Office of Public Health and Science, and National Institutes of Health, Office of the Director; Statement of Organization, Functions, and Delegations of Authority

Part A, Office of the Secretary (OS) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (DHHS), Chapter AC, Office of Public Health and Science (OPHS), the Immediate Office (ACA) as last amended at 62 FR 5009-10, dated February 3, 1997; and Part N, the National Institutes of Health, Office of the Director (NA), Office of Extramural Research (NA3), Office for Protection from Research Risks, as last amended at 65 FR 11792, March 6, 2000, are being amended to reflect the transfer of the human research protection functions from the NIH to the newly established Office for Human Research Protections (OHRP), OPHS, within the OS. The OHRP will be headed by a Director who will report to the Assistant Secretary for Health.

The changes are as follows:

I. Under Part N, National Institutes of Health, Chapter NA, Office of Director, Office of Extramural Research (NA3), make the following changes:

A. Delete the “Office of Extramural Research (NA3)” in its entirety and replace with the following:

Office of Extramural Research (NA3)—(1) Acts on behalf of the NIH Director to provide guidance to the research institutes on the development and management of extramural (grant and cooperative agreement) research and training programs; (2) advises the NIH Director and staff on issues relating to extramural research activities; and (3) oversees the proper care and use of laboratory animals on behalf of the entire U.S. Public Health Service.

B. Delete the “Office for Protection from Research Risks (NA33)” in its entirety.

II. Under Part A, Chapter AC, Office of Public Health and Science, make the following changes:

A. Delete Section AC.10 Organization in its entirety and replace with the following:

Section AC.10 Organization. The Office of Public Health and Science (AC) is under the direction of the Assistant Secretary for Health and consists of the following components:

A. Immediate Office (ACA)

B. Office on Women's Health (ACB)

C. Office of Minority Health (ACC)

D. Office of the President's Council on Physical Fitness and Sports (ACE)

E. Office of Research Integrity (ACF)

F. Office of Population Affairs (ACG)

G. Office of International and Refugee Health (ACH)

H. Office of HIV/AIDS Policy (ACJ)

I. Office of Emergency Preparedness (ACK)

J. Office of Disease Prevention and Health Promotion (ACL)

K. Office of the Surgeon General (ACM)

L. Office for Human Research Protections (ACN)

B. Amend Chapter AC.20 Functions, paragraph A, “Office of Public Health and Science,” paragraph titled, “The Immediate Office (ACA)” by adding the following new clause:

(m) Responsible for overseeing human research subjects protections functions and related functions where research involves the use of human subjects.

C. Under Section AC.20 Functions, add paragraph “L. Office for Human Research Protections (ACN),” to read as follows:

L. Office for Human Research Protections (ACN)—The Office for Human Research Protections (OHRP) fulfills responsibilities set forth in the Public Health Service Act. These include: (1) Developing and monitoring as well as exercising compliance oversight relative to HHS Regulations for the protection of human subjects in research conducted or supported by any component of the Department of Health and Human Services; (2) coordinating appropriate HHS regulations, policies, and procedures both within HHS and in coordination with other Departments and Agencies in the Federal Government; (3) establishing criteria for and negotiation of Assurances of Compliance with institutions engaged in HHS-conducted or—supported research involving human subjects; (4) 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 instructural programs and generating educational resource materials; (5) evaluating the effectiveness of HHS policies and programs for the protection of human subjects; (6) serving as liaison to Presidential, Departmental, Congressional, interagency, and non-governmental commissions and boards established to examine ethical issues in medicine and research and exercises leadership in identifying and addressing such ethical issues; and (7) promoting the development of approaches to enhance and improve methods to avoid unwarranted risks to humans participating as subjects in research covered by applicable statutes and regulations.

1. Office of the Director (ACN1)—The Office of the Director reports to the Assistant Secretary for Health, supervises and manages the development and promulgation of policies, procedures, and plans for meeting the responsibilities set forth above. Additionally, staff of this office advise the Secretary, Assistant Secretary for Health and other HHS officials on ethnical issues pertaining to medicine and biomedical and behavioral research, including all issues relative to the implementation of HHS Regulations for the Protection of Human Subjects. Directs the development, implementation, and compliance oversight activities for HHS Regulations and for the Protection of Human Subjects; exercises oversight and negotiates Assurances of Compliance in all areas of human subject research; maintains liaison and coordinates policy implementation with components throughout HHS that conduct or support research involving human subjects; and directs the development and implement of educational and instructional programs and generates resource materials relating to the responsibilities of the research community for the protection of human subjects.

2. Division of Policy and Assurance (ACN 2)—(1) Negotiates Assurances of Compliance with research entities; (2) provides liaison, guidance, and regulatory interpretation to research entities, investigators, Federal officials, and the public; (3) maintains existing assurance mechanisms; and (4) develops and implements new procedures to ensure that HHS human subjects protection regulations are appropriately and effectively applied to the changing needs of the research community.

3. Division of Compliance Oversight (ACN 3)—(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.

4. Division of Education and Development (ACN 4)—(1) Produces and coordinates conferences and workshops focusing on issues in human subjects protection; (2) promotes cooperative education and development efforts among external groups and consortia to improve human subjects protections and related processes; (3) promptly responds to requests for clarification and guidance regarding ethnical issues in biomedical and behavioral research involving human subjects; (4) provides technical assistance to institutions engaged in HHS-conducted or -sponsored research involving human subjects; and, (5) maintains, promulgates, and updates educational and institutional review guidance materials.

D. Continuation of Policy: Except as inconsistent with this reorganization, all statements of policy and interpretations with respect to the National Institutes of Health and the Office of the Secretary heretofore issued and in effect prior to this reorganization are continued in full force and effect.

E. Delegation of Authority: All delegations and redelegations of authority made officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization.

F. Funds, Personnel, and Equipment: Transfer or organizations and functions affected by this reorganization shall be accompanied by direct and support funds, positions, personnel, records, equipment, supplies and other resources.

G. Effective Date: The effective date of this reorganization is June 18, 2000.