RESEARCH USING HUMAN SUBJECTS

The University of California is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm).

The ethical principles are:

• "Respect for persons," which includes the requirement of an informed consent process;
• "Beneficence," which entails an obligation to protect persons from harm by minimizing risks and maximizing projected benefits;
• "Justice," which requires that selection of subjects be fair and equitable and that particular care be taken when working with populations (e.g., children) whose status puts them in a vulnerable position.

Human Subjects Research Defined

As established by federal regulations (45 CFR 46), human subjects research includes any systematic investigation designed to develop or contribute to scholarly knowledge which uses living humans or identifiable private information about living humans. Some examples of human subjects research projects conducted at UCB are:

• ethnographic interviews
• disease prevention studies
• curricular evaluation studies
• psychology experiments

Human subjects research does not include:

• instruction
• surveys for evaluating the performance of faculty, staff, and students, or other studies for institutional use only
• student course work or undergraduate honors theses, unless they are to be made available to the public or used by other researchers.

Even when student work involving human subjects does not constitute research, faculty members who assign or supervise the work are responsible for educating their students to safeguard the well-being of the subjects.

Institutional Review Board (IRB) — The Committee for Protection of Human Subjects (CPHS)

An Institutional Review Board (IRB), established pursuant to federal regulations, is a committee composed of scientists and laypeople who review all proposed campus human subjects research to ensure that the safety and welfare of subjects are protected. All human subjects research requires review and approval by an IRB prior to subject recruitment and data collection and prior to use of extant data or private information. The IRB at Berkeley is called the Committee for Protection of Human Subjects (CPHS).

CPHS is a joint IRB for both the Berkeley campus and the Lawrence Berkeley National Laboratory (LBNL), and members have the responsibility for reviewing all research involving human subjects conducted at Berkeley and LBNL, regardless of the source of funding. Conducted at or sponsored by means:

• using the facilities of the Berkeley campus or LBNL
• paid for by the campus or with funds administered by the campus or LBNL
• conducted as part of a researcher's progress toward a campus degree
• conducted by a campus faculty member or employee in the course of employment by the Berkeley campus or LBNL
• using UC Berkeley students as subjects

The Office for Protection of Human Subjects (OPHS)

The OPHS provides administrative support to the Committee for Protection of Human Subjects (CPHS). OPHS staff support CPHS by performing record-keeping duties and maintaining a database in order to document institutional compliance. The OPHS staff works with CPHS and researchers to address research protocol and compliance issues. In addition, OPHS serves as a resource for investigators and CPHS members. The OPHS staff has been delegated authority to determine the appropriate level of review required for each research proposal submitted for review.

The Review Process for Human Subject Studies

Federal regulations divide human subjects research into three categories according to the level of risk posed to subjects. Each level has a corresponding requirement for institutional approval or registration. Complete information about the federally defined exempt categories and a greater level of procedural detail is available via the CPHS website (http://cphs.berkeley.edu).

For all projects involving human subjects, researchers must submit an application for CPHS review or a Declaration of Exemption form. Researchers may also need approval from the Sponsored Projects Office or from other oversight committees, such as Radiation Safety, before the research project may commence.

The categories of review are as follows:

(1) Exempt Status: To qualify for this category, the research must fall into one of six exemption categories accepted by CPHS. These categories present the lowest amount of risk to potential subjects because they generally involve either collection of anonymous or publicly available data, or conduct of the least harmful research experiments. Examples of research that qualify for exempt status are:

• anonymous surveys
• research involving normal educational practices
• analyses of discarded pathological specimens without personal identifiers

Institutions are required to have a mechanism for the review of exempt status by someone other than the investigator. Although it is called "exempt," this type of research still requires registration with CPHS. At Berkeley, a "Declaration of Exemption" is reviewed by OPHS staff and the chair of CPHS. In addition, special conditions apply to inclusion of children in research qualifying for exempt status.

There are no deadlines for submission of exemption applications.

(2) Expedited Review: To qualify for this category, research must fall into one of the nine federally defined categories of research that may be reviewed through an expedited review procedure. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Some examples of research qualifying for expedited review are:

• studies involving collection of hair, saliva, or dental plaque samples
• studies of blood samples from healthy volunteers
• analysis of voice recordings
• studies of existing pathological specimens with personal identifier

Review via expedited procedures typically takes four to five weeks.

(3) Full Committee Review: This level of review is reserved for research proposals that involve risk that is greater than that encountered in daily life. Examples include:

• invasive physiological or medical research
• research where there is a non-trivial risk that confidentiality could be violated with severe consequences such as the potential for criminal or civil liability, damage to financial standing or employability

Protocols requiring full committee review may take up to six weeks.

The Implementation of HIPAA and the Privacy Rule:

The Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) took effect April 14, 2003. HIPAA regulates the protection of private health information for individuals. The law's Privacy Rule sets standards for the use and disclosure of all individually identifiable health information obtained from a covered entity. Berkeley's covered entities are the Tang Health Center, the Optometry Clinic, and the Psychology Clinic.

All forms of health information that are associated with any of 18 identifiers defined by HIPAA are considered to be protected health information (PHI) subject to HIPAA regulations. To access this information, all research studies must obtain either an individual's authorization to access their protected health information, granted by the provider of the PHI, or obtain an approval of a waiver of authorization. Use of data from the campus's covered entities must receive prior CPHS approval. For more information see http://cphs.berkeley.edu/content/hipaa/hipaa.htm.

Office for Protection of Human Subjects (OPHS)
101 Wheeler Hall MC 1340
Telephone: (510) 642-7461
Fax: (510) 643-6272
Web site: http://cphs.berkeley.edu