This page includes key information about engagement in research and federal regulations regarding research ethics training. This information may be helpful when communicating with your IRB.
The Common Rule (45CFR 46) regulates activities defined as human subjects research.
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of people involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) offers accreditation for institutions that conduct human subjects research. AAHRPP accreditation means an organization meets AAHRPP standards for protecting human subjects in research.
OHRP provides guidance to institutions on what it means to be engaged in research; this guidance is relied on by most institutions.
In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain:
data about the subjects of the research through intervention or interaction with them
identifiable private information about the subjects of the research
the informed consent of human subjects for the research.
Institutions are generally not considered engaged when they inform prospective research participants about a research participation opportunity, even if they share consent/assent forms or seek or obtain permission for investigators to contact them about research, or allow the use of their facilities for research purposes.
Principal investigators can work with their IRBs to identify which people and which organizations are engaged in human subjects research for each IRB protocol. Not all people who are part of a research team or who help a research project may be considered engaged in human subjects research.
The Common Rule does not regulate training of investigators and key research personnel.
Investigators and all key personnel who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the protection of human subjects and responsible conduct of research education requirements. Most institutions extend this requirement to all regulated research in their Federalwide Assurance (FWA).The National Science Foundation also has educational requirements.
AAHRPP accreditation standards address expectations for researchers and research staff with regard to their education and qualifications in the following elements:
Element I.1.E: The organization has an education program that contributes to the improvement of the qualifications and expertise of individuals responsible for protecting the rights and welfare of research participants.
ELEMENT III.1.D: Researchers determine that the resources necessary to protect participants are present before conducting each research study.
ELEMENT III.2.A: Researchers and research staff are qualified by training and experience for their research roles, including knowledge of applicable laws, regulations, codes, and guidance; relevant professional standards; and the organization’s policies and procedures regarding the protection of research participants.
AAHRPP standards direct institutions to understand that the protection of research participants is a shared responsibility and involves individuals being able to understand and apply several areas of knowledge, including ethical principles, professional standards, organizational policies and procedures, and laws, regulations, codes, and guidance.
AAHRPP standards note “the depth of knowledge and skill required depends on each individual’s specific task and role” and expect that “an organization should have a process to ensure that individuals involved with human research protection have appropriate knowledge and skills.”
These standards further note that researchers (principal investigators) are responsible for ensuring that they have the resources required, including qualified research team members, to conduct research in a way that will protect the rights and welfare of research participants and ensure the integrity of the research. That is, researchers (principal investigators) are responsible for implementing a process for all “persons assisting with the research are adequately informed about the protocol and their research-related duties and functions.”
Lastly, AAHRPP standards note that researchers and research staff should be qualified by training and experience for their roles and responsibilities in conducting research so that they follow the protocol and abide by the organization’s policies and procedures.
The Common Rule does not specify educational standards or methods, though most institutions follow NIH’s recommendations on education requirements for investigators and key research personnel.
AAHRP accreditation standards note that:
key personnel must be educated;
education can be tailored to the role; and
principal investigators bear responsibility for making sure key personnel are qualified.
That is, principal investigators must have protocols to ensure research team members are adequately informed about the protocol and their research-related duties and functions and provide oversight.
Research Ethics for All may be an appropriate education program for community research partners who are engaged in human subjects research.