Office of the Vice President for Research - Research Administration

Accredited since 2009

Reaccreditation awarded 2012

Reaccreditation awarded 2017

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The UT Health Science Center at San Antonio’s Human Research Protection Program was fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc., in 2009.

The five year reaccreditation approval was received in 2012 and in 2017.

 


Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Summary of Updated Policies

  • Complaints Policy and Procedure
    • Minor administrative changes
  • Conduct of IRB Meetings Policy and Procedure
    • Clarification that the VA Research compliance officer is a non-voting consultant to the UT Health San Antonio’s IRB
    • Clarification regarding unaffiliated member participation requirements
    • Chair vote will be counted
  • Continuing Review Policy and Procedure
    • Minor administrative changes
  • Cooperative Off-Site Research Policy and Procedure
    • Updates to include the collaboration with other non-local institutions such as large consortium groups or multicenter trials which would allow other institutions to rely on UT Health San Antonio for review and continuing oversight of human research.
    • Reference to the use of Form K-1, K-2 or other Reliance Checklist which allows the investigator to evidence intent to rely and the relying institution’s agreement for reliance.
    • Clarification provided to ensure PI received a institutional activation letter from UT Health San Antonio before research may commence.
  • Coordination with Other Committees or Offices Policy and Procedure
    • Deleted references to examples of issues that would warrant notification from coordinating committees or offices (CCOs) to the IRB as possible noncompliance. This allows for all concerns, regardless of specific examples provided, to be sent to the IRB.
    • Revised protocol review procedures related to institutional committee approvals.
      • Includes OCR in the in-processing of new business
      • OCR is responsible for ensuring approvals are in place before institutional activation is granted. Should there be a difference in what the IRB has approved versus what the committee has approved, an IRB amendment is requested before institutional activation.
      • Amendments which may alter institutional committee approvals must be obtained before IRB approval is granted.
      • Updates to communication between the IRB office and entities of the HRPP
      • Each affiliate institution will be responsible for ensuring investigators meet its institutions’ educational requirements
    • New section added to outline coordination with UHS
    • Updated procedures when coordinating with the Conflict of Interest Committee:
      • Added process whereby COI may notify the IRB of reports of new conflicts found when an investigator completes the annual COI disclosure.
      • Outlined the role of the COI manager in the process of reviewing potential conflicts of interest.
      • Clarified review and oversight procedures
    • Reference to Office of Regulatory Affairs and Compliance audits has been moved to the Study Reviews for Human Research Policy (institutional).
    • Added process for notifying PRC of new cancer related when study is submitted without PRC approval.
    • Amendments with significant changes to cancer related studies will require PRC notification. IRB approval will not be granted unless, when appropriate, PRC is granted
    • OCR performs review of new human subjects research applications for institutional requirements
    • New section added to outline process for coordination with the Clinical Trials Office (CTO)
  • Determining Whether an Activity is Research Involving Human Subjects Policy and Procedure
    • Clarification provided regarding the request to use newborn screening blood spots in research. Requests must be reviewed by Texas Department of State Health Services and are considered identifiable; therefore, IRB approval is warranted and may not include waivers or alterations of informed consent.
    • Section added to include community outreach as a potential non-research activity.
  • Deviations and Violations Policy
    • New policy drafted in 2014 which details information regarding protocol deviations, protocol violations and emergency violations.
  • DoD Research Policy and Procedure
    • New policy based on a previous guidance document. The policy outlines procedures followed when conducting DoD research.
  • Emergency Use of an Investigational Drug or Device Article Policy and Procedure
    • Combined emergency use of an investigational drug or device into one policy. No changes since the combination in 2015.
  • Evaluation of IRB Membership Policy and Procedure
    • Minor administrative changes
  • Exempt Research Policy and Procedure
    • Allows for exempt determinations for VA studies to be made by any experienced member of the IRB office or by a designated member of the IRB.
    • Outlines changes in study expiration procedures. Any amendment, noncompliance or unanticipated problems will extend expiration date for another five years. After five years of inactivity, the protocol will be inactivated without notification to the PI.
  • Expanded Access Treatment Use of an Unapproved Investigational Drug/Biologic Policy and Procedure
    • No changes since final version 2011.
  • HIPAA in Research Policy and Procedure
    • Minor administrative changes
  • Humanitarian Use Device (HUD) Policy and Procedure
    • Clarification was provided on when HUDs are not considered a clinical investigations versus when they are considered clinical investigations
  • Identification and Recruitment of Participants Policy and Procedure
    • No changes since final version 2011.
  • Informed Consent Policy and Procedure
    • Assent is appropriate when the investigator deems the subject is capable of understanding the nature and consequences of participation in the study regardless of the age
    • Added Electronic Consent procedures.
  • Initial Review of Research Policy and Procedure
    • Instances when an institution requires documentation of research participation in the subjects’ medical records where such documentation increases risks to the subject, may be approved with a different title.
    • Investigators will receive all IRB approved documents after the receiving institutional approval.
  • IRB Education Policy and Procedure
    • Policy was updated to only reflect the requirements of IRB members, IRB and OCR Staff, and the IO. The educational requirements for research personnel have been moved to OCR policy: 1.2.1. Training, Qualifications and Delegation of Authority
  • IRB Approval of Research Policy and Procedure
    • No changes since final version 2011.
  • IRB Member and Consultant Conflict of Interest Policy and Procedure
    • Moved the definition of conflict of interest to the Glossary and other minor administrative changes.
  • IRB Minutes Policy and Procedure
    • Minutes will no longer include documentation of the rationale for IRB’s determination of risk level.
    • Statement included to note in minutes whenever study includes the enrollment of non-Veterans such justification will be made in the protocol and related materials
  • Membership of the IRB Policy and Procedure
    • Minor administrative changes
  • Modifications and Amendments Policy and Procedure
    • Expedited Reviewer considers whether consultation is necessary for review of the research involving vulnerable human subjects
  • Noncompliance Policy and Procedure
    • Includes information external audits where issues were identified that are potential adverse effects to subjects’ rights, safety or welfare or that has a potential to negatively affect the science of the study must be promptly reported to the IRB.
  • PI Self-Assessment Program Policy and Procedure
    • Allows for investigators to inform OIRB that study no longer active.
    • Customized feedback based on assessment responses is sent to the investigator
  • Planned Emergency Research Policy and Procedure
    • Minor administrative changes
  • Policy on Policies Policy and Procedure
    • No changes since final version 2011.
  • Receiving, Routing, and Administrative Review of UTHSCSA IRB Submissions Policy and Procedure
    • Major changes to include current practice of OCR in-processing new business items and routing to the OIRB staff.
    • Updated information related to the tracking of pending items
    • Clarifies procedure for confirming the validity IND or IDE numbers
    • Expedited Reviewer considers whether consultation is necessary for review of the research involving vulnerable human subjects
    • Includes process to allow for a protocol to undergo a Scientific/Ethical Pre-review.
    • Clarified process for routing business items through the office
  • Recordkeeping Policy and Procedure
    • No changes since final version 2014.
  • Reporting Policy and Procedure
    • Updated reporting requirements for Serious/continuing Noncompliance and determinations of UPIRSO/UADE for studies involving the VA. In addition, for local research related deaths that meet criteria for UPIRSO, notification to the VA is completed within two business days after receiving notification.
    • Delineated procedures when HSC IRB is the IRB of record
    • Updated reporting requirements to the FDA and who is copied on the notice.
  • Repository Policy and Procedure
    • Protocol must have plan to track the distribution of materials to recipient investigators.
    • If a waiver of consent/HIPAA Waiver has been granted for the repository activities, the protocol must include a plan to allow subjects to opt-out of the repository or certain aspects.
  • Research Involving a Device Policy and Procedure
    • Clarified procedures for approving the use of non-significant device through the abbreviated IDE requirements.
  • Research Involving Individuals with Diminished Autonomous Decision-Making Capacity Policy and Procedure
    • Clarifications made to who have limited mental capacity and those with limited voluntariness.
    • Provided examples of individuals who are likely to be DADMC
    • Clarified applicability of45 CFR 46, Subpart B
  • Research Involving a Drug Policy and Procedure
    • Clarified IND Exemption Categories 5 and 6
  • Study Inactivation Policy and Procedure
    • Clarified when the Request for Re-Activation Form must be used.
  • Suspension or Termination of Research Policy and Procedure
    • No changes since final version 2011.
  • Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy and Procedure
    • Minor administrative changes