Amendment of Statement of Organization, Functions, and Delegations of Authority for the Office of Human Research Protections

AGENCY:

Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office for Human Research Protections.

ACTION:

Notice.

SUMMARY:

This amendment describes modifications in the functions of the Immediate Office of the Director, Office for Human Research Protection, (OHRP), to include international functions, changes the name and functions of the former Division of Policy and Assurance, establishes a Division of Policy Planning and Special Projects, and updates the 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), Office for Human Research Protections (OHRP), as last amended at 65 FR 37136, dated June 13, 2000, is being amended as following:

I. Part L, description of OHRP, is deleted in its entirety and replaced with the following:

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) 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.

II. Amend Part L, subpart 1, by replacing it in its entirety with the following:

1. Office of the Director (ACN1)—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; and (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.

III. Amend Part L, subpart 2, by replacing it in its entirety with the following:

2. Division of Assurances and Quality Improvement (ACN 2)—(1) Receives and approves assurances of compliance from research entities; (2) provides liaison, guidance and regulatory interpretation to research entities, investigators, Federal officials and the public; (3) operates and maintains a registration system for institutional review boards; (4) maintains and modifies as necessary assurance mechanisms and procedures; (5) develops and conducts quality improvement activities to improve protections for human research subjects; and (6) develops and implements new procedures and instruments to ensure DHHS human subjects protections regulations are appropriately and effectively applied in a manner consistent with the changing needs of the Federal Government, the research community and society.

III. Amend Part L, by adding a subpart 5 as follows:

5. Division of Policy Planning and Special Projects (ACN 5)—(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) conducts public outreach and education or information programs to promote and enhance public awareness of the activities of OHRP and human subject protections; (4) provides staff support to the National Human Research Protections Advisory Committee; (5) provides staff support to the Human Subjects Research Subcommittee, Committee on Science, National Science and Technology Council; (6) 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; (7) coordinates responses to requests for information, technical assistance and guidance from Congress, other DHHS agencies, other Federal Departments and agencies, and non-governmental entities; (8) coordinates responses to requests for OHRP documents and information under the Freedom of Information act; and (9) manages and conducts special projects as requested by the Director, OHRP.

IV. Amend Part E, Chapter AC as follows:

E. Delegation of Authority: The Secretary's authority under Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) has been delegated to the Assistant Secretary for Health, 44 Fed. Reg. 46318 (August 7, 1979). Authority under Section 491 of the Public Health Service Act (42 U.S.C. 289) is re-delegated to the Director, OHRP, to perform all of the authorities previously delegated to the Assistant Secretary for Health, 44 Fed. Reg. 46318. Consistent with the prior delegation of authority to the Assistant Secretary for Health, this re-delegation to the Director, OHRP, excludes the authorities to promulgate regulations, submit reports to the President or the Congress, approve organizational changes, and establish and select members of national advisory councils and boards. Previous delegations and re-delegations of authority under section 491 of the PHS act are superceded.

V. Amend Part G, Chapter AC as follows:

G. Effective Date: The effective date of the foregoing amendments to the organization, functions and delegations of authority for the Office for Human Research Protections is March 18, 2002.