Sponsor Agreements
The Department of Health works with sponsors to ensure that the benefits of knowledge obtained through research are realized and that the interests of current and future research participants are protected.
Before initiating research, DOH insures there is a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that investigators and sponsors will play in publication or disclosure of results. Contracts or other funding agreements require the Sponsor to follow DOH's policies and procedures regarding the publication of findings from sponsored research.
When participant safety or medical care could be directly affected by study results, DOH addresses in the written agreement with the Sponsor how results will be communicated to study participants. Contracts and other funding agreements are required to describe the steps followed to communicate results from a research study to participants when those results directly affect their safety or medical care.
The document, "Approved Additions to Clinical Trial Agreements" satisfies all DOH requirements about agreements with Sponsors.