Frequently Asked Questions about Human Subjects Research
About the Human Subjects Committee (UNA’s IRB)
- What is an IRB?
- Do I need IRB approval to interview people or observe their behavior?
- Why does the title of my protocol have to match the title of the funding application?
- How do I know if I need HSC approval for my study?
- How do I determine which review process is right for a project?
- Why is my research subject to review by the HSC?
- How often does the IRB meet?
- What is the "Common Rule?"
- Who will review my research?
- Who makes up the HSC?
- I've already started a research project and didn't realize that I needed to receive HSC approval first. What should I do?
- What happens if I conduct human research without HSC approval?
- I intend to run a pilot study before my large research project begins. Do I need HSC approval before starting the pilot study?
- I teach a course and several of my students want to conduct a research project involving human subjects. Do they need to file with the HSC?
- Do I need IRB approval if my work will be conducted off campus?
- My research will be done in another country. Do I have to obtain HSC review and approval?
Advertisements
- Do audio, video, print ads have to be approved by the HSC?
Approvals
- Who must obtain advance approval if humans are proposed as subjects of research?
- When must a protocol be renewed?
Compliance
- What will happen if someone working in my study doesn't follow the rules?
- Ultimately, who is responsible for all research activities that are part of a project?
Consent
- Are signed consent forms always required when doing human subject research?
- How do we assure someone is the participant’s “legally authorized representative?"
- If a sponsor is making no provision for injury compensation how should this be stated in the consent form?
Datasets
Definitions
(See also Glossary section of the UNA Human Subject Research Program Policy)
- For purposes of human subjects protection, how is research defined?
- How do I know if I’m collecting or using “human subject” data?
- What does minimal risk mean?
- What is the difference between "anonymous", “identifiable” and “confidential” data?
- What is a medical device?
Exemption
- Can a PI, department head, or faculty mentor approve an exemption?
- How long does approval of an exemption take?
- If my project appears to meet the requirements for an "exemption," does that mean I don't have to do anything else?
HIPAA
- What is HIPAA?
Reporting
- Once my protocol is approved and my research is underway, are there reporting requirements to the HSC?
Special Classes (Populations) of Subjects -
(See also the Special Consideration for Certain Human Subject Populations section of the UNA Human Subject Research Program Policy)
- What additional requirements apply to research with pregnant women or fetuses?
- What additional requirements apply to research with prisoners?
- What additional requirements apply to research with children?
- What additional requirements apply to cognitively impaired and military subjects?
Training
(See also Education and Training tab of UNA Office of Sponsored Programs Human Subject Research web page)
- Who should complete UNA HSC training?
- How often should I complete HSC Training?
Unanticipated Problems/Adverse Events
- What is an unanticipated problem?
- What are adverse events and do they have to be reported to the HSC?
Other FAQs Sources
Do I need HSC approval?
Education and Training
Ethical Principles
FAQs
Policies, Guidelines & Forms
Public Datasets
Regulations
Related Links