ELEMENT I.8.E.

ELEMENT I.8.E.: When participant safety could be directly affected by study results after the study has ended, the organization has a written agreement with the sponsor that the researcher or organization will be notified of the results in order to consider informing participants.

In some cases, findings emerge after a research study has ended that directly affect the safety of past participants and were not anticipated at the time the study was designed or conducted. In such cases, past participants should be notified of the new findings. An organization that works directly with a sponsor or its agents should include in the contract or other agreement how such results will be communicated to the organization.

Regulatory and guidance references

AAHRPP Tip Sheet: Provisions in Contracts and Funding Agreements

Required written materials

Essential requirements:
1. Policies and procedures have contracts or other funding agreements describe the steps followed to communicate findings from a closed research study to the researcher or organization when those findings directly affect participant safety.
  1. Policies and procedures have contracts or other funding agreements specify a time frame after closure of the study during which the sponsor will communicate such findings.
    1. The time frame may be a specific time period (for example, two years).
    2. The time frame may be based on a specific triggering event (such as completion of data analysis)
    3. The time frame may be left open-ended or the requirement can be included or referred to in a survivor clause.
2. For independent IRBs:
  1. If the organization contracts directly with sponsors or clinical research organizations, contracts or other funding agreements include a requirement that sponsors communicate findings from a closed research study to the IRB when those findings directly affect participant safety.
    1. Specify a time frame or triggering event after closure of the study during which the sponsor will communicate such findings (for example, two years; or after the close of data analysis), when appropriate.
  2. Policies and procedures include the process used to ensure that contracts with the researcher obligate the sponsor to notify the researcher or organization conducting the research any study results after the study has ended that could directly affect participant safety, such as an attestation or other written statement from the researcher or clinical research organization, for example a master service agreement or work order.
    1. Specify a time frame or triggering event after closure of the study during which the sponsor will communicate such findings (for example, two years; or after the close of data analysis), when appropriate.
    2. Policies and procedures require researchers or the organization conducting the research to forward this information to the IRB.

Outcomes

Contracts and other funding agreements describe the steps followed to communicate results from a research study to former participants when those results directly affect their safety or medical care.
For independent IRBs attestations or other written statements or agreements describe the steps followed to communicate results from a research study to former participants when those results directly affect their safety or medical care, and to inform the IRB.

Proceed To: STANDARD I-9

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT I.8.E.