Human Subjects Frequently Asked Questions
General Questions
Q. Whom do I contact if I have questions regarding human subjects research and the IRB?
A. 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?
A. IRB Chairs: Stephen Davis, Emergency Medicine, Rev. Matthew Riegel, Community Representative, and Staff.
Q. Where can I find a listing of IRB committee members?
A. 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 10th and 25th of the month (except for November and December). (If this date is a weekend or holiday, the deadline is the next working day. IRB Meeting Dates & Deadlines.
Q. Does WVU have a federalwide assurance?
A. Yes and the Federalwide Assurance number is FWA00005078. This assurance was approved on February 8, 2012 and is valid until February 8, 2017. Click
here
for a copy of the 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
For a copy of the IRB Registration documentation Click
Here
.
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 key personnel 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 (http://www.citiprogram.org), 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: 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. 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 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 Barbara White at (304) 293-5971.
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. 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.
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 at http://oric.research.wvu.edu/human_subjects_research_and_the_irb/ir. 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.
Miscellany
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 $1,750 for initial application reviews and $500 for continuing reviews (renewals).
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 ($1,750 for initial protocol reviews and applications; $500 for continuing reviews and renewals).
Q. I have questions about tissue banking, where can I find the answers?
A. Our tissue banking policy can be found at http://oric.research.wvu.edu/r/download/97595. General questions about tissue banking can be directed toward either Lilo Ast at 304-293-7555 or Jonathan C. Young at 304-293-1119.
Q. Where can I find the tissue banking registration form?
A. The tissue banking registration form can be found at http://oric.research.wvu.edu/r/download/97586.