Additional Requirement – 1: Human Subjects Requirements

If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects, unless that research is exempt as specified in the regulation. All awardees of CDC grants and cooperative agreements and their performance sites engaged in research involving human subjects must obtain (1) an assurance of compliance with the Regulations, and (2) initial and continuing approval of the research by an appropriately constituted and registered institutional review board.

In order to obtain a Federal wide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. Existing Multiple Project Assurances (MPAs) and Cooperative Project Assurances (CPAs) remain in full effect until they expire or until December 31, 2005, whichever comes first.  Applicant institutions holding an MPA or CPA must submit an FWA application to OHRP for approval by December 31, 2005, if the institution is required to have an OHRP-approved assurance of compliance as of January 1, 2006.

To obtain a FWA, contact the OHRP at: https://www.hhs.gov/ohrp.

Or, if your organization is not Internet-active, you may obtain an application by writing to:

Office for Human Research Protections 1101

Wootton Parkway, Suite 200
Rockville, Maryland 20852

OHRP may also be contacted as follows:

• By telephone: (866)447-4777 (toll-free within the United States), or (240)453-6900
• By fax: (240)453-6909
• By e-mail: ohrp@osophs.dhhs.gov

Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project.