Free and Informed Consent in Research
Chapter Ninety
Syllabus topic 4, "Issue of Human Rights Ethics in Scientific and Technological Development."
Pages 537 to 542 of 951
In one line
A patient consents to something meant to help them; a participant consents to something meant to produce knowledge, and the second consent has to carry more.
In the wording a student can write in an exam: consent to research differs from consent to treatment in what must be disclosed, in how it must be given, and in the freedom with which it must be given; article 6(2) of the UNESCO Declaration of 2005 requires consent that is prior, free, express and informed, on information that is adequate and in a comprehensible form and that includes the modalities for withdrawal, withdrawable at any time and for any reason without disadvantage or prejudice; and the Declaration of Helsinki adds a list of matters that must be disclosed and requires that where a potential participant is in a dependent relationship with the researcher, consent be sought by an appropriately qualified individual who is independent of that relationship.
The difference from treatment consent
Set the two standards side by side and the differences are precise rather than impressionistic.
| Treatment (Module II, Samira Kohli) | Research | |
|---|---|---|
| Purpose | The benefit of this patient | Generalisable knowledge |
| Extent of disclosure | What a responsible body of skilled practitioners accepts as normal and proper; remote or theoretical risks need not be explained | A listed set of matters, including funding, conflicts of interest and the qualifications of the researcher |
| Form | Real and valid; writing not required by the general law | Express, and formally documented on paper or electronically; if not, witnessed and documented |
| Withdrawal | Implicit in the right to refuse | Expressly stated: at any time, for any reason, without disadvantage, prejudice or reprisal, and the participant must be told of the right |
| Who may take it | The doctor or a member of the team | Not a person in a dependent relationship with the participant; an independent qualified individual in that case |
| Consent by others | Guardian's consent in defined cases | A community agreement or leader's consent never substitutes for the individual's |
The reason for every difference is the one in the first row. In treatment, the interests of the person consenting and of the person seeking consent are aligned; both want the patient to get better. In research they are not aligned, and consent is the only thing standing between the participant and the use of their body for another purpose.
What must be disclosed
Helsinki lists the matters, and the list repays learning because three of its items appear nowhere in the treatment standard.
Each potential participant must be adequately informed, in plain language, of:
- the aims and methods;
- the anticipated benefits and potential risks and burdens;
- the qualifications of the researcher;
- the sources of funding;
- any potential conflicts of interest;
- the provisions to protect privacy and confidentiality;
- incentives for participants;
- provisions for treating and compensating participants who are harmed as a consequence of participation; and
- any other relevant aspects of the research.
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