Class #12 - Research ethics

Question 1

Nuremberg code include principles?

Answer 1

INformed consent, properly formulated scientific experimentation, risk benefit ratio.

Question 2

Tuskegee lead to? 3 main ethical principles?

Answer 2

Belmont report (78). Respect for persons (be truthful). Beneficence. Justice.

Question 3

Thalidomide lead to?

Answer 3

Declaration of Helsinki

Question 4

NIH came with 7 principle for ethical clinical research (2000).

Answer 4

1. Valuable scientific question: That could improve health. Ensure responsible use of resources and subject dignity (exploitation prevention)
2. Valid scientific method: Ensure responsible use of resources. Concept of “clinical equipoise”.
3. Fair subject selection: Inclusion and exclusion must be justified. Not acceptable: vulnerability, convenience, privilege of subjects. (Exception: study to improve health of refugees). Makes results generalizable and fair distribution of burdens and benefits
4. Favorable risk-benefit assessment: Ensuring potential benefits to subjects/society outweigh or are proportionate to risk. Research Ethic Board ultimate arbiter.
5. Informed consent: Respect for autonomy. Voluntary, INformed and ONgoing. “Therapeutic misconception”, related b/c participant must understands the risks
6. Respect for enrolled subject: Right to withdraw, privacy and confidentiality, ongoing medical evaluation, strong dissemination plan for findings (importance of publishing)
7. Independent review: Research ethics board, provide social accountability

Question 5

“clinical equipoise”?

Answer 5

Assumption that there is not one “better” intervention present for either control or experimental group. (Eg. ASA in MI vs chips)

Question 6

“Therapeutic misconception”?

Answer 6

Tendency of subject to believe they will directly benefit from the study.

Question 7

Member of REB?

Answer 7

2 science, 1 ethicist, 1 with legal expertise, 1 community member

Question 8

CCQ research consent?

Answer 8

given in writing (and verbally if justified). Participant can withdraw anytime even verbally.

Question 9

Binding guidlines=
Cornerstone principle
Accompanying principles (3)

Answer 9

TCPS 2
respect for human dignity
Respect for persons, concern for welfare, justice.

Question 10

Nurses code of ethics OIIQ?

Answer 10

need approval from REB. Whistleblower position. Need to refuse to collaborate if risks appear unacceptable.