What is the effect of a Certificate? What protection does it afford?
Researchers can use a Certificate to avoid compelled “involuntary disclosure” (e.g., subpoenas) of names and other identifying information about any individual who participates as a research subject (i.e., about whom the investigator maintains identifying information) during any time the Certificate is in effect. It does not protect against voluntary disclosures by the researcher, but those disclosures must be specified in the informed consent form. A researcher may not rely on the Certificate to withhold data if the participant consents in writing to the disclosure.
