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The Office of Research Support (ORS) does not administer or oversee HOP policy 5-2011* or training related to the policy. ORS administers HOP policy 7-1210, “Promoting Objectivity in Research by Managing, Reducing or Eliminating Financial Conflicts of Interest” so if you conduct research and have:

  1. Not submitted a Financial Interest Disclosure (FID), you will need to complete mandatory training and file a FID. Instructions for completing these requirements are located at http://www.utexas.edu/research/rsc/coi/training.html.
  2. Previously submitted a FID, you are not required to complete additional training nor re-disclose the same information to comply with the UTS 180/HOP 5-2011 policy requirements.   However, you may have other responsibilities under that policy.

*If you have questions concerning the other policy, HOP policy 5-2011, “Conflicts of Interest, Conflicts of Commitment, & Outside Activities,” you should contact the Provost’s Office evpp_coi@austin.utexas.edu.

Section 5: Initial IRB Review of Research Activities

5.1 Governing Principles/Regulations

The IRB will evaluate each proposed human subjects research project on an individual basis to assess whether or not the investigator is adequately protecting the rights and well-being of the subjects. The governing principles for the IRB derive from those described and discussed in the Belmont Report. The governing regulations for the IRB are 45 CFR Part 46 and 21 CFR Parts 50, 56, 312, 600 and 812.

5.2 Initial IRB Review at a Convened IRB Meeting

Generally, protocols that must be reviewed at a convened meeting are considered to be more than minimal risk studies. The IRB will evaluate each project on an individual basis in order to assess whether the PI is providing adequate protection for the subjects. The assessment will be based on the initial IRB application, which includes the applicable documents listed in Section 5.2.1.

Submission deadlines and the number of copies of the submission packets are listed on the ORS website at http://www.utexas.edu/research/rsc/humansubjects/
meeting_dates.html

All meeting documents will be made accessible to all members including alternates who will be attending in place of primary members. Members may bring laptop computers to access meeting documents. In the event that a member cannot attend in person, teleconference capability is present and members may participate through teleconference.

5.2.1 Submission and Review Schedule

If the proposal meets all requirements for full board review, the following is required to be electronically submitted and included in the submission packet:

  1. A completed original IRB application with electronic signatures of the PI, co-investigator(s), faculty sponsor and, if applicable, Departmental Review Committees (DRCs).
  2. A research proposal describing the rationale for the study, research questions to be answered, information that allows the IRB to determine whether selection of participants will be equitable, methods, procedures, data analysis plan, and other required information that will allow the IRB reviewer(s) to conduct an analysis of the risks and potential benefits. The research proposal must follow the outline in the Research Proposal on the ORS website: http://www.utexas.edu/research/rsc/humansubjects/forms.html
  3. An informed consent document.
  4. Training Verification. (See 3.17 Training Requirements).
  5. Recruitment materials; i.e., flyers, posters, web-pages, email messages, etc.
  6. Data and Safety Monitoring Plan (DSMP) (See 5.2.2 below).
  7. Copies of all instruments if the study involves the use of questionnaires, surveys, or similar instruments.

If applicable:

  1. Letters of support for external sites.
  2. Review/confirmation of Environmental Health and Safety (EHS), Institutional Animal Care and Use Committee (IACUC), and/or Institutional Biosafety Committee (IBC) approval.
  3. Sponsor protocol (and the Investigator’s Brochure, when one exists).
  4. Copy of the Health & Human Services (HHS) grant application.
  5. HHS sample protocol.
  6. HHS sample consent document.

PIs are also requested to submit one paper copy of the entire submission to ORS by the submission deadline.

5.2.2 Data and Safety Monitoring Plans

Research studies in which subjects are at greater than minimal risk of experiencing physical or psychological injury (e.g., clinical/biomedical or behavioral studies that deliver an intervention to subjects) must consider how study data will be monitored and unanticipated problems addressed to assure the ongoing safety and wellbeing of subjects during the study. In these types of studies, a Data and Safety Monitoring Plan (DSMP) that addresses the following must be submitted:

  1. Type of data or events that are to be captured under the monitoring provisions. The monitoring provisions should be tailored to the expected risks of the research, the type of subject population being studied, the nature and size of the study, and the complexity of the research protocol.
  2. Frequency of assessments of data or events captured by the monitoring provisions (e.g., at certain points in time or after enrollment of a certain number of subjects).
  3. Entity or person(s) responsible for monitoring the data collected, including data related to protocol deviations, and unanticipated problems and their respective roles in the research activities (i.e., investigators, research coordinators, statisticians, independent medical monitor, etc.).
  4. Procedures for analysis and interpretation of the data.
  5. Time frames for reporting protocol deviations and unanticipated problems to the monitoring entity.
  6. Definition of specific triggers or stopping rules that will dictate when action is required and what the range of possible actions is.
  7. Reporting mechanisms/procedures for the data monitor and others responsible for communicating with the IRB, the study sponsor, the investigators and other appropriate officials the outcome of the reviews of the monitoring entity.

5.2.3 Assignment of Primary and Secondary Reviewers

IRB Program Coordinators will assign each protocol to IRB members who, as primary and secondary reviewers, will review the protocol in detail and act as a liaison between the IRB and the PI. Primary and secondary reviewers are assigned, as closely as possible, according to their expertise with the research being proposed and/or the subject population(s) being enrolled and their appropriate scientific or scholarly expertise to review the protocol. Protocols are not assigned to reviewers who have a conflict of interest (COI) or have academic appointments in the same administrative unit as the PI. The primary and secondary reviewers may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to ensure a thorough evaluation of risks and benefits of the proposed research.

At times, the IRB may not have the appropriate expertise to review the study for scientific or scholarly validity. In those cases, the IRB Chair will consider who in the University faculty or community has the appropriate scientific expertise to serve as an expert consultant to perform an in-depth review of the study. Consultants will disclose any COI prior to performing the review and those with a COI will not be used for protocol review.

5.2.4 Distribution of Submitted Materials to IRB Members

Meeting documents will be accessible to the IRB members 10-12 days prior to the scheduled meeting. The primary and secondary reviewers are expected to review all materials for their assigned protocol(s). IRB members who are not assigned as primary or secondary reviewers are expected to review at least the application, protocol and consent forms for research studies being considered at the meeting but, of course, may review all submitted materials as follows:

  1. Application form.
  2. Full protocol.
  3. Informed consent document
  4. Request to include vulnerable populations as subjects (pregnant women, fetuses, children, prisoners, decisionally impaired adults).
  5. Recruitment material.
  6. Copies of all instruments if the study involves the use of questionnaires, surveys, or similar instruments.

If applicable:

  1. DSMP.
  2. HHS grant application.
  3. HHS sample consent document.
  4. Sponsor protocol.

5.2.5 IRB Meeting Schedule

The IRB is generally scheduled to meet on the fourth Monday of each month but may be adjusted as necessary to accommodate member schedules, semester breaks, and other factors that affect member availability. The schedule may be viewed on the ORS website.

5.2.6 Presentation and Discussion of Protocols

Protocols undergoing initial and continuing review at the convened meeting are presented individually to the IRB by the Primary and Secondary Reviewers. IRB Program Coordinators will assure members with appropriate scientific expertise, local knowledge and other expertise specific to the protocols are present at the IRB meeting, along with at least one member who is knowledgeable about or experienced in working with vulnerable subjects, when research involving subjects who are vulnerable to coercion are reviewed. If a member with the appropriate expertise, knowledge, or experience in working with the specific vulnerable population cannot be present, the IRB Program Coordinator will notify the IRB Chair to obtain a consultant, if needed, to provide a written report of their evaluation of the protocol.

To be properly presented and discussed, a quorum of the members, which must include a non-scientist, an unaffiliated member and a prisoner representative (if research including prisoners is discussed) must be present for the entire presentation, discussion, and deliberation. The IRB Senior Coordinator (or designee) will determine is a quorum of members in present and inform the Chair when quorum is met. Members not present for a substantial part of the discussion and deliberations should abstain from voting. The presence of a quorum of members is documented in the meeting minutes. For those protocols undergoing initial review, the following are discussed in detail (list is not all-inclusive):

  1. The regulatory criteria for approval at 45 CFR 46.111 are met.
  2. The setting in which the research occurs; i.e. investigators have adequate time, staff and facilities to safely conduct and complete the research.
  3. The scientific and ethical justification for including vulnerable populations (children, prisoners, pregnant women, fetuses, decisionally impaired adults), if applicable.
  4. 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 as a consequence of the research.
  5. The procedures to be used to ensure protection of subject privacy and data confidentiality.
  6. The scientific qualifications and experience of the investigators and their research staff.
  7. The human subjects protection training of the investigators and their research staff.
  8. Potential or disclosed investigator conflict of interest.

If applicable:

  1. The scientific and ethical justification for excluding classes of persons from the research.
  2. DSMP.
  3. Written consultant reports. (If the protocol was reviewed by a consultant, the consultant will not be present for deliberation and the voting on the protocol.)

5.2.7 Criteria for IRB Approval of Research

In order to approve research, the IRB will provide ethical and scientific review of all human subjects research to the extent necessary to determine that all of the requirements of 45 CFR 46.111 Criteria for IRB approval of research are satisfied. Visit the HHS website at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.111

To ensure that all regulatory requirements for review have been met, a Primary and Secondary Reviewer checklist is utilized. Additionally, an IRB Guide containing a list of the requirements and reminders for other required determinations is distributed to each member at the IRB meetings.

5.2.8 Scientific/Scholarly Review

As stated in Section 3.17.3, the IRB relies upon the DRCs to assure that submissions contain appropriate information to facilitate IRB review. The IRB is ultimately responsible for the scientific/scholarly and ethical review of the research.

5.2.9 Length of Approval Period

The IRB will also determine the interval for the continuing review of the research, appropriate to the degree of risks that will be experienced by subjects. The interval for continuing review will be at least once per year (not to exceed 365 days; 366 days during a leap year) but may be shorter. If the protocol was approved or approved with explicit conditions, the expiration date is calculated from the date of the convened meeting. Protocols that have not undergone continuing review will expire at midnight on the expiration date. Research activities may not continue after midnight of the expiration date. The following conditions are likely to require review more often than annually:

  1. There is a high degree of 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 humans.
  4. There have been confirmed instances of serious or continuing noncompliance.
  5. An IRB member believes more frequent review is required.
  6. Other reasons for which the IRB requests closer monitoring.

5.3 Research Appropriate for Expedited Review

If a protocol has been determined to be minimal risk it may be considered for expedited review provided that it fits one of the categories authorized by 45 CFR 46.110 for expedited review.

Research including prisoners and involving direct interaction with the prisoners may be reviewed by the expedited review process if a determination is made that the research is minimal risk for the prison population being studied or included and a prisoner representative must review the research as either a primary or secondary reviewer.

Research that does not involve interaction (e.g., existing data, record review) with prisoners may be reviewed by the expedited review process if a determination is made that the research is minimal risk for the prison population being studied or included. A prisoner representative may review the research but review by a prisoner representative is not required.

The expedited review proposal may be reviewed and approved by the IRB Chair, Vice Chair, ORS Director or other IRB Chair designated reviewer.

5.3.1 Submission and Review Schedule

Protocols submitted for expedited review may be submitted at any time and will be processed within the timeframe listed on the ORS website at http://www.utexas.edu/research/rsc/humansubjects/timeline.html.

At least one IRB member is provided and reviews the complete protocol, including any protocol modifications previously approved by the IRB.

5.3.2 Submission Requirements/Materials Reviewed

If the protocol meets all requirements for expedited review, the following must be electronically submitted:

  1. A completed original IRB application (status report) with electronic signatures of the PI, co-investigator(s), and, if applicable, DRC.
  2. A research proposal describing the rationale for the study, research questions to be answered, methods, procedures, data analysis plan, and other required information. The research proposal must follow the outline in the Research Proposal Template.
  3. An informed consent document.
  4. Training verification. (See 3.17 Training Requirements).
  5. Recruitment materials; i.e., flyers, posters, web-pages, email messages, etc.

If applicable:

  1. Copies of all instruments if the study involves the use of questionnaires, surveys, or similar instruments.
  2. Site letters for extramural research.
  3. EHS, IACUC, IBC approval documentation.
  4. Sponsor protocol.
  5. Copy of the HHS grant application.
  6. HHS sample protocol.
  7. HHS sample consent document.

5.3.3 Assignment of Expedited Reviewer

Upon processing, the IRB Program Coordinators will verify the protocol is appropriate for expedited review. They will work with the PI to assure that all required documentation has been uploaded and the application is complete. The research protocols are then presented to the IRB Chair, Vice Chair, ORS Director, or other IRB Chair designated reviewer. Designated reviewers will be experienced IRB members, defined as having served on the IRB for at least one year. IRB Program Coordinators will assure that reviewers do not have a conflict of interest.

5.3.4 Reviewer Considerations

Protocols undergoing expedited review are reviewed to assure:

  1. The research meets all applicability criteria (See Section 5.3.5) and falls into one or more categories of research eligible for review using the expedited procedure.45 CFR 46.110
  2. The regulatory criteria for approval are met. (See Section 5.3.6 Criteria for IRB Approval of Research)
  3. Investigators and their research staff have appropriate and sufficient qualifications, expertise, and training. (See 3.17 Training Requirements).

5.3.5 Applicability Criteria

The following criteria should be considered for research undergoing expedited review:

  1. The research procedures present no more than minimal risk to subjects.
  2. The identification of 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 the risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
  3. The research is not classified.

5.3.6 Criteria for IRB Approval of Research

In order to approve research, the IRB will provide ethical and scientific/scholarly review of all human subjects research to determine that all of the requirements of 45 CFR 46.111 criteria for IRB approval of research are satisfied.

Protocols that may be minimal risk but are not included on the list of activities that may undergo expedited review are reviewed at a convened meeting of the IRB. The IRB may then designate that a protocol is minimal risk and determine that the protocol may undergo an expedited review process under Category 9  during its subsequent reviews for continuation.

5.3.7 Scientific/Scholarly Review

As stated in Section 3.17.3, the IRB relies upon the DRCs to assure that submissions contain appropriate information to facilitate IRB review. The IRB is ultimately responsible for the scientific/scholarly and ethical review of the research.

5.3.8 Length of Approval Period

The interval for continuing review will be at least once per year (not to exceed 365 days; 366 days during a leap year) but may be shorter. If the protocol was approved or approved with explicit conditions, the expiration date is calculated from the date of review and approval by the IRB Chair or designated reviewer. Protocols that have not undergone continuing review will expire at midnight on the expiration date. Research activities may not continue after midnight of the expiration date.

5.3.9 Reporting of Expedited Review to the IRB

The protocol number, title, PI name, and the category of research for which each protocol that was approved using an expedited review procedure is reported to the IRB at the next scheduled meeting.

5.4 Exempt Research

For HHS-funded research, the following exemptions do not apply if research includes prisoners as research subjects or if the research is FDA regulated. If the research is not HHS-funded, the exemptions will apply for research including prisoners as research subjects unless the research involves interaction with prisoners (including obtaining informed consent).

Research qualifying for exempt status must be in accordance with the University’s ethical standards and training requirements.

The HHS and FDA regulations define some research as exempt from IRB review. The IRB recognizes the exempt categories described in Section 5.4.1. However, depending on the potential risks subjects may experience, the IRB may require a higher level of review either through the expedited process or by the IRB at a convened meeting. PIs who feel their research exactly fits one of the categories for exemption may request such a determination by submitting an IRBaccess application. Upon receipt, the IRB Program Coordinators, in consultation with the ORS Director, Assistant Director, IRB Chair, or Vice Chair as necessary, will evaluate all requests for exemption and determine whether or not the research is eligible for exemption. PIs will be informed of the results of the evaluation by letter. PIs are not allowed to make the final determination of exemption. PIs are not authorized to begin until this letter is received.

Modifications that affect the exempt category or the criteria for exempt determination must be submitted as an amendment. Investigators are strongly encouraged to contact the IRB Program Coordinator(s) to describe any changes prior to submitting an amendment. The IRB Program Coordinator(s) can help investigators determine if a formal amendment is necessary or if the modification does not require a formal amendment process.

Formal continuing review will not be required, but investigators will be contacted at least every three years to determine if the research is still ongoing.

5.4.1 Exempt Research (Not FDA Regulated)

The categories for exemption are as follows:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
    1. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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.
    Note: For HHS-funded research that involves children as subjects, the procedures cannot involve i) survey procedures; ii) interview procedures; or iii) observation of public behavior where the investigators participate in the activities being observed (observation of public behavior where the investigators do not participate is allowable).
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) above, if:
    1. Human subjects are elected or appointed public officials or candidates for public office; or
    2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.
    Note: This exemption would not apply if the investigator(s) collects data in a coded manner since the code would enable subjects to be identified via the code. “Existing” means that the data, documents, records, or specimens must exist and be de-identified at the time the research proposal is submitted.
  5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine:
    1. Public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service programs (e.g., social supportive or nutrition services as provided under the Older Americans Act);
    2. Procedures for obtaining benefits or services under those programs;
    3. Possible changes in or alternatives to those programs or procedures; or
    4. Possible changes in methods or levels of payment for benefits or services under those programs.

      In addition:

    5. The research must be conducted pursuant to specific federal statutory authority.
    6. There must be no statutory requirement that an IRB review the research.
    7. Research must not involve significant physical invasions or intrusions upon the privacy of the subjects.
    8. The exemption should have authorization or concurrence by the funding agency.
  6. Taste and food quality evaluation and consumer acceptance studies if:
    1. Wholesome foods without additives are consumed.
    2. A food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
    3. 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.

5.4.2 Exempt Research (FDA)

The categories of research qualifying for exemption are as follows:

  1. Any investigation that 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 that meets the FDA requirements in effect before July 27, 1981;
  2. 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;
  3. 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;
  4. 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.

5.4.3 Criteria to Determine that Subjects of Exempt Research are Protected

Although exempt research is not covered by the federal regulations, it is not exempt from institutional ethical considerations. The individual making the exempt determination will assure the research meets the criteria of one of the categories for exemption listed in Section 5.4.2 and that ethical standards are met regarding risks, equitable selection of subjects, privacy and confidentiality, and informed consent. The Principal Investigator is responsible for assuring the following during the conduct of the research:

  1. All research personnel are trained in ethical principles, relevant federal regulations, and institutional policies governing human subjects research.
  2. All subjects are provided pertinent information (e.g., risks and benefits, contact information for investigators and the ORS), are selected equitably, and voluntarily consent to participate.
  3. Information or unanticipated problems that may increase the risk to the subjects and cause the category of review to be reclassified to expedited or full board review are immediately reported to the IRB.
  4. Complaints from subjects regarding their risks and benefits are immediately reported to the IRB.
  5. The privacy of the subjects and confidentiality of the research data will be maintained appropriately to ensure minimal risks to subjects.
  6. Reporting, by submission of an amendment request, any changes in the research study that altar the level of risk to subjects.

5.4.4 Length of Approval Period

Since protocols that are exempt from IRB review are not approved by the IRB, there is no approval period. However, PIs will be contacted every 3 years to verify that the research is ongoing and remains exempt. If the research is completed prior to the 3 year period, investigators are requested to notify the IRB of the study’s closure.

5.4.5 Modifications to Exempt Research

Researchers should notify ORS of proposed modifications to research determined to be exempt to assure that the research activities remain exempt for IRB review and exempt determination.

5.5 Possible IRB Protocol Determinations

Either the IRB at a convened meeting or a designated reviewer (expedited protocols) will render one of the following determinations for each protocol:

  1. Approved: Approved by the IRB as written with no explicit conditions.
  2. Approved with Explicit Conditions: Approved with requirements for minor changes or simple concurrence of the PI. These will be identified to the PI and must be completed and documented prior to beginning the research. For these conditions, the IRB Program Coordinator(s), in consultation with IRB Chair’s designated reviewers, upon reviewing the PI’s response(s) to the conditions, may approve the research on behalf of the IRB. PI responses to conditions deemed to be significant or that are directly relevant to regulatory criteria must be reviewed by the IRB at a convened meeting.
  3. Tabled: Generally, the protocol or consent form has 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, and on occasion the PI is asked to attend the full board meeting in order to clarify the points in question. The PI must revise the protocol, consent forms, or other documents as specified by the IRB and re-submit the entire protocol for full review at a convened meeting. The PI may request reconsideration of determination by submitting a written response to the IRB. The IRB will invite the PI to the IRB meeting if the IRB has additional questions. The IRB will reconsider its original decision in light of new information presented by the PI. The second decision is final.
  4. Disapproved: This determination may only be made at a convened IRB meeting. 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. The protocol and/or other documents will need to be completely re-written and re-submitted as a new submission. PIs may request reconsideration of disapproved studies by submitting a written response to the IRB. The IRB will invite the PI to the IRB meeting if the IRB has additional questions. The IRB will reconsider its original decision in light of new information presented by the PI.

For those protocols reviewed using the expedited review process, the designated reviewer may render decisions of approved, approved with explicit conditions, or tabled. The designated reviewer may not render a decision of disapproved. A decision of protocol disapproval may only be rendered by the IRB at a convened meeting.

Due to the high volume of protocols reviewed by the IRB, any protocol for which no PI response to approved with explicit conditions or tabled is received in 60 days will be withdrawn from IRB consideration. Reconsideration of the protocol will require complete re-submission.

5.6 Notification of Determinations

5.6.1 Full Board Review

Within five working days 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. An approval letter requires no further action and the PI can begin research.

Letters giving approval with explicit conditions 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 explicit conditions will need to be reviewed for appropriateness and completeness at another IRB convened 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 in a letter to the IRB office 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 tabled protocols, the PI will be notified by letter the reasons the protocol was tabled. The entire protocol, with all supporting documents, must be revised as needed and resubmitted.

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

5.6.2 Expedited Review

Within five work days after the protocol is reviewed by a designated reviewer, the PI will receive a letter of the IRB determination. An approval letter requires no further action and the PI can begin research. Letters giving approval with explicit conditions 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 in a letter to the IRB office addressing all 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.

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

Due to the high volume of protocols reviewed by the IRB, any protocol for which no PI response to approved with explicit conditions or tabled is received in 60 days will be a withdrawn from IRB consideration. Reconsideration of the protocol will require complete re-submission.

5.6.3 Exempt Research

If the research study is determined to meet the criteria for exempt status and if the PI Assurance Statement has been received, the IRB Program Coordinator will send an Exempt Determination letter to the PI. The exempt determination will be recognized for three years.

By agreeing to the PI Assurance Statement, the investigator assures that all investigators and co-investigators are trained in the ethical principles, relevant Federal Regulations and institutional policies governing human subjects research. The investigator assures that:

  1. Human subjects will voluntarily consent to participate in the research when appropriate (e.g., surveys, interviews) and will provide subjects with pertinent information such as risks and benefits of participation, contact information for investigators and the IRB office, etc.
  2. Human subjects will be selected equitably, so that the risks and benefits of the research are justly distributed.
  3. 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 Board Review.
  4. The IRB will be immediately informed of any complaints from participants regarding their risks and benefits.
  5. Confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects.

5.7 Final Approval and Expiration Dates

If a study is approved with no conditions, the final approval is effective the day the study is approved, i.e., the date of the convened IRB meeting for full board protocols and the date of reviewer’s approval for expedited protocols.

If a study is approved with explicit conditions, the final approval is effective on the day the protocol was reviewed and conditions were imposed by the IRB at a convened meeting (full board protocols) or the date that the reviewer imposed conditions (expedited protocols). This determination will be documented in the IRB meeting minutes. The expiration date for the approval is based on the date it was approved at a convened meeting or approved by a designated reviewer and will be no longer than 365 days (366 days if during a leap year) from the approval date, but may be sooner if more frequent review is stipulated by the IRB.