Institutional Review Board Procedures

Overview

In accordance with federal human subject regulations (including 45 CFR Part 46 and 21 CFR Parts 50, 56, 312, 812) and Santa Fe College Board Rule 2.14, the Santa Fe College (SF or College) Institutional Review Board (SFIRB) reviews all research proposals conducted by or through the College using human subjects.

IRB approval is required if any of the following apply:

if the data gathered are geared for scholars, educators, and/or researchers within a specified field of study to provide input into a field of study;
if the results of the study are presented either by presentation or publication in order to illuminate some topic/issue within one's field of study;
if results from the study are applied to some population in addition to the original sample

The SFIRB ensures that the individuals involved in a project are treated ethically; that all subjects are provided with substantial information about the study and consent to be a subject in the study; and that all private information will be handled with confidentiality.

At SF those individuals seeking to conduct such research may not solicit subject participation or begin data collection until they have obtained clearance by the Santa Fe College Institutional Review Board. In addition, only the SFIRB can determine if a proposal is exempt from the requirements of the federal human subject regulations.

Definitions

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. (45 CFR 46.102)

Systematic investigations can usually be recognized by the fact that they have a question they are attempting to answer, or a hypothesis they are attempting to prove/disprove.

Investigations designed to develop or contribute to generalizable knowledge are those designed to:

draw general conclusions,
inform policy, or
generalize findings beyond a single individual or an internal program (e.g., publications or presentations.)

This definition can vary. Examples of activities that typically are not generalizable include:

biographies
oral histories that are designed solely to create a record of specific historical events
service or course evaluations, unless they can be generalized to other individuals
services, or concepts where it is not the intention to share the results beyond SF or any agency supporting the research
classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the SF community
operational activities such as practice activities in medicine, psychology, social work, and public health (e.g., routine outbreak investigations and disease monitoring) and journalism or political polls unless there is a clear intent to contribute to generalizable knowledge.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

Data through intervention or interaction with the individual, or
Identifiable private information. (45 CFR 46.102)

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102)

Engagement in human subject research:

In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. An institution's employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. "Employees and agents" can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation. (http://www.hhs.gov/ohrp/policy/engage08.html)

FDA Definition of Research (from 21 CFR 50.3(c))

"Any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit." The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies.

Under FDA regulations, the terms "research" and "clinical investigation" are synonymous. A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act (21 CFR 50.3(j)).

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

I. Santa Fe IRB Categories of Review

The SFIRB assessment of risks of research proposals or projects involves: 1) identifying the risks associated with the research, as distinguished from the risks the participants would encounter even if not participating in research; 2) determining that the risks will be minimized to the extent possible; 3) identifying the probable benefits to be derived from the research; 4) determining that the risks are reasonable in relation to the benefits to research participants, if any, and the importance of the knowledge to be gained; 5) assuring that potential participants will be provided with an accurate and fair description of the risks or discomforts and the anticipated benefits; and 6) determining intervals of periodic review, and, where appropriate, determining that adequate provisions are in place for monitoring the data collected. 7) To ensure that selection of subjects is equitable and the rewards given for participation do not compromise the collection of data. In addition, the SFIRB will determine the adequacy of the provisions to protect the privacy of research participants and to maintain the confidentiality of the data, and where the participants are likely to be members of a vulnerable population, determine that appropriate additional safeguards are in place to protect the rights and welfare of these research participants.

Projects requiring the review of the full Board at a convened meeting
Projects require review by the full SFIRB at a convened meeting unless they meet the criteria for expedited review (see B.) or exemption (see C.). Protocols that necessitate review at a convened meeting must be received in the SFIRB office prior to the first work day of the month. Protocols that are substantively complete are sent to SFIRB members at least one week prior to the meeting as part of the meeting packet.
Projects that may receive expedited review
Research that involves no more than minimal risk and falls within one or more of the following categories can receive expedited review under most circumstances:
- Research conducted in commonly accepted educational settings involving normal educational practices, use of educational tests, survey procedures, interview procedures or observation of public behavior provided that the information obtained is recorded in such a manner that the participants cannot be identified and that any disclosure of the participants' responses outside the research could not reasonably place the participants at risk of criminal or civil liability nor be damaging to the participants' financial standing, employability, or reputation.
- Use of educational tests, surveys and interviews in which the participants are elected or appointed public officials or candidates for public office or when Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Collection and recording of data from participants 18 years or older using non-invasive procedures routinely employed in clinical practice (i.e., weighing, testing of sensory acuity).
- Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development where the Principal Investigator does not manipulate participants' behavior and the research will not involve stress to participants research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
- Continuing review for research previously approved by the convened IRB if (a) no new participants will be enrolled and all current participants have completed all interventions, but current participants will be followed-up, OR (b) no participants have been enrolled and no new risks identified OR research remaining is limited to data analysis.
- Continuing review where IRB has determined at a convened meeting that the research involves no greater than minimal risk AND no additional risks have been identified.
This means that most projects that involve no more than minimal risk and are not otherwise exempt from full IRB review (see below), may receive expedited review. This type of review necessitates that a subset of the full IRB, delegated this authority by the Chair or Co-chair, independently evaluates the protocol, and when all reviewers concur, the protocol is approved. All members of the IRB are informed of protocols approved through expedited review. When one or more of these SFIRB members cannot agree to approve a protocol, the protocol is referred to the full IRB for consideration at a convened meeting. Expedited reviews are commonly carried out by the Chair and Co-chair of the SFIRB.

The SFIRB Chair or Co-chair determines, on a case-by-case basis, the number of members scheduled to review expedited protocols. An exempt status may be granted for research if SF has a written agreement with another institution or organization operating an IRB and the research proposal was submitted and approved by that other institution's IRB. The written agreement between SF and the other institution must outline their relationship and include a commitment that the IRB will adhere to the requirements of the SF's FWA. This agreement must be kept on file at both SF and the other institution and made available upon request to OHRP or any U.S. federal department or agency conducting or supporting research to which the FWA applies.
Projects that may be exempt from review by the full IRB
It may be determined by the SFIRB Chair and Co-chair that a research protocol is exempt from full SFIRB review. Research involving the collection of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified, are normally approved as exempt from full SFIRB review. Principal Investigators are cautioned that the decision that a protocol meets all of the criteria for exemption rests with the SFIRB.
Other projects where there is no immediate involvement of human participants, such as training grants or where the research protocol is not complete or the research instruments are yet to be developed, generally fall into a special category ("Indefinite Plans") that are reviewed solely by the SFIRB Chair and Co-chair in the same manner as exempt protocols.
When the funded research plan develops to the point that research involving human participants can begin, a detailed protocol describing the research (including the informed consent process and research instruments) must be reviewed and approved by the SFIRB.

II. The Review Process

The SFIRB evaluates protocols in four basic ways: (1) with full Board review; (2) by expedited review; (3) by exemption; or (4) by identifying a protocol as having indefinite plans for the use of human participants (see above). These are described below in detail.

The SFIRB will consist of the following disciplines:

Counseling/Psychology
Medical practitioner (M.D., Nurse, NP, etc.)
Information Technology/Security
Basic Sciences
Humanities/Ethics
External to the College
Chair and Co-Chair

All IRB members are required to undergo formal training at the time of their initial appointment. Training that satisfies this requirement is the presentation or the on-line tutorial offered by OHRP; https://www.hhs.gov/ohrp/education/training/index.html.

New Protocols
1. Full Board Review (SFIRB)
  New protocols require full board review unless they meet the criteria for exemption or expedited review. New protocols for full board review are those which are first time submissions or resubmissions of expired protocols where the Principal Investigator wishes to re-activate the study. New protocols may be submitted at any time. New protocols must conform to the format and must contain the information outlined in the SF IRB Submission Form. The approval period for a protocol will be determined by the Board, but can be no longer than 12 months from the date of review, and is based on the information available to the IRB reviewers and the perceived risk to the participant as determined by the Board.
  
  SFIRB Reviewer Responsibilities
  1. A packet of information about each new protocol requiring full Board review will be sent to all IRB members. This packet will contain a copy of the completed IRB form and (where applicable), a description of the informed consent process. The reviewer may contact the SFIRB office, or contact the Principal Investigator directly, if more information is needed.
  2. One of the major responsibilities of the SFIRB, and thus the reviewer, is to assess the risks to participants posed by taking part in research. Risk and minimal risk are defined below.
    Risk: The exposure to harm or injury (physical, psychological, social, or economic) through participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk."
    Minimal Risk: Where "the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests" (45 CFR 46.102[i]).
  3. Members are expected to participate in the review of all protocols assigned to them this will include survey instruments, informed consent documents, signage, and any other materials used to solicit enrollment of participants.
  4. The reviewers are encouraged to contact the IRB office if further information is needed.
  5. Special attention should be taken to identify ethical issues, proper sampling techniques.
  6. Members are expected to attend the monthly meeting. Projects to be reviewed at a convened meeting will be forwarded to each member at least one week prior to the meeting. Members are expected to review and be prepared to discuss any and all items on the agenda for that monthly meeting.
  7. Members who are unable to attend a scheduled meeting must contact their alternates to determine how best to fulfill their responsibilities. If an alternate is not available, the member must notify the SFIRB office.
  SFIRB Office Procedures
  1. When a new protocol is received, a project identification number is assigned. This project number indicates the year and sequential number of the protocol (i.e., mm_dd_yyyy_Submission_Title). The project number, protocol title, Principal Investigator's name and SFID (if applicable), and other relevant information are cataloged.
  2. The protocol is screened for the following:
    - SFIRB Submission Form is complete
    - Description of complete informed consent process
      - All required elements
    - Other information, as appropriate
      - Copy of methodology
      - Copy of questionnaires/surveys/instruments
      - Debriefing statement
      - Advertisements
      - Certificate of Confidentiality
      - Informed Consent Form(s)
  3. If the protocol is incomplete, it is returned to the Principal Investigator with a request for more information.
  4. When the protocol is complete, it is sent out for review and/or placed on the agenda for the next SFIRB meeting.
  5. Recommendations made by the Board are recorded in the project file.
  6. Appropriate letters are sent informing the Principal Investigator of the action by the Board (see Section III).
  7. Principal Investigators are advised to contact the appropriate departmental offices regarding any specific policies that they are required to follow in connection with the recruitment of College students as research participants.
2. Expedited Review
  A description of protocols that qualify for expedited review is specified in Section I.B above. Protocols qualifying for this procedure can be reviewed and approved by a subset of members, as directed by the Chair and Co-chair. Protocols can be denied this expedited review and rescheduled for full Board review, but cannot be found to be unable to be approved on behalf of the SFIRB through the expedited review process. If any member votes "unable to approve a protocol" and his/her concerns cannot be satisfactorily resolved, the protocol is scheduled for full Board review. The approval period will be determined by the Board, but can be no longer than 12 months from the date of review, and is based on the information available to the IRB reviewer(s) and the perceived risk to the participant(s) as determined by the Board.
  Reviewer Responsibilities
  1. The Chair and Co-chair will receive protocols potentially eligible for expedited review and forward as necessary to a designated subset of members.from the IR staff.
  2. If the protocol qualifies for expedited review, the Chair or Co-chair or designee(s) will notify the staff of its approval status by returning a completed review sheet.
  3. If the protocol does not qualify for expedited review and is not exempt, the Chair or Co-chair will return the protocol to the staff and request that it be scheduled for full Board review. The staff will forward the protocol to all members.
  4. When Principal Investigators submit amendments to existing approved protocols and these amendments are deemed to be minor changes that result in no increase in risk to participants/
    volunteers, the Chair or Co-chair can use the procedure described in b and c above to review and approve such changes.
  5. A written record is kept of the reviewer, date of review and action taken. This information is recorded in the project file.
  SFIRB Office Procedures
  1. All projects potentially eligible for expedited review will be forwarded to the Chair and Co-chair.
  2. If the protocol is approved as expedited, approval letters will be sent along with a dated, IRB-approved informed consent document (where applicable). The Chair and Co-chair will report about the action on expedited projects on a semi-annual basis to SFIRB members, alternates, and appropriate administrators.
  3. If the protocol requires revisions, the Chair or Co-chair expresses concerns, or requires additional information; the staff will contact the Principal Investigator(s) by letter or electronic mail.
  4. Principal Investigators will be advised to contact the appropriate departmental offices regarding any specific policies that they are required to follow in connection with the recruitment of College student as research participants.
3. Exempt Review
  Research deemed exempt from SFIRB review is described in Categories of Review section I.C above.
  Reviewer Responsibilities
  1. The Chair or Co-Chair will receive protocols that are potentially exempt from principal investigators the IR staff.
  2. If the protocol qualifies for exempt review, the Chair or Co-chair will notify the staff of this status. This information will be recorded and made part of the semi-annual report.
  3. If the protocol does not qualify for exempt review, the Chair or Co-chair will return the protocol and a completed review sheet to the staff.
  SFIRB Office Procedures
  1. All protocols potentially eligible for exempt review will be forwarded to the Chair or Co-chair.
  2. If the protocol is exempt from full Board review, the Principal Investigator will be notified in writing. All exemptions will be noted in the semi-annual report.
  3. If the protocol is not considered to be exempt by the Chair or Co-chair, it will be returned to the staff to schedule the protocol for an expedited or a full Board review, and distribution as appropriate.
  4. All protocols for exempt projects are filed in the SFIRB office.
4. Indefinite Plans
  Proposals lacking definite plans for involvement of human participants may include (but are not limited to): "institutional type grants when selection of specific projects is the institution's responsibility, research training grants in which the activities involving participants remain to be selected, and projects in which human participants' involvement will depend upon completion of instruments" (45 CFR 46.118).
  Reviewer Responsibilities
  1. The Chair or Co-chair will receive protocols with indefinite plans for the use of human participants from the office of Grants and Development.
  2. If the protocol falls into this category, the Chair or Co-chair will review the proposal and make a determination on its likelihood for approval and notify the staff by returning the protocol. This information will be recorded in the computer database and made part of the semi-annual report.
  3. If the protocol does fall into this category, the Chair or Co-chair will return the protocol and a completed review sheet to the Grants and Development Office and maintain a copy in the event funding is obtained and the project comes to fruition.
  SFIRB Office Procedures
  1. All protocols with indefinite plans for the use of human participants will be forwarded to the Chair or Co-chair.
  2. If the protocol falls into this category, the Principal Investigator will be notified in writing. All projects lacking definite plans for involvement of human participants will be noted in the semi-annual report.
  3. If the protocol is not considered by the Chair or Co-chair to lack definite plans for involvement of human participants, it will be returned to the staff to schedule the protocol for an expedited or a full Board review, and distribution as appropriate.
  4. All projects lacking definite plans for involvement of human participants are filed in the SFIRB office.
Tabled Protocols (See section III. C.)
Continuing Review
A reexamination of a current project is made when any of the following occurs:
- when the use of human participants in research is expected to continue beyond the original IRB approval period
- when minor changes are proposed
- when the risk associated with the research changes
- when adverse events, unanticipated problems, or complaints about the research are reported.
All protocols approved by the SFIRB are subject to continuing review at intervals appropriate to the degree of risk (as determined by the IRB), but not less than once in the 12 months following approval.

Reviewer Responsibilities
1. Projects will be reviewed to determine the level of risk.
2. Projects proposing minor or no change shall be reviewed in the same manner as the initial review. (If during an initial review by the full Board, the project was determined to be of minimal risk, AND no new risks have been identified, it can qualify for expedited continuing review.)
3. When a proposed change in protocol is not minor or adverse events have been reported, and/or the project was previously reviewed at a convened meeting, reviewer responsibilities outlined in section II.A.1 apply. (Full board review)
4. If the Chair or Co-chair believes a protocol continuing review packet should be reviewed by the full Board, the Chair or Co-chair will return the packet to the staff for the following information to be distributed to all members.
  - Completed continuing review form
  - Current informed consent process
  - Copy of protocol
  - Brief description by the Chair or Co-chair outlining concerns, if applicable
SFIRB Office Procedures
1. At least six weeks prior to the IRB approval expiration date, the staff will send a continuing review form to each Principal Investigator. A copy of this form is placed in the protocol's file. It is, however, the Principal Investigator's obligation to obtain timely renewal.
2. If the SFIRB has not reapproved a research study by a study's current expiration date, the research will be suspended^[1]. A letter will be sent to the Principal Investigator indicating this action.
3. If no response has been received within one month following the approval expiration date, the protocol will be terminated^[2]. A letter will be sent to the Principal Investigator indicating this action. The protocol will be deleted from the active projects and the paper file will be placed in the inactive files.
4. All continuing review packets (including Principal Investigator's responses to continuing review memos and current informed consents) will be sent for review in the same manner as the initial review.
5. The SFIRB office will supply the reviewers any additional information requested to help determine current risks to participants.
6. If the protocol is approved by the SFIRB, a re-approval letter will be sent to the Principal Investigator along with a copy of the approved informed consent affixed with the SFIRB expiration date, not to exceed one year from the review date.
Adverse Events
Adverse events are undesirable and unintended, although not necessarily unexpected, incidents involving risks to participants or others.

The OHRP requires Principal Investigators to report adverse events promptly and in writing to the Chair or Co-chair. This report must be submitted within 5 working days and provide a description of the adverse event, state whether or not changes are needed in the protocol and the informed consent process, and indicate whether or not participants must be notified regarding the event. These revisions will be reviewed by the full Board. The Principal Investigator is also put on notice that if the events submitted are deemed to place participants at increased risk, the Chair or Co-chair may request resubmission of the protocol for full Board review. In a circumstance where the Board perceives the participant(s) may be placed at immediate significant risk, the SFIRB has the authority to suspend or terminate a protocol. Any such action shall include a statement of the reasons for the SFIRB action, and the Chair or Co-chair will contact the appropriate College officials and the Principal Investigator.

Reviewer Responsibilities
Notification of adverse events will be immediately reviewed by the Chair and Co-chair and distributed to all members.
1. The Chair and Co-chair will review the adverse event letter, current informed consent, the currently approved protocol, and, if applicable, the last continuing review report to determine if there is any increased risk.
2. The staff will assist in obtaining information to assess current degree of risk.
3. The Chair or Co-chair will make a recommendation to the members at the regularly scheduled meeting about the results of the review and record made in the project file. One or more of the following must be recommended:
  - No action is needed.
  - Changes are needed in the informed consent.
  - Current participants must be informed of this new information and risk.
  - The protocol needs to be revised due to this new information.
  - The protocol is put on "suspended" until more information is made available.
4. In the event a protocol is suspended, the Chair or Co-chair will contact the appropriate Vice President and the Principal Investigator with a letter including a statement of the reasons for the IRB action.
5. The Office of Human Research Protections (OHRP) is notified of the incident and actions of the IRB.
SFIRB Office Procedures
1. When notice of adverse events is received by the SFIRB office, the notice and the active protocol file are immediately brought to the attention of the Chair or Co-chair.
2. The adverse event letter, copy of the currently approved protocol, the last continuing review report (if applicable), current informed consent document, and any additional relevant documents are sent to all SFIRB members for review.
3. The project is placed on the agenda for the next regularly scheduled meeting (or a special meeting is set if directed by the Chair or Co-chair).
4. After the meeting, a letter is sent to the appropriate Vice President and the Principal Investigator indicating what action (if any) was taken and the reasons for such action.
5. The Office of Human Research Protections (OHRP) is notified of the incident and actions of the IRB.
Revisions
Changes to a protocol or informed consent process may originate from the Principal Investigator The Principal Investigator is responsible for contacting the SFIRB when protocol changes are proposed; a change in risk associated with the research occurs; and/or adverse events, unanticipated problems, or complaints about the research are reported. A written description of proposed changes to the protocol, informed consent process and/or research instruments must be submitted to the Board for review and approval prior to implementation. The form for revision submission can be obtained from the Office of Institutional Research (IR). Only in the rare circumstance when it is necessary to eliminate apparent immediate hazards to the research participants, as noted in 45 CFR 46.103(b)(4)(iii), is a researcher permitted to modify an approved protocol without the prior review and approval of the SFIRB. In this case, the SFIRB must be informed within 5 days of the change following its implementation. The change will be reviewed to determine that it is consistent with protection of human participants.
1. Changes, which do not increase the risk for previously approved projects, are minor changes to a protocol. These may involve changes to the number of participants, venue of the data collection, etc.). Minor changes need the approval of the Chair or Co-chair under the expedited format (see procedures I.B).
2. Major changes are those which increase risk to participant. These changes need the review of the full Board. The project is placed on the agenda and the revision request forwarded to all members (see procedures I.A).
Reviewer Responsibilities

Minor Changes
1. The Chair or Co-chair receives requests for minor changes in a current protocol from the staff.
2. If the changes are approved, the Chair or Co-chair will make a written, dated note on the request and return the project file to the staff.
3. If the changes are not felt to be minor, the Chair or Co-chair will return the project file to the staff to be distributed to full Board.
Major Changes
1. The full Board will receive a copy of the request; original protocol and current consent process.
2. The request must be reviewed with the same criteria for concern of human participants as used in the review of a new protocol, assessing risks to the participants (see I.A).
3. The project is placed on the agenda and the revision request forwarded to all members (see Categories of Review I A. SFIRB Office Procedures).
SFIRB Office Procedures
1. Date requests for revisions or amendments at time of receipt and attach to the current approved protocol file.
2. Ascertain if the request requires immediate attention. If so, inform the Chair or Co-chair.
3. Send out to full Board for review and enter on the next agenda.
4. Notify the Principal Investigator of the Board's action.
5. Update protocol file to reflect the action and this revision.
Protocol Violations
Protocol violations involve research that is not being conducted in accordance with the SFIRB's requirements.

SFIRB Office Procedures
1. If a protocol violation occurs or is suspected, the Chair or Co-chair will notify the Principal Investigator in writing of the event in question. SFIRB approval for the protocol may be withdrawn until the issue is resolved. The Principal Investigator will have 5 working days to respond in writing to the inquiry.
2. If no response is received from the Principal Investigator, a second letter will be sent to the Principal Investigator, the Department Chair or Co-chair, and the appropriate Vice President.
3. Once the response is received, the Chair or Co-chair will decide what further action, if necessary, will occur. This could include a recommendation to withdraw IRB approval for the study, reinstatement of the study, review by full Board,
4. If the Chair or Co-chair feels the IRB approval for the study should be withdrawn, this recommendation will be brought to the full Board for final review.
5. The staff will notify the Principal Investigator of the Board's decision in writing.
6. The SFIRB will notify the appropriate Vice President of any instances of serious or continuing non-compliance and any suspension or termination of approval in accordance with the requirements at 45 CFR 46.103(b)(5)

III. Actions/Decisions

Protocols Approved as Submitted, No Revisions
Approval letters are generated by the staff at the completion of the review period or, when feasible, the same day as the SFIRB meeting. Approval letters are the first priority of the SFIRB staff. A copy of the SFIRB approved informed consent document with the expiration date affixed will be included with the approval letter sent to the Principal Investigator.
Protocols Approved Pending Explicit Changes
Letters requiring specific revisions necessitating simple concurrence by the Principal Investigator are prepared based on the comments and/or concerns submitted by reviewers during the review period and/or the decision made by the members at the meeting. Protocols approved with explicit changes are the second priority of the SFIRB staff.
The Principal Investigator's response is reviewed by the Chair or Co-chair, or designated, experienced member, for completeness and, if appropriate, the approval letter and approved informed consent document with the expiration date affixed is sent to the Principal Investigator.
Protocols Tabled
Definition: Any protocol under review by the SFIRB in which additional information or substantive protocol modifications or informed consent document revision(s) are required in order to complete the review process.
Reviewer Responsibilities
- Reviewers must write "Tabled" on the IRB protocol form and keep the original packet of material (the protocol, informed consent and other related material) for the next meeting.
SFIRB Office Procedures
1. A letter stating the issues raised is sent to the Principal Investigator following the meeting. The issues are recorded in the minutes.
2. When a response is received from the Principal Investigator, a copy of that response and the letter to the Principal Investigator are sent to the members for the next meeting.
3. Tabled protocols will be listed on the agenda for the next meeting, along with the issues raised.
Protocols Unable to Be Approved
When the Board feels it is unable to approve a protocol, a letter is prepared by the staff to inform the Principal Investigator of the Board's decision and the reasons. Drafts of letters are reviewed by the Chair and Co-chair. Final copies are signed by the Chair and Co-chair prior to their being sent.
Appeal Procedure for Protocols Unable to Be Approved
Any person or entity which demonstrates a genuine interest in the result to be obtained may appeal any aspect of the SFIRB review and decision to an administrative review committee consisting of the Provost, the College's General Counsel, and the pertinent College Vice President. The finding of the IRB will be reported to this administrative review committee by the IRB Chair or Co-chair. It will be the responsibility of the administrative review committee to ensure that the guidelines followed are consistent with 45 CFR Part 46 as well as the policies and practices of this institution. Upon the recommendations of this committee, appeals will be referred to the IRB for disposition as the final authority.

^[1]While suspended, new participant recruitment must stop. Interventions under the research protocol must be stopped unless an over-riding concern for the safety or well-being of the participants, or other ethical issues, are involved. In such cases, the Principal Investigator must contact the SFIRB immediately. The suspension will be lifted when and if the protocol is reapproved by the SFIRB. (This statement has been included at the request of DHHS.)

^[2]When a protocol is terminated, no further participants may be recruited into the study and all participants currently enrolled must be notified of the protocol's termination. Participants may not be followed for research observation or data collection after such termination. (This statement has been included at the request of DHHS.)