OHRP’s Statement of Organization and Functions

Statement of Organization and Functions^[1] for the Office for Human Research Protections (OHRP)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Office of the Assistant Secretary for Health (OASH)^[2]

Part L. Office for Human Research Protections

The Office for Human Research Protections (OHRP) fulfills responsibilities set forth in the Public Health Service Act. These include: (1) Providing leadership for human research subjects protections within the Department of Health and Human Services (DHHS) and for the U.S. Government in cooperation with other Federal Agencies; (2) developing and monitoring as well as exercising compliance oversight relative to DHHS regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services; (3) promoting and coordinating appropriate DHHS regulations, policies, and procedures both within DHHS and in coordination with other Departments and Agencies in the Federal Government; (4) establishing criteria for approval of assurances of compliance for the protection of human subjects with both domestic and foreign institutions engaged in DHHS-conducted or supported research involving human subjects; (5) conducting programs of clarification and guidance for both the Federal and non-Federal sectors with respect to the involvement of humans in research; and directing the development and implementation of educational and instructional programs and generating educational resource materials; (6) evaluating the effectiveness of DHHS policies and programs for the protection of human subjects; (7) serving as liaison to Presidential, Departmental, Congressional, interagency, non-governmental, and international commissions and boards to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues; and (8) promoting the development of approaches to enhance and improve methods, particularly quality improvement at the institutional level, to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes.

65 FR 37136, dated June 13, 2000, as amended by 67 FR 10216, dated March 6, 2002

Subpart 1. Office of the Director

The Office of the Director reports to the Assistant Secretary for Health, and (1) provides leadership within DHHS on ethical and other issues associated with protection of human subjects in research; (2) supervises and manages the development and promulgation of policies, procedures, and plans for meeting the responsibilities set forth above; (3) advises the Secretary, Assistant Secretary for Health and other DHHS officials on ethical issues pertaining to medical, biomedical, behavioral, social, health services, public health and other research, including all issues relative to the implementation of DHHS Regulations for the Protection of Human Subjects; (4) directs the development, implementation, and compliance oversight activities for DHHS Regulations and for the protection of human subjects; (5) establishes criteria for approval of and exercises oversight of assurances of compliance for protection of human subjects in all areas of human subject research; (6) maintains liaison and coordinates policy implementation with components throughout DHHS that conduct and support research involving human subjects; (7) directs the implementation of quality improvement programs through the development and implementation of educational and instructional programs, including generation of resource materials relating to the responsibilities of the research community for the protection of human subjects; (8) engages in international activities related to human research subject protections, particularly global efforts to achieve harmonization of policies and procedures and for the building of global capacity to enhance protections for human subjects participating in research; and (9) provides staff support for the Secretary's Advisory Committee on Human Research Protections.

65 FR 37136, dated June 13, 2000, as amended by 67 FR 10216, dated March 6, 2002, and 68 FR 60392, dated October 22, 2003

Subpart 2. Division of Policy and Assurances

(1) Maintains, develops, promulgates, and updates policy and guidance documents regarding regulatory requirements and ethical issues for biomedical and behavioral research involving human subjects; (2) coordinates appropriate DHHS regulations, policies and procedures with other Departments and agencies in the Federal Government; (3) organizes and coordinates consultations with panels of experts for research involving prisoners and children, when required by DHHS regulations for the protection of human subjects at 45 CFR 46.306 and 46.407, respectively; (4) coordinates responses to requests for information, technical assistance, and guidance from Congress, other DHHS agencies, other Federal Departments and agencies, and non-governmental entities; (5) coordinates responses to requests for OHRP documents and information under the Freedom of Information Act; (6) Negotiates Assurances of Compliance with research entities; (7) provides liaison, guidance, and regulatory interpretation to research entities, investigators, Federal officials, and the public; (8) maintains and modifies, as necessary, existing assurance mechanisms; and (9) operates and maintains a registration system for institutional review boards; and (10) develops and implements new procedures to ensure that DHHS human subjects protection regulations are appropriately and effectively applied to the changing needs of the research community.
65 FR 37136, dated June 13, 2000, replaced by 68 FR 60392, dated October 22, 2003

Subpart 3. Division of Compliance Oversight

(1) Conducts inquiries and investigations into alleged noncompliance with HHS Regulations for Protection of Human Subjects; (2) prepares inquiry and investigative reports; (3) recommends remedial or corrective action as necessary to agency or Department officials as appropriate; and (4) conducts a program of oversight of awardee institution implementation of HHS Regulations for the Protection of Human Subjects.

65 FR 37136, dated June 13, 2000

Subpart 4. Division of Education and Development

(1) Develops and conducts education conferences, workshops and other training tools, and quality improvement activities to improve protections for human research subjects; (2) provides liaison to Federal officials and guidance and regulatory interpretation to research entities, investigators, and the public regarding ethical issues in biomedical and behavioral research involving human subjects; (3) provides technical assistance to institutions engaged in conducted or sponsored research involving human subjects; (4) maintains, promulgates, and updates educational guidance materials and quality improvement activities and materials related to protection of human research subjects; (5) conducts public outreach and education or information programs to promote and enhance public awareness of the activities of OHRP and human subject protections; and (6) provides staff support to the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council^[3].

65 FR 37136, dated June 13, 2000, replaced by 68 FR 60392, dated October 22, 2003