When is a researcher a covered health care provider under HIPAA?.Do the HIPAA Privacy Rule's requirements for authorization and the Common Rule's requirements for informed consent differ?.Are the HIPAA Privacy Rule's requirements regarding patient access in harmony with the Clinical Laboratory Improvements Amendments of 1988 (CLIA)?.What does the HIPAA Privacy Rule say about a research participant's right of access to research records or results?.Does the HIPAA Privacy Rule require a covered entity to create an Institutional Review Board (IRB) or Privacy Board before using or disclosing protected health information for research?.Is documentation of Institutional Review Board (IRB) and Privacy Board approval required by the HIPAA Privacy Rule before a covered entity would be permitted to disclose protected health information for research purposes without an individual's authorization?.Do Department of Health and Human Services (HHS) regulations at 45 CFR part 46 permit the Institutional Review Board (IRB) to review and approve the insertion of authorization language as a single modification that applies to the informed consent documents of multiple protocols previously approved by the IRB?.Can an Institutional Review Board (IRB) use an expedited review procedure to review and approve a modification to a previously approved informed consent document where the modification only involves the addition of a patient authorization for use or disclosure of protected health information?.When must an Institutional Review Board (IRB) review and approve patient authorizations for use or disclosure of protected health information related to human subjects research activities in order to satisfy requirements of Department of Health and Human Services (HHS) regulations at 45 CFR part 46?.By establishing new waiver criteria and authorization requirements, hasn't the HIPAA Privacy Rule, in effect, modified the Common Rule?.How does the Rule help Institutional Review Boards (IRBs) handle the additional responsibilities imposed by the HIPAA Privacy Rule?.Can researchers continue to access existing databanks or repositories that are maintained by covered entities, even if those databases were created prior to the compliance date without patient permission or without a waiver of informed consent by an Institutional Review Board (IRB)?.Does the HIPAA Privacy Rule permit the creation of a database for research purposes through an Institutional Review Board (IRB) or Privacy Board waiver of individual authorization?. Does the HIPAA Privacy Rule prohibit researchers from conditioning participation in a clinical trial on an authorization to use/disclose existing protected health information?.Are some of the criteria so subjective that inconsistent determinations may be made by Institutional Review Boards (IRBs) and Privacy Boards reviewing similar or identical research projects?.Will the HIPAA Privacy Rule hinder medical research by making doctors and others less willing and/or able to share with researchers information about individual patients?.Who must comply with these new HIPAA privacy standards?.If there are additional questions about the HIPAA Privacy Rule and research you would like addressed on this site, please submit them to What Federal agencies are involved in the implementation and enforcement of the HIPAA Privacy Rule? However, for a full understanding of the relevant provisions of the Rule it is important to consult the Rule itself and to discuss compliance issues with the Privacy Officer of your institution. We will also be adding to "Frequently Asked Questions" on an ongoing basis as new questions arise. The following "Frequently Asked Questions" address broadly some of the questions that have arisen about the possible impact of the Privacy Rule on research. Click here for access to the complete set. Office for Civil Rights Frequently Asked Questions on the HIPAA Privacy Rule. Health Services Research and the HIPAA Privacy Rule For guidance on the HIPAA Privacy Rule in research, please see: This website is currently in the process of being updated.
0 Comments
Leave a Reply. |