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.

An application for the use of PHI from decedents must be submitted to the IRB prior to engaging in the research. In order to gain access to the PHI, the principal investigator needs to demonstrate that the use or disclosure being sought is solely for research on the PHI of decedents, adequate documentation of the death of such individuals, and that the PHI for which use or disclosure is sought is necessary for the purposes of the proposed research.

A HIPAA Waiver of Authorization can be obtained from the IRB if access to patient data is needed for recruitment purposes. Describe the need in the “HIPAA Research Authorization and/or Waiver or Alteration of Authorization” section of the protocol template or the protocol site addendum. This section is reviewed by the IRB. If a full or partial waiver is granted, access to identifiable patient data to determine if a patient may be a potential research subject will be authorized. IRB approval is confirmed by issuance of the IRB approval memo for the study.

In general, before any patient information can be used for a research purpose, the patient must sign and date a study-specific consent form that includes the HIPAA authorization elements or a separate HIPAA authorization form which recites the patient’s privacy rights. This is true whether or not the patient is seen by the researcher/physician for medical care. Patient information cannot be used for research-related purposes without a signed patient authorization.