
      • Studies providing an adequate scientific justification precluding Spanish translation may have the requirement waived.
    • Other studies (no direct benefit or studies enrolling <5 subjects) need not proactively obtain translated consents, but must before enrolling any subjects who understand Spanish (and not English).
    Study Type Fewer than 5 subjects expected to be enrolled* 5 or more subjects expected to be enrolled*
    Direct Benefit No proactive Spanish translation required** Proactive Spanish translation required and is audited at annual review
    No Direct Benefit No proactive Spanish translation required** No proactive Spanish translation required**
    *The IRB defines a subject as "enrolled" once the consent form is signed.
    **Spanish speakers (who do not understand English) may only be enrolled with an IRB-approved Spanish consent.

Merger FAQ

  • Is there a new FWA number?
    No. YU/Einstein’s FWA number remains 00000140 and Montefiore’s FWA number is 00002558.
  • Which FWA number do I use?
    Select the FWA number that belongs to the institution named as the recipient on the grant. NOTE: Since new NIH grants are all being processed through Einstein, it will generally be Einstein’s, FWA #00000140.
  • Which IRB do I use?
    For new submissions, see the IRB Selection table.  For amendments, progress reports, etc. on protocols that are already approved, submit to the East Campus IRB if your study was originally approved by the CCI and the West Campus IRB if your study was originally approved by the MMC IRB.
  • Do I need to update the IRB listed on my 1572?
    No. The FDA states, “an updated 1572 is only required when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study. If there are other changes to information contained on a signed and dated 1572, the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update. the IND.” (For more information, see the FDA’s guidance.)
  • Do I need to update the confidentiality section (AKA “Who may see my records?”) of my consent documents?
    Yes, but only at the time that other changes are being made to your consent(s). The language “The people who reviewed this research study as members of the Albert Einstein College of Medicine Committee on Clinical Investigations (CCI) and the Montefiore Medical Center Institutional Review Board (IRB) may also review your research and medical records.” should be replaced with “The people who reviewed this research study as members of the Einstein Institutional Review Board (IRB) may also review your research and medical records.”

iRIS FAQ

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