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.
      • Effective January 1, 2017, all Montefiore, Einstein and PAGNY employees who participate in clinical research must have certification of completion of GCP training that has been taken or renewed within the past three years in order to submit a protocol to the IRB for review and approval. This was changed from our previous renewal requirement of 5 years in response to a recent NIH policy on clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).  As a result, if you completed the CITI GCP course prior to January 1, 2017 the 5 year expiration date noted on your completion report is no longer valid and the new expiration date is now 2 years earlier. 
      • Effective January 1, 2017 all investigators and clinical trial staff (individuals, identified by the investigator, who are responsible for study coordination, data collection and data management) on NIH-funded clinical trials must complete GCP training. A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 
        • Do you have an  NIH-funded clinical trial that does NOT involve drugs or devices that was submitted to the Einstein IRB prior to January 1, 2017? 
          Please contact the Einstein IRB for guidance on submitting an amendment to update your IRB application so GCP requirements may be automatically checked by the Einstein IRB.  
         
       
     
  • 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.
    • To add the refresher course: Under Question 3, select "Yes, I would like take the Refresher GCP course (I previously completed the Initial GCP course at Einstein. NOTE: Completion of this course does NOT satisfy the Human Subjects Education requirement.)" 
     
  • Note: Effective March 2015, CITI will only support Internet Explorer (IE) 8.0+, or use a current version of Chrome, Firefox, or Safari. Users at Montefiore whose computers only have IE 7.0 or earlier may contact the EHIT helpdesk to request that Firefox be installed on their computers.

  • 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 3 years
  • 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, Inc. approved courses;
    • 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?
    As long as your “preferred” email address in CITI matches your email address in iRIS, and you have taken the GCP course while affiliated with Einstein, we will receive automatic notification from CITI.
  • I currently have two learner accounts. Can I merge them into one CITI Program account?
    If you would like to merge two learner accounts, please send an e-mail to support@citiprogram.org and include the following information: 
    • Your first and last name.
    • The name of your institution.
    • The username or Member ID for the account to keep.
    • The username or Member ID for the account to merge.
    For further assistance please contact the CITI Program help desk at (888) 529-5929 or support@citiprogram.org . 
  • 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 enrollment of Spanish-speakers 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?
    Einstein's new FWA # is 00023382 (expires 09/12/2022). YU’s FWA number remains 00000140 (expires 04/28/2022) and Montefiore’s FWA number is 00002558 (expires 09/12/2022).
  • Which FWA number do I use?
    Select the FWA number that belongs to the institution named as the recipient on the grant. NOTE: Since most new NIH grants are processed through Einstein, it will generally be Einstein’s new FWA (00023382). Jacobi Medical Center and North Central Bronx Hospital  (PAGNY) employees should use HHC's FWA, 00009807 (expires 9/9/2020). Yeshiva University employees should use YU's FWA, 00000140.
  • 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.)

iRIS FAQ

Click here to log in