Competence to Consent to Research tests

Question 1

Why do people need to consent to research?

Answer 1

-can cause harm
-The Nuremburg Code (post-Nazi Germany)
-In U.S., rules by Dept of Health and Human Services
-IRBs - local institutional review boards

Question 2

What is included in a consent to research?

Answer 2

1. statement describing research, purposes, duration, procedures
2. reasonably foreseeable risks or discomforts
3. possible benefits to subject or others
4. alternative procedures or tx
5. the extent of confidentiality under Hipaa or other legal rule
6. if more than minimal risk, is there compensation? medical treatments if injured?
7. contact for questions and rights
8. statement of voluntariness, okay to discontinue
   -additional disclosures might be required by IRBs