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Respect for Persons

Choices of autonomous individuals should be respected. People incapable of making their own choices should be protected

Respect for persons in clinical research and verification of that respect depend on administration of and signatures on a formal informed consent document. Having taken on the characteristics of an educational, legal, and accountability document, the typical consent form can have 19 items, requires over ten typed pages, and is frequently signed without a full understanding of its terms. In fact often it fails to educate, to protect legally and to function as an auditing tool.

What An Informed Consent Document Must Cover
  1. Purpose of the study
  2. Procedures
  3. Potential risks and discomforts
  4. Anticipated benefits to subjects
  5. Anticipated benefits to society
  6. Alternatives to participation
  7. Payment for participation
  8. Possible commercial products
  9. Sample remaining at the end of the study
  10. Identification of investigators
  11. New findings
  12. Withdrawal of participation by the investigator
  13. Consequences of withdrawal
  14. Participation and withdrawal
  15. Privacy and confidentiality
  16. Emergency care and compensation for injury
  17. Financial obligation
  18. Rights of research subjects
  19. HIPAA privacy rights
The informed consent document operates largely to define institutional policies and the features of an individual protocol. Recent catastrophic delinquencies in consent forms have led to a general tightening of the process with questionable effects on educational capacity and legal protections. The required paragraph for HIPAA may add to the confusion.

Whatever the weaknesses of the formal consent process, the PI as a fiduciary for the subject, retains the responsibility to explain the rationale and content of the study in such a manner and for a sufficient time so that participants understand it and give fully informed consent.

The consent must also be voluntary. Coerced consent, expressed or implied, may occur under a number of circumstances including: when participation is a contingency for treatment, when enough payment is made to constitute an inducement, when the subject is really not a free agent, (e.g. prisoners and dependent children, or members of cultures where decisions are centralized).

The investigative team must be reasonably sure that surrogates consenting for impaired or underage subjects are fulfilling their fiduciary responsibility to the subjects.
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Chapter 2
Quick Links

Research in Humans

History of Rules About Research in Humans


Federal Mandate

Respect for Persons



Common Rule

IRB Mission



Chapter 2 Download (PDF)