Consent Form Templates
As of January of 2023, the National Institutes of Health (NIH) will be joining the National Science Foundation in requiring researchers to include a data management plan within their proposals and to make data publicly available. NIH is providing guidance at this link on Informed Consent for Secondary Research with Data and Biospecimens, inclusive of sample language. Additionally, NIH’s broader guidance around data sharing may be found here.
Prospective Agreement Forms
TCNJ IRB has been using the traditional informed consent document for most of the prospective data collection in IRB approved studies. With the new Common Rule several studies will be determined as Exempt under a new term Benign Behavioral Interventions. Since Exempt studies are not subject to requiring the traditional elements of informed consent, researchers may opt to use a shorter Prospective Agreement Form with no signature required.