research ethics Flashcards

1
Q

what are the 3 parts of research ethics?

what 2 other things are regulated?

A

1- laws
2- Guidance
3- committees

human gametes and embryos are also regulated

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1
Q

what is the recreation of Helsinki?

A

“The World Health association has developed the declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and date”

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2
Q

what 5 aspects does the declaration of Helsinki cover?

A

1- consent
2- confidentiality
3- risks and burdens
4 - post trial provisions
5- publication

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3
Q

what 3 things are considered human research?

A
  • participants
  • data
  • tissue
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4
Q

what ethical body regulates research ethics in the UK involving the NHS?

what about local level?

what ethical body regulates ethical research outwith the UK?

A

1- national research ethics service NRES

2- NHS research ethics committee NREC

3- research ethics committee REC

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5
Q

4 criteria for valid consent?

A

1- patient must have capacity
2- patient must give consent voluntariliy
3- patient must be informed
4- consent must be continuous

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6
Q

what is the first principle Nuremberg Code?

A

informed consent

New for 2013: Section on Informed Consent
Articles 25 – 32

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7
Q

what should we be aware of for informed consent?

A
  • participants feeling pressure into agreeing
  • the problem of incentives
  • sifficunet info
  • vulnerable patients
  • importance of coding and anonymisation of results
  • distinction between therapeutic and non therapeutic research
  • difference in ethical frameworks in different populations
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8
Q

what happened in the Tuskegee Syphilis trials

A

Began in 1932: “a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks..”
* US Public Health Service (President Clinton apologised 1997)
* 600 African-American men: 399 with syphilis, 201 without
* No informed consent: participants told they were being treated for “bad blood” (not given diagnosis, nor effective treatment)
* Meant to last 6 months, instead lasted 40 years
* Incentives: free medical exams, free meals, and burial insurance
* Examined regularly but not treated for the disease, even after penicillin became drug of choice in 1947 (* note: nor were they allowed to be treated in clinics/hospitals in area)
* 1974: $10 million out-of-court settlement was reached for participants and their families

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9
Q

what happened in the Guatemalan STD trials

A

Guatemalan experiments were uncovered in 2010 by Susan Mokotoff Reverby, took place in 1946–48
* President Barack Obama apologized to Guatemala, launched an investigation: “the Guatemala experiments involved unconscionable violations of ethics, evenasjudgedagainsttheresearchers’own understandingofthepractices and requirements of medical ethics of the day”.
* US govt, with Guatemalan colleagues, experimented on 5000+ Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes
* Justified as “results would have widespread benefits and help Guatemala to improve its public health service”
* No evidence that consent was sought (NB: cf US)
* Exposed 558 soldiers, 486 patients at psychiatric hospital, 219 prisoners, 6
prostitutes, and 39 others to gonorrhoea, syphilis or chancroid
* Measured accuracy of diagnostic tests on orphans, those with leprosy, people at psychiatric hospital, prison and army

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10
Q

what is the case of Henrietta Lacks?

A

1951: cells from Henrietta’s cervix are cultured in vitro, and become the first immortal human cell line HeLa
* 1951: Henrietta dies from cervical cancer
* HeLa cells are shipped all over the world, and used in all
kinds of medical research
* But… Henrietta herself didn’t know this, nor did her family
* No knowledge shared or consent sought
* HeLa cells have made some people a lot of money, Lacks family have struggled to access the healthcare they need

  • Justification? Material was no longer “hers”, material would have been thrown away, for the common good
  • July 2023 Thermo Fisher Scientific settled lawsuit with Lacks family on undisclosed terms
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11
Q

what are the 2 areas where animals are used in research?

A

1) basic research- aimed at improving scientific knowledge/theories

2) applied research - application of theories for example treatment and toxicity

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11
Q

what are the problems that arise in publication ethics?

A

1- authorship
2- conflicts of interest (eg- financial ties)
3- the lack of reproducibility

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12
Q

what does animal research help to do in the making of medicine?

A

in the making of medicine, animal research will rule out any nay medications that would be dangerous to be consumed by humans.

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13
Q

what 7 aspects do we consider in animal research?

A

– Benefits
– Model
– Sentience (e.g., invertebrates/cephlapods) – Value
– Moral agency
– Spiritual/religious potential
– Human achievement

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14
Q

what was Peter Singer’s argument?

A

seeking not equality of treatment, but equality of consideration of interests (and from that Singer’s speciesism argument (Practical Ethics, 1979)

15
Q

what does the home office say in regards to animal research?

A

“in determining whether and on what basis to grant a project license the Secretary of State shall weigh the likely adverse effects on the animals concerned against the benefit likely to accrue as a result of the programme to be specified in the license”
(hence, no cosmetics, toiletries ingredients, tobacco or alcohol productssince 1998)

16
Q

what are the 3 main components of the Animals (scientific procedures) act 1986?

A

1- replacement
2- reduction
3- refinement

17
Q

who advices the home office?

how is eligible research reviewed and monitored?

what are the 3 different types of licence?

A
  • Home Office-advised by Animal Procedures Inspectorate
  • Each local arena-animal ethics committee – review & monitor all eligible research, using ASPA & Home Office guidelines

– Site licence
– Personal license
– Project license