The Process of Approval
Conducting Research on Humans
What kind of projects include HSR (human subject research)?
- Any project that collects data from or about humans may meet the regulatory guidelines and therefore be subject to requirements of the EPA.
- Every research project that involves humans must be reviewed and approved by IRB (institutional review board).
- Also known as the Independent Ethics Committee or the Ethical Review Board
- Was designed to approve, monitor, and review biomedical and behavioral research involving humans
- They conduct some form of risk-benefit analysis to determine if research should be done
- Number one priority is to protect human subject from harm
Rules and Basic Elements
- This needs to be signed by subject
- It contains information the IRB has agreed necessary for individuals to know
- Informed consent 8 basic elements:
- States the study does involve research
- Description of risks
- Description of benefits
- Disclosure of alternatives
- Statement concerning confidentiality
- Description of compensatin and medical treatment for injuries
- Contacts for questioning
- Statement that say participation is voluntary