Human Research Protection Program

The Department of Veterans Affairs Maryland Health Care System (VAMHCS) Human Research Protection Program (HRPP) is a comprehensive and organized system to ensure the protection of human volunteers participating in research. The objective of this system is to assist the institution in meeting ethical principles and regulatory requirements for the protection of human participants in research.

Documents such as the Belmont Report and the Declaration of Helsinki have justifiably become gold standards for the ethical conduct of human research and the guidance provided in these documents is helpful in structuring a framework for a HRPP. In general, however, these documents have emphasized prospective protections of research participants (such as with the establishment of Institutional Review Boards for a protocol approval process, the informed consent process, and so on), which are all instrumental in actualizing the ethical principles of beneficence, autonomy and justice.

The VAMHCS HRPP gives equal emphasis to concomitant protections of research subjects. Adverse events monitoring, quality management, compliance oversight, CQI, continuing education, etc. all have application in the preservation of the ethical principals of beneficence, autonomy and justice throughout the entire research process.

In addition, the Department of Veterans Affairs is one of 17 Departments and Agencies that have agreed to follow the Federal Policy for the Protection of Human Subjects (The Common Rule). The VAMHCS implements the requirements specified in 38 Code of Federal Regulations (CFR) 16, Protection of Human Subjects.