Frequently Asked Questions
Getting Started
- Am I doing human subject research?
- Can I submit to an IRB outside of UVA?
- Do I need to include my research staff or student researchers on the protocol?
- How is a Screening Log/ Enrollment Log defined at UVA?
- 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 to the IRB for review?
- What are the criteria for "NOT ENGAGED" in human subject research?
- What is the difference between a grant and a contract?
- What is the difference between a grant and a protocol?
- What's the difference between reimbursement and compensation?
- Where can I obtain assistance with writing the protocol and consent?
- Which Review or Submission Type is applicable to my study?
- 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
- What are the different review processes the IRB might use to review my project?
- Where may I find information on the review process used by the IRB-HSR?
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?
- Is there a template for the charter for a new Data & Safety Monitoring Board?
- May I maintain a list of names of people who might be interested in a future study?
- What additional issues should I consider if I plan to do my research outside of the United States?
- What must be done before I may contact people who agreed to be contacted for participation in a future study?
- 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?
- How to keep data or specimens for future research after originial study which which they were collected is closed?
- 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?
- What is required to provide "retention incentives" ( e.g. non-monetary gifts or tokens of appreciation, such as totes, books, toys, or other such materials) to subjects?