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FAQs

General Questions

Q. I am a new researcher at WVU. What do I need to know to get started?

A. Please see the Getting Started page for more information. For assistance, contact WVU OHRP at (304) 293-7073 or IRB@mail.wvu.edu. 

Q. Whom do I contact if I have questions regarding human subjects research and the IRB?

A. WVU Office of Human Research Protections at 304-293-7073 or IRB@mail.wvu.edu.

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. Contact the IRB Chairs or the WVU OHRP.

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 (except for holidays). Protocol submissions for an IRB meeting are due two weeks prior to the Board Meeting Date (except for holidays). 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 (Gold) and IRB00002568 West Virginia U IRB #3 (Blue). IRB Registration documentation

Personnel and Training

Q. Who needs to have training?

A. All personnel listed on a Protocol Application must complete the required training or the application can not be reviewed. Affiliated personnel must complete a full CITI course, non-affiliated personnel must complete at least an abbreviated CITI course. Training Requirements

Q. How do I obtain the required training?

A. Training Information

Q. How often do I need to re-take the WVU Required CITI training?

A. The WVU IRB Required CITI training must be renewed every 4 years.

Q. Is there a training certificate that I can obtain?

A. Yes, 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, please click on the link Adherence to Good Clinical Practices .  GCP is required every 3 years.  

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 the CITI Program.  Individuals meting the definition key personnel MUST be listed on the protocol 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 the CITI Program.  Individuals meeting the definition of significant contributor MUST be listed on the protocol application as part of the research team.

Q. My human subject research project is funded by the NIH or NSF. Are there additional regulations that apply?

A. Yes. Under some circumstances, NIH or NSF-funded projects  may be subject to additional training regulations. Refer to the Training section of this website.

Q. Is there CME/CMU credit available for completing the CITI Program training?

A. Yes,  login to CITI, from the main menu and the listing of your completed courses, on the right is the "Print” option to obtain a report of completed training. Select the “CME/CMU Credits.” option for a listing of the fees and the options available. 

Next, select the desired option for evaluation and registration. Complete the survey and select "Done" and the Payment Page is displayed. (payment is to the University of Miami). The certificate will be mailed to you.

Review Process and Review Types

Q. My research project includes suicide ideation. What level of review is required?

A.  The level of review is dependent upon the level of risk incurred by subjects (i.e. More than Minimal Risk or Minimal Risk). Projects 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 research project includes questions regarding suicide. What level of review is required?

A. The level of review depends on type of questions the participants are asked. If the questions regard general opinions about suicide, then the level of review is determined by the risk/benefit ratio.

Q. My research project 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; rather than the type of population targeted by the study. The exception to this is that including prisoners in the population required Full Board approval.

Q. What do I do if my protocol application includes biological specimens?

A. The use of  biological specimens (e.g., human feces, pathogens, human tissue of any type), requires approval from the Institutional Biosafety Committee (IBC) before submitting the protocol application. The IBC will issue a letter of approval which must be attached to the submission in WVU+kc.

Q. If I am a WVU faculty, staff, or student who is conducting my research at any other institution, what are the requirements for submitting a protocol application?

A. Ask the other institution’s IRB if you documentation is required. Typically, the other institution will require a protocol submission to their IRB for approval. The IRB approving the protocol is the IRB of Record. 

WVU requires an Inter-Institutional Authorization Agreement (IAA) to be completed.  WVU's IAA can be found on the Forms section of this website. Note that a form from the other institution can be used.

Submit the completed form to IRB@mail.wvu.edu. The IAA  will be signed by the WVU Institutional Official or his designee and returned to you.  Retain the IAA form in the project files and send a copy to the other institution.

EXCEPTION: If the other institution does not have an IRB, then submit the protocol application to WVU OHRP for review and approval and include an administrative approval letter from the other institution.

Q. I’m not sure if the lay summary in my submission is adequate for review. How can I be sure?

A. Review the examples provided and the Lay Summary Guidance. Free readability checkers are available, this is an example.

Q. What happens to my IRB application after I submit it?

A. After submitting protocol application, the system routes the application as follows:

Requried Department chairs, deans, or administrators for review and approval.

Radiation or biological safety committees as applicable 

Conflict of Interest if checked by the system and notices are sent for missing COI information.

Each person listed on your application is reviewed to verify training as been completed. 

The submission is routed to WVU OHRP for review and assessment of review levels required by the IRB.

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 required to be submitted to WVU OHRP for 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 requires that all human research conducted under the auspices of WVU will be reviewed.

Q. I am doing an electronic survey. Do I need a cover letter?

A. Yes. A cover letter indicating that a participant can choose not to participate in the survey at any time is required. Include this text in question form at the end of the cover letter so the participant can indicate agreement to complete the survey or to opt out.

Q. I am doing an electronic survey. Do the survey and the cover letter need to be reviewed?

A. Yes, both documents must be submitted for review.

Q. When is a telephone script needed?

A. A telephone script is needed for conducting either a telephone survey or a telephone interview. The script must be submitted for review. The script must include that participation is voluntary and that they can choose to stop at any time during the survey. The script must be used for all verbal communication with participants.

Q. I believe my protocol is exempt. Is a review required?

A. Yes. WVU HRPP policy is that proposed exempt research is reviewed by the WVU OHRP  staff in collaboration with the IRB Chairs for approval.

Q. I am not collecting identifying information, is a review required?

A. Yes. Federal regulations and WVU HRPP policy requires that  research (a systematic investigation) involving human subjects be submitted for review.

Q. I am conducting an anonymous survey without collecting identifying information, is a review required?

A. Yes. Federal regulations and WVU HRPP policy requires that research meeting the definition of research(a systematic and generalizable investigation) and the definition of  human subjects research be submitted for review.

Q. I am working with previously collected data, is a review required?

A. Yes. Federal regulations require research projects using existing data, documents, records, pathological specimens, or diagnostic specimens from human subjects, be submitted for review.

Q. My research is based on de-identified tissue samples; is a review required?

A. No. However, research involving 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). 

In this case, submit a protocol application and answer “no” to the questions in the human subjects research section. This action will submit an NHSR form to WVU OHRP for approval. An NHSR is a document that provides assurance your study does not need to be review and approved a WVU IRB. 

Q. My research is based on de-identified database information; is a review required?

A. Research involving existing database that contains information about 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. 

In this case, submit a protocol application and answer “no” to the questions in the human subjects research section. This action will submit an NHSR form to WVU OHRP for approval. An NHSR is a document that provides assurance your study does not need to be review and approved a WVU IRB. 

Q. Is there a way to obtain documentation that my research project does not require IRB approval?

A. Yes. The  “Not Human Subjects Research” (NHSR) form is the document that provides this assurance.

Q. How long does it take to review a protocol application for IRB approval?

A. General approval times are:

Exempt: 10 business days 

Expedited: 15 business days 

WVU IRB Meeting dates and Deadlines. Please note that processing time is impacted by the quality of the submission (no missing or incorrect information, completing pre-submission requirements, and training) and how quickly the PI responds to revision requests. Review the Getting Started page for assistance.

General Submission 

Q. When do IRB Fees apply?

A. Fee Schedule

Q. I will be collaborating with a researcher at another institution; do I need approval from both WVU and the other institution?

A. For collaborative research, contact WVU OHRP. Separate applications may be necessary, or Inter-institutional Agreement (IAA) may be required.

Q. Can I have the WVU IRB review my protocol application if I do not work for WVU?

A. Yes. The WVU IRB will review your protocol application s if you do not work for WVU or are not a WVU student. Fees will apply.

Q. I have questions about tissue repositories where can I find the answers?

A. Review the  Tissue banking policy, contact WVU OHRP for assistance.

Q. Where can I find the tissue banking registration form?

A. Tissue banking registration form

Q. Why did the date on my consent form change after an amendment was approved, even though the consent form(s) did not change?

A. To facilitate tracking WVU+kc will change the consent form to match the amendment approval date. The expiration date remains the same.

Q. I created an amendment and want to find it in WVU+kc .

A. Select Search Protocols, input the protocol number followed by A*. 

For example, if your protocol number is 13111111111

Enter:  13111111111A followed by an asterisk. 

Verify that you selected  Yes next to Active at the bottom of search screen and then select Search. The amendment should be displayed at the bottom of the screen.

Q. Why do consent forms need to be attached in PDF format ?

A. The WVU+kc requires the PDF file format to enable the watermark approval information to be inserted in the document. . The information is a federal requirement and must be present on the form before use.

Q. Why do I need to change the review type when asked to do so? Why can’t WVU OHRP change it for me?

A. Changing the review type may change the questions required on the protocol application. For example, changing the type from exempt to expedited would require more information such as consent forms.