Office of the Institutional Review Board

Policies and Procedures

Note: Posted Policies and Procedures on this website do not represent an all inclusive list. Not all current policies are posted online and some may be under revision. Please call the Office of the IRB at 210-567-8250 with any questions concerning current policy.

 

Vice President for Research Policy

Title Description / Keywords

Study Reviews for Human Research

Reviews of IRB approved research; for-cause reviews; regularly scheduled reviews; voluntary reviews; scope includes IRB documentation, institutional issues, regulatory documents, test article storage/physical space, subject files; follow-up procedures; required actions; compliance; audit

 

Standard Operating Procedures 

Title Description / Keywords

Obtaining Informed Consent

Essential elements; consent template; procedures; explanation and discussion of the study; documentation of informed consent; consent via telephone, mail, email or fax; vulnerable subjects; infants/children; individuals with impaired decision-making ability, diminished autonomy; economically-disadvantaged persons; non-English speaking subjects; emergency situations; non-therapeutic trial; witness; short form; Related Policy: Informed Consent Policy and Procedure

 

 

Purview and Training Policies

Title Description / Keywords

IRB Member and Consultant Conflict of Interest Policy and Procedure

Regular or alternate IRB member or consultant may not participate in review in which they have financial/non-financial conflict of interest (COI). Member/consultant must disclose the COI.

Membership of the IRB Policy and Procedure

Curriculum vitae; regular member; alternate member; institutional liaisons; affiliate institutions; ad hoc/cultural consultant; prisoner representative; appointed by President; membership roster; scientific/nonscientific designation

Policy on Policies Policy and Procedure

Procedures for creation and modifications of IRB policies; applicable references used including federal/state/local regulations concerning determinations
IRB Education Policy and Procedure Research Ethics training requirements for IRB members, IRB chairs, OIRB staff, OCR staff, Institutional Official

Related OCR Policy:
Human Subjects Protection and Ethics Education Policy

UTHSCSA Specific Module

A description of the UTHSCSA specific module on Research Ethics in CITI Program

 

Review Mechanisms/Outcomes Policies

Title Description / Keywords

Complaints Policy and Procedure

ways to report complaints; responsibilities of investigator, OIRB staff, Compliance office, IRB director, IRB; reporting complaints in progress report; reporting complaints as UPIRSO or noncompliance to IRB; IRB Director/Associate Director reviews complaint; determination of further inquiry; IRB review outcomes and actions; appeals

Conduct of IRB Meetings Policy and Procedure

Convened meetings; agenda; IRB members; alternate members; quorum; attendance by teleconference; videoconference; nonscientific member; unaffiliated member; FDA-regulated research; VA research; prisoner representative; DHHS-funded research; vulnerable populations; conflict of interest; chairing the meeting; confidentiality; meeting minutes; vote by proxy not allowed; voting choices; passing vote; approve pending submission of minor revisions

Continuation Review Policy and Procedure

substantive and meaningful continuation review at intervals appropriate to the degree of risk; expedited review procedures for continuation review; 2018 Final Common Rule; FDA-regulated studies; minimal risk; greater than minimal risk; enrollment; data analysis; clinical care data; no longer than one year approval period; approval expiration; reminder notices; continuation review report; study inactivation; application screening procedures; unanticipated problem report; UPIRSO, UADE; amendment; noncompliance; HIPAA/FERPA concerns; continuation review procedures by a convened IRB; member review packet; regulatory criteria for approval; observation of consenting process; vulnerable populations; reviewer responsibilities; conflict of interest disclosure; expedited continuation review report; VA research; review outcomes: approved, conditional approval, tabled/deferred, disapproved; shorter approval period; lapse of approval

Determining Whether an Activity is Research Involving Human Participants Policy and Procedure

Non-exempt human research requires review and approval by IRB; newborn screening blood spots; research according to DHHS; human subjects involvement; human research according to FDA; DHHS funding; health surveillance; public health surveillance; criminal justice and intelligence activities; routine quality improvement; medical quality assurance; program evaluation; customer satisfaction surveys; class projects; case reports; community outreach; scholarly and journalistic activities; publicly available data; repository research, tissue banking, and databases; anonymous pre-existing data sets or specimens; coded pre-existing or coded prospective data or specimens

Exempt Research Policy and Procedure

Determination made by IRB/OIRB; minimal risk; may involve prisoners; not FDA regulated research; limitations to involving children; educational settings; educational practices; educational tests; observation of public behavior; benign behavioral intervention; secondary research use of identifiable private information; research supported by department or agency heads; taste and food quality evaluation; broad consent; ethical principles relevant to exempt research; review outcomes; appeals; institutional follow-up

HIPAA in Research Policy and Procedure

Privacy; confidentiality; privacy board; PHI; protected health information; HIPAA authorization; preparatory to research; waiver/alteration of authorization; de-identify PHI; safe harbor method; limited data set; data use agreement; covered entity

Identification and Recruitment of Participants Policy and Procedure

Privacy; confidentiality; payments to employees; conflict of interest; undue influence; compensation for recruitment; finder’s fees; bonus payments; compensation for services rendered; HIPAA waiver; private identifiable information; informed consent; 2018 Common Rule Requirements; UT Medicine; established relationship; initial contact; cold calling; advertisement; dear doctor letter; compensation; HIPAA authorization; coercion

Related Guidance:
Guidelines for Advertising for Research Subjects
Guidance on UT Medicine Patient Recruitment

Initial Review of Research Policy and Procedure

Non-exempt human subjects research; convened IRB; expedited review; administrative pre-review; targeted review; scientific/ethical pre-review; minimal risk; conflict of interest; Common Rule; informed consent process; informed consent documentation; waiver; primary reviewer; secondary reviewer; ad hoc scientific or cultural consultant; application forms/packet; regulatory criteria for approval; medical record; review determinations: approved, conditional approval, full board review required, tabled/deferred, disapproved; length of approval; continuing review; institutional review; shorter approval period; approval date; expiration date; appeals; response to stipulations; stipulation reviewer; administrative reviewer

IRB Approval of Research Policy and Procedure

Non-exempt human research activities; approval criteria; risks to subjects are minimized; risks to subjects are reasonable in relation to benefits; risk level; equitable selection; informed consent will be sought for each prospective subject or LAR; informed consent documentation; waiver; Data and Safety Monitoring; safety of subjects; privacy; confidentiality; deferral; disapproval; suspension; termination; approval expiration; initial review; continuing review; amendment; limited English proficiency; review by consultant; minimal risk; more than minimal risk; minor increase over minimal risk

Modifications and Amendments Policy and Procedure

Immediate hazard; administrative change; single subject exception; minor change; major change; institutional change; changes that affect institutional committees; emergency violation; prompt report; expedited review procedures; convened IRB review procedures

Receiving, Routing, and Administrative Review of UTHSCSA IRB Submissions Policy and Procedure

Pre-review; routing required for special types of studies: exempt from IND; Drug or Biologic Being Tested in Research; Radiation Safety Committee; Conflict of Interest; off-site research; prisoners; institutional issues; investigational new drug; investigational device exemption; vulnerable subjects; HIPAA; FERPA; informed consent; scientific/ethical pre-review; review routing; administrative review; expedited review; convened IRB review

Repository Policy and Procedure

Human data management center; human specimen repository; collection/storage/distribution of human data/tissue/specimens; personal identifiers; consent; HIPAA; consent withdrawn; coding; key; controlled access; security procedures; certificate of confidentiality; tracking; waiver; collector-investigator; local repository; local collection; external repository

Review Fees Memoranda

Faculty engaged in research supported by pharmaceutical or device firms and other for-profit entities; initial review; annual re-approval; institutional approval; IRB approval; budget approval; non-UT Health entities for which UTHSA provides IRB services through an IRB authorization agreement; full board review; expedited review; determinations

Suspension or Termination of Research Policy and Procedure

Suspend; terminate; unexpected serious harm; authority to terminate; rights/welfare of research subjects; immediate threat of harm; noncompliance; unanticipated problems; continuation review; compliance review; audit; complaints; alternative actions to protect subjects from harm; alternatives to termination; administrative hold in VA research

Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO) And Unanticipated Adverse Device Effects (UADE) Policy and Procedure

Prompt reporting; adverse events; investigator responsibilities and determinations; unreasonable risk to subjects; prompt reporting timeframe; immediate hazard; halting the study; halting enrollment; amendments; multi-site trials; OIRB responsibilities; Reviewer responsibilities; Reviewer decisions: meets criteria, insufficient information, does not constitute; noncompliance; Institutional official responsibilities; IRB responsibilities

 


Special Requirements Policies

DoD Research Policy and Procedure

Department of Defense (DOD) Directive 3216.02; experimental subject; prisoner of war; educational requirements; informed consent; exception from informed consent; vulnerable populations; dual compensation; survey research; pregnant women; children; prisoners; adult subjects unable to provide informed consent; compensation for research related injury; research monitor; scientific merit; reporting to the DOD human research protection officer; recordkeeping

Emergency Use of an Investigational Drug or Device Article Policy and Procedure

Onetime use of unapproved investigational drug, biologic or device; benefits; life-threatening; severely debilitating; sufficient time to obtain IRB approval; prior-use requirements; use requirements; post-use requirements; IND; IDE; FDA; regulatory criteria for emergency use; noncompliance

Expanded Access Treatment Use of an Unapproved Investigational Drug/Biologic Policy and Procedure

Test article; IND; FDA; serious or immediately life-threatening disease; Single patient IND; Small group Treatment IND; a full protocol Treatment IND; open label protocol; open protocol IND; group C treatment IND; parallel track; AIDS; HIV; waiver of local IRB review; informed consent

Humanitarian Use Device (HUD) Policy and Procedure

Humanitarian device exemption (HDE); safety and effectiveness data; clinical investigation; informed consent; appeals; medical device report; adverse event; unanticipated problem; HDE progress report

Informed Consent Policy and Procedure

Legally effective informed consent; legally authorized representative; incompetent; impaired decision-making capacity; Belmont Principle; respect for persons; informed decision; voluntariness; elements of informed consent; VA requirements; waiver of informed consent; waiver of documentation of informed consent; short form written consent document; illiterate subjects; assent; decisionally impaired; minors; emancipated; non-English speaking subjects; monitoring of informed consent process; alteration of informed consent; planned emergency research; emergency use of an investigational drug or biologic product; waiver of parental or guardian permission; FDA-regulated research; electronic consent; eConsent; participant withdrawal

Related Guidance:
Guidance on Observation of the Consenting Process

Planned Emergency Research Exception from Informed Consent Requirements Policy and Procedure

FDA regulated; OHRP; HHS Secretarial waiver; informed consent; life-threatening situation; legally authorized representative; community consultation; public disclosure; data monitoring committee; therapeutic window; IND; IDE

Related Guidance: Planned Emergency Research

Research Involving a Device Policy and Procedure

DHHS; FDA; investigational device; clinical investigation; investigational use; IDE; abbreviated requirements; significant/nonsignificant risk device determination; NSR; minimal risk; approved/cleared device; diagnostic device; testing of device; custom device

Research Involving a Drug Policy and Procedure

Biologic; DHHS; FDA; investigational drug; clinical investigation; IND; exemption; in vitro biological product; dietary supplement; botanical; radioactive drug

Research Involving Individuals with Impaired Decision-Making Ability Policy and Procedure

Informed consent; limited mental ability; mentally handicapped; cognitively impaired; incompetent; incapacitated; limited voluntariness; children; prisoners; fetuses; students; emergency situations; military personnel; economically/educationally disadvantaged; marginalized; fatal/incurable disease; relevance; feasibility; sufficient safeguards; mental capacity

Previously titled Research Involving Individuals with Diminished Autonomous Decision-Making Capacity Policy and Procedure

Subject Payments for Studies Involving Minors Policy and Procedure

Legally authorized representative; coercion; undue influence; children; reimbursement; compensation; appreciation payment; inducement; wage payment model; independent child advocate; withdrawal of subjects

 


Recordkeeping and External Reporting Policies

Title Description / Keywords
Deviations and Violations Policy Immediate hazard; departure; exception; amendment; UPIRSO; noncompliance; prompt reporting; emergency violation; continuing review

IRB Minutes Policy and Procedure

Discussion; deliberation; decision; reviewed and approved by Chair, AVPRA, IO; agenda; written minutes; members present/not present; primary member; alternate member; videoconference; teleconference; consultant; guest; recusal; actions taken by the IRB; controverted issues; IRB determinations; votes for, against, abstentions; conflict of interest; VA requirements; Expedited Report

Noncompliance Policy and Procedure

Prompt reporting; possible noncompliance; allegation of noncompliance; serious noncompliance; continuing noncompliance; identification of noncompliance; IRB Subcommittee on UPIRSO/Noncompliance; convened IRB; designated IRB Reviewer; UPIRSO; protocol violation; protocol deviation; external audit; Compliance Office; VA; complaints; prompt reporting timeframe for PI; allegation justified/unjustified; research misconduct; suspend IRB approval; inquiry members; dismissal of allegation; finding of noncompliance; Regulatory Specialist; IRB actions; management plan; terminate IRB approval; remedial actions; appeals

Recordkeeping Policy and Procedure

Paper and electronic IRB records; access to records; storage of files; official protocol record; retention; VA/non-VA research; access security; hybrid records; protocol files; policies and procedures; membership rosters; IRB actions; Federalwide Assurance; Memorandums of Understanding; IRB correspondence; alleged noncompliance records; federally mandated reports; IRB training records; IRB budget/accounting records; electronic files; physical files; storage of physical inactivated protocol files; destruction date; archive files

Reporting Policy and Procedure

UPIRSO; UADE; serious or continuing noncompliance; suspension; termination; appeals to reports; OHRP; FDA; principal investigator; chair; dean; director, VPR; AVPRA; Compliance Office; OSP; DoD; STVHCS; UHS; AAHRPP; affiliate institutions; IRB/OIRB determinations; inclusion of pregnant women, fetuses, neonates, children, prisoners; IRB membership changes; certification of IRB approval; exception from the general informed consent requirements for planned emergency research; agency-requested reports; legal counsel; Privacy Officer; Compliance Officer; IND/IDE number

Study Inactivation Policy and Procedure

PI initiated inactivation; final review; premature closure; UPIRSO; IRB initiated inactivation; non-response from PI; terminate IRB approval; final report; administrative OIRB inactivation; expedited review; lapse period; noncompliance; progress report; department chair; expiration date; inactivation due to non-response; inactivation due to non-enrollment; change in PI in lieu of inactivation; reactivating IRB approval

 

Quality Improvement & Assessment Policies

Title Description / Keywords

Evaluation of IRB Membership Policy and Procedure

Chairs; members; primary; secondary; alternate; composition; annual evaluation; IRB Director; appropriate representation; quality of review; meeting attendance; preparation; knowledge; expertise; diversity; perspectives; contributions; performance; qualifications; VA representative; AVPRA; meeting management; resolution of problems; consensus building; recruitment; prospective member; HRPP; performance feedback

PI Self Assessment Program Policy and Procedure

Quality improvement program; regulations; policies; recordkeeping; institutional educational programs; HRPP; ICH; GCP; DEB; IDEAS; corrective actions; prompt reporting; noncompliance; unanticipated problems; scientific misconduct
Quality Assurance and Improvement Program Policy and Procedure RPP; OIRB; OCR; strengths; weakness; efficiency; effectiveness; AAHRPP; HRPP; assessment; evaluation; accreditation; Compliance Office; quality control; IRB protocols; protocol database; protocol system; turnaround times; concierge feedback; forum feedback; client feedback; committee member analysis; metrics; Lean Six Sigma; PI self assessment

 


Coordination Policies

Title Description / Keywords

Cooperative Research Policy and Procedure

Collaborative research; off-site research; multi-site research; IRB authorization agreement; memorandum of understanding; affiliated institution; non-affiliated institution; individual investigator agreement; Federalwide Assurance; international research; coordinating center; lead PI; lead investigator; community members; engaged in research; relying institutions; broad/reciprocal agreement; limited agreement; single study agreement; study sites; education; training; independent investigator; VA research; OHRP; AAHRPP; AAHRPP IRB Evaluation Checklist; Central IRB; single IRB; sIRB; institutional activation; SMART IRB; communication plan; geographically separate off-site location; cultural context; cultural consultant; expertise; performance site; cooperative review agreement; authorized official; reviewing IRB; OCR; sub-award agreement; legal counsel; local regulatory issues; local social and cultural norms; community laws; reciprocal exchange; site visit; community attitudes

Coordination with Other Committees or Offices Policy and Procedure

HRPP; complaints; concerns; comments; questions; UPIRSO; noncompliance; coordinating committees; CCOs; prompt notices; quality assurance/improvement findings; audit report; inspection report; joint policy/procedure; Radiation Safety Committee; Medical Radioisotope and Radiation Control Committee; Radioactive Drug Research Committee; Radiation Safety Officer or Chair; IND; institutional approval; OCR; Radiation Worksheet; South Texas Veteran’s Health Care System; STVHCS; VA R&D Committee; Associate Chief of Staff (ACOS) for Research; VHA Handbook; University Health System; UHS; Senior Research Director; education requirements; standard operating procedures; Conflict of Interest Committee; AVPRA; COI Manager; COIC Chair; externally funded research; conflict of interest report; management plan; protocol related conflict of interest; Institutional Biosafety Committee; Assistant Vice President for Risk Management & Safety; Biological Safety Manager; Office of Sponsored Programs; Director of Sponsored Programs; certificate of proposal; award agreement; extramural award; clinical trial agreement; HIPAA; termination or lapse in IRB approval; Office of Regulatory Affairs & Compliance; Chief Compliance Officer; Research Compliance Manager; Mays Cancer Center Protocol Review Committee; Office of Clinical Research; OCR Manager; institutional requirements; Clinical Trials Office; Financial Planning Manager; participant payments; billing review

 

 

Guidance & HOP/OCR Policies

  Online Glossary of Human Research Terms

  Guidance

  HOP and OCR Policies applicable to IRB, IRB Members and Investigators

 

 


 


If you have questions concerning submission of a research protocol for IRB review, please call the Office of the IRB at 210-567-8250.