Chapter 3

Submitting Documents for IRB Review

Set up an account or log in to ClinSphere® eReview Manager to submit a new study. (Clients who use IRBNet to submit should submit new studies through there.) Please note we do not accept submissions via fax or postal mail. If you need assistance submitting, contact clientcare@wcgclinical.com.

If a submission is made and we are subsequently instructed to withdraw that submission, a fee will be charged to cover the costs of the work done on the submission prior to withdrawal.

All studies require a Principal Investigator (PI) to assume responsibility for the conduct of research either for the study as a whole or for an individual site. This includes studies where there is no direct participant interaction, such as online surveys, retrospective chart reviews, and studies using biospecimen samples sourced from a third party vendor. If no PI or site information is provided with the initial review submission, it will need to be submitted in the future to WCG or another IRB before beginning research activities.

Please note that for research conducted outside North America, WCG IRB is happy to provide U.S. review in conjunction with a local IRB when required for funding or regulatory reasons. Other cases can be considered on an individual basis. We do not provide IRB review of research in other countries where there is not a local IRB. This includes research for which it is unclear if local regulations require IRB review, such as stem cell research, device research, tissue collection studies, and questionnaires and surveys.