SOP 037: Research Related Injury | Office of Human Research Protections

Document	Version #	Effective Date
SOP-037	2.0	08/08/2022

1. Purpose

This SOP lays out the process and responsibilities for the WVU IRB to assure that research participants have knowledge of compensation and treatment availability for injury that may occur as a result of participating in research activities. This policy does not apply to remuneration or other compensation for research participation. For commercially sponsored studies, compensation, or payment of immediate necessary care for injury related to participation in research activities shall be provided according to the Informed Consent Document.

2. Procedures

2.1. The researcher will insert language into the Informed Consent Document regarding immediate necessary care in the event of a research-related injury.

2.2. For commercially sponsored studies, the investigator will include language regarding compensation or payment of immediate necessary care for injury related to participation in research activities. The contractual agreement between the sponsor and the West Virginia University made through the Office of Sponsored Programs will have a general statement which explains the description of who will be responsible for medical care costs stemming from research-related injuries is found in the Informed Consent Document.

2.3. The IRB will review and approve the proposed compensation and injury language as a part of the new study submission.

2.4. The IRB will render its determination for approval of compensation or medical treatment for medical injury by: verifying that the template language for injury is contained in the Informed Consent Document; and reviewing the injury language to assure readability and understandability, and non- exculpation in relation to the proposed target study population.

2.5. In the event the sponsor requests conflicting language in the contract during the negotiation with the Office of Sponsored Programs, the contract may not be finalized until the Informed Consent Document is verified to be congruent with the sponsor’s contract language. The Office of Sponsored Programs and the WVU OHRP staff will work together to ensure the accuracy of the language. If any changes are made to the approved Informed Consent Document, they must be approved by the IRB.

2.6. Contracts or other funding agreements require the sponsor to promptly (no longer than within 30 days) report to WVU any findings that could:

Affect the safety of participants.
Influence the conduct of the study or alter the IRB's approval to continue the study.

2.7. Contracts or other funding agreements require the sponsor to send data and safety monitoring plans and reports to WVU. Contracts or other funding agreements specify the time frame for providing routine and urgent data and safety monitoring reports to WVU as indicated in the data and safety monitoring plan approved by the IRB.

2.8. The researcher or contract research organization provides an attestation or other written statement that contracts obligate the Sponsor to notify the researcher or organization conducting the research of any study results after the study has ended that could directly affect participant safety. A time frame of notification must be specified. This time frame is based on the appropriate time frame for each individual study. Researchers or the organization conducting the research are required to forward this information to the WVU IRB.

3. References

AAHRPP:
Standard I-8