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Belmont Report Notes

The document discusses principles of bioethics related to informed consent in research involving human subjects. It covers the following key points: 1. Participants must provide voluntary informed consent, including full disclosure of the research purpose and risks/benefits in an understandable way, without coercion. 2. Research must maximize benefits and minimize harm/risks to participants based on a systematic assessment of risks and benefits. 3. Fair procedures should be followed in the selection and recruitment of research subjects, avoiding vulnerable populations.

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0% found this document useful (0 votes)
64 views2 pages

Belmont Report Notes

The document discusses principles of bioethics related to informed consent in research involving human subjects. It covers the following key points: 1. Participants must provide voluntary informed consent, including full disclosure of the research purpose and risks/benefits in an understandable way, without coercion. 2. Research must maximize benefits and minimize harm/risks to participants based on a systematic assessment of risks and benefits. 3. Fair procedures should be followed in the selection and recruitment of research subjects, avoiding vulnerable populations.

Uploaded by

Erika
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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• No giving of stipend -> this will deprive them of the

Principles of Bioethics/ autonomy to say yes or no

- Participant has to make the choice to participate

Biomedethics • Right to full disclosure

- Absence of deception or concealment

- Fully describe what the research is about

Beneficence
• Problem: causes bias with study result

- General Rule: Do No Harm


- Sometimes, knowing what the research is about would
interfere with respondent’s answers (placebo)

• Beneficence: Maximize benefits


- Knowing for example that the study is about
- Prevent killing

- Prevent infliction of needless pain


correlation of grades with substance use, those who
- Prevent incapacitating others
use substances wont probably join

- [Applicable in situations where harm is probable]


- Covert data collection and deception are okay, but one has to
be careful

• Nonmaleficence: minimize harm


- Individuals with diminished autonomy are entitled to additional
- Do not kill

- Do not cause needless pain


protections

- Do not incapacitate others


• children, prisoners, elderly

- [Can be done by doing nothing]

- Associated human rights:


APPLICATION (INFORMED CONSENT):

- Three elements:

• Right to freedom from harm and discomfort

• Right to protection from exploitation


• Information (Don’t exclude anything)

- Protect whatever information is given. It should not be used • Comprehension (Info should be understandable)

- Hold reflective conversations

to harm a participant

• Voluntaries (own autonomy)

- Researchers must have the interests of the participants in mind


- Doctor MUST recommend an optimal option

- Participants must be treated in an ethical manner


- Doctor may persuade without pressuring

- The one signing must be competent !!

• Decisions will be respected

• Well-being will be secured


• If patient is not competent:

- Use known prior preferences (consult pt charts and


check his/her past choices)

- Surrogate must decide based on what pt would most


APPLICATION (Assessment of Risks and Benefits):

- Elements:
likely prefer

- If there is disagreement= meeting with all parties ->


• Nature and Scope of Risks and Benefits

- Possible harms: include nature, probability, and severity


raise to institutional ethics committee -> raise to the
- R&B affecting other units of society: include the extent of the courts

effect

- Health and welfare-promoting benefits

• Systematic Assessment of Risks and Benefits

- Thorough and precise -> how the assessment of info about Justice

the justifiability of the research should be


- Main Principle: equitable distribution of benefits and burdens

• Assessment of Justifiability of Research

- Different aspects of morality are how they are justified in the • Fair distribution of needs

research are discussed here


• Medical needs are determined in terms of:

- Ethical Dilemmas:
- benefit to patient

- urgency of need

• Non-maleficence > Beneficence


- change in quality of life

- Don’t harvest organs from a not-quite-dead man to help two


- duration of benefit

patients

• Patient’s decision on a treatment > Doctor’s strong • Medical needs are NOT determined in terms of:

- patient contribution to illness (ex: attempted suicide)

recommendation (what doctor believes will give the greatest - ability to pay (maximize benefits always!)

benefits)
- social worth (no discrimination)

• Patient’s interest > Family’s interest


- obstacles to treatment

- Ex: family doesn’t want treatment because of the financial


- use of past resources

burden
- Associated human rights:

• Offering treatments:

- Obligatory to offer: GREAT benefit, SMALL harm


• Right to fair treatment

- Non-obligatory (even if patient wants it): GREAT harm, small - No systematic selection of subjects based on:

benefit
• easy availability

- Optional: Benefit is not that significant from harm


• compromised position (institutionalised [bc they are
handy] or marginalized)

• If there is disagreement: hold conversations or meetings


(disagreements are inevitable)
• Right to privacy (confidentiality, anonymity)

FORMULATIONS

- Equal share

- Individual need

Respect for human dignity


- Individual effort

- Main Principle: Autonomy


- Societal contribution

- Merit

• Respect for persons (each indiv has the right to make own
choice)

- Associated human rights:


APPLICATION (Selection of Subjects)

- Fair procedures and outcomes

• Right to self-determination
- Consider subject’s appropriateness for the research. Be aware of
- Absence of coercion (persuasion)

involvement of vulnerable populations

- Fair recruitment and criteria (for inclusion and exclusion)

APPLICATION (Medicine)

- National level:

• Consider cost of goods (to prevent scarce resources)

• Consider economic factors (to prevent destruction of economy)

- Institutional level:

• Triage: considers medical indication only

- Helpful for scarce beds in the ICU

- Individual level:

• Don’t ration at the bedside

Answering Ethical Dilemmas

1. Answer using these 4 principles

2. Refer to scientific or social facts

3. Describe potential effects of the decision

4. Identify core ethical consideration

5. Explain how the decision addresses this consideration

6. State strength and weaknesses of other solutions

Sample Ethical Dilemmas

1. Would you recommend or give life-sustaining therapy when you


judged that it was futile? (incapable of producing useful results)

2. Would you consider halting life-sustaining therapy because of family


demands, even if you feel that it was premature? What if death is
imminent? Quality of life is poor?

3. Would you ever hide information from a patient about a terminal or


pre-terminal diagnosis in an effort to bolster their spirit or attitude?

4. Would you cover up a mistake if the mistake would not cause harm
to the patient?

5. Should physician-assisted suicide be allowed in some situations?

6. You are part of the healthcare team and your patient comes from a
culture in which it is considered wrong to tell patients that they are
dying. You're unclear how to respond to a family's request to
conceal the truth from a dying patient

7. You are a physician and some may think it is time to withdraw life
support and let nature take its course, yet the dying patient's family
insists that you "do everything possible" to keep the patient alive.
You're unclear how to solve this problem and worry that "doing
everything" might cause the patient pain and discomfort without
offering any benefit.

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