Frequently Asked Questions

Getting Started

• Am I doing human subject research?
• Can I submit to an IRB outside of UVa?
• Who needs to be listed on the protocol?
• Do I need to include my research staff or student researchers on the protocol?
• How do I change the font size on a website?
• How do I use Track Changes in Microsoft Word?
• I am an investigator transferring my research to UVa. Where do I start?
• If departmental or personal funds are used to support research, is IRB approval required?
• Is my project Quality Improvement (QI) or Research?
• Is there a different submission process for internal vs. external grant applications?
• Is there a fee for submitting a protocol?
• What are the criteria for "NOT ENGAGED" in human subject research?
• What are the criteria for Research Involving Coded Private Information or Biological Specimens?
• What is the difference between a grant and a contract?
• What is the difference between a grant and a protocol?
• What needs to be included in the human subjects section of a grant application (Section E for NIH Grants)
• What's the difference between reimbursement and compensation?
• Which UVa IRB should I submit to?
• Who are the IRB-HSR board members?
• Who can be the principal investigator?
• Who needs to be listed on the protocol? Do all researchers (including collaborators) need to be listed?

Protocol Review Process

• Does my study meet Exempt or Expedited Approval criteria?
• How many copies do I submit to the HSR?
• May I use an IRB outside of UVa?
• Where can I get protocol and consent writing assistance?

Special Issues

• How do I apply for a Certificate of Confidentiality?
• How do I close a Grant with the IRB?
• How do I obtain IRB approval for a Humanitarian Use Device (HUD)?
• Is there a procedure for how to compensate research trial participants?
• May I maintain a list of names of people who might be interested in a future study?
• May I use a Central IRB if I plan to do an expanded access protocol?
• What additional issues should I consider if I plan to do my research outside of the United States?
• What do I do if a subject understands English but cannot read or write?
• What must be done before I may contact people who agreed to be contacted for participation in a future study?
• What should I do if a potential subject does not speak English?
• What's the difference between waiver of consent and waiver of documentation of consent?
• When is it justifiable to provide compensation if the tax information ( name, address, Social Security number of recipient)  cannot be collected?
• When is it justifiable to provide compensation using an alternative method of payment (gift card, petty cash etc) while still collecting tax information?
• Use of data from which Public Data Sets is NOT considered Human Subject Research?

Managing Protocol after Initial Approval

• How do I advertise for research participants?
• How do I close a Protocol?
• How do I Consent Subjects who do not Read, Speak or Understand English Informed
• How do I make a change to my study?
• May I obtain verbal permission from a parent/ guardian for a child to participate in research?
• What are my recordkeeping responsibilities?
• What are the requirements for re-consenting a subject?
• What do I need to do with a protocol violation/ enrollment exception?
• What is an Adverse Event and when must they be reported?
• What is an Unanticipated Problem and when must they be reported?
• What is involved in post approval monitoring?
• What is involved with the continuing review process?
• Who Can Obtain Consent from Potential Subjects?