IRB-HSR Home Institutional Review Board for Health Sciences Research
For: 
Researchers IRB Members Research Subjects IRB STaff


 

 

 

 

 

 

+ Calendars & Deadlines
+ Office Information
+ Directions & Hours
+ Staff Directory
+ Frequently Asked Questions
+ IRB-HSR Membership Lists
+ FWA Information
+ Organizational Charts
+ Research Concerns
+ Standard Operating Procedures
 
+ Getting Started
+ Protocol Review Process
+ Managing Protocol After Initial Approval
+ Special Issues
   
+ Protocol Builder and IRB On-Line: On Grounds or UVa VPN access only
+ Forms
+ CITI Training
+ Education
+ Regulations/Guidelines
+ Ethical Principles
+ Search IRB-HSR Protocols
+ Glossary/Acronyms
+ Useful Websites
   
+ Go to full list >>

 

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
  • What do I do if a subject understands English but cannot read or write?
  • A person who speaks and understands English, but does not read and write, can be enrolled in a study by "making their mark" on the consent document, when consistent with applicable state law.

    A person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. If:

    • the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and
    • is able to indicate approval or disapproval to study entry, they may be entered into the study.

    The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document. A video tape recording of the consent interview is recommended.  From FDA IRB Information Sheets

 

Legally blind or illiterate subjects

If subjects who cannot read the consent materials due to illiteracy, blindness, or the subject’s surrogate is legally blind, the following consent process is recommended:

  • Have an impartial witness observe the consent process, such as a subject advocate or someone not affiliated with the research team.  Family members are not recommended to serve as witnesses.
  • The consent forms should be presented to potential subjects orally and the potential subject.  You may wish to provide the subject with an audiotape of the discussion for their reference. 
  • If potential subjects have access to equipment that can read the consent document for them, provide them sufficient time to review the consent document independently of the research team.
  • As would be expected for any consent process, ensure sufficient time is allowed for questions to be asked by the potential subject, subject’s surrogate to ensure that the consent process was clear and effective.
  • Add a statement to the consent form that the subject was unable to read the consent form and that they were read to the subject by a member of the research team designated to obtain informed consent.
  • The subject signs and dates the consent form, if capable of doing so.  In the case that informed consent is being obtained from the subject’s surrogate the surrogate will instead sign and date the form.
  • The witness signs and dates the consent form. A statement should precede the witness’ signature that attests that the consent information was explained and that the subject apparently understood the information, and informed consent was given freel

 
  • 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.