Institutional Review Board

I. Definitions

1. 1. Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. 
      1. 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.
      2. Interaction includes communication or interpersonal contact between investigator and subject. 

      3. 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.²

   2. Institutional Review Board, or IRB, is the Fort Lewis College body established in accordance with and for the purposes expressed in Title 45 of the Code of Federal Regulations, Part 46.
   3. IRB Approval is the determination of the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and by other institutional and federal requirements.³ 
   4. 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. (see Appendix 3: Risks of Harm)
   5. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.⁴
   6. PI means any Fort Lewis College faculty or staff member that submits a research protocol as the Principal Investigator. Students cannot serve as the PI.  

¹ Material for this policy has been used with permission from Cornell University.
² 45 CFR § 46.102(f).
³ 45 CFR § 46.102(h).
⁴ 45 CFR § 46.102(d).

III. Composition of the IRB⁷ 

1. 1. The FLC IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience, expertise and diversity of its members, including consideration of race, gender, and cultural backgrounds, to safeguard the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. 
      
   2. Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. 
   3. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

⁷ 45 CFR §46.107

V. Researcher Responsibility

1. 1. Training for PI and co-PI
      1. Before the IRB can approve the research protocol, the PI and all co-PIs (including student researchers) must successfully complete the IRB online training addressing the appropriate conduct of human participant research. Proof of completion of this training is required by all PIs and co-PIs.
      2. All researchers named on a protocol are required to renew their training every 3 years.
   2. Online Submission guidelines can be found on the IRB website.
   3. Data Handling
      
      1. PIs will securely store data for at least 180 days after the study is completed.
      2. PI will securely store and/or destroy data 180 days after the study is completed.

VII. Requests for Exemptions from IRB 

1. 1. A PI may not self-determine that his or her own research protocol qualifies for exemption from IRB review.
   2. A PI requesting an exemption must submit a Request for Exemption from IRB Review. The IRB Chair will determine if the research project meets the eligibility requirements for exemption from IRB review.  The Chair may also send the Request for Exemption to an IRB member for secondary review.
   3. If the research activities are not eligible for exemption, the research project must receive either expedited or full committee review by the IRB. 
   4. Research activities may not commence until the PI receives a written notice of exemption from IRB.
   5. Changes to any of the research activities or materials made after submission must be reviewed by an IRB Chair and/or member to verify that the project continues to be eligible for exemption from IRB review.
   6. Researchers are responsible for ensuring full and continuing compliance with all FLC and IRB policies in the conduct of their research. 

IX. Quorum Requirements for Votes on Convened IRB Decisions

1. 1. A convened IRB meeting is one at which a quorum is present (or participating via teleconference), which means that a majority (more than half) of the members of the IRB are present, including at least one member whose primary concern is in a non-scientific area. For studies that are FDA-regulated, the quorum must include at least one physician. Members attending by telephone- or video-conference count towards the quorum and may vote providing they have received all pertinent material prior to the meeting and they can participate actively and equally in the discussion of the protocols. The IRB minutes should document that these two conditions are met.

   2. Approval of research is by a majority vote of the IRB quorum, minus the Chair, who does not vote except to break a tie.

   3. A quorum can fail during a convened meeting, by inter alia loss of a majority through recusal of members with conflicts of interest, early departures, or the absence of a non-scientist member. In the case of quorum failure, the remaining group may continue discussion of protocols, but may not take further actions unless and until the quorum can be restored.

XI. Procedures for Prompt Reporting and Review of Unanticipated Problems within FLC:
(see Appendix 5: Timeline)

1. 1. Unanticipated Problems Defined: 

      1. An unanticipated problem involving risk to human participants or others is one that (1) was unforeseen at the time of its occurrence, and (2) indicates that participants or others are at an increased risk of harm (See Appendix 3: Defining Risks of Harm). The Principal Investigator (PI) and/or any person familiar with the research project should promptly report to the IRB any harm experienced by a participant or another person which is both unanticipated and related to the research, regardless of whether the harm was an on-site or off-site event, and regardless of whether the harm was serious or non-serious. An unanticipated problem is related to the research if the problem was more likely than not caused by the research procedures or if it is more likely than not that the problem affects the rights and welfare of current research participants.
         One type of unanticipated problem is the adverse event, which is any harm experienced by a participant regardless of whether the occurrence was on-site or off-site and which is both unexpected and related to the research. An adverse event is unexpected when its specificity and severity are not accurately reflected in the informed consent document.

      2. Serious adverse events requiring immediate reporting to the IRB within 24 hours of the first awareness of their occurrence, whether such awareness is first attained by the PI or another personor a member of the IRB: 
         1. death of a research participant;
         2. serious injury to a research participant. 
      3. Examples of non-serious unanticipated problems, including non-serious adverse events, requiring reporting as soon as possible and not later than 2 weeks of the first awareness of their occurrence, whether such awareness is first attained by the PI, another person familiar with the research, or a member of the IRB: 
         
         1. Negative, non-life threatening physical reactions in a research participant to drugs administered in a study.
         2. Physical consequences to a research participant from dietary manipulations (e.g., fainting).
         3. Negative, non-life threatening physical reactions in a research participant who has a chronic disease (e.g., diabetes, heart condition).
         4. Unanticipated accident to a research participant (e.g., participant’s falling off a treadmill during an exercise study).
         5. Display of unanticipated emotional upset or degree of emotional upset by a research participant.
         6. Accidental or unintentional change to the IRB-approved protocol that harmed research participants or others or that indicates that such persons may be at an increased risk of harm
.
         7. Release, including inadvertent release, of personal information of a research participant, or some other breach of confidentiality.
         8. Sponsor-imposed suspension for risk
.
         9. Acquisition of information that indicates a change to the risk-benefit analysis of the research, such as publication of a paper from another study showing that risks or potential benefits of the Fort Lewis College research study may be different from what was presented to the IRB.

         10. Failure of equipment during a study if such failure did or could have resulted in harm to a research participant
.
         11. Change to the protocol intended to eliminate an apparent immediate hazard to a research participant, without prior IRB review
.
         12. Complaint of a participant that indicates unanticipated risks .
   2. Prompt Reporting of Unanticipated Problem
      
      1. Serious adverse events must be reported to the IRB immediately, with a written report by either the PI, an IRB member or another person within 24 hours of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant. Even if such events are not related to the conduct of the research study, and, thus, are not required to be reported to OHRP, a PI should obtain documentation from the hospital or another appropriate source tending to show that the death or serious injury is not related to the research. 
      2. All other non-serious unanticipated problems should be reported to the IRB as soon as possible and not later than 2 weeks two of the first awareness of the problem by the PI, an IRB member, or another person. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB. 
      3. A PI, IRB member, or another person should report an unanticipated problem to the IRB by completing and submitting an Unanticipated Problem Report Form. (See Appendix 4: Unanticipated Problem Report Form).
   3. IRB Review of Unanticipated Problem Report Forms 
      
      1. Upon receipt of the Unanticipated Problem Report Form (“UP Report Form”) the IRB Chair will review it within 5 days to determine whether the reported occurrence qualifies as an unanticipated problem, as defined above. 
         
         1. If the occurrence does not qualify as an unanticipated problem, no further action will be taken unless it is determined that serious or continuing non-compliance has occurred.  (See Section 12)
         2. If the occurrence does qualify as an unanticipated problem, the IRB will determine  (1) whether the reported occurrence is a serious adverse event requiring review and modifications by the convened IRB; or (2) whether the reported occurrence is a non-serious unanticipated problem that can receive expedited review by the IRB Chair or the Chair’s designated reviewer(s). The Chair of the IRB will ensure prompt and appropriate reporting of the occurrence to the OHRP, FDA and other regulatory agencies, as appropriate.
      2. If the reported occurrence is determined to be a serious adverse event, as defined above, the Chair of the IRB can suspend the protocol for up to 2 weeks until the convened IRB reviews and acts on the protocol. The PI can request an extension to the 2 week suspension, if needed. The IRB Chair will place the UP Report Form on the agenda for the next meeting of the convened IRB for their discussion and resolution. 
      3. If the reported occurrence is determined to be an unanticipated problem, as defined above, the Unanticipated Problem (UP) Report Form will be assigned for Expedited Review, which should be completed within 5 days. The IRB Chair may assign the UP Report Form to himself or herself for review or to an Expedited Reviewer with the relevant expertise, or may obtain consultation to obtain that expertise. The Expedited Reviewer may suggest any action with respect to the protocol and place the UP Report Form on the agenda of the next meeting of the convened IRB for their discussion and resolution. The Expedited Reviewer may, however, request the Chair of the IRB to suspend a protocol until the convened IRB reviews and acts on the protocol. IRB will email the Expedited Reviewer’s comments, questions, and/or decisions to the PI. The PI will respond in writing to IRB, and this response will be reviewed by the Expedited Reviewer and/or the Chair of the IRB. The PI, the Expedited Reviewer, or the Chair of the IRB may request that the UP Report Form be referred to the convened IRB for a decision, which will have 2 weeks to make and communicate the decision . If the UP form was submitted by an IRB member, the IRB member will recuse themselves from voting on whether the project meets UP criteria and/or corrective action.  If the UP Report Form is not so referred, the IRB agenda will notify the other IRB members of the decision(s) made by the Expedited Reviewer with respect to the UP Report Form. 
      4. The range of possible actions that could be taken by the IRB with respect to the UP Report Form include: 
         

         1. Modification of the protocol
.

         2. Modification of the information disclosed during the consent process
.

         3. Providing additional information to past participants.


         4. Notification to current participants when such information might relate to participants’ willingness to continue to take part in the research.

         5. Requirement that the current participants re-consent to participation.

         6. Modification of the continuing review schedule.


         7. Monitoring of the research
.

         8. Monitoring of any modified informed consent process
.

         9. Suspension of the research
.

         10. Termination of the research.


         11. Referral to other organizational entities (e.g., Institutional Biosafety Committee).

         12. Obtaining additional information
.

         13. Termination of a previously approved protocol, which occurs when the IRB permanently withdraws approval for all research activity.

      5. Following a final determination of an action with respect to the UP Report Form, the IRB will draft and email a letter to the PI on behalf of the Chair of the IRB, setting forth the IRB actions and any required modifications. The PI will provide written notification to the IRB when he or she has made the required modifications. 

XIII. Suspensions and Terminations of IRB Approved Research Proposals

1. 1. Definitions

      1. Suspension is defined as a temporary halt to all research activities. It occurs when the Chair of the IRB or the convened IRB places a temporary hold on the previously approved research, such that no research activities can be conducted, including recruitment/enrollment of new participants, further research interventions (unless necessary for the safety and well-being of the enrolled participants), follow-up (unless it is in the best interests of the participants and approved by the IRB), analysis of data, publications, and presentations. Suspended research is still subject to Continuing Review. Eventually, a notice of suspension is withdrawn by the IRB or the suspended protocol becomes subject to termination procedures by the IRB. A PI may resume research upon withdrawal of a suspension notice.

      2. Termination is defined as a permanent halt to all research activities, including recruitment/enrollment of new participants, further research interventions, analysis of data, publications, and presentations. It occurs when the convened IRB, with impartiality and without prejudice votes to withdraw approval or stop all research activities permanently. However, future follow-up may be conducted with the approval of the IRB to monitor the well-being of and any potential risks to participants. Terminated research is no longer subject to Continuing Review. Resumption of a terminated protocol requires the submission of a new protocol application for review and approval by the IRB. 

   2. Circumstances Meriting Potential Suspension or Termination
      1. The IRB may suspend or terminate its prior approval of research that: (1) is not being conducted in accordance with IRB policies and procedures, the protocol as previously approved by the IRB, federal regulations, and/or institutional policies governing research and human participant protection (i.e., non-compliance); or (2) is associated with serious unanticipated problems.
      2. Examples of non-compliance with IRB policies and procedures are: (a) conducting research using human participants without IRB review and approval; (b) deviating from the protocol submitted by the PI and approved by the IRB; (c) continuing to use human participants past the approved expiration date and in the absence of submitting a continuation application to the IRB; (d) failing to follow the IRB-approved consent process; (e) failing to report protocol changes to the IRB; and (f) failing to follow recommendations by the IRB to ensure the safety of research participants. 
      3. The IRB may become aware of such a circumstance upon the receipt of a complaint from a participant, researcher, Fort Lewis College employee, or member of the public; from the interpretation of information received during a Continuing Review; or from the findings of a random or for-cause audit. 
   3. Authority to Suspend or Terminate IRB Approval
      

      1. The convened IRB has the authority to suspend or terminate research activities, taking into consideration protections for current participants’ rights and welfare. The IRB Chair also has the authority to suspend research until a convened IRB meeting and to report the suspension to the convened IRB at their next available meeting. The convened IRB must discuss suspensions of all protocols previously approved by the IRB. The Chair, however, does not have the authority to terminate IRB approval unilaterally.

      2. A member of the IRB who is acting as the Expedited Reviewer of an Unanticipated Problem Report Form may request the IRB Chair to suspend a protocol until the convened IRB reviews and acts on the protocol. 
      3. The PI may request a meeting with the IRB Chair regarding any decision to suspend and/or terminate a protocol. In addition, the PI may be present during the question-and-answer period of the convened IRB’s discussion of his or her suspended protocol. 

      4. A PI may decide voluntarily to suspend, withdraw, or terminate some or all research activities that may be under current review or investigation. The PI should inform the IRB Chair, and place the protocol on the agenda for the next available IRB meeting. 


      5. The IRB does not have the authority to take disciplinary action against any individual relating to circumstances meriting suspension or termination of IRB approval. Instead, disciplinary action shall be the responsibility of the institution.

   4. Criteria to Consider for Suspensions or Terminations 

      1. In reviewing information, including complaints, that potentially shows non-compliance or unanticipated problems, the IRB should consider:

         1. Whether the information supports a determination of non-compliance or increased risk;

         2. Whether the information indicates that a serious unanticipated problem has occurred which warrants further investigation and/or suspension of research in order to protect human participants or others; 
         3. Additional actions to protect the rights and welfare of currently enrolled participants;
         4. Whether procedures for withdrawal of enrolled participants account for their rights and welfare; 
         5. Whether participants should be informed of the termination or suspension; and 
         6. Whether to require any unanticipated problems or outcomes to be reported to the IRB.
   5. Resolution of Suspensions by the Convened IRB 
      
      1. Whenever the IRB Chair issues a suspension notice for a protocol, the IRB will place the suspension as a discussion item on the agenda for the next available convened meeting of the IRB and provide the IRB with all relevant information, including the protocol, any UP Report Form (link), and any investigation results. The Chair and members of the IRB will discuss the situation and recommend a plan of action. The PI may be invited or may request to attend part of the meeting to answer questions. The particular details of the discussion are documented in the minutes of the convened meeting. 
      2. The IRB will suggest a corrective plan that minimizes risks to participants or ensures compliance with all applicable policies and regulations and will establish a time frame for the implementation of the plan. 
      3. The IRB will monitor the PI’s implementation of the corrective plan based on a pre-determined action plan. If the plan is implemented within the requisite timeframe, the convened IRB or the IRB Chair may withdraw the suspension notice and research may resume. If, however, the suspension has not been resolved by the PI after the expiration of the time frame, the IRB Chair may place the suspension on the agenda of the next available meeting of the Convened IRB in order to proceed with termination of IRB approval. 
   6. Terminations by the Convened IRB
      
      1. Criteria for Termination: The convened IRB may vote to terminate IRB approval of a research protocol when: 
         
         1. 1. a corrective plan approved by the IRB has not been implemented in a complete and satisfactory manner; and/or
            2. the IRB determines at any time that termination is in the best interests of the safety and welfare of the research participants.
      2. Written Notifications: If the convened IRB votes to terminate a research protocol, IRB will notify within 7 days, in writing, the following:
         
         1. 1. PI
            2. Department Chair, Center Director, and/or College Dean of the PI
            3. Sponsoring federal agency, when applicable, OHRP, when applicable.
      3. Appeal Process:
         1. 1. Time for Appeal: Within 10 days after notice of IRB decision, either party may request an appeal.  The request shall be in writing, delivered to the Provost either in person or by mail, and shall include a statement of the reasons for appeal and the specific facts or circumstances which justify further review.If an appeal is not requested within 10 days, an appeal is deemed to be waived and the IRB’s report and recommendation shall be forwarded to the Board for final action.
            2. Grounds for Appeal: The grounds for appeal shall be limited to the following:
               
               1. There was substantial failure by the IRB to comply with this Policy during the hearing, so as to deny a fair hearing; and/or
               2. the recommendations of the IRB were made arbitrarily or capriciously.
            3. Nature of Appellate Review:
               
               1. If the Provost approves an appeal, the case will be brought to an external institutution’s IRB that has an existing MOU with Fort Lewis College. The external IRB will consider the record of the hearing upon which the recommendation before it was made and recommend final action to the Board.
               2. Each party shall have the right to present a written statement in support of its position on appeal.  The party requesting the appeal shall submit a statement first and the other party shall then have ten days to respond.  In its sole discretion, the external IRB may allow each party or its representative to appear personally and make oral argument not to exceed 30 minutes.

               3. When requested by either party, the external IRB may, in its discretion, accept additional oral or written evidence. Such additional evidence shall be accepted only if the external IRB determines that the party seeking to admit it has demonstrated that it is relevant, new evidence that could not have been presented at the hearing, or that any opportunity to admit it at the hearing was improperly denied.

            4. Final Action: A written report of the external IRB review will be presented to the Provost, who will make the final decision on whether or not the FLC research is terminated.

XV. Responsibilities

For following policy:  Faculty, Staff and Students

For enforcement of policy:  Provost and Vice President for Academic Affairs

For oversight of policy:  Provost and Vice President for Academic Affairs

For notification of policy:  Policy Librarian

For procedures implementing the policy:  Faculty Chair(s) and IRB Members