Dear all, I posted the mini IRB Survey to both Biomch-L and Sportscience. I've received 13 responses so far. Considering the total number of members of both lists this is a poor turnout (13 / ~8,000). Nevertheless, I really appreciate those colleagues who have responded promptly to my inquiry.
As you can see in the summary below, I've got 8 responses from the institutions that do not require chair's signature. I DO HOPE to hear more from colleagues with institutions requiring chair's signature on the IRB form. The survey is not closed yet so please keep send me your responses. In general, it is evident that department chair's role is perceived as administrative. 8 out 13 institutions do not require the signature and several responses from the institutions that require signature also state that. I will need more responses to make a substantial conclusion though. Enjoy the report. Thanks a million! <<<---------------------------------- SUMMARY: THE ROLE OF THE DEPARTMENT/UNIT CHAIR/HEAD IN THE IRB APPLICATION PROCESS QUESTIONNAIRE 1. Total responses: 13 2. Your position - Chair: 7 - IRB member: 5 - Chair/IRB member: 1 3. Does your institution require department/unit chair's signature on the IRB form? - YES: 4 - NO: 8 - Depends on the department policy: 1 4. What is the department/unit chair's role in the IRB process? - Administrative role only. (Chair/IRB) - How can the Chair make a meaningful decision on all the research that will come through the department? It is the role of the IRB to determine the risk/benefit and safety of a research project. (Chair) REGULATIONS: - There is nothing written as to the role/responsibility of the chair when he/she signs the form. (IRB) - Hard to say, as I think it varies with the individual chair. It was included because some of the chair's stated they didn't know what research was coming out of their depts. I've typically told mine before I submitted a proposal. The deans of the college the dept is in must sign off too and the rationale is the same, they wanted to know what was going on. Both must sign off, but don't have that much input unless they want to. I've never had any question what I'm doing and in the case of the chair, he usually just signs when I hand it to him. (IRB) - IRB applications here must carry a signature from the department prior to review. That signature comes from the Department Head or his/her designee. I signed off on IRB proposals in my first couple of years here. I established a position in the department called Director of Research to assist in a variety of research responsibilities and had this person review and sign-off on IRB proposals. (Chair) - Historically this has been primarily an administrative step that keeps the chair informed about HS research proposed in the department. Our campus policy says there may be "unit regulatory bodies" at other levels, but is vague about their function or reporting. (Chair) PERSONAL BELIEF: - Chair role is administrative, to be aware that the study is being proposed in his/her dept. It is not to approve the contents from a human subjects review standpoint. The chairs do not have the experience and expertise to determine if the project meets human subjects requirements. (IRB) - I personally don't see that it's necessary, but as I said I usually inform my dept chair when I submitted something. (IRB) - The emphasis has always been to help the faculty/student create a case for their work to be approved at higher levels. In some respects there might be some thought to limit errors or liability issues. Here most all our studies are approved at the university level by the chair of the university HS committee because most all our studies are non-invasive and can be "expedited" reviews. Only a small percentage see the full committee for approval. (Chair) - The department review usually is not extensive. Most applications can be addressed in 10 minutes or less. A substantial reason for the short time devoted to this task is an existing working knowledge of the research my faculty (and their graduate students) are engaged in. In nine years as a department chair or head, I can't recall a situation in which I required changes in an IRB application before providing the necessary signature. (Chair) - From my perspective, the role of the department head is not as a critical reviewer of the procedures and risks to subjects. That is the role of the IRB. Rather, the department signature acknowledges familiarity with the planned research and confirms those investigators linked to the department are sufficiently qualified to conduct the research. (Chair) 5. What do you think are the key concepts that define the role of the department chair in the IRB process? - To ensure that the study is feasible (e.g., is there space to do the study in the dept) and to keep him/herself aware of what the faculty are doing. (IRB) - My guess is it is responsibility, liability. However, as noted above I don't think many are that involved. Perhaps if there's been a faculty member that has been a problem (questionable ethics, research, etc. in the past) they might check it more in depth. (IRB) - I think the chair is a service position and should adopt the mindset that their duty is to help faculty get research proposals approved, all the while trying to balance the need to protect the students and the unit from harm. (Chair) - Professionalism and scientific integrity (Chair/IRB) 6. Does the chair's signature on the form imply any professional or legal responsibilities/liabilities? - No, there is only an implication that the proposal has met departmental standards for scientific inquiry. (Chair/IRB) REGULATIONS: - Nothing written that I am aware of. (IRB) - Not that I'm aware of. (IRB) - I believe our university policy does imply that signatures and approvals from "unit regulating bodies" do have a responsibility to monitor research and its protection of HS. The legal extent of this is not my area of expertise. It may be why many chairs and deans carry insurance policies to help protect them beyond what the university provides in lawsuits. (Chair) PERSONAL BELIEF: - No. (IRB) - Responsibility to monitor yes, legal liability for most problems no. (Chair) - To be honest, I don't know exactly what the legal responsibilities or potential ramifications are by signing off. I certainly do not believe that my signature makes me liable for any adverse outcomes that develop from the research procedures. I don't believe the University has that expectation either. Fortunately, I've never been in a situation in which my understanding of responsibility has been challenged. (Chair) 7. If your institution has any policy/position statements in the regulations and/or on the IRB form related to this issue, please include them here. - None that I am aware of. (IRB) - No, but I can see why a nervous legal counsel or chair may have shifted the emphasis from protecting human subjects to protecting their @$$7$. (Chair) - The following reflects the language used on our IRB application form that effectively reflects the department head's responsibility: "I hereby confirm that I have read this application and my signature denotes departmental/unit approval of this project. To the best of my knowledge, the information in the attached application relating to members of my department is correct. The investigator(s) who are members of my department are qualified to perform the roles proposed for them in this application. Any novice researchers from my department will be supervised by qualified investigators." (Chair) 8. Miscellaneous - The federal policy does not require a department chair/head signature on IRB applications. We do require that faculty advisors sign the form when a student researcher is submitting an IRB application. Furthermore, we require only one faculty member sign the form when multiple faculty members are listed as researchers. (IRB) ---------------------------------->>> Young-Hoo ------------------------------------------------ Young-Hoo Kwon, Ph.D. Director, Biomechanics Laboratory Associate Professor of Kinesiology Texas Woman's University P O Box 425647 Denton, TX 76204-5647 USA Office & Fax: +1-940-898-2598 Email: [EMAIL PROTECTED] / [EMAIL PROTECTED] ------------------------------------------------ Post messages to [EMAIL PROTECTED] To (un)subscribe, send any message to sportscience-(un)[EMAIL PROTECTED] View all messages at http://groups.yahoo.com/group/sportscience/. Yahoo! Groups Links <*> To visit your group on the web, go to: http://groups.yahoo.com/group/sportscience/ <*> Your email settings: Individual Email | Traditional <*> To change settings online go to: http://groups.yahoo.com/group/sportscience/join (Yahoo! ID required) <*> To change settings via email: mailto:[EMAIL PROTECTED] mailto:[EMAIL PROTECTED] <*> To unsubscribe from this group, send an email to: [EMAIL PROTECTED] <*> Your use of Yahoo! Groups is subject to: http://docs.yahoo.com/info/terms/
