Week 6: Informed consent in research

why conduct research?

Research involving humans is premised on a fundamental moral commitment to advancing human welfare, knowledge, and understanding, and to examining cultural dynamics.

3 reasons why we need research ethics

1\.) Correct past problems and abuses

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2\.) Prevent new problems and abuses

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3\.) Law is not enough

What 2 major atrocities in the 20th century led to codification of research ethics

1. Nazi science
2. Tuskagee Institute (Alabama)

Tuskagee Institute (1932-1972)

Dr. T. Clark

Tuskagee Institute, Macon County, Alabama

* 1931 USPHS Survey Results
* 399 untreated syphilitic African Americans
* "Study in Nature"
* Observe natural history of disease

opportunity?

An unusual opportunity to study the untreated syphilitic patient from the beginning of the disease to the death of the infected person

Nuremberg code 1947

War trials of Nuremberg

“The voluntary consent of the human subject is absolutely essential

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Nuremberg code 1947 Article 1

Declaration of Helsinki 1964 (World Medical Association)

\*Physician and Treatment Focus

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**Therapy and Research**

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Distinction between research where aim is:


1. diagnostic or therapeutic for the patient
2. purely scientific without implying therapeutic value to the person subjected to the research

Right to standard of care (declaration of Helsinki amended in 1996)

Every patient including those of a control group, should be assured of the best proven diagnostic and therapeutic method

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Declaration of Helsinki 1996 II, 3.

TPS (Tri-council policy statement) AKA Tri-council code

This joint policy expresses the continuing commitment of the three Councils to the people of Canada, to promote the ethical conduct of research involving human subjects.

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\- abiding by the Tri-Council Code is a condition for public funding of research (and many universities have similar rules for private funding for its researchers). 

4 basic principles of the Tri-council code 1997

1\.) Respect for Persons

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2\.) Non-Maleficence

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3\.) Beneficence

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4\.) Justice

9 guiding ethical principles

1\.) Human Dignity

2\.) Free and Informed Consent

3\.) Vulnerable Persons

4\.) Privacy and Confidentiality

5\.) Justice and Inclusiveness

6\.) Balancing Harms and Benefits

7\.) Non-Maleficence

8\.) Minimizing Harm

9\.) Maximizing Benefits

consent as a patient

* As a patient, your consent must be respected.
* As a research subject, your consent must be scrutinized – and can (*and in the right cases must*) be rejected.

what is the difference between the 2 informed consents?

it is based in rights:

* you have the right to medical care
* you don’t have the right to be a research subject

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(*it’s your free choice, but not guaranteed to you as an inalienable right*). 

Volunteering in a lab to be a research subject

When you appear in a lab to be a research subject, the researcher’s obligation is to determine if there is any coercion at work in your decision.

* the researcher is obligated To examine your consent for hidden reasons
* If one becomes apparent, the researcher should refuse you.
* Your consent to experimentation is not the same as it is for medical treatment.

example 1: experiments on inmates

inmates used to volunteer for super random trials why?

* to seem cooperative
* they don’t really care what happens
* if the intervention relates to the crime

example 2: HIV

* lots of people were spending lots of money to try and cure HIV
* they go to places were transmission rate was super high
* these places happened to be were research guidelines were not very strict
* eg. pimp forcing his sex workers to get vaccine (becomes involuntary)
* dilemma:
* cure HIV or free the sex workers

coercion

expectation of favour - reference for parole, example of good behaviour, coincides with treatment

Vulnerable populations

groups who have structural/systemic vulnerability to the powerful who may want to research using them.

* more susceptible to coercion

characteristics of vulnerable populations

1. Institutionalized disparity of power

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2. An inability to respect their own best interests

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3. If the population have to consider punishment of rewards before participating

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4. Susceptibility to power

Coercion vs. Inducement

Coercion = forcibly, against your will 

* threat of force is almost always not allowed in research participation/recruitment

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Inducement = reward, ultimately your choice 

* are allowed, so long as their not “undue”

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voluntariness

* Can be addressed in the case of coercion or inducement:

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“would I do this, if I wasn’t going to have this bad thing/harm happen?” 

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“would you participate in the research if it turned out that the inducement was *“out?”*