Section 6: Initial IRB Review of a Research Proposal Involving Human Participants

6.0 Requirements for Initial IRB Review
6.1 Submission Schedule Requirements
6.2 Initial Evaluation of Submitted Projects
6.3 Exempt Research Review Process
6.3.1 Criteria for Exempt Status
6.3.2 Categories of Research that May be Reviewed by the IRB through an Exempt Review Procedure
6.3.3 Research populations for which the exempt determinations may not be used
6.3.4 PI Assurance Statement
6.3.5 Procedures for Exempt Determination
6.4 Expedited Research Review Process
6.4.1 Categories of Research that may be Reviewed By The IRB Through an Expedited Review Procedure
6.5 Greater Than Minimal Risk Protocols
6.5.1 Primary Reviewer Checklist
6.6 Appeal of Decisions Made by the Institutional Review Board
6.7 Non-Compliance with IRB Polices, Procedures, or Decisions
6.7.1 Non-Compliance Reviewer Form

6.0 REQUIREMENTS FOR INITIAL IRB REVIEW

Any faculty member, staff or student from University of Texas at Austin who proposes to engage in any research activity involving the use of human subjects must submit the following to the IRB Office (all forms may be downloaded from the IRB web page at http://www.utexas.edu/research/rsc/humansubjects/forms.html).  Submissions to the IRB are done using IRBaccess.  Additional documentation should be uploaded with the application.  If you have questions about IRBaccess please consult the User Guide (Appendix H).  The ORS or the IRB reviews all submitted materials.  Please see section 2.3 for an approval timeline.  IRB members receive a complete set of all submitted materials (including the primary and secondary reviewer form) 10 –14 days prior to full board meeting. 

1. Required. A completed original IRB Application with collaborator(s), co-investigator(s), and Departmental Review Committee Chair’s electronic signature (if applicable);
2. Required. A research proposal describing the rationale for the study, research questions to be answered, methods, procedures, data analysis plan, and other required information (see http://www.utexas.edu/research/rsc/humansubjects/forms.html for template of research proposal). The research proposal must follow the outline in the proposal outline template;
3. One complete copy of the DHHS grant application, if applicable, and a Certificate of Consistency (see http://www.utexas.edu/research/rsc/humansubjects/forms.html) which is sent to DHHS to verify that the IRB has compared your grant proposal to your IRB proposal;
4. An informed consent form or justification for Waiver of Informed Consent or Waiver of Documentation of Consent;
5. If the study involves the use of questionnaires, surveys or similar instruments, copies must be submitted;
6. Required. Training Verification. This is to meet the University requirements for training of researchers in the protection of human subjects in research (see 4.1);
7. Site Letters, if applicable, for extramural research (see 3.0).
8. Additional approval documentation (EHS, IACUC, IBC).
9. Recruitment materials (flyers, posters, web-pages, email messages, etc.,)
10. Sponsor Protocol, if any.
11. DHHS sample protocol, if any.
12. DHHS sample consent document, if any.

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6.1 SUBMISSION SCHEDULE REQUIREMENTS

There is one IRB meeting per month. Meetings are held on the fourth Monday of each month, except for the months of May and December when special dates are assigned. Please see the home page of the web site for the list of meeting dates and submission deadlines http://www.utexas.edu/research/rsc/humansubjects/
meeting_dates.html.  Electronic applications must be submitted to the IRB office by midnight of the deadline date listed.  All additional documents must be uploaded with the application.  The deadline for submission packets is approximately 17 days prior to the meeting date. An attempt is made to send the packets to the IRB members within 10-14 days of that deadline.  If the study is eligible for an “Expedited or Exempt Review” process, it may be submitted at any time and will be reviewed in the order received and administratively approved.

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6.2 INITIAL EVALUATION OF SUBMITTED PROJECTS

The ORS receives all research applications.  The IRB Program Coordinators review all applications verifying the PI requested the appropriate review level: exempt, expedited, or full board, using the initial review checklist.  Any questions about the appropriate review level, applicability of definition of human participants, jurisdiction of IRB, or otherwise relating to necessity of review are directed to the ORS Director and/or the IRB Chair.  IRB staff or the IRB Chair reviews the agenda for protocols involving vulnerable populations and determines that the IRB includes persons knowledgeable about or experienced in working with these participants or obtains consultation.

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6.3 EXEMPT RESEARCH REVIEW PROCESS

Summary: Federal regulations identify specific categories of research activities that are exempt from the federal regulations on the protection of human subjects in research. It is important to note that while a project may be exempt from the regulations, the ethical principles of conducting research with humans still apply. At the University of Texas at Austin, the investigator may not make the determination of exempt status. To request exempt status, investigators should submit an initial application to the IRB office selecting exempt as the category of review. Once a complete (approved by the local DRC) application has been received, the Institutional Review Board (IRB) staff will make a determination of Exempt status within 7 business days after evaluating the investigator’s application against a detailed checklist. The IRB staff will review the complete application using the exempt reviewer sheet (Appendix M) and make the determination, consulting with the chair of the IRB, or the chair’s designate, as appropriate.

Exempt protocols will be approved for a three-year period.  Amendments to the protocol are required as noted below in instances in which the amendment increases the exempt determination of the study as listed below in section 6.3.1. All administratively approved protocol titles and PIs will be reported in the appropriate agenda and minutes to the IRB at the next meeting.

This policy and procedure is substantially revised from the previous policy on exempt determinations. The investigator is responsible for knowing and adhering to the ethical principles of human subject research. The investigator is also responsible for informing the IRB immediately of any adverse or unexpected events that would alter the Exempt status, and when the research is completed. The IRB staff is responsible for review of the exempt application, determination of status and PI Assurance Statement.

The IRB chair or members are involved in the evaluation and determination in specific limited instances, e.g., if the staff denies Exempt status, when requested by staff.

This policy is now revised to reduce the need for annual continuing review requirements within the three-year approval period, and reduce the need for formal approval of certain amendments to the study.

Determination of Exempt Status

The investigator may not make the determination of Exempt status. This is in compliance with the Terms of the Federal Wide Assurance that requires written procedures for “Verifying, by a qualified person or persons other than the investigator or research team, whether proposed human subject research activities qualify for exemption from the requirements of the Common Rule.” The investigator may submit an application to the IRB office requesting Exempt status. The application process follows the same procedures as for other Initial applications and must be submitted by the Responsible Investigator (The University of Texas faculty member with the rank of assistant professor or higher, or researcher who has a formal written agreement with the University, such as a code 1000 affiliation).

See Section 6-9-B “Graduate Student Research” of the HRP Manual for details regarding graduate student research.

The IRB staff will review the application and make the determination, consulting with the chair of the IRB, or the chair’s designate, as appropriate. The determination requires that the research activity meets the criteria for Exempt status and meets the criteria for protection of research participants in Exempt research. The IRB staff will then issue a letter of Exempt designation to the investigator.  For projects approved prior to this policy’s effective date the IRB staff will determine the project’s Exempt status either at the time of annual renewal of the original research protocol, or by special request of the investigator before the annual renewal date.

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6.3.1 Criteria for Exempt Status

The criteria for Exempt status follow all applicable federal regulations including:

• 45 CFR 46.101(b)(1) through (6),
• 45 CFR 46.301(a),
• 45 CFR 46.306(a) and (b),
• 45 CFR 46.401(b), and
• 21 CFR 56.104.

The criteria are applied to all research regardless of funding or funding source. These regulations identify specific categories of Exempt research activities and also identify when there are exceptions.

To be classified as Exempt, the research:

1. Must involve only procedures or be a type of study listed in one or more of the Exempt Categories (listed above);
2. Cannot involve children being surveyed, interviewed or interactively publicly observed;
3. Cannot involve prisoners as research subjects
4. Cannot be greater than minimal risk, and
5. Cannot be FDA-regulated, except for category (6).

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” 45 CFR 46.102(i)

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6.3.2 Categories of Research that May be Reviewed by the IRB through an Exempt Review Procedure

If a specific research activity meets the exemption criteria for one applicable regulation but not another, the research activity will not be given the Exempt status but will be processed under procedures for Expedited or Full Review.

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6.3.3 Research populations for which the exempt determinations may not be used

6.3.3.a Children

Research involving children cannot be classified as Exempt if the research involves:

1. Survey
2. Interview procedures
3. Observations of public behavior when the investigator participates in the activities being observed.

Research involving children can be classified as Exempt if the research involves only educational tests and observation of public behavior where the investigator does not participate in the activities being observed and meets the other conditions of 45 CFR 46.101(b)(2).

The regulations require additional protections for research involving children. The only Exempt Category above that applies to children as research subjects is Exempt Category (2). This category applies to research involving children as subjects only under specific conditions as specified in 45 CFR 46.401(b):

“Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.” 45 CFR 46.401(b).

6.3.3.b Prisoners

The federal regulations on exemptions listed above do not apply to research involving prisoners. Research involving prisoners as subjects is never Exempt from the regulations.

“The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health and Human Services involving prisoners as subjects.” 45 CFR 46.301(a) “Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or supported by DHHS shall not involve prisoners as subjects.” 45 CFR 46.306(b).

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6.3.4 PI Assurance Statement

 Research that is determined to be Exempt from IRB review is not Exempt from protection of the human subjects. The following criteria to protect human subjects must be met:

The investigator assures that all investigators and co-investigators are trained in the ethical principles, relevant Federal Regulations and institutional policies governing human subject research;

1. The investigator assures that human subjects will voluntarily consent to participate in the research when appropriate (e.g. surveys, interviews) and will provide subjects with pertinent information, e.g. risks and benefits, contact information for investigators and IRB chair, etc.;
2. The investigator assures that human subjects will be selected equitably, so that the risks and benefits of the research are justly distributed.
3. The investigator assures that the IRB will be immediately informed of any information, unanticipated problems that would increase the risk to the human subjects and cause the category of review to be upgraded to Expedited or Full Review;
4. The investigator assures that the IRB will be immediately informed of any complaints from participants regarding their risks and benefits; and
5. The investigator assures that confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects.

The criteria specified in the PI Assurance Statement, must be acknowledged in the application before Exempt approval will be granted. The Responsible Investigator’s signature acknowledges that he/she understands and accepts these conditions. Investigators can refer to the University website, www.utexas.edu/irb for specific information on training, voluntary informed consent, privacy, and how to notify the IRB of unanticipated problems.

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6.3.5 Procedures for Exempt Determination

6.3.5.a Initial Applications

The investigator must submit an Initial Application to the IRB including instruments, surveys, data abstraction sheet, etc. If the investigator selects the Exempt category on the application, he/she must also submit the PI Assurance Statement acknowledging they have read and accepted the responsibility to protect research participants.

IRB staff will review the application and determine if the research meets the criteria for Exempt research including the criteria that participants are protected. The determinations are documented using an Exempt worksheet. If the staff cannot make the determination, the IRB chair, or chair’s designee (IRB member) will make the determination whether the research meets the criteria after evaluating the application and completing the Exempt worksheet. The completed worksheet will reference all categories under which the exemption is granted.

The completed worksheet is placed in the file and the protocol will be processed based on the category of review.

Determination - Exempt
If the project is determined to meet the criteria for Exempt Status and if the PI Assurance Statement has been received, the IRB staff will send an Exempt Determination Letter to the investigator. If the signature page has not been received, the investigator will be prompted.   The Exempt Determination letter will grant a three-year approval for the research.  No continuing reviews will be necessary during that period.

Determination - Not Exempt (Expedited or Full)
If the IRB staff determines that the project does not to meet the criteria for Exempt Status, the IRB chair (or designate) reviews and signs the worksheet. The IRB staff will send an email to the investigator informing him/her of the determination. The email will include an explanation of why the project did not meet the Exempt criteria. The IRB staff will assign the appropriate category to the application, request additional information as needed and initiate the relevant expedited or full IRB review process).

Timeframe
Processing of complete applications for Exempt Status is estimated to take 7 working days, though IRB Staff will work to process as rapidly as possible. Processing time may increase if the application is incomplete, or staff must seek additional information to complete the determination.

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6.3.5.b Amendments

Note – this procedure is substantially revised from the previous procedure for exempt protocols. Effective with the implementation of this policy revision (March 18, 2008), investigators are not required to submit amendments to the IRB once a project is designated as Exempt as long as those changes do not affect the Exempt category or criteria for Exempt determination (changing from Exempt Status of the project to Expedited or Full Review, or changing criteria for requesting Exempt Status). 

Amendments in procedures that would change the Exempt category include but are not limited to:

1. New knowledge that increases the risk level;
2. Use of any methods described in the Expedited review categories that do not meet the Exempt criteria (e.g. video taping, blood draws);
3. Surveying or interviewing children (under 18) or observing public behavior of children and participating in the activities being observed;
4. Change in the way identifiers are recorded (directly or indirectly) from existing data, documents, records, pathological specimens, or diagnostic specimens so that subjects can be identified;
5. Addition of an instrument, survey questions, etc. that would pose more than minimal risk to subjects;
6. Addition of an instrument, survey, etc. from which information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation;
7. Addition of prisoners as research subjects; and / or
8. Addition of other vulnerable populations that may pose more than minimal risk, such as interventions or interactions with individuals confined in mental hospitals, nursing homes, or other facilities where the individual’s freedom of movement is restricted.

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6.4 EXPEDITED RESEARCH REVIEW PROCESS

Protocols determined to be minimal risk but not falling into any exempt category, may be considered for expedited review (see 6.4.1).  ORS staff review the protocols fulfilling all requirements for expedited review (6.4.1).  The ORS staff member reviews the packet for completeness and corresponds with the principal investigator by e-mail and/or phone until the packet is complete.  A reviewer then completes the primary and secondary reviewer checklist (Section 6.5.1). As a second step, the packet must be reviewed by the IRB Chair or IRB designate, who is a voting member of the IRB, and administratively approved.  Expedited protocols are not “disapproved” by the ORS or IRB chairperson. If the PI is ultimately unwilling to make these changes, then the expedited study will be placed on the agenda for the next full board meeting.  All expedited items (new proposals, amendments, continuing reviews, unanticipated problems, closures, terminations) are listed in a monthly agenda and corresponding minutes, as a method of informing IRB members.

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6.4.1 Categories of Research that may be Reviewed By The IRB Through an Expedited Review Procedure

The Director of ORS provides IRB staff with a list of experienced IRB members designated by the ORS Director and IRB Chair to be eligible to conduct expedited review, and updates this list as needed.  To be considered experienced, a member must have served on the IRB for six months and conducted at least ten training reviews under the mentorship of the IRB Chair or ORS Director.  IRB staff reviews the application for completeness and then selects the Chair, the Vice Chair, the ORS Director, or one of the reviewers on the list so that a person without a conflicting interest conducts reviews.  If the required expertise is not available in a non-conflicted member, then the review will be assigned to the IRB Chair, ORS Director, or other member if the Chair or Director has a conflicting interest, and consultation will be arranged per IRB Policies and Procedures Manual, Section 2.5.

Review Process Guidelines:

• The reviewer may approve the protocol or request modifications in order to secure approval.
• When requesting modifications, if the reviewer and investigator cannot agree on the proposed modifications required to secure approval, the protocol is sent to a convened IRB for review.
• If a reviewer believes the protocol should be disapproved, the protocol is sent to the convened IRB for review.
• In conducting initial or continuing review, the reviewer must determine that all applicability criteria are met and that all research activities fall into one or more categories of research allowing review by the expedited procedure.
• In conducting review of modifications to a previously approved protocol, the reviewer must make sure that the modification is a minor change as defined by policies and procedures.
• In conducting review, the reviewer is to complete the Primary Review Checklist and all other checklists that would be used for review by a convened IRB.
• In order to grant approval the reviewer must determine that the protocol meets all regulatory requirements for approval.
• When granting initial or continuing approval the reviewer must document the category allowing review by the expedited procedure.
• When granting initial review, the reviewer must document any determinations required by the regulations for waiver or alteration of consent, waiver of consent documentation, research involving prisoners, pregnant women, fetuses, neonates or children, and must document protocol specific findings that justify those determinations.

Applicability for Initial Review:

1. Research activities that:
   1. present no more than minimal risk to human subjects, and
   2. involve only procedures listed in one or more of the following categories may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

      The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

2. The categories in this list apply regardless of the age of subjects, except as noted.
3. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented, so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
4. The expedited review procedure may not be used for classified research involving human subjects.
5. IRBs are reminded that the standard requirements for informed consent (or its waiver, amendment, or exception) apply, regardless of the type of review, expedited or convened, utilized by the IRB.
6. Categories (A) through (G) below pertain to both initial and continuing IRB review:
   1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
      2. Research on medical devices for which
         1. an investigational device exemption application (21 CFR Part 812) is not required; or
         2. the medical device is cleared or approved for marketing and the medical device is being used in accordance with its cleared/approved labeling
   2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
      1. from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
      2. from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
   3. Prospective collection of biological specimens for research purposes by noninvasive means.  Examples include:
      1. hair and nail clippings in a non-disfiguring manner;
      2. deciduous teeth at time of exfoliation, or if routine patient care indicates a need for extraction;
      3. permanent teeth, if routine patient care indicates a need for extraction;
      4. excreta and external secretions (including sweat);
      5. uncannulated saliva collected, either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
      6. placenta removed at delivery;
      7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
      8. supra- and sub-gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
      9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
      10. sputum collected after saline mist nebulization.
   4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing (studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications).Examples include:
      1. physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;
      2. weighing or testing sensory acuity;
      3. magnetic resonance imaging;
      4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
      5. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
   5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101 (b)(4). This listing refers only to research that is not exempt.)
   6. Collection of data from voice, video, digital, or image recordings made for research purposes.
   7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.  NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.

Applicability for Continuing Review

• Research eligible for initial review by an expedited procedure.
• Research previously approved by the convened IRB as follows:

1. Where:
   1. the protocol is permanently closed to the enrollment of new participants;
   2. all participants have completed all research-related interventions; and
   3. the protocol remains active only for long-term follow-up of participants; or
2. Where no participants have been enrolled and no additional risks have been identified; or
3. Where the remaining research activities are limited to data analysis.

• Research, not conducted under an investigational new drug application or investigational device exemption where the above two categories do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

In addition, each of the above items must meet the following three applicability criteria:

• The research presents no more than minimal risk to subjects. (Not applicable for category (8)(b) Where no participants have been enrolled and no additional risks have been identified);
• The identification of the subjects or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. (Not applicable for category (8)(b) Where no participants have been enrolled and no additional risks have been identified); and
• The research is not classified.

Applicability for Review of Modifications to Previously Approved Research

• The modification to the protocol or consent forms is minor, defined as a modification that does not increase the risk or decrease the potential benefit to participants; does not involve the addition of procedures involving more than minimal risk to participants; and all added procedures fall into categories (1)-(7) of research that can be reviewed by the expedited procedure.

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6.5 GREATER THAN MINIMAL RISK PROTOCOLS

All submissions for initial review, continuing review, or review of modifications to previously approved research determined by ORS staff or DRC to not be eligible for exemption or review by expedited procedures (failing to meet 6.4.1 or 6.5.1) by regulation must be reviewed and approved, at a fully convened IRB meeting. The Institutional Review Board adheres to the following process to facilitate the thorough review of each protocol according to Federal regulations (45 CFR 46 and 21 CFR 50 and 56):

After submission, each new protocol is given an IRB specific number for tracking purposes.  ORS provides a complete set of documents provided by the investigator to each IRB member each of whom is asked to review the protocols and supporting documentation in detail.  Additionally the ORS Director specifically assigns each new protocol to two IRB members for “primary and secondary review.”  ORS makes every effort to identify reviewers based upon expertise, relevance, interest, and possible conflict of interests.  Each reviewer is responsible for completing the “Primary and Secondary Reviewer Checklist” (6.5.1) and returning it to ORS.  Prior to the IRB meeting the reviewers may correspond with the investigator(s) to resolve any questions.  Furthermore, any IRB member may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to insure a thorough evaluation of risks and benefits of the proposed research.   The Primary and Secondary Reviewer Checklist documents regulatory determinations and protocol specific findings and is maintained in the IRB files.

The IRB meets on the fourth Monday of each month (except for May and December) to review and discuss each protocol. The protocols undergoing initial review are presented and discussed individually by the IRB, as well as those protocols undergoing continuing review. The primary reviewer (if not present the secondary reviewer) presents each new study to the board following the format of the “primary and secondary reviewer checklist” and raising any additional points for discussion.  After complete and individual discussions, each protocol is voted upon for one of four possible dispositions. The Board may vote to approve, disapprove, table, or approve with explicit conditions.  The IRB accepts and endorses without reservations “approved” studies.  Studies approved with explicit conditions, the IRB accepts and endorses provided the investigator concurs with the explicit changes and recommendations.  A study may be tabled because the Board did not have sufficient time, expertise, or appropriate personnel present (i.e., absence of prisoner advocate for a study involving prisoners) to vote on the study, or because the Board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study. A study may be approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the IRB member or another member designated by the Chair may approve the revised research protocol under an expedited review procedure to determine whether the investigator has incorporated the specified explicit conditions into his or her project.  The potential IRB actions are:

1. Approved – Accepted and endorsed as written with no conditions.
2. Approved with Explicit Conditions – Accepted and endorsed with explicit minor changes or simple concurrence of the principal investigator.  All explicit conditions requested of the PI (ORS sends formal letter) must be completed and documented prior to beginning the research.  For these conditions, the IRB Chair or designated reviewer can, upon reviewing the PI’s response(s) to stipulations, approve the research on behalf of the IRB. If your study has received approval with Explicit Conditions, return one copy of the corrections to the IRB or ORS with any changes underlined or in bold.
3. Tabled – All clarifications, explanations, and justifications of the protocol, consent form, or other application materials.  Generally, if the protocol, consent form, or other materials have deficiencies that prevent accurate determination of risks and benefits or requires significant clarifications, modifications or conditions that, when met or addressed, require full IRB review and approval of the PI’s responses and revisions. The deficiencies will be specified to the PI (ORS sends a formal letter), and on occasion the PI is asked to attend the full board meeting in order to clarify the points in question. If your study was tabled, re-submit revisions via IRBaccess to ORS.  Please indicate changes by underlining, bolding, or highlighting.
4. Disapproved – The protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas. A principal investigator has the right to appeal the disapproval of his research protocol to the Board and asked to have the decision reconsidered.  Investigators may submit a written response to the IRB for a protocol that is disapproved or tabled.  The written response will be reviewed by the IRB.  The IRB will invite the investigator to the IRB meeting if the IRB has additional questions for the investigator.  The IRB will reconsider its decision.  The second decision is final.

If the protocol disposition is “Approved” or “Approved with Explicit Conditions” and the protocol requests inclusion of a vulnerable population(s)¹⁷, special determinations for the vulnerable population(s) are performed at this time.

Following the presentation and discussion of protocols receiving either initial or continuing review, a listing of protocols reviewed and administratively approved for continuation, a listing of protocol modifications, a listing of unanticipated problems reported (off-site and at University of Texas at Austin), a listing of those protocols approved through expedited review procedures and other information relating to ongoing research activities are reported to the IRB. Protocols requesting significant modifications or of special interest to the IRB are discussed in detail, and voted upon by the convened IRB. The principal investigator is notified of the status of approval within 3 days of the IRB meeting. Letters are sent to the PI through campus mail and by electronic mail as necessary.

There are times when the risks associated with a particular protocol are such that continuing review should take place more frequently than annually (e.g., prior cases of non-compliance, significant risks to human subjects, etc.). In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval or after a specified number of subjects (e.g., after each subject or after 3 subjects) are enrolled. The PI’s reports must describe the observed effects of the research activities and/or how the subject(s) responded to the research interventions. The determination will be recorded in the IRB minutes and reports forwarded to the IRB, by the IRB office, when they are submitted.

6.5.1 Primary Reviewer Checklist

See Appendix N.

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6.6 APPEAL OF DECISIONS MADE BY THE INSTITUTIONAL REVIEW BOARD

Approvals, favorable actions, and recommendations made by the IRB are subject to review and further restriction by the institutional administration (VP for Research, President). For example, protocols could be approved by the IRB on a scientific and ethical basis, but be restricted or disapproved by institutional administration due to the potential for adverse public/community reaction. Protocol disapproval, restrictions or conditions imposed by the IRB upon any activity involving human subjects cannot be rescinded or removed except by subsequent action of the IRB.  Investigators may appeal tabled and disapproved studies. A principal investigator has the right to appeal the disapproval of his research protocol to the Board and asked to have the decision reconsidered.  Investigators may submit a written response to the IRB for a protocol that is disapproved or tabled.  The written response will be reviewed by the IRB.  The IRB will invite the investigator to the IRB meeting if the IRB has additional questions for the investigator.  The IRB will reconsider its decision.  The second decision is final.

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6.7 NON-COMPLIANCE WITH IRB POLICIES, PROCEDURES, OR DECISIONS

Human subjects research that deviates from the policies, procedures, stipulations, decisions, state, or federal law is non-compliant and subject to further inquiry by the IRB and ORS.  All reports and complaints of non-compliance should be directed to the ORS (via email, phone, mail, or in person).  The ORS will immediately investigate all allegations of non-compliance.  If necessary  (see suspension/termination policy), the ORS will send the investigator/s in question a notice requesting the immediate suspension of all specified research activities while the issue of non-compliance is reviewed, consistent with Federal Mandate 45 CRF Part 46.113.  This initial notice will also include a statement detailing the rationale for the IRB’s action.  There are three categories of non-compliance: general, serious, and continuing.

1. Non-compliance: Any deviation from University of Texas at Austin IRB policies and procedures, federal regulations, or state law is “non-compliance.” Failure to follow requirements and determinations of the IRB is also considered “non-compliance.”
2. Serious Non-compliance: All Non-compliance substantially affecting participants’ rights and / or welfare, or impacting upon the risks or benefits is serious non-compliance.
3. Continuing Non-Compliance: Is a pattern of non-compliance that indicates an inability or unwillingness to comply with the regulations or the requirements of the IRB.
4. Allegation of Non-Compliance: An unproven assertion of non-compliance.
5. Finding of Non-Compliance: Non-compliance that is true in fact.  A finding of non-compliance may exist because there is clear evidence, an admission, or an investigation into an allegation has determined the allegation to be true.

All non-compliance will be brought to the attention of the Director of the Office of Research Support.  If the general non-compliance is clearly neither serious nor continuing, and there is a corrective action plan that can be readily implemented to prevent recurrence, then the matter may be filed and no further action is needed (for example, failure to sign the application or lost consent forms).  Otherwise, the Director will refer allegations and findings of non-compliance to undergo an evaluation by an ad-hoc IRB Non-Compliance Sub-Committee, selected by the chair.  This sub-committee, composed of two members of the IRB and one staff member from the Office of Research Support, will review the nature of the non-compliance, complete the non-compliance form, and make a recommendation based on each specific case. The sub-committee issues recommendations to the IRB for a vote.  For allegations of non-compliance the sub-committee recommends whether the allegation has a basis in fact. When allegations are found not to have a basis in fact, the investigation is closed. For findings of non-compliance, when allegations are substantiated, the sub-committee considers the following recommendations: modifying the research protocol; modifying the consent process; contacting past or current participants with additional information (for current participants whenever that information might affect their willingness to continue to take part in the research); re-consenting participants; modifying the approval period; suspension; termination; or utilizing the Peer Review Process.  The IRB non-compliance sub-committee will also recommend whether the non-compliance was serious or continuing.

The IRB will review the recommendation(s) of the IRB non-compliance sub-committee at a convened meeting.  All IRB members will be provided with a copy of the approved protocol, current consent documents, and the report of the IRB non-compliance sub-committee with any supporting documents.  A member of the IRB non-compliance sub-committee will serve as a primary reviewer.  The relevant IRB files, if any, will be made available at the meeting.  The IRB may accept, modify, or reject the sub-committee’s recommendation(s). The IRB will then assess whether the incident of non-compliance was serious and/or continuing.  If necessary, the IRB may request additional information before issuing determinations.  The IRB reserves the right to request any appropriate additional consultation and expertise to resolve non-compliance. Deliberations and determinations of the convened IRB will be fully documented in the minutes.  All cases of non-compliance which the IRB determines to be serious or continuing noncompliance will be reported according to the Reporting Policy found in Section 2.0.6.

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6.7.1 Non-Compliance Reviewer Form

See Appendix O.

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