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IRB-HSR > FAQ > Getting Started Answers

 

 

 

 

 

 

Frequently Asked Questions Getting Started Answers

  • If departmental or personal funds are used to support research, is IRB approval required?
    Yes. UVa has assured the federal regulatory agencies that the institution will review and approve all research involving human subjects before it is initiated. This assurance covers all research regardless of funding.

  • Who needs to be listed on the protocol? Do all researchers (including collaborators) need to be listed?

    Add personnel to UVA protocol if:
    They are faculty, staff or students of UVA, who will be doing any of the items listed below.  This is true regardless of where the study is being conducted.

    • intervene with subjects by performing research procedures 
    • manipulate the environment for research purposes
    • participate in the recruitment and/or selection of subjects
    • participate in the informed consent process
    • collect or report subject identifiable data; or
    • have access to subject identifiable study data

    Also list them if they are NOT faculty, staff or students of UVA, but they will have contact with subjects or identifiable data from this study AND all of the following apply:

    • they are not under the oversight of a PI at another site with which you have a contract,
    • the study will not be approved by their IRB, ethics board etc.
    • their institution does not have a Federal Wide Assurance(FWA) number

    Do NOT add personnel to UVa protocol if:

    • Personnel will only receive data that meets the criteria of a Limited Data Set ( e.g will receive health information and the only HIPAA identifiers shared will be dates and/or town or city, state, zip code).  The recipient will need to sign a Material Transfer Agreement written by Grants and Contracts.  Any electronic data set shared will need to be reviewed by the CDR to confirm the data meets the criteria of a Limited Data Set.
    • Personnel will only receive data that meets the criteria of being de-identified under HIPAA regulations ( e.g NO HIPAA identifiers).  Any electronic data set shared will need to be reviewed by the CDR to confirm the data meets the criteria of being de-identified.

    NOTE: HealthSouth or nutrition services employees are not employees of UVa.
    Some employees may have a joint appointment.

    If your research team should change once the project is approved, you must submit a modification to your protocol adding the new investigator(s) or removing those no longer involved.

  • Do I need to include my research staff or student researchers on the protocol?
    Anyone who has direct contact with subjects and/or access to subjects’ identifiable data in the context of research must be listed on the protocol.  For staff personnel - if the individual's role on the project is part of his or her regular paid duties (i.e. phlebotomist, x-ray technician) and involvement in the project is limited to performing those duties without contributing to the research endeavor, then such individuals need not be listed as sub-investigators or research personnel..

  • What is the difference between a grant and a contract?
    Grants: the investigator has submitted a "grant application" to the funding source asking them to fund his/her research.  The funding source always has a format the investigator has to follow.  Ninety-nine percent of grants funded by the NIH are in the form of a grant, so if they tell you the money is coming from the NIH, you can be almost assured it involves a grant.  The only exception to this is situations where an investigator from another site (ex: the University of Michigan ) is the PI on the grant application to the NIH and they then subcontract some of the work to UVA.  In that case our part of the work is done under a contract.  Other examples of grants are funding sources such as foundations (American Cancer Society), etc.

    Contracts are those in which the investigator does not submit a "grant application" to the funding source to ask for funds.  The most common type is an investigator at UVA doing a multi-center trial for a pharmaceutical company.  If the protocol is a multi-site trial and the sponsor is a pharmaceutical company then you can be 99% assured this is a contract.

    Both grants and contracts are approved by the Grants and Contracts Office.  Most biomedical research is handled through the UVA School of Medicine Grants and Contracts Office.  Grants and contracts for all other biomedical research are handled through the UVA Office of Sponsored Programs.

  • What is the difference between a grant and a protocol?
    In simple terms, the grant is the application you submit to a funding source to obtain money.  It includes an overall summary of the "protocols" you plan to conduct with the funding you are applying for. 

    A protocol includes the specifics of each individual study involved in your grant application. It is possible to have one grant funding several protocols or for one protocol to be funded by several grants.

    If you know you will not be able to do the work unless you get funding, then the grant must be submitted prior to or at the same time as the protocol.  If you plan on doing the protocol even if your grant is not funded, then the protocol may be submitted stating there is no sponsor.  If at a later date you obtain funding to conduct a protocol, then you can submit the grant to the IRB-HSR at that time and modify your protocol to notify the IRB-HSR of the new funding.

    If you have stated on your grant application to the sponsor that your project will involve human subjects, then your grant will need to be reviewed and approved by a UVA IRB.  If your project involves biomedical research, then the IRB-HSR would be the IRB to review your grant.  Once the IRB-HSR has approved your grant, you can submit this approval to the sponsor to obtain your funding.  All IRB-HSR numbers of grant approvals have a G prior to the IRB-HSR number (ex: GHSR 1000).  For specific steps on how to get your grant approved by the IRB-HSR, please see the Grant Application Submission Summary below.  Be aware that all grant reviews must be done by the full committee, therefore, you need to pay attention to full committee submission deadlines.

    Please note that IRB-HSR approval of your grant does not allow you to enroll human subjects or perform a study using data/specimens from humans.  A protocol approval is required to do this.

    To get protocol approval from the IRB-HSR, you must submit a "protocol" and "consent form(s)" (if applicable) to the IRB-HSR.  A protocol may meet the criteria of Full Committee, Expedited, or Exempt review by the IRB-HSR.

  • Is there a different submission process for internal vs. external grant applications?
    Yes, a grant application for an internal grant does not require IRB-HSR approval of the grant.  An example of this type of grant:  The UVA Center for Creative Research has obtained a one million dollar grant.  The UVA Center for Creative Research then accepts grant applications from UVA investigators and determines how the money will be distributed.  (Note that the IRB-HSR would still have to approve the protocol.)

    An external grant application does require approval from the IRB-HSR.  An example of this type of grant:  a grant application to the NIH or a foundation.  (Note that the IRB-HSR would also have to approve the protocol.)

  • Is there a fee for submitting a protocol?

    The Vice President for Research (VPR)) Office assesses a one-time fee of $2000 to Commercially Sponsored Protocols that require Full Board Review.  This fee ONLY applies if the Principal Investigator for the protocol is from the School of Medicine. The fee is considered a direct cost and is subject to F&A.  There are no additional fees for such things as continuations or modifications/amendments.  This charge is made after the study has been approved by the IRB-HSR Board and the Contract office has opened an account.

    Information regarding F&A may be found on the Office of Sponsored Programs website at http://www.virginia.edu/sponsoredprograms/glossary.html#f

    Current F&A rates may be found at:
    http://www.virginia.edu/sponsoredprograms/FA_RATES_ANNOUNCEMENT_2009.pdf

    Questions regarding this fee may be referred to the School of Medicine Office of Research at 243-7088

  • What's the difference between reimbursement and compensation?
    Reimbursement is used when the subject is paid back for travel expenses such as mileage, lodging, food while traveling.  Compensation is "payment" for things such as time, discomfort, inconvenience. 

    What are the requirements for reimbursement?
    Reimbursements must be paid with Oracle Expenditure types found under the Travel Heading.  For instructions on how to process a reimbursement please see "Goods and Services Procurement Guide".  You may also call the Procurement Help Desk at 924-4212.  The money will not be reportable to the IRS as income, but will be withheld if the subject owes money to the state. You may want to speak to procurement regarding the typically turn around time for reimbursements, so that you are including accurate information in the consent form.   Another option for reimbursements is a petty cash fund.  Speak with Procurement regarding this option. Please do not state in the consent form that you are "reimbursing" the subject if you do not plan to process the payment under the expenditure type found under the Travel Heading- since the tax ramifications are different.

    What are the requirements for compensation?
    Compensation may be given in several different forms. These may include check via Oracle, gift cards, petty cash or small gifts such as pencils/ stickers. The state encourages the use of check via oracle for most payments, however circumstances do allow other methods of compensation in special circumstances if approved by the IRB.  If using oracle the expenditure type of Services, Human Subject Payments found under Contractual Services should be used.  Please note that the paid amount will be reportable to the IRS as income and will be withheld if the subject owes money to the state.  It is critical that the researcher does not imply in the consent form that one is being "reimbursed" if you plan to process the payment via compensation methods, since there are very different tax implications for the subject.

  • How do I change the font size on a website?
    Hold down the Ctrl key and press + or - to increase or decrease the font size.

  • I am an investigator transferring my research to UVa.  Where do I start?
    Investigators who transfer research to University of Virginia from their previous institution are required to submit the protocols/grants to the IRB for review and approval in order to continue the study. Please feel free to contact the IRB's for further information. See IRB Contacts.

  • How is a Screening Log/ Enrollment Log defined at UVa?  
    A Screening Log is a log which is shared with an outside entity (usually the sponsor) that would include potential subjects who have not yet signed a consent form. Some sponsors also have documents they call enrollment logs. Per IRB-HSR guidance, an enrollment log is a document which records all subjects who have already signed a consent form. Regardless of what the sponsor calls this form, the IRB-HSR is only asking about a form in which information will be shared about subjects who have NOT yet signed a consent form. This may be done by different methods ( e.g. hard copy form faxed to sponsor, electronic data entry)

    Which IRB should I submit too?
    IRB-HSR Protocol Submission Procedures
    IRB-HSR Grant Submission Procedures

    *Taken from UVa IRB-HSR Research Guidance