I am performing clinical research that involves treatment. What steps do I need to take to deal with both the clinical and research issues?
Either an authorization or a waiver of authorization by an IRB will cover all aspects of the research study. However, it is important to note that in most clinical trials, authorization will be required, at least as it concerns enrollment in a study. It is important that your clinical consent for each participant contains a copy of your research authorization or waiver to identify the participant as a research participant as well as a clinical subject. All participants undergoing clinical treatment must be offered the Notice of Privacy Practices prior to collection of PHI. 24. How does the Certificate of Confidentiality relate to the HIPAA changes? HIPAA does not affect the protections provided by a Certificate of Confidentiality. An authorization or waiver of authorization would still be required for those studies under a Certificate of Confidentiality.
