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OHRP FAQ

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 resouces.


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).

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 contact  WVU+kc IT for technical and access issues for WVU+kc.


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 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. Affiliated personnel must complete a full CITI course, however non-affiliated personnel must complete at least an abbreviated CITI course. 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?

The Social and Behavioral and also the Biomedical researcher CITI training must be renewed every 4 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 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 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?

The Biomedical Research Investigators or Social and Behavioral Research Investigators training in CITI in required. Refer to CITI Ethics Training for more information.


How do I create a protocol application?

Login to  WVU+kc, and navigate to the IRB tab and select "Create IRB Protocol." Enter all required fields.  For a brief (6 minute) video on starting a protocol, check out our YouTube channel.


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.


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.”


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 patients are deceased complete the Decedent form and attach it to the Notes and Attachment section with the submission.


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

To edit a protocol, you must be either be the PI or be 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?

Yes. Projects meeting the definitions of "research" and "human subjects research” conducted by undergraduate and graduate students require IRB approval. 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 but requires the review of the WVU OHRP and may be designated as an NHSR protocol. Refer to the Get Started page for more information.


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 and withdrawal.



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, suicide 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.  For more information, refer to the Guidance section.


Review Process and Review Types

My study includes suicide 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 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.

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 biological specimens?

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.


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?

The other institution's IRB will determine the required documentation. Typically, this includes a protocol application. The IRB approving the protocol is the IRB of Record.

WVU requires an IRB Authorization Agreement (IAA) signed by the other institution's IRB or representative along with a summary of the research and the other institution’s IRB approval letter. Contact WVU OHRP for an IAA.

The IAA will be reviewed and acknowledged by WVU OHRP and processed for signature.


What happens to my protocol application after I submit it?

Depending on the protocol, the application can be routed to A protocol can be routed to department chairs, deans, or administrators that are required to approve the protocol prior to submission. 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. Is a Cover Letter required?

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


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 WVU OHRP for 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. To verify that the research project meets the definition of de-identified, submit the protocol for review using the "not human subjects research" (NHSR) protocol type. 


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. To verify that the research project meets the definition of anonymous, submit the protocol for review using the "not human subjects research" (NHSR) protocol type.

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

Federal regulations and WVU policy require that ALL  projects using existing data, documents, records, pathological specimens, or diagnostic specimens from human subjects be submitted for review.


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). An NHSR acknowledgement from the IRB provides assurance that the project does not require IRB oversight.  To obtain the NHSR acknowledgement, submit a protocol and answer “no” to the questions in the human subjects research section. An NHSR protocol form will be submitted to the IRB for verification and acknowledgement.

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. An NHSR acknowledgement from WVU OHRP provides assurance  that the project does not require IRB oversight.  To obtain the NHSR acknowledgement, submit a protocol and answer “no” to the questions in the human subjects research section. An NHSR protocol form will be submitted to the IRB for verification and acknowledgement.


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

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


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. 


Miscellany

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.


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

A Tissue and Data Repository form is required to be completed, signed and attached to protocol submissions. Contact WVU OHRP for more information.  


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 information is a federal requirement and must be present on the form before presenting the form to a participant. 


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.