IRB Member Handbook. Introduction

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1 IRB Member Handbook Introduction The IRB consists of 11 members and one ex-officio member (the head of the Office of Research and Sponsored Programs-ORSP). The 11 regular members include 9 faculty (three from each college), one academic staff and one community member. Each member serves a 3-year term. During the first year of membership each IRB member will be trained. First, they will complete the National Institute of Health s training module (see training website, under Resources) and send the completion certificate to the ORSP. After completing the training, the new member will be assigned a mentor (see Mentoring). A member who does not complete both the website and the mentoring process within one year will be replaced. Resources Training Website must be completed by all members, the certificate needs to be printed and sent to the IRB Chair: IRB Manual Refer to for UW-Platteville s general policies: Government Documents include detailed information on research involving human subjects and the rules that IRB s must follow: IRB Meetings: The IRB meets monthly during the school year (usually the 3 rd Weds of each month), however if needed due to a full board protocol, the IRB may meet more often. Complete minutes are to be kept for each meeting and upon approval, posted on the IRB website. These minutes must record the details of votes that are taken (# of yes, no and abstaining votes). Votes for full board protocols can only be taken if there is a quorum. For a full board protocol, a quorum does not exist if a non-scientific member is not present. If helpful, outside consultants may be brought in to provide information. These outside consultants do not need to be given a protocol and are not to be present when a vote is taken. Conflicts of Interest: Any IRB member with a conflict of interest in a protocol shall not be involved in the review of that protocol. A conflict of interest may result from: The member being a principle investigator (PI) or co-investigator for the protocol The PI is the member s department chair

2 The IRB member is related to the investigator as a family member, teacher, supervisor, student, mentor, etc. The IRB member has personal beliefs that conflict with the research planned The IRB member has a poor personal relationship with the investigator(s), or negative opinions of them Other potential conflicts. An IRB member with a conflict of interest needs to report the conflict of interest immediately to the IRB chair, so the protocol can be reassigned. At the start of a full board protocol, the chair should ask if any conflicts of interest exist - whether any exist or not needs to be documented in the meeting minutes. The IRB member with a conflict of interest cannot participate in the discussions, except for informational purposes only. When a vote is taken, members with conflicts of interest must leave the room and the departure needs to be documented in the minutes. Description of review process Protocols are sent by the researcher to the IRB Chair. The chair assigns the protocol a number of the form ##. For example, the 5 th protocol received during the school year would be numbered The protocol is then logged in a spreadsheet and the chair determines the level of review that is required (refer to section III of the UW-Platteville IRB manual). All protocol documents are saved to a folder on the IRB S: drive. Reviewers are then assigned and referred to the correct folder on the S: drive for the protocol documents. Reviewers are assigned on a rotating basis to ensure an equal distribution of protocols. For expedited reviews, the IRB chair has 10 business days to get back to the researcher with a decision; therefore reviewers need to usually make a decision within one-and-ahalf weeks or less. Full board protocols are reviewed by all members of the IRB and a meeting of the members must be held to determine whether approval is merited. These protocols are to be submitted to the IRB at least 10 business days prior to a regularly scheduled IRB meeting. Expedited protocols are reviewed by two board members usually the chair and one other member. If the chair has a conflict of interest with a protocol, then two other IRB members will review the protocol. A guide for reviewing protocols is attached see appendix B. The reviewer can either recommend that the protocol be approved, that revisions be made to the protocol and then be resubmitted, or recommend that the protocol go to the full board. If a protocol is revised, the revisions are submitted to the IRB Chair who determines whether the revisions are satisfactory and whether approval is warranted. There are two forms of protocols that can be submitted by a researcher. Most are submitted using the standard form, however some may be submitted using the Teaching Improvement Form, a condensed form used for teaching improvement projects involving normal educational practices. These two forms are not treated differently during the protocol review process. When a protocol is approved, an approval letter is completed and signed by the IRB Chair. A copy of the approval letter is sent to the PI and one is saved to the protocol folder on the S: drive. Refer to the diagram in Appendix A for a summary of the review process.

3 Criteria for Approval of a Protocol: The criteria for approval of a protocol are specified in the Code of Federal Regulations, Title 45 part 46: Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits to subjects, if any, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by (5) Informed consent will be appropriately documented, in accordance with, and to the extent required by (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

4 Mentoring Each new member of the UW-Platteville IRB will be assigned a mentor. When the mentor receives a protocol to evaluate, the new member will also receive a copy of the protocol. After both have read the protocol, the new member and mentor will meet and discuss it. This process will continue until both the mentor and the new member feel the new member is ready to evaluate protocols on their own. The chair should be informed when this point has been reached. Additional Chair Duties The IRB Chair will report to the IRB members on a monthly basis about the current status of protocols that have been received. The chair will also provide a report to the Provost of protocols received over the past 6 months in January and July.

5 Appendix A Researcher submits to IRB Chair Chair assigns protocol number. logs into spreadsheet Chair determines level of review Full Board Protocolreview by all members Expedited Protocolreview by 2 members IRB Decision Approve protocol Recommend revision Disapprove protocol Only full board can do this Resubmit to IRB Chair

6 Appendix B University of Wisconsin-Platteville IRB Checklist Three basic steps for IRB reviewers 1. Assess and understand protocol as written 2. Apply principles of Belmont Report Respect for Persons (Ensure consent is sought and appropriately documented; Protect participants confidentiality and/or anonymity; Additional safeguards for protected groups) Beneficence (minimize potential harms/risks; maximize potential benefits) Justice (Equitable distribution of research costs/benefits; Equitable selection of participants) 3. Seek additional information/revision, as needed Y/N / N/A Protocol Components Comments COVER PAGE Principal Investigator(s): Identified on cover sheet. address(es) included. Sponsor(s): Only applicable if PI is student. address(es) included. Dates: Start date for data collection only data collection must begin after IRB approval. If the end date exceed one year, a continuation will be needed. *Common Problems*: Data collection start date precedes submission to IRB Signatures: PI(s); Sponsor(s), if applicable; HSR/Department Chair

7 PART I. DESCRIPTION OF STUDY Research Question: Readability (minimal jargon); purpose of study clearly outlined; appropriate citations (check Part I, E), if applicable Participant Selection: Estimated number of participants Selection/exclusion criteria and who will be making that determination (investigators, self-reporting by participants, etc.) Is the selection of participants equitable? Are participants from protected groups (minors < 18 yrs, prisoners, fetuses, pregnant women, mentally disabled)? If so, the necessity of using these groups should be clearly described. Procedures: (clearly outlines how, when, where, who, duration) Recruitment procedures and inducements Location of study (if conducted at another institution, IRB approval may be needed from that institution, as well) Who besides PI will be involved in data collection, along with qualifications, if applicable Step-by-step procedures (specific descriptions of procedures to be performed, including any audio/video taping; time required to complete them; who will carry out procedures). A numbered outline is preferable. Attachment(s): recruitment materials (if any), copy of approval letter/permission from other institutions requiring IRB approval (if applicable), copies of instruments, survey/interview questions, data collection forms, etc. *Common Problems*: Step-by-step procedures not clearly explained; attachments not included PART II. HUMAN PARTICIPANT PROTECTION Potential Risks: Are the risks (including physical, psychological, emotional, legal, and/or economic) reasonable? Investigator(s) should not state that there is NO risk; risks are always present, but they may be minimal Are risks minimized by using procedures that do not unnecessarily expose participants to risk? Safeguarding Participants Identity: Describe all anticipated methods for distributing research results NOTE: For projects to be under IRB review, they must contribute to generalizable knowledge (knowledge made public through formal presentation or publication). Formal presentations include conference presentations; community presentations; and oncampus presentations to the UWP community not presentations given in the classroom or to individual departments/committees. Publications made available online count as generalizable knowledge, as anyone can access them electronically.

8 Descriptions of methods used to ensure confidentiality (coding, summary reports, etc.) NOTE: Confidentiality is required unless specifically waived by participants in the informed consent document. Descriptions of methods used to ensure privacy (not violating a participant s personal space, not observing or recording what people expect to be private, etc.) Specific details of record retention (passwords, access to data, locked locations, disposal of data, etc.) *Common Problems*: No clear explanation of how data will be collected without being able to trace back to specific participants; No mention of record retention for signed consent forms; not enough information about distributing research results Expected Benefits: (to the PI and to participants) Payment is NOT considered a benefit Are the risks reasonable when considering anticipated benefits, if any, to participants, as well as the importance of the knowledge that might reasonably be expected to result from the study? Does scientific merit outweigh anticipated risks? A debriefing statement provides a reasonable understanding of the project and its goals to the participant. At minimum, there should be a verbal debriefing; it is preferable that participants receive a physical debriefing statement. Also, a debriefing statement needs to accompany an electronic/online survey. Attachment(s): Debriefing statement, if not summarized in this section. Deception: Intentionally misleading or providing false information to participants is NOT recommended; if deception is involved, a clear justification should be provided Withholding information about the nature of the study in order to reduce bias or expected behaviors by participants is not necessarily deception; in most cases, investigator(s) are required to debrief participations after study is completed. CONSENT FORM Should the IRB waive requirements to document informed consent? (See IRB Manual, Section VI) Should the IRB waive all or some elements of informed consent?

9 General/Structure: Study title; investigator(s); sponsor(s), if applicable; identify UWP affiliations Appropriate language/format for intended participants (children, parents, adults, etc.); avoid jargon and scientific terms Text and readability appropriate for the age, mental capacity, and maturity of participants Purpose: Clear statement of purpose for research project it must be stated this is research. Procedures: What will be expected from participants; length of the study and expected time commitment for participants; location of study Benefits Description of potential benefits to participants included. Risks: Description of potential risks. Sensitive topics: If applicable, this should be noted in the consent form; mention of services, such as Counseling Services, for participants who may be affected by sensitive topics. Anonymity/Confidentiality: Extent to which participants will be identifiable How the investigator(s) will provide for anonymity/confidentiality (anonymity = individuals cannot be identified by anyone, including researchers; confidentiality = researchers know or have access to participants identities, but will not divulge that information) Explanation of coding system, if applicable Explanation of who will have access to data, and when documents containing identifying information will be destroyed

10 Participants Rights & Contact Information: Statement that participants are free to withdraw from study at any time without penalty Participants should be given a copy of the consent form or an alternative short form. Explanation of whom to contact for answers to questions about the research and participants rights: If you have concerns about how you were treated in this study, please contact: Kathryn Lomax, Director, Office of Sponsored Programs ( ; lomax@uwplatt.edu). Include contact information for investigator(s) and, if applicable, sponsor(s) If investigator is affiliated with a different campus/organization, UWP should still be included in contact information *Common Problems*: No statement for contacting Kathryn Lomax; incomplete contact information Permission/Signature: Statement that participants are giving their voluntary consent Signature line (signed consent is not always necessary, as long as the study presents no more than minimal risk and/or the only record linking the participant and the research would be the consent document) NOTE: If using an unsigned consent form, there should be a phrase similar to: By completing this survey you are giving your consent to be involved in the research. If study involves minors, investigators should obtain permission from the minors, as well as from their parents/guardians OTHER COMMENTS: Adapted, with permission, from the University of North Dakota IRB Checklist