Midterm 1 Flashcards

Question

What was the pediatric scurvy research?

Answer 1

- An example of human research subjects. - A research study conducted by Hess and Fish - Diets of orphaned children modified to induce scurvy and rickets Criticism: Safeguarding the vulnerable Pain and suffering Voluntary consent Defenses: Progress of medicine Conditions uniquely uniform and controllable Paying back society

Answer 2

Above all, participation in research must be voluntary. The results of research must be useful and unobtainable by other means The study must be rationally based on knowledge of the disease or condition to be studied. IT must avoid unnecessary suffering The study cannot include death or disabling injury as a foreseeable consequence Its benefits must outweigh its risks The study must use proper facilities to protect participants The study must be conducted by qualified individuals Participants may withdraw from the study if they wish Investigators must be prepared to stop

Answer 3

``` Section A: Prioritizing participant health Standards of monitoring Section B: Expanded view of ‘voluntarism’ Section C: Combining research with clinical care ```

Answer 4

``` Ethics and Clinical Research (1966) Similarity between Nazi science and American research 22 unethical studies Preventable deaths Undue risks Use of vulnerable subjects Administrative convenience Implications: misconduct in a peace-time, democratic setting? ```

Answer 5

``` National Research Act Regulatory system Written consent Institutional Review Boards Belmont Report Principles to resolve complex ethical questions Respect for persons Beneficence Justice ``` ``` Principles: Respect for persons, Beneficence, Justice: Practices: Informed Consent Risk and Benefit Analysis Appropriate Selection of Patients ``` Respect for Persons: Autonomy is a form of personal liberty of action where the individual determines their own course of action in accordance with their chosen plan. Respect for individuals as autonomous agents entitles them to such autonomous determinations without limitation on their liberty being imposed by others Beneficence: Requires not only that we treat persons autonomously and that we refrain from harming them, but also that we contribute to their welfare including their health. Thus the principle asserts the duty to help others further their important or legitimate interests…to confer benefits and actively to prevent or remove harms…and to balance possible goods against the possible harms of an action. Justice: Requires the fair and equal distribution of benefits and risks of participation in a research study. Recruitment and selection of participants must be done in a fair and equal manner. Justice forbids exposing one group of people to the risks of the research solely for the benefit of another group. Community representatives have the responsibilty to ensure that community participation in a research study is justified.

Answer 6

Goal: Patients receive the interventions that best promote their health and wellbeing Physician presents the patient with selected information to encourage patient to consent to intervention the physician considers best. Assumes that there are shared objective criteria for determining what is best Physician has duty to seek the best interest of the patient Physician acts as a guide Vision of autonomy: assent or rejection of physician’s choices

Answer 7

Goal: Physician provides patient with all relevant information, patient selects and then physician carries out the selected interventions Assumes that patients values are known, what they need is facts Physician is a technical expert Patient autonomy involves control over medical decision making

Answer 8

Goal: To identify patient’s value and help patient to select the available treatments that realize those values. Physician provides facts Physician assists patient in making their own values more clear Physician is a counselor Autonomy involves self-understanding as the patient comes to better understand who they are and act in a manner that is consistent with their identity.

Answer 9

Goal: help the patient determine and choose the health-related values relevant to the clinical situation. Physician’s values and patient’s values are clarified Physician acts as a friend presenting and evaluating alternative approaches Autonomy involves dialogue about preferences, alternatives, values and their implications for treatment

Answer 10

‘The good of the whole community, where that is taken to include both the good of each and the good of all, in an acknowledgement that one depends on the other.’ - Respect - Fairness - Right distribution of risks - Right distribution of benefits - Two issues of social justice in medicine include; - Rights of patients during trials - Rights of patients following completion of trials

Answer 11

1997 AZT trials Following successful trial of drug therapy for HIV transmission from mother to child At the time, 65% of world’s population of HIV infected people live in sub-Saharan Africa They experience a higher rate of transmission of HIVE from mother to child (30-45%) According to one estimate, more than 80% of deaths among people 25-55 were attributable to HIV infection Controversy involved the participants in control arm of the trials Placebo-control groups For: Local standards of treatment did not include HIV prophylactic intervention Placebo controlled studies are most efficient way to obtain information It would be ‘ethical imperialism’ to use US standards to design medical research Against: Duty to protect all members of a trial Placebo controlled studies are easily compromised ‘Ethical relativism’ of experimenters justifies trials that would never be possible in US, creating incentive to exploit developing and post-colonial countries Revision of the Helsinki Declaration- placebos should not be used when standards of treatment are known. The benefits, risks, burdens, and effectiveness of new treatments must be tested against the best alternative methods US FDA Alternative guidelines ‘whether a particular placebo controlled trial of a new agent will be acceptable to subjects and investigators when there is a known effective therapy is a matter of patient, investigator, and IRB judgement, and acceptability may differ among regions and populations chosen. ‘ - lack of consent

Answer 12

Meningitis that took place in Nigeria | - Lack of consent

Answer 13

- Body is a source of valuable and marketable materials - It is commodified - Why? 1. ) Shift toward joint ventures between university and industry. 2. ) Patenting of genetically modified organisms. 3. ) Expanding markets for tissue.

Answer 14

- Genetic mapping - Understanding and surveillance of diseases - Origin of individual racial groups - Preservation from 'extinction' - Clash with Indigenous groups - Racial profiling - Future uses of information - Biopiracy

Answer 15

- Cord blood is divided between public blood banks and family blood banks. - In the public blood bank system, the blood is donated to society - A third is discarded, a third is used for unrelated transplants, and only a third of the total amount of blood is used for related transplants - In family blood banks, the family owns the cord blood - A third is stored without use, another third is used for stem cell therapy, and the final third is used for related transplants

Answer 16

- The case involving a company that found the genetic coding for breast cancer and ovarian cancer - Involve patent to reveal DNA of patients, which is owned by patients not by doctors and scientists - Need more info

Answer 17

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Discovered as part of basic research into how bacteria fight viral infections CRISPR allows scientists to delete or insert DNA in cells Disease prevention Mutations to BRCA1 and BRCA2 breast cancer genes Gene drives Control of malaria through mosquito population Treatments Cancer Deletions and rearrangements of 100s or 1000s of DNA letters Mutations far from target site Mutations may be benign or cancerous

Answer 18

Chinese scientist He Jiankui Alters CCR5 gene, a gene that creates a protein that makes it possible for AIDS to infect cells Implants embryos in a volunteer Twin girls: Nana- both copies of CCR5 gene disabled Lulu-only 1 copy of CCR5 gene is disabled The study was risky Changes will be inherited by all children’s progeny Susceptibility to West Nile Virus, Japanese encephalitis, influenza The study didn’t address an unmet medical need There was a risk of ‘mosaicism’ The study was carried out in secrecy The volunteers didn’t have adequate information to provide informed consent There was an unmet medical need Even routine medical procedures carry some risk Mutations related to CRISPR have overwhelmingly been benign Objectors have hyped the risks of CRISPER

Answer 19

The term mosaicism is used to describe the presence of more than one type of cell in a person

Answer 20

``` Harold Garfinkel ‘breaching experiments’ Social processes: Language and imagery Influence of political and economic interests Boundary work Alliances Trust ```

Answer 21

See HIV Co-Discovery

Answer 22

``` Co-discovery of Human Immunodeficiency Virus (HIV) Gallo (1981): T cells Cell culturing Techniques Montagnier & Barre-Sinoussi(1983): Isolates new virus from AIDs patient Publication in Science Gallo (1985) Isolates virus Techniques for growing virus Test for detecting virus in blood Publication in Science Controversy Similarity in genetic sequence of AIDS virus Did Gallo use French virus for his own experiments? ```

Answer 23

``` Pons and Fleishmann ‘Cold Fusion’ Studying controversies: The Strong Programme of Social Construction Openings and closures of debates ‘Symmetrical approach’ Avoiding the ‘sociology of error’ ```

Answer 24

An accepted scientific fact: Vitamin C is not a treatment for cancer A typical argument: Researchers eventually learned that vitamin C does not cure cancer because vitamin C does not cure cancer But there is a problem with this argument… Vitamin C believers Dr. Linus Pauling Nobel laureate in molecular biology ‘Molecular disease’ Sickle cell anemia ‘Orthomolecular medicine’ ``` Uncovering networks: Dr. Ewan Cameron Scottish surgeon ‘Holistic health’ proponents Health food industry ```

Answer 25

An accepted scientific fact: Vitamin C is not a treatment for cancer A typical argument: Researchers eventually learned that vitamin C does not cure cancer because vitamin C does not cure cancer But there is a problem with this argument…

Answer 26

``` Calculating potential risks and benefits Animal suffering Pregnancy losses, sickness and death of young The effects of cloning on genetic variation Effects on human welfare Food safety Values: Cloning is ‘unnatural’ Cloning gives too much power to humans Commodification of animals Implications for unwanted animals ```

Midterm 1 Flashcards

(50 cards)