Understanding required contract language
Help for researchers: Understanding DOH's required contract language.
The attached file includes DOH's required language concerning human subjects protections. The attachment addresses the following outcomes:
- Contracts need to include the attachment, or the language in the attachment, or otherwise meet the following requirements:
- Contracts and other funding agreements indicate that the Department of Health and its agents will follow the protocol and applicable law.
- When DOH determines it is appropriate, arrangements for medical care or other care or services for research-related injury are defined before the research starts.
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Contracts and funding agreements require the sponsor to promptly report to the Department of Health any
findings that could: Affect the safety of participants; Affect the willingness of participants to continue participation; Influence the conduct of the study; Alter the IRB’s approval to continue the study. - Contracts or other funding agreements require the sponsor to follow the Department of Health's policies and procedures regarding the publication of findings from sponsored research.
- Contracts and other funding agreements describe the steps followed to communicate results from a research study to participants when those results directly affect their safety or medical care.
