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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
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.
- Purpose of the study
- Potential risks and discomforts
- Anticipated benefits to subjects
- Anticipated benefits to society
- Alternatives to participation
- Payment for participation
- Possible commercial products
- Sample remaining at the end of the study
- Identification of investigators
- New findings
- Withdrawal of participation by the investigator
- Consequences of withdrawal
- Participation and withdrawal
- Privacy and confidentiality
- Emergency care and compensation for injury
- Financial obligation
- Rights of research subjects
- HIPAA privacy rights
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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Research in Humans
History of Rules About Research in Humans
Respect for Persons
Chapter 2 Download (PDF)