Initial Review of All Submissions  

IRB staff screen all submissions for completeness.  PIs will be notified by phone or e-mail if a submission is missing documentation or necessary signatures.  The IRB staff, in consultation with the Chair or an IRB member, screens the protocol to verify the PI’s initial determination for exempt, expedited or full board review.  Any questions concerning the appropriate review level, applicability of the definition of human participants and/or the definition of research, jurisdiction of IRB, or otherwise relating to necessity of review are directed to the IRB Chair.

Exempt Procedures (New Protocol Submissions)

The PI must complete and submit the IRB-5 Request for Exemption from Continuing Review protocol form to the ORC.  Exempt research must be minimal risk.  Only the IRB Chair, IRB member, or IRB staff (acting as a designee of the Chair), may determine if a protocol is granted exempt status under the six categories described in 45 CFR 46.101(b).  In most cases, an IRB staff member reviews the protocol application and all of the material required for submission for exempt studies.  The IRB staff member may contact the PI directly to resolve any questions or concerns, or to require amendments prior to approving the exempt status.  Contact will generally be made via e-mail to provide documentation of the correspondence.  The IRB staff, after consultation with the IRB Chair or an IRB member, may determine that the research qualifies for expedited or full-board review, but may not deny the project.  The PI will be notified via e-mail or by letter if expedited or full board review is required, be given the reasons why it is required, and be asked to resubmit the study on the IRB-1 Protocol Application form.  Requests for Exemption from Continuing Review are generally reviewed within two weeks of receipt.

Although the regulations do not require informed consent for exempt research, the IRB has determined that informed consent is ethically appropriate to ensure that prospective participants are informed of the research and have an opportunity to decide for themselves whether or not to participate.  In most cases, the IRB will waive written consent and ask that the PI prepare an information sheet according to the requirements set forth under 45 CFR 46.116.

If the study qualifies for exempt status, the IRB staff will notify the PI via the standard exempt approval letter.  As a designee of the Chair, the IRB staff will issue the approval letter on behalf of the Chair and sign or initial the Chair’s name.  The approval letter describes the exempt category under which the study was approved.  The letter will also inform the PI that the study is subject to audit by the IRB Monitor.  A list of exempt approvals is provided to the IRB for review and approval by the IRB at each meeting.  Any member can request to review the entire IRB file for an exempt study.

For administrative purposes of maintaining the InfoEd database and files, the IRB staff may periodically contact the PIs of exempt studies during the three year approval period to determine if the study is still active.

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

Federal regulations allow six specific categories of human participant research to be exempt from continuing IRB review.  Although these six categories do involve research with human participants, the research does not expose participating participants to psychological, social or physical risks.  Per 45 CFR 46.101(b), the exempt research categories are:

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 participants can be identified, directly or through identifiers linked to the participants; and
   2. any disclosure of the human participants’ responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.
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 (b)(2) of this section, if:
   1. the human participants 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 participants cannot be identified, directly or through identifiers linked to the participants.
5. Research and demonstration projects which are conducted by or participant to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
   1. Public benefit or service programs;
   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
6. Taste and food quality evaluation and consumer acceptance studies,
   1. if wholesome foods without additives are consumed or
   2. 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.

Category 4 applies to retrospective studies of specimens and/or data that have already been collected.  The materials must be “on the shelf” (or in the freezer) at the time the protocol is submitted to the IRB.  Research that involves the ongoing collection of the specimens and/or data does not meet the criteria for category 4.  Category 5 pertains only to studies sponsored or funded by DHHS.  Research participant to FDA regulations does not qualify for exemption categories 1 – 5.

Per 45 CFR 46.101(i), the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, subpart C.  Also, the exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

In addition, although not required by regulations, IRB polices and procedures do not allow exemption of most research involving deception, audio or video taping, or HIV+ individuals.

Initial Review by Expedited Procedures

The PI must complete and submit the IRB-1, IRB-7 or IRB-9 Protocol Application for the Involvement in Human Participants in Research protocol form to the ORC.  Expedited research must be no more than minimal risk.  As defined in the federal regulations, “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)).  Only the IRB Chair or an IRB member may determine if a protocol is granted expedited status under seven of the nine categories as published in the federal register as 45 CFR 46.110 and 21 CFR 56.110.  Categories 8 and 9 do not pertain to initial review.

Only the Chair or an IRB member can make one of the following three determinations in regard to the protocol and consent forms:

• APPROVED:  IRB approval indicates that the IRB reviewer(s) has concluded that the research and consent forms meet the federal criteria for approval.
• MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL:  The IRB reviewer(s) withhold approval pending submission of revisions/additional information.
• FULL REVIEW REQUIRED: The IRB reviewer(s) may determine that the protocol requires full review by the IRB at a convened meeting.

The Chair or IRB member may not disapprove any research reviewed using the expedited procedure.  An IRB staff member screens the protocol and material required for submission for completeness and corresponds with the PI by e-mail and/or phone until the submission is complete.  Once the submission is complete, an IRB staff member conducts a preliminary review of the protocol application and material required for submission of expedited studies.  The staff member may also complete the Primary Reviewer Checklist.  The preliminary review consists of the following: (1) a review of the protocol to determine if there is missing information or information that requires further clarification, (2) a review of the consent form to see if it contains the required elements set forth in 45 CFR 46.116 and 117 and University policy, (3) a review of the recruitment procedures, (4) approval category, (5) if applicable, permissible categories and required findings for vulnerable populations and/or waivers or alterations of the consent process, and (6) a recommendation regarding one of the three determinations described above.  The IRB staff does not review scientific issues such as the study design, feasibility of specific aims or data analysis plans.  IRB staff prepares a draft review letter to the PI.  The IRB staff, in consultation with the IRB Chair, selects an experienced IRB member (the “Reviewer”) with appropriate scientific experience to review the protocol and material required for submission as well as the draft review letter.  The Reviewer may contact the PI directly to discuss questions or concerns.  The Reviewer may complete the Primary Reviewer Checklist.  The purpose of the checklist is to assist the reviewer.  It is an unofficial document that does not become part of the study file.

The preliminary review and the review conducted by the IRB Chair or IRB member Reviewer is conducted in accord with the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111.  In addition, the Reviewer must also determine 1) that the research is minimal risk, 2) that if identification of the participants and/or their responses reasonably place them at risk of criminal or civil liability or could be damaging to the participants’ financial standing, employability, insurability, or reputation, or be stigmatizing there are reasonable and appropriate protections that will be implemented so that risk related to invasion of privacy and breach of confidentiality are no greater than minimal, and 3) that the research is not classified or does not involve prisoners, with the exception that the expedited review of minor amendments for approved studies involving prisoners may be used.

If the Reviewer determines the protocol is approved, the IRB staff will notify the PI or correspondent via the standard expedited approval letter.  The IRB staff will issue the approval letter on behalf of the Reviewer and sign or initial his/her name.  The approval letter describes the expedited category under which the study was approved.  The letter will also inform the PI that the study is subject to audit by the IRB Monitor.  The approval period for studies approved through expedited review will be for one year from the date the initial approval or approval for continuation is granted.  Approval is valid through the expiration date (also known as ‘valid through’ date) noted in the approval letter.  For example, an expedited study given approval (either initially or for continuing review) on October 8, 2007 would be approved as valid through October 8, 2008, meaning that research is approved to be conducted on October 8, 2007, but will no longer be approved on October 9, 2008, and may not be conducted on or after that date without continuing approval by the IRB.  A list of studies approved via the expedited mechanism during the interim between agenda dates is provided to the IRB for review and approval IRB at each meeting.  Any member can request to review the entire IRB file for an expedited study.

If the Reviewer determined the protocol requires modifications to secure approval, he/she reviews and may revise the draft preliminary review letter prepared by IRB staff.  The Reviewer may add comments to the letter directly or provide comments about the protocol and letter to IRB staff by e-mail.  The IRB staff incorporates the revisions and sends the letter by e-mail to the PI or correspondent listed on the protocol.  If the research is student directed, the student will also receive a copy of the letter by e-mail. If the requested revisions or clarifications are minor, the PI may be notified by e-mail to provide documentation of the correspondence.  The PI responds to revisions requested by the IRB in writing and sends the response to the ORC.  PIs are encouraged to submit a point by point response to the IRB’s initial determination letter to facilitate review.  The PI must submit one copy of the protocol and/or consent form with the revisions highlighted and one copy of the protocol “clean,” without revisions highlighted, to expedite review of the revisions.  The IRB staff member who conducted the preliminary review will review the revisions to determine if the Reviewer’s concerns were properly addressed.  Any requested revisions involving the addition or deletion of specific elements is eligible to be reviewed by IRB staff.  Any revisions that involve controverted issues or pertain to the scientific review will be reviewed by the Reviewer rather than IRB staff.  In addition, any new procedures added to the protocol that result from the IRB’s review will be reviewed by the Reviewer.  In most cases, the IRB staff member will forward the revisions to the Reviewer by e-mail.  If the IRB staff and/or the Reviewer determines that all concerns have been addressed, the IRB staff will issue the approval letter on behalf of the Reviewer and sign or initial his/her name.  The approval letter describes the expedited category under which the study was approved.  The letter will also inform the PI that the study is subject to audit by the IRB Monitor.  The approval period for studies approved through expedited review will be for one year from the date the initial approval or approval for continuation is granted.  If the Reviewer and the investigator cannot agree on the amendments required for approval, the research will be sent to the convened IRB for review.  The PI will be notified by the IRB staff via e-mail or by phone if full board review is required, given the reasons as to why it is required, and may be asked to submit additional copies.

Continuing Review (Re-Approval) by Expedited Procedures  

To request re-approval, the PI must complete and submit the IRB-2 Re-Approval/ Completion form along with any required material as described in the instructions.  An IRB staff member screens the IRB-2 form and, if applicable, the protocol, consent form or material required for completeness and corresponds with the PI by e-mail and/or phone until the submission is complete.  To be eligible for expedited review, the research protocol must satisfy the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111 for the IRB to approve the protocol for continuation.  The IRB may only use expedited review procedures for continuation review under the following circumstances:

1. The study was initially eligible and continues to be eligible for expedited review procedures; OR
2. The research is permanently closed to the enrollment of new participants; all participants have completed all research-related interventions; and the research remains active only for long-term follow-up of participants; OR
3. Where no participants have been enrolled and no additional risks have been identified either at the University or at any site if the research involves a multi-site study; OR
4. The research involves the study of drugs and/or medical devices AND either does not require an Investigational New Drug (IND) (21 CFR Part 312) and/or an Investigational Drug Exemption (IDE) (21 CFR Part 812) and/or the device is approved for marketing and being used in accordance with the approved labeling. The IRB must also have determined and documented at a convened meeting that the research is no greater than minimal risk and no additional risks have been identified.

 

Categories 1 through 9, excluding 8b, apply to continuing review.  In accord with federal requirements, the IRB approval period can extend no longer than one year after the start of the approval period.  The PI may not continue research after expiration of IRB approval; continuation is a violation of federal requirements specified in 45 CFR 46.103(a) and 21 CFR 56.103(a).  If the IRB approval has expired, the PI must cease all research activities and may not enroll new participants in the study after the expiration of the IRB approval.  However, if the IRB determines that an overriding safety concern and/or ethical issue is involved or that it is in the best interests of the individual participants to continue participating in the research activities, the IRB may permit the participants to continue in the study for the time required to complete the re-approval process.

If the request for re-approval meets the circumstances defined above, the continuing review is conducted in the same manner as a new expedited protocol submission whereby IRB staff conduct a preliminary review and forwards the review to the IRB Chair or an IRB member.

Continuing review and approval for expedited studies must be obtained prior to the end of the day on which IRB approval expires.  Any amendments that are made at the time of re-approval will be reviewed in accord with the procedures for Review of Amendments to Previously Approved Research by Expedited Procedures.

For expedited review, the outcomes of continuing review are the same as the options outlined under Initial Review by Expedited Procedures.

Review of Amendments to Previously Approved Research by Expedited Procedures  

A PI may amend his/her approved protocol by submitting an IRB-3 Amendment Review form.  An IRB staff member screens the IRB-3 form and, if applicable, the protocol, consent form or material required for submission for completeness and corresponds with the PI by e-mail and/or phone until the submission is complete.  The IRB staff, in consultation with the IRB Chair or an IRB member, conducts a preliminary review of the IRB-3 to determine if the requested amendment is eligible for review under expedited procedures.  To be eligible for review under the expedited procedures the amendment must be minor.  A minor change is one which makes no substantial alteration in:

• The level of risk to participants;
• The research design or methodology;
• The participant population;
• Qualifications of the research team;
• The facilities available to support the safe conduct of the research; or
• Any other factor which would warrant review of the proposed changes by the convened IRB.

If the IRB Chair or an IRB member determines that the research qualifies for expedited review, the amendment is reviewed in the same manner as a new expedited protocol submission whereby IRB staff conducts a preliminary review and forwards the review to the IRB Chair or an IRB member.  Amendments of research involving vulnerable populations may be approved via the expedited process.  However, for research involving prisoners, the prisoner advocate will also be asked to review the requested change or addendum to determine that it meets the definition of minor change to previously approved research.

For expedited review, the outcomes of review of amendments are the same as the options outlined under Initial Review by Expedited Procedures..

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

Federal regulations allow nine specific categories of human participant research to be reviewed through an Expedited Review Procedure.  Per 45 CFR 46.110 and 21 CFR 56.110, the research should present no more than minimal risk to human participants and involve only procedures listed in one or more of the following categories:

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 (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:
   1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, 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 children1 considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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 nondisfiguring 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 participant or an invasion of the participant’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 nonresearch 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 participants. 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 participants 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 convened IRB as follows:
   1. Where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research 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.
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 convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

 

Initial Review by the Full Board

Proposed research that does not qualify for either exempt status or expedited review will be sent to the convened board for review.  The PI must complete and submit the IRB-1 Protocol Application for the Involvement in Human Participants in Research form to the ORC.  The application form used for expedited and full board review is the same.  If the PI indicates that he/she believes the research is more than minimal risk and requires review by the convened board, the original and 15 copies of the protocol and material are submitted.  This packet is set aside for the next IRB meeting.  Prior to the meeting, the IRB staff, in consultation with the IRB Chair or an IRB member, reviews the protocol to determine if the PI’s assessment is correct.  If the submission is determined to be of no greater than minimal risk and satisfies the criteria for expedited review, the protocol is added to the queue for review by expedited procedure.

Protocols that do not qualify for either exempt or expedited review are assigned a primary reviewer for initial review at the convened meeting.  Each member of the IRB receives a complete copy of the protocol submission.  The Chair and primary reviewer also receive a copy of the grant application, when applicable.  In cases where the standardized assessment measures are substantial, only the Chair and primary review will receive copies.  IRB members are informed that the packet they receive is not complete and may request a copy of the material by contacting the ORC.  The full file is also available to all IRB members at the meeting.  The primary reviewer is responsible for the following: (1) comparing the detailed grant application or industry protocol with the IRB application; (2) informing the full IRB of any discrepancies between the detailed protocol and the summary application materials; and (3) conducting an in-depth review.  Any member of the IRB may request to see additional information, including all of the information presented to the primary reviewer, the IRB file and previous minutes related to the study.  Each reviewer is provided with the Primary Reviewer Checklist and other review sheets as an aid to making determinations.  These work sheets are unofficial documents that do not become part of the study file.  The determinations of the convened board are noted in the minutes.

At the convened meeting, the primary reviewers will present a summary of the study, any concerns with specific items on the reviewer sheet and any additional concerns or comments.  Discussion and voting will follow.  IRB members are expected to be familiar with all items on the agenda and contribute toward the discussion or each item.  If the primary reviewer is absent, the review will be presented by the Chair or Vice-Chair.

Full Board reviews are conducted in accord with the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111.  The Board can make one of the following four determinations in regard to the protocol and consent forms:

• APPROVED:  IRB approval indicates that the Board has concluded that the research and consent forms meet the federal criteria for approval.
• MODIFICATIONS REQUIRED IN ORDER TO SECURE APPROVAL: A vote for amendments required indicates the IRB has given the meeting Chair the authority to approve the minor revisions.  The IRB withholds approval pending submission of minor revisions/additional information.
• DEFERRED:  The IRB withholds approval pending submission of major revisions / additional information.  For some studies, the IRB may appoint one or more members of the IRB to discuss the reasons with the investigator.  Once the revisions have been made by the PI and submitted to the ORC, the revised protocol is added to the next IRB meeting agenda for review.
• DISAPPROVED:  Disapproval of a protocol usually occurs when the IRB determines that the risk of the procedures outweighs any benefit to be gained or if the proposed research does not meet the federal criteria for IRB approval.

If the full board determines the protocol is approved, the IRB staff will notify the PI or correspondent via the standard full board approval letter.  The IRB staff will issue the approval letter on behalf of the individual chairing the meeting and sign or initial his/her name.  The letter will also inform the PI that the study is participant to audit by the IRB Monitor.  During the convened meeting, the IRB determines the approval period, as appropriate to the degree of risk but not less frequently than once per year.  The IRB will generally set a shorter approval period for high risk protocols or protocols with high risk/low potential benefit ratios.  When a protocol receives final approval, the IRB staff assigns the start of the approval period as the date of the convened IRB meeting.  If a protocol was determined to require amendments to secure approval and the PI completes the revisions, the approval period starts from the meeting date of the convened IRB at which the protocol was initially reviewed.

If the full board determined the protocol requires modifications to secure approval, the IRB staff prepares a draft determination letter based upon the IRB’s discussion at the meeting.  The letter describes the revisions requested by the IRB.  If the revisions requested are particularly controverted or complex, the staff may first e-mail the draft letter to the primary reviewer for review and comment.  The draft letter is then e-mailed to the meeting Chair for final review and approval.  The primary reviewer and Chair may add comments to the letter directly or provide comments about the protocol and letter to IRB staff by e-mail.  The IRB staff incorporates the revisions and sends the letter by e-mail to the PI or correspondent listed on the protocol.  If the research is student-directed, the student will also receive a copy of the letter by e-mail.  A hard copy of the letter is sent as a follow-up.  The PI responds to revisions requested by the IRB in writing and sends the response to the ORC.  PIs are encouraged to submit a point by point response to the IRB’s initial determination letter to facilitate review.  The PI must submit one copy of the protocol and/or consent form with the revisions highlighted and one copy of the protocol “clean,” without revisions highlighted to expedite review of the revisions.  If the revisions are straightforward and minor, the IRB staff may review the revisions to determine if they were addressed.  Any revisions that involve controverted issues or pertain to the scientific review will be reviewed by the primary reviewer or meeting Chair rather than IRB staff.  In addition, any new procedures added to the protocol that result from the IRB’s review will be reviewed by the primary reviewer or meeting Chair.  The Chair or primary reviewer may request that the new procedures be reviewed by the full board.  In most cases, the IRB staff member will forward the revisions by e-mail.  If the IRB staff, primary reviewer and/or the meeting chair determines that all concerns have been addressed, the IRB staff will issue the approval letter on behalf of the meeting Chair and sign or initial his/her name.  The letter will also inform the PI that the study is subject to audit by the IRB Monitor.  During the convened meeting, the IRB determines the approval period, as appropriate to the degree of risk but not less frequently than once per year.  The IRB may set a shorter approval period for high risk protocols or protocols with high risk/low potential benefit ratios.  When the protocol was determined to require modifications to secure approval and the PI completes the revisions, the approval period starts from the meeting date of the convened IRB at which the protocol was initially reviewed.  If the IRB and the investigator cannot agree on the modifications required for approval, the research will be sent to the convened IRB for further review.  The PI will be notified by the IRB staff via e-mail or by phone if full board review is required, given the reasons as to why it is required, and may be asked to submit additional copies.

If the full board determines that a protocol must be deferred, the IRB staff will prepare a draft determination letter based upon the IRB’s discussion at the meeting.  The letter lists the reasons for the deferral and includes a description of the revisions or clarifications requested.  The draft letter is reviewed according to the same procedures described above.  The approved letter is sent by e-mail to the PI or correspondent listed on the protocol.  If the research is student directed, the student will also receive a copy of the letter by e-mail.  A hard copy of the letter is sent as a follow-up.  The PI responds to revisions requested by the IRB in writing and sends the response to the ORC.  PIs are encouraged to submit a point by point response to the IRB’s initial determination letter to facilitate review and to met with IRB staff to discuss revisions.  The PI must submit one clean copy of the protocol and/or consent form and 15 copies of the protocol and/or consent form with the revisions highlighted.  The protocol is then added to the agenda for the next scheduled IRB meeting.  When a protocol that was initially deferred receives final approval, the IRB staff assigns the start of the approval period as the date of the meeting the protocol was approved or required modifications to secure approval.

If the full board determined the protocol must be disapproved, the IRB prepares a draft determination letter based upon the IRB’s discussion at the meeting.  The draft letter is reviewed and approved in the same manner as described above.  The approved letter is sent to the PI by hard copy.  If the research is student-directed, the student will also receive a copy of the determination letter.  A copy of the disapproval determination letter is also sent to the IO, AVPR, the PI’s Department Head, Sponsored Program Services (if applicable), and other University offices, as necessary.

Continuing Review (Re-approval) by the Full Board

To request re-approval, the PI must complete and submit the IRB-2 Re-Approval/ Completion form along with any required material as described in the instructions.  The application form used for continuing review for expedited and full board review is the same.  A primary reviewer system is used for continuing review.  Reviewers are selected in the same manner as described for Initial Review by the full board.  Each member of the IRB receives a complete copy of the protocol submission.  The Chair and primary reviewer each receive a copy of the grant application.  In cases where the standardized assessment measures are substantial, only the Chair and primary reviewer will receive a copy.  IRB members are informed that the packet they receive is not complete and may request a copy of the material by contacting the ORC.  The full protocol file is available at the meeting.  The research protocol must satisfy the criteria set forth in 45 CFR 46.111 and 21 CFR 56.111 for the IRB for the IRB to approve the protocol for continuation.

If a request for continuation is received early, the study will be reviewed at the next convened meeting and the review cycle will be adjusted accordingly based on that meeting date.  The instructions for the request for continuation form describe in detail the requirements for submission.

For full review, the outcomes of continuing review by the convened board are the same as the options outlined under Initial Review by the Full Board.

Review of Amendments to Previously Approved Research by the Full Board     A PI may amend his/her approved protocol by submitting an IRB-3 Amendment Review form.  The application form used for amendments for expedited and full board review is the same.  Minor changes can be approved by expedited review.  All other changes will be reviewed by the full board.  A primary reviewer system will be used to review requests for amendments to determine whether the modified research continues to fulfill the criteria for approval.  Reviewers are selected in the same manner as described for Initial Review by the full board.  Each member of the IRB receives a complete copy of the protocol submission.  The Chair and primary reviewer each receive a copy of the grant application.  In cases where the standardized assessment measures when are substantial, only the Chair and primary review will receive a copy.  IRB members are informed that the packet they receive is not complete and may request a copy of the material by contacting the ORC.  The full protocol file is available at the meeting.  The instructions for the request for amendment form describe in detail the requirements for submission.

For full review, the outcomes of review of amendments by the convened board are the same as the options outlined under Initial Review by the Full Board.