Below is information about engagement in research and federal regulations regarding research ethics training that may be helpful when communicating with your IRB.
In the US, the Common Rule (45CFR 46) regulates activities defined as human subjects research.
The US 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 on engagement in human subjects research; this guidance is relied on by most institutions.
In general, an institution is considered engaged in a non-exempt human subjects research project when its employees or agents obtain for the purposes of the research project:
Institutions are generally not considered engaged when they inform prospective research participants about a research participation opportunity, even if they share consent or 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 IRB to identify which people and which organizations are engaged in human subjects research for each research project. Some people who are part of a research team or who help a research project may not 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 NIH’s protection of human subjects and responsible conduct of research education requirements. Some funders, including PCORI, adhere to NIH’s policy. Most institutions extend NIH’s requirement to all regulated research in their Federalwide Assurance (FWA), an assurance of compliance with the US federal regulations for the protection of human subjects in research. 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:
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 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 research study’s 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; other funder requirements may also apply.
AAHRP accreditation standards note that:
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 because it is tailored to the roles of community research partners and addresses the type of research activities in which they are likely to engage.