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 443.1C (November 2019)

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, regardless of funding source), or by DOE contractor personnel (regardless of funding source or location conducted), and whether done domestically or in an international environment, including classified and proprietary research, may be initiated without both a Federalwide Assurance (FWA) or comparable assurance (e.g., Department of Defense assurance) and approval by the cognizant IRB in accordance with 10 CFR Part 745.103.
2. The Human Subjects Protection (HSP) Program Manager (and when an NNSA element is involved, the NNSA HSP Program Manager) must be notified in writing prior to initiation of the HSR portion of a new project, even if it meets the regulatory definition of exempt HSR as outlined in 10 CFR Part 745.104, that involves:
  1. An institution without an established IRB.
  2. A foreign country.
  3. A potential for significant controversy (e.g., negative press or reaction from stakeholder or oversight groups).
  4. Research subjects in a protected class (prisoners, children, individuals with impaired decision making, or DOE/NNSA federal or DOE/NNSA contractor employees as human subjects, who may be more vulnerable to coercion and undue influence to participate) that is outside of the reviewing IRB’s typical range/scope.
  5. The generation or use of classified information.

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