If a patient’s record is reviewed for a treatment purpose (e.g., to view lab results or consult with a referring provider) the research-related rules do not apply. However, once a patient’s medical information is viewed for a research-related activity (e.g., to screen for eligibility or review, to review a unique case for possible study, or to collect data) the research-related HIPAA rules apply. For example, if a provider is reviewing a patient’s lab report for regular care, this access would be for treatment purposes and the research-related rules would not apply.

When an established patient is being considered for participation in a research study by a clinician involved in the patient’s care, the HIPAA rules can be confusing. HIPAA applies when a provider is reviewing a patient’s medical record for both treatment and research purposes. In general, under the HIPAA privacy rules, a patient’s medical information may be accessed for a treatment, payment or operational purpose without obtaining prior written consent. Access to a patient’s medical record for any other purposes may require additional steps to be in compliance with privacy laws and rules.

Penn State has developed an Electronic Regulatory Binder (eReg Binder) that can be uploaded to Research Electronic Data Capture (REDCap) as a project that investigators can use to stay in compliance with documentation requirements for good clinical practice and federal regulations. The eReg Binder is an online "filing cabinet" for all study documents and conforms to the ICH GCP guideline.

Penn State has approved Federal Wide Assurances with the Department of Health & Human Services. Penn State's two IRBs are also registered with the Department of Health & Human Services.

The Code of Federal Regulations is a compendium of the general and permanent rules and regulations published in the Federal Register by the federal executive departments and agencies. The CFR is divided into 50 titles that represent broad areas subject to Federal regulations. Title 45 CFR encompasses regulation of Public Welfare. Title 21 CFR is administered by the FDA and covers regulations of Food and Drugs. Title 45 CFR 46 (The Common Rule) is a core set of regulations defining protection of Human Subjects in clinical research.

The U.S. Department of Health and Human Services (HHS) is the government’s principal agency for protecting the health of all Americans. It comprises several public health services agencies including the FDA (Food and Drug Administration), OHRP (Office of Human Research Protection), the NIH (National Institutes of Health), and the Centers for Medicare and Medicaid Services (CMS).

To learn about IRB approvals associated with multi-site research and external collaborations, see the IRB page on single IRBs and authorization agreements.

Depending on the nature of your study, the IRB may require other approvals:

Clinical Research Center Advisory Committee: Research involving the use of services at the Clinical Research Center (CRC) for any reason, including the use of personnel as back up to the research team or plans to use personnel in the event of an emergency, need to be reviewed by the CRC Advisory Committee. CRC Advisory Committee approval is not required before the IRB will approve the study.