HRPP Step 5

What happens after approval?

Once you have received IRB Approval Letter or an Exempt Determination Memo you may immediately begin data collection.

Modifications to the Protocol

Investigators may decide to make changes to their study protocol. Such changes may not be implemented by the research team until they have been reviewed and approved by the Vice/Chair.

However in the event that a modification is necessary to eliminate apparent immediate hazards to subjects ( 45 CFR 46.103b.4.iii ), the change may be implemented without prior IRB approval and should be reported to the IRB as a Reportable New Information. This will be handled by the IRB accordingly

Proposed modifications must be submitted through the research compliance administrator. It is important to remember that in addition to submitting an Amendment/Modification the study application, protocol and/or any of the study documents already finalized in your application may need to be updated to reflect those changes.

IRB Unanticipated Problems or Adverse Event Reporting

Examples of unanticipated problems or adverse events that should be reported to the IRB include:

- Publication in the literature or other finding that indicates an unexpected change to the risk/benefit ratio of the research;

- Breach in confidentiality resulting from a disclosure of confidential information or from lost or stolen confidential information, that may involve risk to that individual or others;

- Complaint of a participant or family member that indicates an unanticipated risk;

- Disqualification or suspension of investigators;

- Accidental or unintentional change to the IRB-approved protocol that involves risks or has the potential to recur;

- Deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research participant

- Any deviation from the IRB-approved protocol that increases the risk or affects the participant’s rights, safety, or welfare.

- If you believe you have suffered harm physically or psychologically from participation in a research study, please seek appropriate medical attention immediately then report the incident/problem to the Office of Research and Graduate Studies as soon as possible at 210-784-2317 or at irb@tamusa.edu.

Continuing Review

- Although, the regulations no longer require continuing review (CR) for certain categories of minimal risk research the investigators must be aware that the following requirements are still intact:

- PI may be required to submit an Annual Report (as indicated on the Determination Memo) so that we can verify there have been no changes that could affect the review category and/or make sure they are closed out.

- Any changes to the research must be submitted to the IRB for review and approval prior to implementation;

- Unanticipated problems or other reportable events as described in SOP HRP-029 must be reported to the IRB within 5 days of learning about the incident;

- Notifying the IRB of study completion;

- All FDA regulated research and any study greater than minimal risk still requires annual continuing review.

- Continuing Review is still required for all research approved before January 21, 2019 up until notifying the IRB of study closure;

- Upon initial review of any protocol, an IRB member may still request annual continuing review of any research if it would enhance the protection of subjects and the rationale is documented in the IRB records

See Step 2 above for Annual Report requirements

Continuing Review of human research projects is required for certain approvals under expedited categories 2 and 3 or all Full Board approved studies. The continuing review requirement is required until the research team has completed all study activities, as described in the IRB-approved research protocol.

When should I send my Continuing Review?

Submission date will be included in the Approval Letter.
The Principal Investigator is responsible for submitting the Continuing Review no later than 30 days before the study’s current expiration date to ensure adequate time for the IRB to review and approve it. For Full Board studies, it is recommended to submit the continuing Review 45 days before the expiration date.

Will I be notified of upcoming expiration dates?

While the IRB Admin will make every effort to notify Investigators of protocols’ upcoming expiration dates, it remains the responsibility of the Primary Investigator to submit the Continuing Review Form in a timely manner in a timely manner to avoid suspension of research.

What if my study has expired?

If IRB approval expires all Human Research procedures related to the protocol under review must cease immediately, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information.

If the Principal Investigator believes it is necessary to continue a subject or subjects in a lapsed study for safety reasons or otherwise, contact the HRPP Office.

The investigator may resume the research activity only once continuing review and approval by the IRB has occurred.

NOTE: If a study is allowed to lapse by the research team or if a continuing review is not submitted and reviewed by the expiration date, the investigator will be restricted from submitting new IRB submissions until the continuing review has been approved.

Post Approval Reviews
Any active study is subject to a post approval review. Most of these reviews are not for-cause; they are what we call “routine” reviews. The purpose of these reviews is to help investigators stay in compliance, to monitor compliance and to educate. Reviews may also be requested by the IRB, HRPP or Institutional Official to investigate allegations of non-compliance or other incidents. These would be “for cause” reviews.

Closing the Study
All studies require closure upon completion. If all research-related activities with human subjects have been completed, and data collection and analysis of identifiable private information described in the IRB-approved research plan are finished, then the study should be closed with the IRB. Similarly, if the study was never initiated and the Investigators no longer have plans to pursue this project then the study should be closed with the IRB.

How do I close a study?
Complete the form at the link and submit to irb@tamusa.edu to close a study.

Voice a Concern

If you have a compliant, concern or question about a research study or about your rights as a research participant, please contact the Human Research Protection Program at irb@tamusa.edu

You can also submit a human subject’s research concern form or submit a report to Texas A&M-San Antonio Ethics Point .

If you have questions about whether an activity is Human Research contact the Human Research Protection Program.

Research with Children

When is written parental permission required for research with minors?
What else do I need to know when conducting research with minors in an educational setting?

Student/Classroom Research Projects

Do I need IRB review for A&M-SA classroom-based research projects conducted by students?
Do I need IRB review for A&M-SA classroom-based research projects conducted by faculty?

Recruitment

What is an appropriate recruitment method?

Consent Information
How do I obtain informed consent from participants ?
Do research participants have to sign a consent document?
How do I document consent or assent?
How do I obtain a waiver of alteration of informed consent?

Additional Resources

Research Ethics

Information about the ethical codes that serve as the foundation for the conduct of research with human participants may be found here:
The Belmont Report

Regulatory Agencies
Many federal agencies have specific regulations or requirements with regard to research with human participants.