Human Research Protection Program

Announcements

• Interested in serving on a biomedical IRB? Click here for information.
• Interested in serving on a social/behavioral/educational IRB? Click here for information.

• Effective January 18, 2012, the HRPP has revised our procedure for Certificates of Confidentiality. Revisions to the procedure are available here.
• (October 26, 2011) The Office for Human Research Protections (OHRP) has issued a notice of proposed changes to federal human research protection regulations, requesting comments from the research community. Click here to see the notice, and here to view Yale’s response.
• Dr. Sandra L. Alfano has been named to assume interim leadership responsibilities for the HRPP as Acting Director. Dr. Alfano has served for almost six years as Chair of one of the biomedical Institutional Review Boards, the Human Investigation Committee (HIC), and will continue in that role during this interim period. Her focus on knowledge of the current HRPP and its commitment to facilitating sound, ethical research incorporating protection of human subjects will serve to guide the program through this transition period.
• Investigators and Research staff: See an important announcement concerning approval notations and validation dates.
• Investigators and Research staff: See the announcement regarding continuing education.

Mission

Yale strives to adhere to the highest ethical standards in the protection of human research participants and seeks to identify and implement means for ensuring the protection of its research participants. The program seeks to ensure that Yale:

• Create a culture of respect for, and awareness of, the rights and welfare of human research participants at Yale and its affiliated research partners while advancing scientific knowledge and facilitating the highest quality research.
• Is guided by the ethical principles set forth in the Belmont Report: Respect for Persons, Beneficence and Justice.
• Assess the effectiveness and independence of the Institutional Review Boards (IRBs) in their review of research activities.
• Facilitate compliance of its researchers with the federal regulations, and protection of research participants.
• Develop new approaches that better serve the overarching mission of the HRPP, such as continuing education and training, ensuring scientific integrity, tracking and monitoring research activities and assessing the overall effectiveness of the HRPP.

Objectives of the HRPP

Yale University recognizes that the protection of individuals participating in research transcends traditional personnel and departmental jurisdictions. Therefore Yale maintains an integrated human research protection program (HRPP) under the oversight of the Associate Vice President for Research Administration. The HRPP includes mechanisms to:

• Establish a formal process to monitor, evaluate, and continually improve the protection of human research participants.
• Exercise oversight of research protection.
• Educate investigators and research staff about their ethical responsibility to protect research participants.
• When appropriate, intervene in research and respond directly to concerns of research participants.
• Ensure Research Partners maintain the resources need to support the research infrastructure.