research ethics Flashcards
what are the 3 parts of research ethics?
what 2 other things are regulated?
1- laws
2- Guidance
3- committees
human gametes and embryos are also regulated
what is the recreation of Helsinki?
“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”
what 5 aspects does the declaration of Helsinki cover?
1- consent
2- confidentiality
3- risks and burdens
4 - post trial provisions
5- publication
what 3 things are considered human research?
- participants
- data
- tissue
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?
1- national research ethics service NRES
2- NHS research ethics committee NREC
3- research ethics committee REC
4 criteria for valid consent?
1- patient must have capacity
2- patient must give consent voluntariliy
3- patient must be informed
4- consent must be continuous
what is the first principle Nuremberg Code?
informed consent
New for 2013: Section on Informed Consent
Articles 25 – 32
what should we be aware of for informed consent?
- 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
what happened in the Tuskegee Syphilis trials
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
what happened in the Guatemalan STD trials
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
what is the case of Henrietta Lacks?
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
what are the 2 areas where animals are used in research?
1) basic research- aimed at improving scientific knowledge/theories
2) applied research - application of theories for example treatment and toxicity
what are the problems that arise in publication ethics?
1- authorship
2- conflicts of interest (eg- financial ties)
3- the lack of reproducibility
what does animal research help to do in the making of medicine?
in the making of medicine, animal research will rule out any nay medications that would be dangerous to be consumed by humans.
what 7 aspects do we consider in animal research?
– Benefits
– Model
– Sentience (e.g., invertebrates/cephlapods) – Value
– Moral agency
– Spiritual/religious potential
– Human achievement
