Human Research Protection Program

Coast Guard operations involve a complex combination of personnel proficiencies, equipment systems, infrastructure, and doctrine. Increasingly, the Coast Guard must engage in necessary research activities to support the development and implementation of new operational systems and to ensure the safety of members as they serve in challenging operational environments.

Support from all echelons is required to maintain the highest standards of research conduct and to ensure for the ethical treatment and well-being of personnel participating in research projects.  COMDTINST M6500.1 regulates all research activities to ensure the protection of human subjects as indicated under DHS requirements. For this purpose, the CG uses the ethical principles outlined in the Belmont Report, “Ethical Principles and Guidelines for the Protection of Human Subjects in Research,” as the foundation for its human research protection program.

COMDTINST M6500.1 ensures that the rights, welfare, interests, privacy, confidentiality, and safety of human subjects is held paramount at all times and that all research projects will be conducted in a manner that avoids all unnecessary physical or psychological discomfort, and economic, social, or cultural harm.

The Human Research Protection program applies to:

• All research (e.g., biomedical, social-behavioral, human systems integration, technology/ infrastructure test and development, or survey) involving human subjects conducted by CG activities or personnel, involving CG personnel and CG employees as research subjects or supported by CG activities through any agreement (e.g. contract, grant, cooperative agreement, or other arrangement) regardless of the source of funding, funding appropriation, nature of support, performance site, or security classification. It also applies to human subject research using CG property, facilities, or assets.
• Human subject research conducted in the development, testing or evaluation of any item, system, vehicle, aircraft, piece of equipment, or other materiel, even if a person is not the direct object of the research (e.g., training exercises associated with the testing of personal protective equipment when worn by a person).

Point of Contact:

Dr. Carlos Comperatore

Email Dr. Comperatore

Related Links

Health, Safety, and Work-Life Service Command

Downloads and Links

Adverse Event Definitions (.pdf)

COMDTINST M6500.1

Exemption Request Example (.pdf) or (.doc)

Informed Consent Form Example (.pdf)

IRB Submission Requirements (.pdf)

Report of Serious and Unexpected Adverse Event form (.pdf) or (.doc)

Witness Consent of Interview Form (.pdf) or (.doc)