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IRB-HSR > Managing Protocol After Initial Approval > Recordkeeping Responsibilities

 

 

 

 

 

 

Recordkeeping Responsibilities

Overview

The IRB maintains an official protocol file for each study to meet the University's regulatory obligations for record keeping. The IRB staff is not responsible for maintaining study documents for the researchers, or for providing copies of official documents to research staff. Keeping accurate and complete protocol records is the responsibility of the study team.

The following guidelines are provided to assist investigators and research staff with recordkeeping of approved IRB protocols documents and to facilitate submissions of correct versions of protocol documents for the life of the study.

Records to Keep While a New Study is Being Reviewed by the IRB

The study team should keep electronic files of all study documents (e.g., protocol, informed consents etc.) in order to make requested revisions that may be required for IRB approval.

Records to Keep Once a Study is Approved by the IRB

Hard Copies

  • If applicable: Consent(s) with Approval Stamp. This original stamped consent form should be used to make copies of the consent for enrolling research participants.
  • All documents previously submitted to the IRB.
  • All documents received from the IRB.

Electronic Copies

  • The electronic file of the currently approved protocol and consent form(s) if applicable should be retained for future IRB submissions such as modifications or continuations.

Protocol Modifications Submissions

  • The study team must incorporate revisions into the most recently approved electronic file version of the protocol and consent form(s), and other protocol documents, as applicable.
  • Note that some studies are modified frequently and the most recent approved version must always be used for each modification request.
  • Versions checks of protocols and consent forms are performed routinely by the IRB staff. Revisions submitted on older versions of the protocol or consent cannot be reviewed by the IRB and will be returned for correction.

Continuing Renewal Submissions

  • The study team must keep copies of all documents, including the Status Forms, submitted to the IRB at the time of the continuation review.

Record Retention Requirements

Step 1: Determine which regulation applies to your research.
It is important to determine which regulation applies to your research because different regulations have different timelines. It is also important to keep in mind that multiple regulations may apply to the research. If multiple regulations apply, the investigator should keep the data for the longest required amount of time.

Below are examples of regulations that might apply to your research:

  • Office for Human Research Protections (OHRP) Regulations  (applies to all research at UVa)
  • The Health Insurance Portability and Accountability Act (HIPAA) (applies to all research involving Protected Health Information)
  • Food and Drug Administration (FDA) Regulations (applies to all research overseen with an IND or IDE)
  •  If the study is under a sponsored project (grant or contract) you must comply with any terms for record retention detailed in the award from the sponsor.

Step 2: After determining which regulation applies, determine the time requirement.

(1) Office for Human Research Protections (OHRP): Research records must be retained for at least 3 years after the completion of the research. Research is completed when all research-related interventions/interactions with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished. http://answers.hhs.gov/ohrp/categories/1567

(2) Health Insurance Portability and Accountability Act (HIPAA): Any research that involves collecting protected health information is subject to HIPAA requirements. These records must be retained for at least 6 years after the personal health information was used or disclosed. http://answers.hhs.gov/ohrp/categories/1567

(3) Food and Drug Administration (FDA): Research records must be retained for 2 years after either (1) the date a marketing application is approved or (2) the investigation is discontinued and the FDA is notified. http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.`0.1.1.3.4


*Taken from UVa IRB-HSR Research Guidance