Frequently Asked Questions about Human Subjects Research

About the Human Subjects Committee (UNA’s IRB)

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  • 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
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