3 Comments
As discussed in recent Open Mike blog posts, NIH issued a new policy to enhance the privacy protections of individuals participating in NIH funded research studies. The policy eliminates the need for NIH funded investigators to apply for a certificate of confidentiality (CoC). As of October 1, 2017, NIH funded researchers no longer have to request a CoC. The CoC will be issued automatically to awards funded wholly or in part by the NIH that collect or use identifiable, sensitive information.
We encourage you to visit our Certificates of Confidentiality website which we have recently updated to reflect the new CoC policy and the disclosure rules that apply to those that hold CoCs.
I cannot find guidance on the specific language we need to put into informed consent forms about the CoC. Myself, I will use language I have used in past studies where I was sent that guidance but new researchers need an EASY way to find that language. Would you amend the NOT-OD-17-109 (not just a blog) to add the ICF language needed?
Additional information related to consent form language for Certificates of Confidentiality can be found here: https://humansubjects.nih.gov/coc/suggested-consent-language
It’s too bad a lot of these policies weren’t implemented long ago when patients’ information was was easily given with a simple phone call or letter. It’s nice to see that you take privacy so seriously.