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IRB-HSR > Frequently Asked Questions

 

 

 

 

 

 

Frequently Asked Questions

SPECIAL ISSUES

  • How do I apply for a Certificate of Confidentiality?
    NIH
    | FDA (Required if study involves a drug or device)

  • What should I do if a potential subject does not speak English?
    Instructions for using foreign language consent forms.
    Foreign Language Consent Short Forms
  • May I use a Central IRB if I plan to do an expanded access protocol?
    Please contact the IRB-HSR office at 924-9634 to discuss this. It may be allowed in certain circumstances.
  • What additional issues should I consider if I plan to do my research outside of the United States?

    Tips for Conducting Health Sciences Research in International Settings

  • What's the difference between waiver of consent and waiver of documentation of consent?
    Guidelines

  • How do I obtain IRB approval for a Humanitarian Use Device (HUD)?
    To IRB-HSR Form.

  • How do I close a Grant with the IRB?
    Submit a Grant Closure Form by emailing the completed form to IRB-HSR@virginia.edu along with a Routing Form. These should be submitted when all work on the grant is completed.

  • May I maintain a list of names of people who might be interested in a future study?
    The answer to this question is actually regulated by HIPAA. Keep in mind that HIPAA ONLY applies to studies involving health information. If the future study is related to health issues- the following steps must be taken.
  • HIPAA: If the researcher wants to keep a list of potential subjects for future studies that is not associated with an active approved protocol, they will need to obtain IRB approval for the list of names (“a database protocol”) before creating the list of names.

  • What must be done before I may contact people who agreed to be contacted for participation in a future study?
    There are two oversight bodies whose regulations might affect this answer:

    1. HIPAA:if health information involved (privacy/confidentiality) and
    2. DHHS/IRB regulation (recruitment part of IC process)

    HIPAA: doesn’t require researchers to have prior subject approval to make contact about future studies. If the researcher wants to keep a list of potential subjects for future studies that is not associated with an active approved protocol, they will need to obtain IRB approval for the list of names (“a database protocol”) before creating the list of names.

    DHHS/IRB regulation: researcher must also obtain IRB approval for telephone script or text of letter PRIOR to contacting the potential subjects

    • Note: since the researcher already had permission from the subjects, this is not considered “cold contacting,” so the researcher does not need permission from each potential subject’s primary physician before making first contact about the new study

     
    • When is it justifiable to provide compensation using an alternative method of payment (gift card, petty cash etc) while still collecting tax information?

    Answer:  There is no black and white answer to this question.  The answer is based on the specifics of the study, however, some possible justifications may include:

    • Subjects are poor and need the compensation in order to buy gas to get home. 
    • Subjects are young children, for which immediate gratification is helpful.
    • When is it justifiable to provide compensation if the tax information ( name, address, Social Security number of recipient)  cannot be collected?

    Answer:  There is no black and white answer to this question.  The answer is based on the specifics of the study, however, some possible justifications may include:

    • Subjects will be compensated $50 or less per year for this protocol and subjects may hesitate to enroll in the study if it requires they share their Social Security number for such a small amount of money.
    • Study involves a survey of subjects as they leave the local grocery store.  The study would not be able to be performed if tax information is needed as subjects would not be willing to give their social security number to a total stranger.
    • Study involves a highly sensitive issue such as spousal abuse, where any connection between the subject and the payment may put them in additional harm.