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 Directive 1200.05(3) section (15), VHA Directive 1200.01(1) section 10

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. Collaborative Research is human participants research activities involving researchers from VA and at least one non-VA institution.
  1. Each institution is responsible for safeguarding the rights and welfare of human participants and providing oversight of the research activities conducted by that institution.
  2. Each collaborating institution engaged in human participants research must obtain approval from its IRB of Record and hold an FWA or another assurance acceptable to VA (e.g. DoD assurance).
  3. VA researchers must submit a protocol or other documentation to their VA IRB of Record and the R&D Committee that clearly delineates 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).
  4. 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.
    1. 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.
  5. The protocol, protocol addendum, and/or subcommittee application must describe the data (identifiable or de-identified) to be disclosed to collaborators, the entity(ies) to which the data are to be disclosed, the method of how the data are to be transmitted, and the person who will own or have responsibility for the disclosed copies of the data. This includes data developed directly from the research including the analytic data and the aggregate data.
    1. All disclosures and data transmission must meet privacy and security requirements per VHA Directive 1605.01 and VA Handbook 6500.
  6. The protocol, addendum, and/or subcommittee application must describe the applicable collection, use, transfer, and disposition of biospecimens obtained or collected.
  7. For VA facilities:
    1. Each VA facility must retain a complete record of all data obtained during the VA portion of the research in accordance with privacy requirements, the Federal Records Act, and VHA Record Control Schedule 10-1.
    2. A Material Transfer Agreement (MTA) must be used to transfer biospecimens from VA unless the biospecimens’ transfer is addressed in another agreement executed between VA and the receiving institution or party, such as a CRADA, subaward, or MOU. NOTE: If a CRADA is executed for a research study where the scope of work specifically describes analysis, retention, and disposal of biospecimens by a central laboratory, then an MTA is not required.

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.