The Process of Approval

Conducting Research on Humans

By Jeanette Govern

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).

The IRB

  • 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

The Rules

Informed Consent

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:
  1. States the study does involve research
  2. Description of risks
  3. Description of benefits
  4. Disclosure of alternatives
  5. Statement concerning confidentiality
  6. Description of compensatin and medical treatment for injuries
  7. Contacts for questioning
  8. Statement that say participation is voluntary