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Q. I am a new researcher at WVU. What do I need to know to get started?
Q. Whom do I contact if I have questions regarding human subjects research and the IRB?
A. IRB Staff.
Q. Whom do I contact if I have serious concerns about the welfare and safety of research participants, or about misconduct involving human subject research?
Q. Where can I find a listing of IRB committee members?
Q. When are IRB meetings and submission deadlines?
A. The IRB meets at 8:30 AM on the 2nd and 4th Wednesdays of every month. Protocol submissions for an IRB meeting are due on the first and third Wednesday of the month (except for November and December). IRB Meeting Dates & Deadlines.
Q. Does WVU have a Federalwide Assurance?
A. Yes and the Federalwide Assurance number is FWA00005078. FWA documentation
Q. What are the registration numbers for the IRBs?
A. IRB00000314 West Virginia U IRB #1 and IRB00002568 West Virginia U IRB #3. IRB Registration documentation
Personnel and Training
Q. Who needs to have training?
A. Anyone listed on an IRB application must have training or the application will not be reviewed. Affiliated personnel must complete a full CITI course, however non-affiliated personnel must complete at least an abbreviated CITI course.
Q. How do I obtain IRB training?
A. Training can be obtained at IRB Required Training.
Q. How often do I need to re-take the CITI training?
A. The CITI training must be renewed every 3 years.
Q. Is there a training certificate that I can obtain?
A. Yes, and to see the documentation please click on the link Certificate of Training Compliance.
Q. Does the Research Compliance Office adhere to Good Clinical Practice?
A. Yes, and to see the documentation please click on the link Adherence to Good Clinical Practices .
Q. Who are key personnel?
A. The PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant, are considered to be key personnel. Typically these individuals have doctoral or other professional degrees, although other contributing individuals without professional degrees may be considered key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet the definition. All key personnel must have ethics training through CITI. Please note that ALL key personnel MUST be listed on your IRB application as part of the research team.
Q. How are key personnel different from significant contributors to a protocol?
A. Significant contributors are the members of a research team who do not meet the definition of key personnel, but who still intervene or interact directly with human subjects, or who analyze and/or input identifiable data and/or analyze tissue derived from humans for the purposes of the activity in question. All significant contributors must have ethics training through CITI. Please note that ALL significant contributors MUST be listed on your IRB application as part of the research team.
Q. My human subject study is funded by the NIH or NSF. Are there additional regulations that apply?
A. Yes. Under some circumstances, your NIH or NSF-funded study may be subject to additional training regulations. Please see this guide to find out whether these regulations apply.
Q. Is there CME/CMU credit available for completing the CITI training?
A. Yes, there is CME credit available for you. If you login to CITI, you will be taken to your main menu where you’ll see a listing of your completed courses. Immediately to the right of the “Print” option for your completion report, you’ll see a link that says “CME/CMU Credits.” Click that and you’ll be taken to a page listing the fees for the credit and the options available. Click the appropriate button for the evaluation and registration. This will take you to a brief survey. Once you are finished with that, click Done at the bottom of the screen and you will be taken to the payment page (you will need to pay the University of Miami). Your certificate will then be mailed to you soon thereafter.
Review Process and Review Types
Q. My study includes suicide ideation. What level of review is required?
A. The level of review is dependent upon the level of risk incurred by study subjects (i.e. More than Minimal Risk or Minimal Risk). Studies involving suicide ideation must include the following elements:
- research staff who are qualified to assess suicidality, when possible;
- a plan to link participants with psychological help if needed, and include written materials listing those resources as an attachment to the protocol;
- a plan to address the situation if a participant is assessed to be a danger to themselves, but refuse treatment.
Q. My study includes questions regarding suicide. What level of review is required?
A. It depends on what type of questions you are asking. If the questions regard general opinions about suicide, then the level of review is determined by the risk/benefit ratio.
Q. My study involves vulnerable populations. What level of review is required?
A. The level of review depends on whether the study is no risk, minimal risk, or more than minimal risk; not the type of population targeted by the study (with the exception of involving prisoners, which must be reviewed at the full board levels).
Q. What do I do if my IRB application includes biological specimens?
A. If your IRB application includes biological specimens (e.g., human feces, pathogens, human tissue of any type), then you must obtain approval from the Institutional Biosafety Committee (IBC) to conduct your research. After you have obtained IBC approval, you can submit your IRB application. Please note that the IRB will not review the protocol without the IBC approval letter attached.
Q. If I am a WVU faculty, staff, or student who is conducting my research at any other institution, what do I need to submit to the WVU IRB?
A. You will need to go to the other institution’s IRB and ask if you need any documentation. Usually, they will ask you to submit a protocol to their IRB for review. Once it has been approved by their IRB, they will be the IRB of record. You will need an Inter-Institutional Authorization Agreement (IAA; found at the Forms link on this website) signed by their IRB or representative (you may use their form or our form).
After approval from the other IRB is given and an IAA is obtained signed by their IRB representative, submit the IAA form, together with a summary of the study and the other institution’s IRB approval letter to the IRB office or to Sarah.Stutler@mail.wvu.edu. The form will be signed by the Director of ORIC or his representative and returned to you, please give one copy to the lead institution. The fully executed IAA form then should be kept in your files.
If the other institution does not have an IRB, then submit the protocol to WVU and include an administrative approval letter from the other institution rather than following the directions above.
Q. I’m not sure if the lay summary in my IRB submission is adequate for review. How can I be sure?A. Our office has provided a listing of 6 example lay summaries to aide you in determining whether your lay summary is adequate for review. The examples are listed at Lay Summary Examples . We have also provided a short document in order to provide some guidance in writing your lay summary. That document is at Lay Summary Guidance .
Q. What happens to my IRB application after I submit it?
A. After you submit your IRB application, it is routed to any necessary department chairs, deans, or administrators that are required to sign your protocol before it reaches the ORIC. Additionally, if your study involves radiation or biological safety concerns, then they may be routed to those respective committees for approval. Next, each person on your application is reviewed to see if they have the required training. If the training is completed, then your document is routed to the IRB managers and through them to other appropriate persons (the IRB if full board) for review.
Q. When am I required to submit a human participants proposal?
A. All proposed research projects involving the use of human participants conducted under the auspices of West Virginia University are to be submitted for IRB review.
Q. I am just doing a simple survey; do I need to have it reviewed?
A. Yes. WVU’s Assurance with the Department of Health and Human Services says all human research conducted under the auspices of the institution will undergo the IRB review and approval process.
Q. I am doing an electronic survey. Do I still need a cover letter?
A. Yes. You will need to provide a cover letter that mentions the person can choose not to participate in the survey at any time. This should be in question form at the end of the cover letter in order for the person to indicate agreement to take the survey or to opt out.
Q. I am doing an electronic survey. Does the IRB need to review both my survey and the cover letter?
A. Yes. You will need to provide both documents for IRB review.
Q. When is a telephone script needed?
A. A telephone script is needed when you are conducting either a telephone survey or a telephone interview. You must inform the participant that participation is voluntary and they can choose to stop at any time during the survey. You must use the script for all verbal communication with your participant, and a copy of the script must be provided to the IRB for review.
Q. I believe my protocol is exempt. Do I have to have it reviewed?
A. Yes. It is the policy of the WVU IRB that all proposed exempt research is reviewed by the IRB staff for final determination of status. If necessary, please contact us at (304) 293-7073.
Q. I am not collecting any identifying information; do I need to file for approval?
A. Yes. Federal regulations and WVU regulations require that ALL research (a systematic investigation) involving human subjects be submitted for review.
Q. I am conducting an anonymous survey study without collecting any identifying information; do I need to file for approval?
A. Yes. Federal regulations and WVU regulations require that the study be submitted for review if it meets the definition of human subjects research (a systematic and generalizable investigation).
Q. I am only working with previously collected data; do I need to file for approval?
A. Yes. Federal regulations require that if the study will use existing data, documents, records, pathological specimens, or diagnostic specimens from human subjects, it is to be submitted for review.
Q. My research is based on de-identified tissue samples; is IRB review needed?
A. No. However, research involving the study of existing pathological specimens from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for “not human subjects research” (NHSR). An NHSR is a document that provides assurance your study does not need to be approved by the IRB. You can submit a protocol and answer “no” to any of the questions in the human subjects research section. This will submit an NHSR form to us for approval.
Q. My research is based on de-identified database information; is IRB review needed?
A. Research involving the study of existing database information from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for “not human subjects research” (NHSR). Whether the database is publicly or not publicly available is of no concern as long as the not publicly available data can be de-identified. An NHSR is a document that provides assurance your study does not need to be approved by the IRB. You can submit a protocol and answer “no” to any of the questions in the human subjects research section. This will submit an NHSR form to us for approval.
Q. Is there a way to obtain documentation that my study does not need IRB approval?
A. Yes. The document that provides assurance that your study does not need to be approved by the IRB is called a “Not Human Subjects Research” (NHSR) form.
Q. How long does it take to review an application for IRB approval?
A. Generally, we allow 10 business days for an exempt protocol and 14 business days for an expedited protocol. IRB meetings are held every 2nd and 4th Wednesday of each month (unless holidays interfere). A schedule of deadlines and meeting dates can be found on the IRB Meeting Dates & Deadlines page. Please be aware that estimated processing times are contingent upon the Principal Investigator’s swiftness in responding adequately to any modifications our staff or boards may request.
Q. When do IRB Fees apply?
A. IRB fees apply if your study is sponsored by a private or industry sponsor. Fees do not apply when your study is government agency, non-profit, or WVU sponsored. Standard fees are $2,500 for initial application reviews, $1,000 for continuing reviews (renewals), and $500 for major amendments. Industry-sponsored clinical trials that are reviewed through the Chesapeake IRB must pay an initial administrative fee of $750 for each protocol to WVU in addition to the normal fee to be paid to the Chesapeake IRB. Only phase II through IV studies are able to go through the Chesapeake IRB. For all phase I clinical trials, normal WVU fees and procedures apply.
Q. I will be collaborating with a researcher at another institution; do I need to file for IRB approval at both WVU and the other institution?
A. Investigators should contact an IRB staff person whenever collaborative research is planned. Separate applications may be necessary, or an IRB collaboration agreement (IAA) may be submitted to be signed by both institutions.
Q. Can I have the WVU IRB review my protocol if I do not work for WVU?
A. Yes. The WVU IRB will review your protocol if you do not work for WVU or are not a student. However, your application will be subject to normal fees ($2,500 for initial application reviews, $1,000 for continuing reviews (renewals), and $500 for major amendments).
Q. I have questions about tissue banking, where can I find the answers?
General questions about tissue banking can be answered by calling (304) 293-7073.
Q. Where can I find the tissue banking registration form?
Q. Why did the date on my consent form change after an amendment is approved, even though the amendment did not involve changes to the consent form(s)?
A. Please note that to ease tracking concerns the electronic system is set to change the consent form last approval date to match that of the amendment approval date. The expiration date remains the same as from the initial review, resp. the continuing review.
Q. I created an amendment and need to find it in the WVU+kc system. How is this done?
A. You can find an amendment by first logging into WVU+kc with your WVU MyID and password. Once logged in, you should click on Search Protocols, then input your protocol number followed by an A followed by an asterisk in the very top field. For example, if your protocol number is 13111111111, then you will need to put “13111111111A” in the top field followed by an asterisk. Make sure you have Yes selected next to Active at the bottom of this search and then click Search. You should see your amendment appear at the bottom of the screen.
Q. Why do consent forms need to be attached in PDF format in the KC system?
A. Consent forms must be attached in PDF format because the system will not otherwise stamp the protocol with the correct approval and expiration dates once the protocol is approved. These dates must be present on the form for use in a research setting.
Q. Why do I need to change the review type when asked to do so by the IRB? Why can’t the IRB change it administratively?
A. The IRB staff cannot change the review type simply because doing so may change the questions that are required on the protocol document itself. For example, changing the type from exempt to expedited would require more information be added to the protocol such as consent forms. Only the researcher has the information needed to inform the IRB about what will happen during the study.