Who is Required to Complete Ethical Principles of Human Subjects and Good Clinical Practice Training?

Q: Do IRB and Research & Development Committee members have to take training in human research protection and Good Clinical Practices?

A: Yes. The only exception is the community IRB member (not otherwise affiliated with the institution and not part of the immediate family of a person affiliated with the institution). HOWEVER, the Common Rule mandates that ALL IRB MEMBERS (including community IRB members) must be trained sufficiently to perform their duties in order to be voting members.

Q: Do Chiefs of Staff, ACOS/R, Chief Medical Officers, and others involved in managing research activities need to take the human subject protection and GCP training courses?

A: Yes. If they are involved in managing research activities, then they must complete annual training. If they do not manage research activities, then annual training is not required.

Q: Do those who work on VA research without compensation (WOC) have to take training and be credentialed?

A: Yes. WOCs are considered to be VA employees. If they are actively engaged in VA research they need to have training and be credentialed.

Q: Do we need to review the credentials and/or training (human research protection and Good Clinical Practices) of those individuals whose studies involve chart reviews (patient medical records) or surveys where the IRB has granted either a waiver or an exemption from informed consent?

A: Yes, to both credentialing and education because they are doing human research.

Q: Do clinical personnel (e.g., x-ray and medical laboratory technologists in the hospital) have to take the training and be credentialed?

A: If clinical laboratory people are hired by the hospital or clinical lab (i.e., not by researchers), and if their main work centers on regular, non-research clinical medicine, they do not have to be credentialed or have special training. If someone works in a research lab, even if they perform the same tests as clinical laboratory personnel, they are considered to be research personnel and will need to be credentialed and meet the annual training requirements in human research protection and Good Clinical Practices.

Q: Do summer interns who work on projects that involve human subjects need to be credentialed?

A: Yes. All persons involved in VA human research need to be credentialed and receive training in protection human subjects and GCP training.

Q: If some of our co-investigators are based at another VA facility, is it our responsibility to see that they are credentialed and trained for the Stand Down?

A: No. It is the responsibility of their home VA facility.

Q: What kind of training is required of non-profit Directors?

A: None is required; however, non-profit directors may wish to avail themselves of the web-based training available through the PRIDE web site.

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Who is exempt from training?

Q: What people can be exempted from ORD training and credentialing requirements?

A: After a lot of discussion with many people, including many people in the field, the following people will not be required to go through the ORD training or credentialing process:

• People who are based at an affiliate or other outside institution, and who do not come to the VA or directly interact with VA research participants. (NOTE: people who are based at an affiliate or other outside institution, but who do come to the VA to conduct human research, do have to have training and credentialing).

People who are not affected include the following:

• Non-profit directors
• Co-investigators who do not do work at the VA (e.g., a VA researcher may collaborate with researchers from outside the VA, but the VA portion of the study is conducted at the VA with VA personnel. The outside people may be co-investigators on a VA study, and have their names listed on consent forms given to VA enrollees, but if the outside researchers do not come to the VA to perform the research or enroll VA patients, they are not affected - only the VA researcher and his/her VA research team are affected).
• Biostatisticians (e.g., VA researchers may send their data to an affiliate- or other outside-based statistician for processing. The outside biostatistician does not have to be trained nor have credentials checked).
• Lab technicians (e.g., a VA researcher may send VA specimens to be processed at an affiliate or other outside lab. ORD training and credentialing requirements do not apply to the outside technicians).

Volunteers from the community who serve on an IRB or Research & Development Committee do not have to take the ORD required training or have the credentialing. HOWEVER, the Common Rule mandates that ALL IRB MEMBERS must be trained sufficiently to perform their duties in order to be voting members. We will be happy to discuss the exact nature of this training with you or your IRB chair.

Members of groups like data safety monitoring boards (DSMB) who are recruited from non-VA institutions don't have to go through the ORD required credentialing or training.

Clinical personnel who periodically perform tests on research patients as part of their routine jobs (e.g., x-ray, nuclear medicine, or medical laboratory technologists who occasionally perform a test on a research patient as part of their routine clinical duties). However, if someone like a nurse or an x-ray tech was hired primarily to do clinical work but becomes part of a research team, he or she is affected and does have to take training and be credentialed.

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New Hires:

Q: Must a newly hired person complete the educational requirements prior to beginning employment?

A: No. A newly hired person may start work before taking the training courses, BUT he/she must complete the training prior to assuming his/her duties related to human research. You may want to incorporate the training courses into the orientation for new employees.

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Training Options:

Q: Many of our investigators have taken a class on protection of human research subjects through our university affiliate or elsewhere. Does this satisfy the requirement for training on protection of human research subjects for the annual training requirement?

A: Generally yes, as long as the course covers at least the material provided in the NCI training course, and the training was completed in the past year. If you have a face-to-face or web-based training program in human research protection that you feel would satisfy the human research training requirements, you can seek approval by contacting Marisue Cody, PhD, RN (Director of COACH) at Marisue.Cody@va.gov . On PRIDE's website, you will find a list of Non-VA courses that have been approved by the Office of Research and Development to meet the training requirement in ethical principles of human research protection. Please remember that, unless someone has also had other training in Good Clinical Practices, they will still need to take the online Good Clinical Practices Training course.

Q: Can the Dunn and Chadwick book, Protecting Study Volunteers in Research, be used to satisfy the requirement for human subject protection training?

A: Yes. We suggest that you require people who take this course to submit the test at the end of the book to verify their compliance.

Q: Will we have to take the same training courses next year?

A: No. The PRIDE website offers a list of VA courses and non-VA courses that have been approved by the Office of Research and Development. Also, your local affiliate course may be ORD approved. However, it is important to note that training in BOTH human subjects research and Good Clinical Practices (GCP) is required annually. Some of the courses fulfill only human subjects or only GCP, and necessitate taking a second course to complete the annual training requirements. It is also not necessary to take a different course every year. You may choose to repeat a course to satisfy the annual requirements.

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Updating Training:

Q: Some courses in protection of human subjects have led to certificates that are good for more than a year. For the purposes of the annual training requirement, does this training count if it was more than a year ago?

A: No. Training must be updated annually. There is no grace period. However, facilities have the option of defining "annual" as 365 days, calendar year, or fiscal year. Each facility must specify which definition of "annual" it uses in its policies and procedures, so you can find out when your annual training is due from your research office staff.

Q: In March 2001 the CRADO issued guidance on educational requirements that stated all investigators must re-certify every three years. Does the Stand Down educational component change this requirement?

A: Yes. The Stand Down training requirements of March 2003 replace those in the March 2001 CRADO issued guidance. The March 2003 guidance requires annual training in both protection of human research subjects and Good Clinical Practices. A new training directive is in preparation. Until that time, the March 2003 training guidance is still applicable.

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