Rice University Research Policy No. 326-98

 

PROTECTION OF HUMAN SUBJECTS PARTICIPATING IN RESEARCH OR EDUCATIONAL ACTIVITIES  

As required by Rice Policy 301, no research or educational activities involving human subjects may be undertaken at Rice University unless the Institutional Review Board (IRB) for the Protection of Human Subjects at Risk has reviewed and approved the activity. Moreover, appropriate certification of such review and prior approval must have been provided to the sponsor.

The only procedure of an invasive nature that may normally be undertaken for research or instructional purposes is the collection of blood samples by venipuncture. Volunteer subjects must be at least 18 years of age who certify that they are in good health and not pregnant. Blood samples may be drawn no more than twice a week with an upper limit in volume of 450 milliliters over an eight week period. Signed and witnessed consent forms, available in the Office of Sponsored Research, are required in all cases. These procedures may be performed only by medical personnel, i.e. physicians, licensed nurses, or certified medical laboratory technicians/phlebotomists.

Noninvasive procedures to be used with human subjects, for example, in memory testing, must be justified by the Principal Investigator in writing and are subject to review and approval by the IRB. Consent forms are required in these cases also.

Laws and regulations regarding the protection of human subjects are detailed in the Code of Federal Regulations, Title 45 CFR Part 46.

 

Supersedes:

Policy No. 326-89

Revised January 15, 1998