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Find quick answers to common questions about WVU Research administration.

General Questions

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

Welcome!  Please visit the Get Started page for basic information about starting a project, submitting a protocol, training, and access to systems and resources. Additional guidance, including videos, is available in the Learning Center.

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

Please contact the WVU Office of Human Subjects Research (OHRP) at

Whom do I contact if I have serious concerns about the welfare and safety of research participants, or about misconduct involving human subject research?

The Concerns page provides information regarding submitting a concern. Additionally, you may contact the WVU IRB Chairs or the WVU OHRP Staff.

Whom do I contact if I have questions about WVU+kc?

Please submit a ticket in the WVU ITS Help Center for technical and access issues related to WVU+kc. (Hint: Suggested articles/information will appear as you type your question.)

Where can I find a listing of IRB committee members?

IRB Committee Members

When are IRB meetings and submission deadlines?

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 (deadline is end-of-day - 4:45pm) to the board meeting. See IRB Meeting Dates & Deadlines for the exact dates.

Does WVU have a Federal-wide Assurance?

The Federal-wide Assurance number is FWA00005078.
FWA documentation

What are the registration numbers for the IRBs?

IRB00000314 West Virginia U IRB #1 and IRB00002568 West Virginia U IRB #3.
IRB Registration documentation

Personnel and Training

Who needs to have training?

All personnel listed on a protocol application must complete the required training for the application to be reviewed. Refer to CITI Ethics Training for more information.

How do I obtain IRB training?

Training information can be obtained at Required Training.

How often do I need to re-take the CITI training?

CITI training (either the Biomedical Research Investigators or Social & Behavioral Research Investigators option) must be renewed every 5 years.

Does the WVU adhere to Good Clinical Practice?

Yes, and to see the documentation please click on the link Adherence to Good Clinical Practices.

Who are key personnel?

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 WVU affiliated key personnel MUST be listed on the protocol application as part of the research team.

How are key personnel different from significant contributors to a protocol?

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 WVU affiliated significant contributors MUST be listed on the protocol application as part of the research team.

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

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

Is there CME/CE credit available for completing the CITI training?

CME/CE credit is available. Login to CITI, from the main menu where you’ll see a listing of your completed courses, on the right is the “Print” option for a completion report.  Select the “CME/CE Credits” link to access a list of the fees for the credit and available options. Select the applicable button for the evaluation and registration. After completing the brief survey, the payment page is displayed. (Payment is made to the University of Miami.) A certificate will be mailed to you.

Student FAQ

I am an undergraduate or graduate student: May I be the Principal Investigator (PI) on a protocol?

No. Students are encouraged to write and submit research protocols, but a faculty member must act as PI and certify the application before the protocol can be reviewed.

I am listed as Personnel––what training is required?

You must complete either the Biomedical Research Investigators or Social and Behavioral Research Investigators training in CITI. Refer to CITI Ethics Training for more information.

How do I create a protocol application?

Please work with your faculty advisor and seek their assistance/guidance. Ultimately, the faculty advisor will be responsible for the project as the principal investigator and should be heavily involved in the creation and review of the IRB submission. 

Login to WVU+kc, and navigate to the IRB tab and select "Create IRB Protocol." Enter all required fields. If you have questions or need assistance, please contact For video guidance, visit the Learning Center.

How can I search for a protocol application?

Login to WVU+kc, navigate to the IRB tab and select "Search Protocol." Enter the protocol number and add an asterisk "*" at the end of the number to list the Active Renewals, Amendments, and/or base Protocol.

How do I submit my protocol application for review?

In the edit mode in the protocol, navigate to the "Protocol Actions" tab. Select Available Actions, then Submit for Review.

If I am not the PI can I submit a protocol application?

You must submit the application to the PI, who must then review the information and submit it to the IRB.  HINT - Inform the PI that the application is complete and awaiting review and submission. 

I have to revise my protocol application; however, the system won't allow me to edit.

Log in to WVU+kc and enter the protocol number in the search option. Options to Edit, Copy, and View are displayed. Select "Edit" to edit the protocol.  You must be either be the PI or be designated as an Aggregator on the Permissions Tab. Other troubleshooting options are to clear your cache and/or use Firefox or Chrome.  If you still experience challenges, log out and access WVU+kc via the OHRP website link. Search for the protocol. (Hint: Use our Advanced Search Instructions if you're having difficulty finding your protocol in WVU+kc.)

I am doing an Electronic Survey. Do I need a cover letter?

A cover letter is required, stating that participation is optional. Include this language in the form of a question at the end of the cover letter with the options of “I agree to participate” or “ I prefer to opt-out.” Visit our Forms page for a Cover Letter template. Please note: There are two Cover Letter Templates - one for expedited protocols and one for flex/exempt.  

When is a telephone script needed?

A telephone script is needed when to conduct a telephone survey or a telephone interview. You must inform the participant that participation is optional and that they can choose to stop at any time during the survey. You must use the script for all verbal communication with your participants; a copy of the script must be provided with the protocol submission.

I am doing a Retrospective Chart Review that includes PHI. Will I need a HIPAA Waiver of Research Authorization Form?

Yes, you will need to complete and submit this form. Note: if all records are from decreased patients, please see the NHSR webpage for additional guidance. 

Who can make corrections on the protocol application or add additional information?

To edit a protocol, you must either be the PI or designated as an Aggregator on the Permissions Tab. Once the protocol has been approved by the IRB, it can only be changed by submitting an Amendment.

Do research projects conducted by students require IRB approval?

It depends. Projects meeting the definitions of "research" and "human subjects research” conducted by undergraduate and graduate students require IRB approval. Refer to the Get Started and Not Research/Not Human Subjects Research pages for more information.

If the research is to be used in the classroom setting to teach research methods, the project may not meet the definition of human subjects research. 

What is minimal risk?

Minimal risk (OMR-Only Minimal Risk) means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

What is the Faculty Advisor's role in a student's research project?

The Faculty Advisor:
  • Is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student.
  • Is knowledgeable of and discusses the ethical and regulatory requirements of human subjects research prior to the initiation of any project involving human subjects with the student researcher.
  • Helps students determine whether their project requires Institutional Review Board (IRB) review and guide students through the IRB application process.
  • Supports the student in the conduct of the research project after IRB approval is attained, giving special attention to maintaining participant protections (including privacy, confidentiality, and informed consent), minimizing risk, and ensuring voluntary participation.

What does an advertisement require?

Advertisements must:

  • Clearly state that the project is research
  • Provide the name, address, and department of the PI
  • Clearly summarize eligibility criteria
  • Clearly state the benefits of the research
  • Provide the time or commitment required for participation
  • Provide the location(s) of the research
  • State that WVU IRB approval is on file

What web browser is recommended for using the WVU+kc system?

Mozilla Firefox or Chrome are recommended to provide the best performance for WVU+kc. 

What is excluded from a Flex submission?

Federally funded research projects, research with FDA regulated elements, sensitive topics, suicidal ideation, traumatic life events, drug misuse/abuse, criminal history, prisoners, tribal members, military, wards of State, cognitively impaired participants, and research projects that include an NIH Certificate of Confidentiality are not eligible for Flex.  For more information, refer to the Guidance section.

Review Process and Review Types

My study includes suicidal ideation. What level of review is required?

The level of review is dependent upon the level of risk incurred by participants (i.e., More than Minimal Risk (MMR) or Only Minimal Risk (OMR)). Studies involving suicidal 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 refuses treatment.

My study includes questions regarding suicide. What level of review is required?

The level of review depends on the type of questions the participants are asked. If the questions include general opinions about suicide, the level of review is determined by the risk/benefit ratio. If you are uncertain of the protocol type that you should use for submission, contact WVU OHRP for assistance.

My study involves vulnerable populations. What level of review is required?

The level of review depends on whether the research is considered "not human subject research" (NHSR), only minimal risk, or more than minimal risk; not the type of population targeted by the study (with the exception of those involving prisoners, which must be reviewed at the full board levels).

What do I do if my protocol application includes recombinant DNA, pathogens, or toxins?

The use of recombinant DNA, blood-borne pathogens, or infectious agents associated with disease in humans, requires approval from the Institutional Biosafety Committee (IBC) before the protocol can be approved by the IRB. The IBC will issue a letter of approval which must be attached to the human subject protocol submission.

If I am a WVU faculty, staff, or student who is conducting my research at another institution, what do I need to submit to the WVU IRB?

Please reference the Reliance page or contact for specific guidance. 

What happens to my protocol application after I submit it?

Depending on the protocol, the application can be routed to department chairs, deans, or administrators for review. If radiation will be used or biological safety concerns are involved, the protocol is routed to the applicable committees for approval. Conflict of Interest is checked by the system and notices are sent for missing COI information.  Each person on the application is reviewed to see if they have the required CITI training. If the training is completed, the application is routed to WVU OHRP for review and then to WVU IRB members as applicable.  

HINT: The status of a protocol can be checked at any time in system using the Route Log in the Protocol Actions tab of the protocol.

When am I required to submit a human subjects research protocol?

All proposed research projects involving the use of human participants conducted under the auspices of West Virginia University must be submitted for review using the WVU+kc system.

My project is a simple survey; is a submission/review required?

Yes. WVU’s Assurance with the Department of Health and Human Services requires all human subjects research conducted under the auspices of WVU be submitted for review.

My project includes an electronic survey. Do both the survey and the cover letter require review? 

Yes, both items require review and must be submitted with the protocol application. 

When is a telephone script needed?

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

Do exempt protocols require submission and review?

Yes, exempt protocol submissions are reviewed by the WVU OHRP and/or IRB for a final determination of review requirements for the protocol submission. Contact WVU OHRP for assistance. 

I am not collecting any identifying information; is a submission/review required?

Federal regulations and WVU policy require that ALL research projects meeting the definition of human subjects research be submitted for review. For additional guidance, start with Step 1 on the Get Started page and/or find more information on the Not Research/Not Human Subjects Research page. 

I am conducting an anonymous survey study without collecting any identifying information; is a submission/review required?

Federal regulations and WVU policy require that ALL projects meeting the definition of human subjects research be submitted for review. For additional guidance, start with Step 1 on the Get Started page and/or find more information on the Not Research/Not Human Subjects Research page. 

I am working with previously collected data; is a submission/review required?

It depends. For additional guidance, start with Step 1 on the Get Started page. 

My research is based on de-identified tissue samples; is IRB review needed?

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). Please visit the Not Research/Not Human Subjects Research page for more information. 

My research is based on de-identified database information; is IRB review required?

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 if the "not publicly" available data can be de-identified. Please visit the Not Research/Not Human Subjects Research page for more information. 

Is there a way to obtain documentation indicating that my project does not require IRB review or oversight?

Yes, please submit an NHSR protocol in WVU+kc. The acknowledgment letter can serve as documentation that the project does not require IRB review. 

How long does it take to review an application for IRB approval?

Generally, reviews are completed in ten business days for exempt protocols and 14 business days for expedited protocols. IRB meetings are held every 2nd and 4th Wednesday of each month (may change with holidays).  Check the schedule to determine the meeting dates. Please be aware that review completion times are contingent upon complete and accurate submissions. Pre-review of the protocol by WVU OHRP staff is not included in this timeline. An application is considered complete after all pre-review concerns have been addressed. 


I will be collaborating with a researcher at another institution; is a submission required for WVU and the other institution?

For collaborative research, contact WVU OHRP. Separate applications may be necessary, or an IRB Authorization Agreement (IAA) may be required. Email for questions.

I have questions about specimen banking, where can I find the answers?

Banks must be approved by WVCTSI. Please visit the Forms page to submit the WVCTSI HSC New Onsite Biospecimen Repository Approval Form (WVU Build Form). Please contact WVCTSI to determine what biospecimens may already be available. 

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

To facilitate accurate tracking, the system automatically changes the date on the consent form to match the amendment approval date.  The expiration date remains the same.

How do I find an amendment in WVU+kc?

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

For example, if the protocol number is 13111111111, enter “13111111111A*” . 

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

Why do consent forms need to be attached in PDF format in the KC system?

The system requires the PDF file format to enable the watermark approval information to be inserted in the document. The watermarked document must be utilized when consenting participants. 

Why can't WVU OHRP change the review type for me? 

Changing the review type may change the protocol application type when the review type changes. Different questions may be required to be answered. For example, changing the type from exempt to expedited would require more information be added to the protocol such as a consent form. WVU OHRP cannot add this information.