The National Institutes of Health (NIH) requires researchers to acknowledge federal funding in peer-reviewed publications by citing any NIH grants that supported the research process described in the publication. In addition, the NIH Public Access Policy requires that all investigators “funded by the NIH,” be it through direct funding or through use of resources of an NIH-funded center (such as Penn State Clinical and Translational Science Institute) submit an electronic version of their final, peer-reviewed manuscripts to PubMed Central (PMC) upon acceptance of publication.

For drugs, according to 21 CFR 312.62(c), an investigator shall retain records required to be maintained under the part for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the applications is not approved for such indication, until two years after the investigation is discontinued and FDA is notified.

Once the project is terminated by the sponsor or the grant or contract end date expires, the Controller’s Office receives a monthly report from Research Accounting. The Controller’s Office notifies the appropriate financial administrator for closeout or extension and provides an Account Closeout/Extension (ACE) form for completion. Once the financial administrator returns the ACE form to the Controller’s Office, the Controller’s Office notifies OSP of the expiration. OSP updates the SIMS database.

You can close a study with the IRB when it meets four conditions:

Account Closure or Extension Forms (ACE Forms) are sent to the financial contact -- usually a college or department research administrator -- when an account has an end date in the accounting system. The Controller’s office receives a restricted fund report from Research Accounting at University Park with accounts that have end dates. The financial contact works with the investigator and study team to either extend the end date if the contract allows, request an amendment from the sponsor or close out the account in the accounting system.

HIPAA rules require that a record be made of a disclosure of any personally identifiable information that is made without an authorization by the research participant. Therefore, tracking of disclosures will have to be undertaken for all disclosures if a waiver of authorization, an approval for review preparatory to research or an approval for the use of a decedent’s PHI is obtained for purposes of research, and for any disclosures not previously specified in a signed authorization document.

Because it may be necessary for a researcher to obtain access to and review PHI in order to prepare a research study, HIPAA rules allow such a review upon compliance with specified criteria. An application for review of PHI preparatory to research must be submitted to the IRB for review and approval.