ELEMENT I.1.D.

ELEMENT I.1.D.: The organization has and follows written policies and procedures setting forth the ethical standards and practices of the Human Research Protection Program. Relevant policies and procedures are made available to sponsors, researchers, research Staff, research participants, and the Institutional Review Board or Ethics Committee, as appropriate.

The protection of research participants is the responsibility of many individuals involved with the HRPP, including IRB or EC members, chairs, and staff; researchers and research staff; and the organizational official. The organization should define the roles and responsibilities of individuals responsible for the conduct or oversight of human research. Individuals should understand their roles and responsibilities. This Element includes both the responsibility to follow laws, regulations, codes, and guidance and the requirement to understand and apply ethical principles governing research.

An organization should communicate its expectations of those involved in research. The level of communication required depends on the degree of involvement and role within the HRPP. For example, the policies and procedures most relevant to researchers and research staff are different from those relevant to the IRB or EC staff. An organization should make copies available of policies and procedures, or provide guidelines, abstracts, summaries that communicate the relevant points.

Organizations must apply DHHS regulations to covered research. However, organizations can apply different but equivalent policies to research not covered by DHHS regulations.

An organization should define all of the components (internal and external) that are involved with human research protection and ensure that those components communicate among themselves and function as an integrated program of protection.

Independent IRBs or ECs should consider not only components within their organization but also the components of organizations for which they serve as the IRB of record.

Regulatory and guidance references

DHHS: 45 CFR 46.103(b)(4), 45 CFR 46.103(b)(5)
DOJ: 28 CFR 512
EPA: 40 CFR 26, 40 CFR 26.201-203, 40 CFR 26.304, 404-405, 40 CFR 26.1101-1125, 40 CFR 26.12.01-1203; EPA Order 1000.17 Change A1
FDA: 21 CFR 56.108(a), 21 CFR 56.108(b)
ICH-GCP: 2.1, 2.3, 2.6, 2.13, 3.3.6, 4.5.1
VA: 38 CFR 16.103(b)(4), 38 CFR 16.103(b)(5), VHA Handbook 1200.05, 7,8
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. Policies and procedures describe the ethical principles that the organization follows to govern the conduct of research involving human participants.
2. Policies and procedures describe the ethical obligations and expectations of:
  1. Researchers and research staff, including students involved in the conduct of research.
  2. IRB or EC members and chairs.
  3. IRB or EC staff.
  4. The organizational official.
  5. Employees.
  6. Students.
3. Policies and procedures describe the mechanism for communicating or making available the policies and procedures of the HRPP to all individuals.
4. Policies and procedures describe the mechanism for communicating changes in the policies and procedures to all individuals.
5. Policies and procedures include a description of all components that are involved with human research protection, including:
  1. The roles and responsibilities for each component.
  2. The relationships among the components.
  3. A description of the ways the components of the organization communicate and work together to protect participants.
When following DOJ requirements:
1. For research conducted within the Bureau of Prisons, the organization, IRB or EC, and researchers and research staff must follow the requirements of 28 CFR 512, including:
  1. The project must not involve medical experimentation, cosmetic research, or pharmaceutical testing.
  2. The research design must be compatible with both the operation of prison facilities and protection of human participants. The researcher must observe the rules of the institution or office in which the research is conducted.
  3. Any researcher who is a non-employee of the Bureau must sign a statement in which the researcher agrees to adhere to the requirements of 28 CFR 512.
  4. All research proposals will be reviewed by the Bureau Research Review Board.
When following EPA regulations:
1. Policies and procedures include that for research conducted or supported by the EPA:
  1. EPA prohibits research involving the intentional exposure of pregnant women, nursing women, or children to any substance.
  2. EPA requires application of 40 CFR 26 Subparts C and D to provide additional protections to pregnant women and children as participants in observational research, i.e., research that does not involve intentional exposure to any substance.
  3. EPA requires submission of IRB determinations and approval to the EPA human subjects research review official for final review and approval before the research can begin.
2. Policies and procedures include that for research not conducted or supported by any federal agency that has regulations for protecting human research participants and for which the intention of the research is submission to the EPA, the EPA regulations protecting human research participants apply, including:
  1. EPA extends the provisions of the 40 CFR 26 to human research involving the intentional exposure of non-pregnant, non-nursing adults to substances.
  2. EPA prohibits the intentional exposure of pregnant women, nursing women, or children to any substance.
When following the ICH-GCP (E6) guideline:
1. Policies and procedures include a statement that clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and the applicable regulatory requirements.

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

HRPP plan
IRB or EC policies and procedures
Researcher handbook

Outcomes

The organization follows ethical standards and practices.
Individuals in the organization follow ethical standards and practices.
The organization makes available to individuals involved or likely to be involved in research policies and procedures governing research with human participants.
Individuals are kept up to date with new information and policies and procedures.
Individuals are able to access policies and procedures.

Proceed To: ELEMENT I.1.E.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.1.D.