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 Protections 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.
HSP training must be renewed every three (3) years
to maintain your credentials
What HSP training must I complete?
What if I am 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.
COI training must be renewed every four (4) years
to maintain your credentials.
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.).
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