Institutional Review Board for Health Sciences Research
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HUMAN RESEARCH PROTECTION PROGRAM
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Determining Human Subjects Research
Determining HSR or SBS
Frequently Asked Questions
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?
How is a Screening Log/ Enrollment Log defined at UVa?
Protocol Review Process
Does my study meet
May I use an IRB outside of UVa?
Where can I get protocol and consent writing assistance?
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?
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?
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?
Last Modified: Tuesday, 18-Jul-2017 11:02:59 EDT