ELEMENT I.1.B

ELEMENT I.1.B: The organization delegates responsibility for the Human Research Protection Program to an official with sufficient standing, authority, and independence to ensure implementation and maintenance of the program.

An organization should have an identified, knowledgeable leader of the HRPP who is responsible for the program and has the authority to implement the program. Although this individual may rely on others for the interpretation of laws, regulations, codes, and guidance and the day-to-day operations of the HRPP, this individual should have a basic understanding of the relevant laws, codes, regulations and guidance that govern research involving human participants, the responsibilities of an organizational official, and the responsibilities of the IRB or EC and researchers and research staff in protecting research participants. This individual should be directly involved in the allocation of resources to the HRPP. In some circumstances, more than one individual serves in this capacity.

This Element is applicable to all organizations, regardless of whether the organization has a federal assurance of compliance. If an organization has a federal assurance of compliance, the identified leader of the HRPP might or might not be the official who signs the assurance

Regulatory and guidance references

DHHS: 45 CFR 46.103(c)
DOE: 10 CFR 745, DOE Order 443.1B, Chg. 1 (April 21, 2016), DOE Notice 443.1 (January 21, 2016), and their accompanying Contractor Requirements Documents (CRDs)
VA: VHA Handbook 1200.01, 05, 06; VA Handbook 1058.01

Required written materials

Essential requirements:
1. Policies and procedures describe the responsibilities of the organizational official.
2. If more than one person is designated as an organizational official, the unique responsibilities of each individual that relate to the HRPP are stated.
When following DOE requirements:
1. No human participant research conducted with DOE funding at DOE institutions (Headquarters or sites/ laboratories, regardless of funding source), or by DOE employees and contractor personnel (regardless of funding source or location conducted), and whether done domestically or in an international environment, including classified and proprietary research, shall be initiated without both a Federalwide Assurance and approval by the cognizant IRB in accordance with 10 CFR Part 745.103.
2. For research conducted at a DOE facility, the DOE Institutional Official is responsible for:
  1. Ensuring the Central DOE Review Board and the Central DOE Institutional Review Board-Classified comply with applicable requirements.
  2. Formally appointing the chair, vice-chair, and other IRB members.
  3. Approving classified research conducted with DOE funding at its sites/laboratories and by its employees and contractors after IRB approval and prior to initiation.
3. For research conducted at a DOE facility, the DOE Human Subjects Protection Program Manager is responsible for:
  1. Developing procedures for the classified research program in consultation with the National Nuclear Safety Administration Human Subject Protection Program Manager.
  2. Conducting biennial performance reviews of all IRBs that review classified research involving human participants to assess compliance, in consultation with the National Nuclear Security Administration human participant protection program manager.
  3. Reviewing and approving local plans to correct noncompliance or mitigate adverse events and unanticipated problems involving risks to participants or others.
  4. Reviewing and approving statements of work for classified Human Terrain Mapping projects submitted by DOE’s non-National Nuclear Security Administration sites or projects.
  5. Making recommendations to the Secretary after concurrence from the organizational Official, on a project by project basis, regarding exemptions from the requirements for classified research.
  6. Concurs on human participant provisions for classified research in interagency agreements, in consultation with the National Nuclear Security Administration, as appropriate.
  7. Maintaining an unclassified list of classified projects.
When following VA requirements:
1. Policies and procedures describe the responsibilities of the facility director:
  1. Serves as the organizational Official responsible for the facility’s research program, and the development and implementation of a human research protection program. This responsibility cannot be delegated.
  2. Oversees the research and development committee, the IRB, other subcommittees of the research and development committee, and all VA researchers and research staff.
  3. Delegates authority in writing for respective roles and responsibilities for the HRPP. This delegation of authority must provide the organizational structure and ensure leadership for oversight activities for all human subjects research conducted at or by the facility.
  4. Obtains permission from the central research and development officer if the facility wants to establish a new IRB or change the IRB of record, and ensuring any IRB is established according to VA requirements, and has approval from the Office of Research Oversight (ORO).
  5. When the facility engages another entity’s IRB, ensures responsibilities are detailed in a memorandum of understanding or authorizing agreement.
  6. Obtains accreditation of the facility’s HRPP by the accrediting organization specified by the VA Office of Research and Development (ORD), in accordance with a schedule determined by ORD.
  7. Ensures that IRB members, researchers and research staff are appropriately knowledgeable to conduct research in accordance with ethical standards and all applicable regulations.
  8. Develops and implements an educational plan for IRB members, staff, researchers, and research staff including initial and continuing education.
  9. Fulfills all educational requirements mandated by ORD and OHRP.
  10. Appoints one or more research compliance officers to conduct annual research consent document audits and triennial regulatory audits, and to assist in the VA facility’s assessments of regulatory compliance.
  11. Unless a waiver for a part-time research compliance officer is approved by the under secretary for health, each VA facility conducting research must designate at least one full-time research compliance officer.
  12. Reports any appointment, resignation, or change in status of the research compliance officer to Office of Research Oversight VHA Central Office, with a copy to the relevant ORO research officer, within 10 business days after the appointment, resignation, or change takes effect.
  13. Reports to ORO in writing within two business days after being notified of any research-related citation or determination of non-compliance by any state or federal agency; or any situation that has generated media attention or Congressional interest.
  14. The facility director’s written report is required regardless of whether disposition of the event has been resolved at the time of the report.
  15. Follow-up reports detailing any additional findings and appropriate remedial actions must be provided to the relevant ORO office at intervals and in a manner specified by that office.
  16. Provides a copy of any ORO compliance reports regarding the research program to the associate chief of staff for research, Research and Development Committee, any relevant research review committee(s), and the research compliance officer in a timely fashion.
  17. Reports the following research events to ORO Central Office, with a simultaneous copy to the appropriate ORO research officer:
  18. IRB changes in number of IRBs and changes in membership rosters.
  19. Substantive Memorandum of Understanding (MOU) changes must be reported to ORO Central Office within five business days.
  20. Ensures that individuals working under a contract with VA cannot serve as VA investigators, but may participate in research in other ways, such as collaborators or consultants.

Common types of materials that may be used to meet the element

Letter or memorandum from senior management stating the delegation
Job description of the organizational official

Outcomes

The organizational official has overall responsibility for the HRPP.
The organizational official is identifiable by those within the organization.
The organizational official has sufficient standing, authority, knowledge, and independence to ensure implementation and maintenance of the program.

Proceed To: ELEMENT I.1.C.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.B