This month’s Feature Article focuses on exempt category 13, which covers most types of minimal risk research that involves adults who are able to provide abbreviated consent. This category encompasses a wide variety of research methods. Understanding whether your study qualifies for exempt category 13 will enable you to adequately plan for considerations such as selecting the correct IRB application review path, using the appropriate “abbreviated consent” template, and determining when verbal consent is sufficient.
Q. I’m currently drafting a study protocol and have a question regarding the inclusion of NIH Certificate of Confidentiality (CoC) language. The study is NIH-funded and involves recruitment sites across multiple countries, each of which will follow its respective national privacy and confidentiality regulations.
The U.S. institutions involved serve as home institutions for the study investigators and are not recruitment sites. However, one of the U.S. institutions will host and manage the central study database.
Given this context, are we still required to include CoC language in the protocol? Does the NIH CoC apply to the U.S. institutions involved given the lack of direct involvement in participant recruitment and management?
This month’s Feature Article focuses on exempt category 13, which covers most types of minimal risk research that involves adults who are able to provide abbreviated consent. This category encompasses a wide variety of research methods. Understanding whether your study qualifies for exempt category 13 will enable you to adequately plan for considerations such as selecting the correct IRB application review path, using the appropriate “abbreviated consent” template, and determining when verbal consent is sufficient. 