Element II.2.I.

Element II.2.I.: The IRB or EC has and follows policies and procedures for managing multi-site research by defining the responsibilities of participating sites that are relevant to the protection of research participants, such as reporting of unanticipated problems or interim results.

This Element applies when the IRB or EC reviews research where the researcher under the oversight of the HRPP is responsible for the overall conduct of the study. That is, the researcher is the lead researcher of a multi-site study or provides study-wide services such as for data coordination. In such cases, policies and procedures should describe the steps the IRB or EC follows to communicate among the sites involved in the multi-site study on issues other than IRB or EC review. Such communications might include reporting of unanticipated problems, protocol modifications, and interim

results.

Regulatory and guidance references

DoD: Instruction 3216.02 2 (3) (b); SECNAVINST 3900.39D 6f
VA: VHA Handbook 1200.05, 9; VHA Handbook 1200.01

Required written materials

Essential requirements:
1. Policies and procedures describe oversight of research where the researcher is responsible for the overall conduct of the study (for example, serving as the lead researcher of a multi-site study)
  1. Policies and procedures have applications include information about the management of information that is relevant to the protection of participants, such as:
    1. Unanticipated problems involving risks to participants or others.
    2. Interim results.
    3. Protocol modifications.
  2. When the researcher is the lead researcher of a multi-site study, policies and procedures have the IRB or EC evaluate whether the management of information that is relevant to the protection of participants is adequate.
When following DoD requirements:
1. When conducting multi-site research, policies and procedures indicate that a formal agreement between organizations is required to specify the roles and responsibilities of each party. (See Standard I-9)
When following VA requirements:
1. Policies and procedures indicate that for a VA multisite study, not only the principal researcher, but also all local site researchers, must obtain written approvals from the relevant local VA facilities’ IRBs of record and all other local committees, subcommittees, and other approvals according to the respective applicable local, VA and other federal requirements.
  1. Research cannot be initiated at any given site until the local researcher has obtained written notification that the research can be initiated from the local associate chief of staff for research and development.
  2. Policies and procedures include a definition of collaborative research.
  3. Policies and procedures indicate that collaboration is encouraged when non-VA researchers have a substantial role in the design, conduct, or analysis of research.
  4. Policies and procedures indicate that collaborative research may not be undertaken without a signed agreement that addresses the responsibilities of each party, including ownership of data and reuse of data for other research.
2. Collaborative research is human participants research activities involving researchers from VA and at least one non-VA institution. Collaborative Research includes VA and non-VA institutions.
  1. The protocol or other documentation submitted to their VA IRB of Record must clearly delineate which research activities will be conducted as the VA portion of the overall Collaborative Research study (e.g., by VA researchers on VA time or VA property).
  2. The VA informed consent document must clearly state when procedures conducted at other non-VA institutions are part of the VA’s portion of the study.
  3. Each institution engaged in the collaborative research must use the informed consent document required by its respective institutional policies for participants recruited from that institution, or procedures requiring participation of the participants at that institution. The informed consent document may contain information on the project as a whole as long as the document clearly describes which procedures will be performed under VA’s auspices and which will be performed under a non-VA institution’s auspices.
  4. The protocol, addendum, and/or IRB of Record application must describe the data to be disclosed to collaborators, the entities to which the data are to be disclosed, how the data are to be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom. This includes data from individual participants as well as other data developed during the research such as the analytic data and the aggregate data.

Outcomes

There is communication among the IRBs of sites participating in a multi-site study.

Proceed To: STANDARD II-3

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

Element II.2.I.