Data collection about sensitive issues (such as illegal behavior, alcohol or drug use, or sexual practices or preferences) requires the protection of confidentiality beyond preventing accidental disclosures.
Under Federal law, researchers may obtain a Certificate of Confidentiality (CoC) that will provide protection against compulsory disclosure, such as subpoena, for research data.
Under Federal law, a CoC allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.
Whether or not a CoC is necessary depends on the sensitivity of the research data and the potential impact it may have on subjects should it be disclosed (e.g., potential damage to their financial standing, employability, insurability, or reputation). Examples of sensitive research data include:
The Certificates of Confidentiality were developed to encourage participation in research by granting certain protections to a subject divulging possible compromising information.
The Certificates, however, do not exempt investigators from performing ethical research nor do they allow investigators to abdicate the responsibility to act in the public good.
Therefore, investigators are required to include a statement in the consent form that alerts potential subjects of the legal and ethical mandate compelling researchers to report certain criteria.
The IRB is required to determine whether the risks to subjects are minimized, informed consent is appropriate, and privacy and confidentiality protections are adequate.
Effective December 13, 2016, DHHS enacted new provisions that automatically provide a Certificate of Confidentiality for any study funded by the Federal government that will collect identifiable sensitive information. No application for a Certificate of Confidentiality is required and no Certificate will be provided by the NIH.
Per the 21st Century Cures Act ( sec 2012) “Identifiable Sensitive Information” is defined as information that is about an individual and that is gathered or used during the course of research described in paragraph (1)(A) and :
Paragraph (1)(A) includes biomedical, behavioral, clinical or other research including research on mental health and research on the use and effect of alcohol and other psychoactive drugs.