CHAPTER 6

6.0 Initial Screening and Requested Modifications

All IRB applications are screened and revisions may be requested by the IRB administrative staff. The assignment to full board, expedited, or exempt review is done at this stage.

6.0.1 Administrative Modification Cycles

PIs will be given one week to complete all administrative modifications. Upon adequate preparation, the submission will be accepted and assigned to an IRB member or members for review.

6.0.2 Administrative Modification Correspondence

If there are questions regarding IRB submissions, the IRB staff will provide written notice to the investigator specifying the additional information needed.

6.0.3 Potential IRB Submission Documents

The documents listed below must be submitted for review and approval, as applicable:

• Complete Research Protocol Application
• Informed Consent or Information Sheet
• Recruitment materials, such as flyers, posters, webpages, social media postings, email scripts, distribution emails, etc.
• Data and Safety Monitoring Plan (DSMP)
• Questionnaires, surveys, or similar instruments
• Letter of support from collaborators, such as private offices, daycare centers, and school districts
• Any other documents, as requested

6.1 Governing Principles and Regulations

The IRB will evaluate each proposed human subject research project on an individual basis to determine if the investigator is adequately protecting the rights and well-being of participants. The IRB is governed by the principles of the Belmont Report and the regulations in 45 CFR 46 (HHS) and 21 CFR 50, 56, and 812 (FDA).

6.2 IRB Meeting Schedule

The IRB is scheduled to meet at least once a month, at a date agreed upon with IRB member schedule availability. Schedules may be modified to accommodate semester instructional schedules, semester breaks, or other factors that may affect member availability. Full board meetings are generally held in person, but exceptions can be made for virtual attendance on a case-by-case basis.

6.3 Scientific/Scholarly Review

The IRB is responsible for the scientific/scholarly and ethical review of the research as it relates to determining that the risk-benefit ratio of a study is acceptable and the IRB criteria for approval are met.

6.4 Submission Review at a Full Board IRB Meeting

Protocols that are scheduled to be reviewed at a full board meeting are typically greater than minimal risk studies. Other items may be placed on the agenda for discussion, even if these items are not a greater than minimal risk study. The IRB will evaluate the documents submitted in the initial IRB application.

IRB Meeting submission deadlines and meeting dates are available at https://www.utep.edu/research/human-subjects-research/irb/#schedule

All meeting documents will be made accessible to all members not less than a week prior to the full board meeting.

6.4.1 Assignment of Primary and Secondary Reviewers

Each protocol is assigned to a primary and secondary reviewer to review the protocol in depth. Primary and secondary reviewers are assigned based on how closely the protocol content matches their expertise. Primary and secondary reviewers may contact the PI, Co-PI, other IRB Members, or outside sources to ensure a thorough evaluation of risks and balances are made. Members with a COI will recuse themselves from a review assignment.

The IRB may not have the appropriate expertise to review a study for scientific or scholarly validity. In such cases, the IRB Chair will consider who in the University or community has that expertise and ask them to serve as an expert consultant. Consultants will disclose any COI prior to performing the review.

6.4.2 Distribution of Study Documents to Reviewers

All submitted study documents and relevant study materials will be accessible to all IRB members in the electronic protocol system not less than one (1) week prior to the scheduled meeting to allow for discussion contribution. Primary and secondary reviewers are expected to review materials no later than the Monday before the full board meeting.

6.4.3 Presentation and Discussion of Protocols

Protocols undergoing initial and continuing Full Board Review at the full board meeting are presented individually to the IRB by the primary and secondary reviewers. PIs are often invited to attend to provide clarification or answer IRB questions. Members with appropriate scientific expertise, local knowledge, or other expertise specific to the protocols should also be present. If research involving vulnerable participants is reviewed, at least one member should be knowledgeable about or experienced in working with that population. If a member with the appropriate expertise cannot be present, the IRB staff will notify the IRB Chair to defer the review to the next regular meeting or have a consultant provide a written report of their evaluation of the protocol.

A quorum of members, including a non-scientist, must be present for the entire presentation, discussion and deliberation. A prisoner representative must be present if research involving prisoners is discussed. IRB staff will determine if a quorum of members is present and will inform the Chair when the quorum is met, then document the quorum in the meeting minutes. Members who are not present for a substantial part of the discussion and deliberation should abstain from voting. The following are discussed in detail for protocols in initial review:

• The regulatory criteria for approval at 45 CFR 46.111 or 21 CFR 56.111 are met.
• That investigators have adequate time, staff, and facilities to safely conduct and complete the research.
• The scientific and ethical justification for including vulnerable populations (children, prisoners, pregnant women, fetuses, decisionally-impaired adults), if applicable.
• An analysis of the procedures to minimize risk that includes PI access to a population that will allow recruitment of the necessary number of participants and the availability of medical or psychosocial resources that participants might need because of the research.
• The procedures used to ensure protection of subject privacy and data confidentiality.
• The scientific qualifications and experience of the investigators and their research staff.
• The human subjects protection training of the investigators and their research staff.
• Potential or disclosed investigator conflict of interest.
• The scientific and ethical justification for excluding classes of persons from the research.
• Data Safety Management Plan (if necessary).
• Written consultant reports. (If the protocol was reviewed by a consultant, the consultant will not be present for deliberation and voting on the protocol.)

6.4.4 Criteria for IRB Approval by the Full Board

The IRB will provide ethical and scientific review of all human subject research to the extent necessary to determine that all the requirements of 45 CFR 46.111 (Criteria for IRB approval of research) are satisfied. Criteria for approval include risks to subjects are minimized by implementing a series of key points. Using procedures that are consistent with sound research design, and which do not unnecessarily expose subjects to risk, and procedures already being performed on the subjects for diagnostic or treatment purposes. Risks to subjects continue to be reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result from the research. In evaluating risks and benefits, the IRB will consider only those risks and benefits that may result from the research, as distinguished from risks and benefits of therapy the subjects would receive even if not participating in the research. Selection of subjects is equitable and considers the purpose of the research and the setting in which the research will be conducted. Special attention is paid to problems of research involving vulnerable populations such as, children, prisoners, pregnant women, fetuses, and decisionally-impaired adults. Unless waived by the IRB, informed consent will be appropriately sought from each prospective subject or LAR in accordance with and to the extent required by appropriate local, state, and federal laws or regulations. The IRB is responsible for the review and approval of the informed consent form submitted by the PI. Informed consent will be appropriately documented according to local, state, and federal laws or regulations. Where appropriate, there are adequate provisions to protect the privacy of the subjects and to maintain the confidentiality of their identifiable data. When appropriate, the research plan continues to make adequate provision for monitoring the data collected to ensure the safety of subjects. When some or all subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study and in the IRB review process, to protect the rights and welfare of the subjects.

Reviewer checklists may be used to ensure that all regulatory requirements for review have been met.

6.4.5 Full Board Length of Approval Period

The interval for the continuing review is appropriate to the degree of participant risk. The approval period for full board review is normally one year but may be shorter. Protocols expire at midnight on the expiration date. Research activities may not continue after midnight of the expiration date. The following conditions may require shorter approval periods if any of the following apply:

1. Greater than minimal or high risk to subjects.
2. The stage of research is such that many of the risks are unknown.
3. The proposed procedures have not been used in human subjects.
4. There have been confirmed instances of serious or continuing non-compliance by the PI on record.
5. An IRB member voices more frequent review is required, with appropriate justification, and is agreed upon by the full board.

6.4.6 Full Board Determination Notifications

After each IRB meeting a letter is prepared and sent to the PI of each protocol notifying them of the IRB determination for the protocol. A letter of approval requires no further action, and the PI can begin research.

Letters requiring modification(s) to secure approval will contain a list of required conditions, and PIs will not receive final approval until all required conditions have been met. Along with the determination, the IRB will determine whether the PI’s responses to the conditions will need to be reviewed for appropriateness and completeness at another IRB full board meeting or by the IRB Chair or designated reviewer. Responses to clarifications that are directly relevant to regulatory criteria must be reviewed by the convened IRB. When the PI has responded to all conditions appropriately and completely then final approval is granted. The PI will be notified by an approval letter that research can begin and when the protocol will require continuing review.

For deferred/tabled protocols, the PI will be notified by letter of the reasons the protocol was deferred/tabled. To have the protocol reviewed again, the PI must respond to all the tabled reasons by adjusting the protocol and supporting submission documents or attaching additional supportive documentation.

Any protocol may be withdrawn from IRB consideration if there is no PI response to modifications required to secure approval or tabled items received in 60 days. Reconsideration of the protocol may require complete re-submission.

The PI of protocols that are disapproved will receive a letter that gives the reasons for disapproval.

6.4.7 Full Board Final Approval

During a full board review, the approval date is either the date IRB meeting or all conditions/stipulations have been adequately addressed. For example, if a full board meeting is on January 10th, and stipulations are not satisfied until January 15th, the study will not receive approval until January 15th. The interval for the continuing review is determined based on the participant risk level. Continuing review intervals may be three (3) months, six (6) months, or twelve (12) months. The review period may be discussed during full board continuing review discussions, if determined by the IRB reviewer and full board that a change in the review period is appropriate.

6.5 Expedited Review

Minimal risk protocols may be considered for expedited review if they fit one of the categories authorized by 45 CFR 46.110 for expedited review, listed below:

1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
   • 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.)
   • Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/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:
   • From healthy, nonpregnant 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
   • 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: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) 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: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) 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 surveys, 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.)
8. Continuing review of research previously approved by the IRB as follows:
   • Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
   • Where no subjects have been enrolled, and no additional risks have been identified; or
   • Where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a full board meeting that the research involves no greater than minimal risk and no additional risks have been identified.

The expedited review proposal may be reviewed and approved by the IRB Chair, Vice Chair, or other designated IRB member reviewers.

6.5.1 Submission and Review Schedule

Expedited protocols may be submitted at any time and are processed within 10 business days.

Expedited reviews are normally assigned to an IRB member, provided with the complete submission details to determine whether approval criteria has been met. Designated reviewers will document their recommendations in the electronic protocol system no later than the deadline date provided.

6.5.2 Assignment of Expedited Reviewers

IRB staff will screen and verify that the project is appropriate for expedited review and collaborate with the PI to ensure that required information has been provided and is complete. The protocol is then assigned to an IRB member for review. Reviewers having a COI with an assigned project should notify IRB staff who will then reassign the project to a different reviewer. Reviewers who cannot review the assignment by the designated due date should notify IRB staff as soon as possible who will then reassign to another member.

6.5.3 Applicability Criteria

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

Expedited categories apply regardless of the age of subjects, except as noted.

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.

The expedited review procedure may not be used for classified research involving human subjects.

IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or full board--utilized by the IRB.

6.5.4 Reviewer Considerations

Protocols undergoing expedited review should:

• Meet all applicability criteria
• Fall into one or more categories of research eligible for review using the expedited procedure. 45 CFR 46.110
• Meet regulatory criteria for approval.
• Investigators and their research staff have appropriate and sufficient qualifications, expertise, and training.
• Adequately manage any real or perceived conflicts of interest.

6.5.5 Criteria for Expedited IRB Approval of Research

Protocols that may be minimal risk but are not on the list of expedited review activities must be reviewed at a full board meeting. The IRB may determine that the project is minimal risk and may undergo an expedited review process under category 9 during subsequent continuation reviews.

6.5.6 Expedited Review Length of Approval Period

Projects that qualify for expedited review are not assigned a continuing review date unless the designated reviewer determines otherwise. The PI remains responsible for submitting any modifications or unanticipated problems for review and a closure report when the project meets criteria for closure. The UTEP IRB is authorized to administratively close research protocols that have had no research activity for a period of three years or more. This may include those without subject enrollment, funding, and/or in data analysis phase.

6.5.7 Expedited Review Determination Notifications

Modifications or Information Required: Substantive changes or requirements, requests for more information for IRB consideration, and other issues related to the criteria for approval are required and the project can be reviewed and approved by the IRB.

Approved: Made when all criteria for approval are met. Approved by the IRB as written with no explicit conditions.

Approved With Conditions: Criteria for approval are met but corrections are required. These are identified to the PI and must be completed and documented prior to beginning the research. Minor or prescriptive changes or requirements will be reviewed for approval by the IRB chair or a designated IRB member, typically the IRB staff person assigned to the study.

Please note: The reviewer may refer for review to the full committee/board for consideration. The designated reviewer may not render a decision of disapproval. A decision not to approve the protocol may only be rendered by the IRB at a full board meeting.

6.5.8 Expedited Review Notifications and Final Approval

After the protocol is reviewed by a designated reviewer, the PI will receive a letter of the IRB determination. A letter of approval requires no further action, and the PI can begin research. Letters requiring modification(s) to secure approval will contain a list of required conditions and PIs will not receive final approval until all conditions have been met. When the PI has responded appropriately and completely met conditions, then final approval is granted. The PI will be notified by an approval letter that research can begin and when the protocol will require continuing review.

6.5.9 Reporting of Expedited Review to the IRB

The protocol number, title, PI name, and expedited review category are reported to the IRB in the minutes generated.

6.6 Exempt Review

FDA-regulated research, including prisoners as research subjects, are not exempt from IRB review. DHHS-funded research, including prisoners as research subjects, may be exempt from IRB review if the research does not require any interaction with prisoners.

Federal regulations define when research is exempt from IRB review. UTEP IRB recognizes these exempt categories. A higher level of review may be necessary, through an expedited process or full board review, depending on the potential risks participants might face. IRB staff will evaluate all submitted projects and determine an appropriate level of review. Researchers should not determine the level of review.

Protocols may be considered for exempt review if they fit one of the categories authorized by 45 CFR 46.104 (d) for exempt review, listed below:

1. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   • Any disclosure of the human subjects responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7).
3. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
   • Any disclosure of the human subjects responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
   • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7).

   For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

   (i) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
   • The identifiable private information or identifiable biospecimens are publicly available;
   • Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   • The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
   • The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   • Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing research involving human subjects.
   • [Reserved]
6. Taste and food quality evaluation and consumer acceptance studies:
   • If wholesome foods without additives are consumed, or
   • If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by § 46.111(a)(8).
8. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
   • Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with § 46.116(a)(1) through (4), (a)(6), and (d);
   • Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 46.117;
   • An IRB conducts a limited IRB review and makes the determination required by § 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and
   • The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

Sections 46.104 (d) (5), (7) and (8) are not utilized by UTEP. Category 5 applies to projects conducted or supported by, or subject to, the approval of Federal department and agency heads. Researchers should contact the IRB office if they feel their project meets the criteria. Categories 7 and 8 rely on broad consent and will not be utilized.

6.6.1 Submission and Review Schedule

Exempt protocols may be submitted at any time and are processed within 10 business days.

Exempt reviews are normally assigned to an IRB member, provided with the complete submission details to determine whether approval criteria has been met. Designated reviewers will document their recommendations in the electronic protocol system no later than the deadline date provided.

6.6.2 Assignment of Exempt Reviewers

IRB staff will screen and verify that the project is appropriate for expedited review and collaborate with the PI to ensure that required information has been provided and is complete. The protocol is then assigned to an IRB member for review. Reviewers having a COI with an assigned project should notify IRB staff who will then reassign the project to a different reviewer. Reviewers who cannot review the assignment by the designated due date should notify IRB staff as soon as possible who will then reassign to another member.

6.6.3 Applicability Criteria

Research activities that present no more than minimal risk to human subjects, and involve only procedures listed in one or more exempt categories may be reviewed by the IRB through the exempt review procedure authorized by 45 CFR 46.104 and 21 CFR 56.104.

IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--exempt , expedited, or convened--utilized by the IRB.

6.6.4 Reviewer Considerations

Protocols undergoing exempt review should:

• Meet all applicability criteria
• Fall into one or more categories of research eligible for review using the expedited procedure. 45 CFR 46.104(d)
• Meet regulatory criteria for approval.
• Investigators and their research staff have appropriate and sufficient qualifications, expertise, and training.
• Adequately manage any real or perceived conflicts of interest.

6.6.5 Criteria for Exempt Research

Although exempt research is exempt from IRB review, it is not exempt from institutional ethical considerations. The IRB staff member making the exempt determination will ensure that research meets the criteria for exempt review and ethical standards are met regarding risks, equitable selection of participants, privacy and confidentiality, and informed consent.

The PI is responsible for the following during the conduct of the research:

• Ensure all research personnel are trained in ethical principles, relevant federal regulations, and institutional policies governing human subject research.
• Ensure all participants are provided with pertinent information (e.g., risks and benefits, contact information for investigators and the IRB), are selected equitably, and voluntarily agree to participate.
• Promptly report to the IRB any instances of non-compliance or unanticipated problems that may increase the risk to the subjects.
• Promptly report complaints from subjects regarding their risks and benefits. If a researcher is unsure whether a complaint involves risks or benefits, contact the IRB staff for assistance.
• Ensure that the privacy of the participants and confidentiality of the research data is maintained appropriately to ensure minimal risks to subjects.
• Submitting an amendment in the electronic protocol system.
• Submitting Project Status Reports if the project is not yet complete.
• Submitting a Closure/Final Report when the project is complete.

6.6.6 FDA Regulated Exempt Research 21 CFR 56.104

• Any investigation which commenced before July 27, 1981, and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.
• Any investigation commenced before July 27, 1981, and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.
• Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.
• Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

6.6.7 Limited IRB Review 45 CFR 46.111(a)(7)

Research eligible for limited IRB review is deemed to be no more than minimal risk and meets exemption categories 2 or 3. A designated reviewer will review the submission and assure the research meets the criteria of exempt category 2 or 3, and that ethical standards are met regarding risks, equitable selection of subjects, privacy and confidentiality, and informed consent. The designated reviewer will ensure there are adequate protections for the privacy interests of participants and the confidentiality of identifiable data. If a designated reviewer finds that research is greater than minimal risk, the reviewer must document the rationale for this determination and the rationale for review by the convened IRB. The designated reviewer may not disapprove or deny the research. Only the convened IRB may disapprove or deny research.

6.6.8 Exempt and Limited Review Length of Approval Period

Projects that are exempt from IRB are not assigned an approval period, or expiration date. A Closure/Final Report is requested to notify the IRB when the project is complete. The PI remains responsible for submitting any modifications or unanticipated problems for review and a closure report when the project meets criteria for closure. The UTEP IRB is authorized to administratively close research protocols that have had no research activity for a period of three years or more. This may include those without subject enrollment, funding, and/or in data analysis phase.

6.6.9 Exempt and Limited Review Determination Notifications

Modifications or Information Required: Substantive changes or requirements, requests for more information for IRB consideration, and other issues related to the criteria for approval are required so the project can be reviewed and approved by the convened IRB.

Acknowledged: Made when all criteria for exemption has been met, as written with no explicit conditions.

Please note: The reviewer may refer for review to the full committee/board for consideration. The designated reviewer may not render a decision of disapproval. A decision not to approve the protocol may only be rendered by the IRB at a full board meeting.

6.6.10 Exempt and Limited Review Notifications and Final Approval

If the research study is determined to meet the criteria for exempt or Limited Review status, the IRB staff will provide a determination letter to the PI.

6.6.11 Reporting of Exempt Review to the IRB

The protocol number, title, PI name, and exempt review category are reported to the IRB in the minutes generated.

6.7 Other Determinations

Including the typical IRB determinations there are determinations that are reserved for administrative use projects that are not considered to be human subject research.

• Acknowledged: Administrative determination used in study amendments or continuing status reports when there are very minor, or no changes to the project.
• Not Research: The project involves human subjects but is not considered research as defined by 45 CFR 46.
• Research – Not HSR: The project can be considered research but does not involve human subjects as defined by 45 CFR 46.

6.7.1 Not Human Subject Research Determination Notifications

Projects that do not meet the definition of research or human subjects will be sent a Not Human Subject Research determination letter.