The privacy of researchers referred to in point 301 (d) is protected by the issuance of confidentiality certificates. These confidentiality certificates protect against the forced disclosure of identifying information about subjects in biomedical, behavioural, clinical or other research. This protection is not limited to publicly funded research. Confidentiality certificates protect subjects from forced disclosure of credentials, but do not prevent the voluntary disclosure of researchers` identification characteristics. Therefore, researchers are not prevented from voluntarily disclosing certain information on research topics such as evidence. B child abuse or the threat of violence of a subject on himself or others. However, where a researcher intends to provide such voluntary information, the authorization form should make this clear. In addition, confidentiality certificates do not prevent violations of other types of deliberate or non-deliberate breaches of confidentiality. Therefore, investigators and the IRB must ensure that other appropriate mechanisms and procedures are in place to protect the confidentiality of identifiable private information to be obtained in the proposed investigation. Guidance: OHRP does not issue confidentiality certificates. Confidentiality certificates are issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or forced disclosure.
They allow the examiner and others with access to research records to refuse the disclosure of identifying information about researchers in civil, criminal, administrative, legislative or other matters, whether federal, regional or local. Confidentiality certificates may be issued for studies that collect information that, when disclosed, could have negative consequences for topics such as.B. By protecting researchers and institutions from disclosing information that would identify research topics, confidentiality certificates help minimize risks to subjects by adding an additional level of protection for the confidentiality of private information. The parties are aware that the REL Act does not protect oral communications with all other parties present or documents that one party makes available to all other parties. The parties also understand that they can and agree to ensure greater confidentiality. In particular, they accept that oral communications containing all other parties or documents provided by one party to all other parties are treated confidentially during this mediation. Finally, the parties understand that despite this additional confidentiality agreement, external parties may continue to have access to statements or documents, as required by law (for example. B the Freedom of Information Act). No party is bound by anything that has been said or done during mediation, unless a written transaction agreement is reached and executed by all the necessary parties. .
NOTE: CES REPLACES GUIDANCE THE 9/1998 OHRP GUIDANCE: “Privacy Protection for Human Research Subjects, Certificates of Confidentiality.” THIS GUIDANCE IS UPDATED IN FORMAT, IS THE FOCUS ON JAM CERTIFICATES, AND PROVIDES LINKS TO RELEVANT MATERIALS ON THE NATIONAL INSTITUTES OF HEALTH (NIH) WEBSITE. For more information on privacy certificates and their restrictions, see grants.nih.gov/grants/policy/coc/index.htm. Area of application: The purpose of this document is to provide guidance on confidentiality certificates and to help find resources for obtaining a confidentiality certificate for the privacy of researchers.