Human Subjects

The Committee for the Protection of Human Subjects (CPHS) (http://socrates.berkeley.edu:7006/) is responsible for reviewing and approving the use of human subjects for research. Changes to an approved protocol, such as to the personnel, location(s), and procedures, are considered "significant" by regulation and require a modification to be approved by the CPHS. Protocols must be renewed annually.

Before approving a project, the CPHS must determine that all of the following requirements are satisfied:

Risks to subjects are minimized and are reasonable in relation to anticipated benefits to subjects and the importance of the knowledge that may reasonably be expected to result;
Selection of subjects is equitable;
Informed consent will be sought from each prospective subject or legally authorized representative and will be appropriately documented;
Consent procedures are non-coercive;
Provision exists for monitoring the data collected to insure the safety of subjects; and
Adequate provisions exist to protect the privacy of subjects and the confidentiality of data.

The CPHS must report any serious or continuing protocol noncompliance by researchers, serious unanticipated injuries or other serious problems involving risks to subjects or others, and any suspension or termination of research protocol approvals by the CPHS.

Principal investigators are responsible for the design, implementation and management of specific research grants and contracts. They are directly responsible for the proper treatment of human subjects used in their research and for the compliance with all applicable laws, regulations, and University policies regarding human subjects.

Principal investigators and all personnel who are directly responsible for the design and conduct of the human subjects part of a project funded by the National Institutes of Health must undergo training in the protection of human subjects in research prior to working with human subjects. This includes key foreign and domestic personnel on subcontracts and consultants, and applies whether or not these individuals are compensated from the award. More information on the training requirements can be found on the Sponsored Projects Office web site at http://www.spo.berkeley.edu/nihtraining/procedures.html.

Because funding agencies look to the University for prevention, detection, and investigation of research misconduct, all administrative officials have indirect responsibility to ensure that compliance with laws and regulations is achieved with respect to human subjects.

Noncompliance with regulations and policies can result in the loss of the privilege to conduct human subject research for the principal investigator and UC Berkeley, as well as the potential for the loss of all federal funding to the University.