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Education is a key component in the protection of human subjects in research.  It is essential that all key personnel engaged in human subjects research understand the regulations that govern research that involve the use of information and specimens obtained from human subjects.  All WCM investigators, research coordinators, and research staff who are engaged in research involving living human subjects, human tissue samples, or identifiable private information must complete the required Human Subjects Protection (HSP) training mandated by the terms of our Federal Wide Assurance before they can submit their protocols in WRG-HS.

What constitutes "Key Personnel"?

Key Personnel includes any individual who is "engaged in research with human subjects".  Key Personnel includes the Primary Investigator(s) and can be WCM faculty, staff, or WCMC students who:

  • Enroll individuals
  • Obtain subjects' informed consent by engaging in the consent process ("process" involves more than simply handing out or collecting forms, or providing contact information for available research studies)
  • Intervene or interact with subjects (this includes both non-invasive AND invasive procedures)
  • Collect data/identifiable private information from or follow-up with subjects
  • Have access to information that links subject names or other identifiers with their data
  • Act as an authorized representative of the PI(s)

Human Subjects Protection Training

Weill Cornell Medicine requires that all researchers and research staff engaged in human subjects research complete specialized training in human subjects protection. A notice of completion must be recorded by WRG-HS for all members of a research team before a submission can be processed.

Note: HSP training must be renewed every three (3) years to maintain your credentials

What HSP training must I complete?

  • Clinical Research Investigator and Staff: Biomedical Research Investigators and Key Personnel course (ID 1407)
  • Social-Behavioral Research Investigator and Staff:Social/Behavioral Research Investigators and Key Personnel (ID 227454)

If you are an external investigator listed on a WCM Study Protocol

You will not be required to complete the WCM-specific CITI courses. However, record of training completion in biomedical research human subjects protections, and good clinical practice must be provided. While the WCM IRB does not require external investigators complete the WCM-specific CITI courses, this does not preclude any requirements imposed by regulatory agencies, grantors or sponsors.

Conflict of Interest Training

WCM is dedicated to maintaining the integrity of the research conducted at our institution.  Part of this effort is ensuring that all individuals involved in research undergo appropriate training in the regulations for, and identification and reporting responsibilities of, any Conflicts of Interest. Federal regulations requires all research personnel on PHS-funded studies only to complete the Conflict of Training course available on CITI prior to engagement in any research endeavor. 

Note: COI training must be renewed every three (3) years to maintain your credentials

What COI Training Must I Complete?

Please visit the COI Office web site for training requirements

Good Clinical Practice (GCP) Education

The training of investigators and research teams to conduct clinical research is crucial to successful translation of novel drugs, devices and interventions. In order to secure comprehensive competency-based training for clinical research personnel, we will require certification of training in Good Clinical Practices (GCP) for all investigators and personnel directly involved in new and ongoing clinical studies that involve the testing of drugs or devices, including all FDA-registered studies as well as investigator-initiated protocols. This requirement applies to studies reviewed by both the WCM IRB, as well as approved external IRBs (e.g. BRANY, NCI CIRB, etc.).

Note: GCP training must be renewed every three (3) years to maintain your credentials

What GCP Training Must I Complete?

  • Clinical Research Investigator and Staff: CITI Good Clinical Practice (ID: 54618)

  • Social-Behavioral Research Investigator and Staff: not required

The WCM IRB will not issue approval for a research protocol if any key personnel has not satisfied the education requirement.

Need a Consultation?

The Human Research Compliance (HRC) Office is pleased to offer consultation hours to assist investigators, study coordinators, residents, and students with pre-review and other questions about IRB submissions.

Thirty minute appointments will be offered via Zoom during the following times:
  • Mondays: 11:00am - 1:00pm
  • Thursdays: 10:00am - 12:00pm, and 2:00pm - 4:00pm (no appointments between 12pm and 2pm)

Researchers may use the 30-minute time slot to receive assistance in:

  • Determining the feasibility of a project and possible regulatory implications
  • Pre-reviewing your draft IRB application, including your protocol and consent form
  • General uestions about the IRB and other regulatory requirements

Submit a consultation request and we will be in touch with you within 3-5 business days.

Please note that these consultations are only advisory in nature;
they do not take the place of a formal IRB review.

If applicable, you will still need to submit your final application to the WCM IRB for formal review.