Office of Human Research Affairs


Research and IRB FAQ

  • When is IRB review required? 

    • IRB review is required for research involving human subjects.
  • What is research? 

    • The FDA has a broad definition of research: Any experiment that involves a test article (drug, biologic, device or diagnostic test) and one or more human subjects, and that meets any one of the following:
      • any use of a drug other than the use of an approved drug in the course of medical practice
      • any activity that evaluates the safety or effectiveness of a device or diagnostic test
      • any activity the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit
    • All other research at Einstein/Montefiore is under the HHS definition (45 CFR 46.102(3)): Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
  • What is a human subject? 

    • The FDA also has a broad definition of human subject: An individual who is or becomes a subject in research, either as a recipient of the test article (drug, biologic, device or diagnostic test) or as a control. A subject may be either a healthy human or a patient. A human subject includes an individual on whose specimen (identified or unidentified) a medical device is used.
    • All other research at Einstein/Montefiore is under the HHS definition (45 CFR 46.102(3)): A living individual about whom an investigator obtains:.
      • data through intervention or interaction with the individual, or
      • identifiable private information.
  • What is Identifiable Private Information?
    • Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. The Einstein IRB considers all private information that contains any of the 18 HIPAA identifiers to identifiable private information. 
    • HIPAA IDENTIFIERS (most common in bold red)
      1. Patient Names 
      2. Geographical elements (such as street address, city, county or zip code)
      3. Dates related to the health or identity of individuals (including birthdates, date of admission, date of discharge, date of death, or exact age of a patient older than 89)
      4. Telephone numbers 
      5. Fax numbers
      6. Email addresses 
      7. Social security numbers 
      8. Medical record numbers 
      9. Health insurance beneficiary numbers
      10. Account numbers
      11. Certificate/license numbers
      12. Vehicle identifiers
      13. Device attributes or serial numbers
      14. Digital identifiers, such as website URLs
      15. IP addresses 
      16. Biometric elements, including finger, retinal, and voiceprints
      17. Full face photographic images
      18. Other identifying numbers or codes

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 (  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 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 . 

  • 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 12/12/2023). YU’s FWA number remains 00000140 (expires 04/28/2022) and Montefiore’s FWA number is 00002558 (expires 01/04/2024).

  • 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.)