• Institutional Review Boards
• Human Subjects
• General Policies

General Policies

Policy

Pursuant to federal regulations and College policy, all research involving human subjects must be reviewed arid approved bythe College’s Human Subjects Research Review Committee.

Background

In accordance with the College’s Federal Wide Assurance (PWA) maintained with the Department of Health and Human Services (DHHS), Ofñce of Human Research Protections (OHRP), all research involving human subjects conducted by or under the auspices of Occidental College will be performed in accordance with Title 45 Code of Federal Regulations, Part 46 (45 CFR46). A copy ofthe regulations is available at litio  s. govffolirp/lzuinaiiszib Í  i ê ance/ 45. 

As mandated, the College designates and inipanels the Human Subjects Research Review Committee (HSRRC) to protect the rights and welfare of human research subjects. The Research Compliance Officer is also appointed to oversee the three Institutional Review Boards on campus: Human Subjects Research Review Committee (HSRRC), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC), as well as to support the investigators in their compliance.

Definitions

Human Subject
A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Thus, the scope of “subject” is interpreted broadly. Even if the investigator is “just interviewing” people, human subjects are involved in the research.

Research
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Risk
Risk is a possible harm to a human subject. It can be social, psychological, physiological, as Well as physical. The investigator shall identify the possible risks for HSRRC review. HSRRC shall evaluate Whether such risks may be beyond the minimal risk. Risks are an inevitable part of life. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the perfomance of routine physical or psychological examinations or tests.

Informed Consent
Potential research subjects must be given all available information that might reasonably be expected for their voluntary participation in the research. Investigators need to help them to understand fully the nature ofthe study being conducted, and the research risks and benetits associated with it, so that they can make an informed decision on participation. This information should be provided in a culturally appropriate manner and in language understandable to the Subject or his/her authorized representative. ln addition, the informed-consent materials should be free of any language that appears to be coercive, to waive any ofthe subjeet’s legal rights, or to release the investigator and/or sponsor frorn liability for negligence.

Certain groups of human subjects require special considerations:

• Minors: subjects under the age of 18 require parental/ guardian consent.
• Mentally Disabled: Subjects may or may not be Capable Of giving Consent.
• Prisoners: subjects are severely limited since such subjects’ ability to voluntarily consent is limited by the nature ofthe environment they are in.

Student Projects

All student-initiated research must be submitted with a faculty supervisor. In the case that a student is to work on a faculty’s project that already has HSRRC approval, the faculty investigator shall submit an amendment to the HSRRC to name the student as a student investigator.

Record Maintenance

The faculty principal investigator or the faculty supervisor shall maintain all documents pertaining to each research project. These documents and the signed consent fonns must be kept for a minimum of three (3) years following tennination of the study, and made available for internal reviews and external audits as necessary.

Noncompliance

Any research project involving human subjects that is carried out Without HSRRC approval is a noncompliance. The HSRRC cannot approve any proj ect if the investigator has begun data collection prior to receipt ofthe HSRRC approval.

For HSRRC-approved research projects, any signíñcant protocol deviation by an investigator, and a protocol change without prior HSRRC approval of an amendment are examples of noncompliance.

All incidences ofnoncornpliance shall be promptly reported to the Research Compliance Officer, and to the Dean ofthe College for possible referral to the Secretary of the Department of Health and Human Services and for other actions as necessary.

 

revisions approved by Robert A Skotheim, President on January 30, 2009