Study Closure

Study closure is required within a reasonable time frame of completion of all IRB-approved research protocols. A closure report is also required if the investigator is leaving the university. The closure report updates the IRB on the conduct and the outcomes of the study, any new risks, safety issues or problems that may have arisen since the last study renewal, and informs the IRB of the final disposition of research records and data.

• When a study should be closed

  An IRB-approved study should be closed when:

  • the study was not and will not be initiated,
  • the study was discontinued prior to completion (i.e., lack of funding,  investigator leaves the institution, sponsor termination); or
  • the study has been completed.

  Relationship to funding: Neither Federal human research regulations nor ETSU policy require a study to maintain IRB approval for the duration of a grant or contract. 

• When a study is considered complete

  For IRB purposes, a study is considered complete when:

  • All research participants have completed all study-related interventions and procedures, including any follow-up; and
  • The research team has obtained all private identifiable data and/or specimens from all participants (or from data/specimen sources if your study involves secondary analysis of data/specimens); and
  • The research team has completed analysis of all private identifiable data and specimens, as described in the IRB application.

  If enrollment and data/specimen collection are complete, and the research team has stripped the data/specimens of identifiers, the study can be closed even if data/specimen analysis continues.

• When a study should remain open

  Studies must remain active and continue to receive ongoing IRB review and approval when:

  • Enrollment is on-going.
  • Research-related interventions and/or follow-up is ongoing.
  • Participant follow-up is ongoing.
  • Biological specimens containing personally identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research is ongoing. If, however, specimens were transferred to a separate repository that has ongoing IRB approval, the study may be closed.
  • Data analysis or manuscript preparation that involves the use or access to personally identifiable information is ongoing.
  • If there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB.
  • ETSU is the IRB of record for external sites, and research activities are still occurring at any of the relying sites.

Review of Study Closures

Investigators should inform the IRB when a study reaches completion or is never initiated. Study Closures should be submitted within a reasonable time frame of study completion. Investigators may submit the Administrative Check-in xForm in OneAegis (formerly IRBManager) to report a Study Closure for study that do not require continuing review. For study that require continuing review, the Continuing Review xForm should be submitted to request Study Closure. Either the HRPP Staff or the IRB Chairs review Study Closure requests, and a notification of study closure will be sent to the Principal Investigator documenting the closure.

How to submit a study closure request xform in OneAegis (formerly IRBManager).

Investigator Responsibilities

For the duration of the research study, there a number of responsibilities for the investigator including:

• The PI is responsible for submitting a study closure to the IRB when the research is completed.
• It is the responsibility of the PI to provide the IRB information needed in order to carry out review and facilitate oversight of research involving human subjects.
• The PI is responsible for being responsive to IRB requests for information.
• The PI is responsible for complying with all applicable research retention policies, regulations, and requirements.
• The PI is responsible for submitting reports adverse events and unanticipated problems involving risk to participants and others to the IRB according to IRB policies and procedures, sponsor requirements, and appropriate Federal agencies as required. 

The investigator continues to have responsibilities for a study even when IRB oversight of a study is no longer required. These include:

• Record Retention

  Investigators should know that data from the completed study should be stored and protected in the manner approved by the IRB (i.e., specified storage locations) and consented to by the research participant so as to maintain the privacy and confidentiality of the participants. Whenever possible, the data should be permanently de-identified. 

  ETSU policy requires research records be maintained for a period of six years from the end of the calendar years in which the study is closed with the IRB. The investigator is responsible for appropriately maintaining the research records so that records are readily accessible in the case of an audit. Investigators should be aware that other laws and requirements (e.g., funding agency, VA, HIPAA, FDA) may require a longer record retention period and must comply.

• Confidentiality and data security

  If a study team plans on sharing data or specimens with individuals or entities not previously described in the IRB application, the study team must consult with the IRB office to ensure that the conditions under which the IRB approved the collection and use of the data/specimens are met.
• Commitments to participants

  The investigator must continue to honor any commitments made to participants as part of the approved research. Examples include: only sharing their data as described in the consent; only using their data for stated purposes in the consent; providing information about study results; payment for research participation.
• HIPAA authorization

  The investigator may have obtained HIPAA authorization from subjects to access their medical records, with an expiration date that is far in the future. If the researcher still has permission to access medical records at the time s/he wants to close the study, that permission may not be used after the study closure.
• Secondary analysis of existing data/specimens

  Study teams must consult with the IRB office prior to use of data or specimens from a closed research study if the original investigators seek to use the data/specimens to investigate new research questions/topics OR if other investigators wish to use those data/specimens to study a new research question or topic, as this may constitute new human subjects research requiring IRB exemption or approval.

Administrative Closure of IRB Studies

The Human Research Protection Program and ETSU IRBs may administratively close a study in any of the following situations:

• The study’s IRB approval has expired and a Continuing Review has not been submitted to the IRB for at least 90 days. 
• The study team has not responded to any IRB query for at least 60 days.
• No research activities have begun or no participants have been enrolled within 3 calendar years from the date of the IRB approval of an initial application.
• The study was granted an exemption and the HRPP has received correspondence of study completion from the investigator or faculty advisor.
• The HRPP received correspondence from the investigator that the study was never initiated and will not be initiated.

Investigators will be notified of administrative closures by the HRPP and will need to submit a New Protocol Submission in order to re-open the protocol to resume research.

Departure of Principal Investigator from ETSU

When Principal Investigators (PIs) leave ETSU, they are responsible for ensuring the disposition of their human subjects research studies prior to their departure.  Likewise, faculty advisors and department chairs have a responsibility to ensure these duties are carried out before the PI leaves. Please follow the instructions below depending on the status of the study and future plans:

• Study Completed

  If the study is complete, follow the guidelines above to submit a Study Closure request.
• Study Active & PI will no longer be involved

  If the study will remain active at ETSU, and the departing PI will have no further involvement with the study, submit a Modification Request xform to remove the departing PI from study staff and add or designate a new PI to take over the study.
• Study Active & PI wishes to continue involvement

  If the study will remain active at ETSU and the departing PI wishes to continue as part of the research team, submit a Modification Request xform to remove the departing PI from study staff and add or designate a new PI to take over the study.
  
  

  Then, the former PI is to stop all research activities and obtain IRB approval at their new institution.

  Next, the ETSU PI will submit a Modification Request xform to Add a Study Site and provide documentation of the former PI's new IRB approval to collaborate on the study.

• Study Active but no ETSU involvement

  Any departing investigators wanting to keep their study active, but there are no plans for continued ETSU involvement, should transfer the research to their new institution. The investigator should work with each IRB office (ETSU and the new institution) to determine the best way to facilitate the transfer of the research while maintaining compliance and oversight of the research. There may be additional agreements required such as Data Use Agreements or Material Transfer Agreements to facilitate the transfer of any research data or specimens, and the Vice Provost for Research will assist with those agreements.