Mandatory Training in the Protection of Human Subjects (UC Berkeley memorandum from Vice Chancellor for Research)

Human Subjects Training Certification form

NIH Research Ethics and Human Subjects Research Tutorials list
  NIH Office of Extramural Research (OER) on-line tutorial Protecting Human Research Participants (PHRP)
    NIH Guidance on NIH OER on-line tutorial Protecting Human Research Participants (2/29/08)

Berkeley Campus Procedures

The National Institutes of Health (NIH) has announced that effective October 1, 2000, all principal investigators and key personnel conducting clinical research on NIH grants or contracts will be required to undergo training in the protection of human subjects in research.

What is Clinical Research?

NIH defines clinical research as follows:

1. Patient-oriented research
Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) in which an investigator or collaborator directly interacts with human subjects and subject identification is necessary. Areas include:

• mechanisms of human disease,
• therapeutic interventions,
• clinical trials, and
• development of new technologies.

2. Epidemiological and behavioral studies

3. Outcomes research and health services research

Excluded are in vitro studies in which the human materials studied can not be directly identified with specific individuals.

Who must be trained?

Principal Investigators (PIs) on projects involving human subjects research and all personnel who are directly responsible for the design and conduct of the human subjects part of the project must be trained prior to working with human subjects. This includes key personnel on domestic and foreign subcontracts and foreign and domestic consultants and applies whether or not these individuals are compensated from the award. Excluded are individuals who are not involved with the human subjects part of a study. Key personnel who join the project after it has begun must also be trained; certification is to be provided with the appropriate progress report.

It is the responsibility of the named PI or Project Director (PD) to identify those personnel to be trained and to certify completion of the training. Training of personnel is required only once during the project period.

What is required and when?

Beginning October 1, 2000, all new proposals for competing grants or contracts require a statement from the PI/PD describing and certifying completion of the required training, or that the research is exempt from the training requirement. To accomplish this, a Human Subjects Training Certification form has been developed that must be submitted to the Sponsored Projects Office (SPO) along with the proposal. This certification will be submitted to NIH upon request and must be signed by an institutional official.

For proposals submitted prior to October 1, 2000, the PI/PD will be asked to submit a Human Subjects Training Certification form to SPO only upon request of NIH.

For all non-competing grant and contract renewals beginning after October 1, 2000, the Human Subjects Training Certification form must be submitted to SPO in order to receive the next allotment of funding. NIH also requires that a statement from the PI/PD describing and certifying the training be included in the first progress report submitted after October 1, 2000.

What type of training/education is required?

NIH does not require a specific course of study. NIH provides an online course, "Protecting Human Research Participants (PHRP)." This web-based tutorial is intended for use by those involved in the design and conduct of research involving human participants and available at http://phrp.nihtraining.com/users/login.php.

NIH provides links to other tutorials and case studies at http://bioethics.od.nih.gov/.