Questions

Question 1

Why was human experimentation an essential component of the antivivisectionist movement?

Answer 1

Anti-vivisectionists were concerned about the welfare of animals and thought they were the slippery slope to human vivisection. The ASPCA advocated for the criminalization of vivisection but they were split on the limits of human and animal experimentation. Animals were associated with the sick and helpless and led to a general decreasing in moral conscience and that the still living would be dissected. The AMA defended human experimentation and rallied against regulation, they pointed to the benefits of research. Vivisection in the 19th century was interchangeable with experimentation

Question 2

What motivated antivivisectionists? What motivated medical leaders to oppose the antivivisectionists even when such opposition was contrary to personal beliefs?

Answer 2

Antivivisectionsist, who were mostly women, saw the connection between care of animals and care of society’s vulnerable, like children, the ill, and women. The AMA opposed the anti-vivisectionists, citing the benefit to humanity. They also feared losing their cultural authority. Even though some leaders of the AMA were opposed to human vivisection, they made a strong defense of medical experimentation and the ability of the profession to depend on its own moral sense. Eventually they began to self-regulate.

Question 3

How did the medical community view the notion of consent before the 1940s?

Answer 3

Was viewed as not terribly important. Though it was expected that researchers would get consent, it was not considered important if the procedure was not risky. At the turn of the century law suits precipitated written consent over verbal. American law generally permitted experimentation if it produced good results.

Question 4

Describe the practices and social effects of self-experimentation.

Answer 4

Researchers assuaged criticism with prior experimentation on animals and the willingness to do self-experimentation or experimentation with family and students.

Question 5

How did public sentiment about research shift from the mid-19th century to the mid-20th century?

Answer 5

There were real debates between antivivisectionsists and the AMA in the 19th century. The AMA wanted to regulate itself, stressed consent and less risky experimentation, but did not want regulatory statements. The antivivisectionists opposed all experimentation on vulnerable populations. But this changed with the wars. Patriotism was high and many saw experimentation as necessary to help soldiers. People saw experimentation was advantageous and altruistic.

Question 6

Why do you think that the AMA chose not to adopt a code of ethics for clinical research before the 1940s?

Answer 6

Physicians wanted to self-regulate. They attempted to limit damage by physicians who acted too controversially and debated ethical standards internally. The public trusted the medical profession and came to glamorize experimentation and research subjects.

Question 7

What was the thesis of Beecher’s 1966 article? What was the significance of his article?

Answer 7

Beecher believes that mainstream medical research used unethical designs that jeopardized the lives of participants. He argues that these results should not be published and that rEsearchers must be responsible, informed and conscientious. The article exposed that major stakeholders like medical centers and the government were openly doing research on vulnerable. People lost confidence that researchers could self regulate.

Question 8

How does Rothman explain the unethical conduct described by Beecher?

Answer 8

Rothman believes that during WWII research became well-coordinated and well-funded. It was designed to help individuals other than subjects. Consent was not vital, subjects were considered akin to draftees of the war. Scientists needed to help the war effort by finding cures to diseases, and this carried over, even after the Nazi doctor trials, to a ‘war against disease’ mentality. In the 1960s the revolt against human experimentation was not a result of Beecher’s paper but a general skepticism towards authority and the fruits of scientific research.

Question 9

Describe the shifting views of justice in research that Mastroianni and Kahn articulate. What do Mastroianna and Kahn understand to be a just situation in human subjects research?

Answer 9

They believe that in the 1970s policies on HSR emphasized risks of harm and protection of subjects. In the 90s, policies try to ensure access to the benefits of research. The authors believe that benefits and access need to be balanced with harms/protection because research is inherently risky. Exclusion for the purpose of protection cannot be so strict as to unnecessarily deny benefit to individuals and the groups they represent.

Question 10

What are the two ways to justify research for Jonas, and does he think either is a sufficient justification? Why or why not?

Answer 10

1. Social Progress: individuals do not have any obigation to sacrifice herself for research, this sacrifice is not required by the social contract theory. This is about public actions, social contract theory actually elevates the primacy of the individual. We only have the duty to maintain our current state. We haven’t sinned if we fail to find cures.
   
   2. Consent of the Subject: the problem is that asking is a kind of conscripting. Physicians have a lot of authority.

Question 11

Who should participate in research, according to Jonas?

Answer 11

There should be a descending order, from medical professionals, to the highly educated, and then the least dependent. Also, healthiest to least healthy.

Question 12

What are the five possible ethical ways to recruit individuals for bad choice research, according to Wertheimer?

Answer 12

1. Don’t use people in bad choice research
   
   2. Argue that we have a duty to participate in bad choice research for the good of society
   3. Promote altruism
   4. Use other incentives to turn ‘bad choice’ into ‘good choice’
   5. Find background contexts where the same research is good

Question 13

Compare the way that Eisenberg and Jonas argue for or against the possibility of ethical research.

Answer 13

Jonas uses rights language and Eisenberg is very consequentialist. Eisenberg believes that the human cost of ineffective care is greater than the human cost of research

Question 14

What are the criteria for ethical research outlined in the Belmont Report?

Answer 14

1. Respect for person, treat individuals as autonomous agents
   
   2. Beneficence
   3. Justice - how to distribute the burdens and benefits of research (to each an equal share, according to individual need, effort, societal contribution, merit)

Question 15

What are the major documents used to inform the research ethics and laws we have today?

Answer 15

1. Nuremberg Code (1947) - Response to Nazi atrocities
   
   2. Declaration of Helsinki (1946-1996) Helps fill in gaps of Nuremberg Code, focuses on risk-benefit ratio and independent review, therapeutic vs. Non-therapeutic research
   3. Belmont Report (1976) - outline broad principles for research in response to Tuskegee and Willowbrook
   4. CIOMS: International Ethical Guidelines for Biomedical Research Involving Human Subjects (1982-1993): applies declaration of Helsinki to developing countries
      Combined they give us 7 criteria: Social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent, respect for potential and enrolled subjects

Question 16

Under what conditions could a researcher be held legally responsible for failure to negotiate consent?

Answer 16

Researcher must ensure: Informed consent (1. Competent 2. Voluntary 3. Informed and 4. Comprehending); traditionally failure to get informed consent was battery and today is considered engligence

Question 17

What are the components of informed consent?

Answer 17

1. Informing: (1) Invitation, (2) Statement of overall purpose (not just immediate purpose), (3) Basis for selection, (4) Explanation of procedures, (5) Description of discomforts and risks (over-informing versus under-informing; reasonable person standard + idiosyncratic person standard best), (6) In case of injury, (7) Description of benefits (hopes for, not guaranteed; subject not only intended beneficiary), (8) Disclosure of alternatives (presentation of data matters), (9) Confidentiality assurances, (10) Financial considerations (right to profit from marketable products developed?), (11) Offer to answer questions, (12) Offer of consultation, (13) Noncoercive disclaimer (moral obligation to participate in research? Promise to continue in research?), (14) Consent to incomplete disclosure (when disclosure of purpose would invalidate the study results), (15) Other elements, (16) Continuing disclosure
   
   2. Comprehension: literature reveals little about whether informed consent accomplishes its purposes; subjects may forget information that they understood at the time; subjects remember info that is important to them
      
      3. Autonomy: physicians can usually persuade patient to do almost anything; advantages and disadvantages of having one person as physician-investigator

Question 18

What are some barriers to informed consent?

Answer 18

Barriers to informed consent (based on Katz and Fox): Authority (need to trust patients to share in decision-making), Autonomy (no one entirely rational in decision making, definition of autonomy should take this into account), Uncertainty (when to inform patients about lack of knowledge due to ignorance or limitations of current science)

Question 19

What does Beauchamp think about the five components of informed consent?

Answer 19

Traditionally: (1) competence, (2) disclosure, (3) understanding, (4) voluntariness, (5) consent
Beauchamp tosses out competence because it is a precondition of informed consent, not part of the process, and disclosure if a pt already has access to the information

Question 20

For Beauchamp, what grounds informed consent?

Answer 20

Autonomy, nonmalefience, from the Nuremberg code

Question 21

What is Beauchamp’s theory of autonomy?

Answer 21

Autonomous action: by chooser acting (1) intentionally (intrinsic or instrumental- action/effect willed in accordance with plan, including merely tolerated effects), (2) with understanding, and (3) without controlling influence (no one absolutely autonomous, but “the everyday choice of general competent persons are autonomous”). (Intentionally (black white) without controlling influence (degrees))

Question 22

What was the Jewish Chronic Disease Hospital Experiment?

Answer 22

Jewish Chronic Disease Hospital Experiment- 1963: measure rate of rejection of live cancer cells in chronically ill patients without cancer (injections into thigh)

Question 23

Why do we require informed consent for research?

Answer 23

Investigator has professional status
• Investigator has superior knowledge
• Investigator has expert understanding of the nature of the research and the risks
• Physician-investigator has the authority to prescribe treatments
• Investigator may have access to experimental interventions not available in clinical practice=can be seen as based on soft paternalism

Question 24

What is therapeutic misconception and what distinctions does Miller introduce to the topic?

Answer 24

Therapeutic misconception: confusing scientific orientation of research participation with therapeutic orientation of medical care = 62% of subjects. need to distinguish potential disadvantages (stemming from scientific method) from predictable disadvantages (stemming from design of particular trial). Not clear that every manifestation of therapeutic misconception invalidates consent- depends on details of particular trial.

Question 25

Why does therapeutic misconception matter?

Answer 25

Comprehension of what they are consenting to is defective

Question 26

According to research on informed consent, what measures can be taken to improve understanding?

Answer 26

a. Combination of qualitative and quantitative methods critical for advancement of consent research
b. difficulties of enrolling consent subjects must be overcome by contact with and education of researchers about the importance of the research
c. policies must be developed to identify the appropriate interventions when the consent being observed is inadequate
d. policies must be developed for how consent research itself will be used to improve institutional standards without exposing researchers who have agreed to being observed to punitive sanctions
- -

Question 27

What is Miller and Wertheimer’s preferred model of consent and why?

Answer 27

Fair transaction model (FT): Consent transaction between B and A is morally transformative if B tokens consent… or, in the case of a flawed or unsuccessful consent transaction, that A is permitted to proceed in the absence of B’s consent if it is fair for A to do so (fairness may depend on situation)
NOT: Lock-and-key/autonomous authorization model (LK/AA) - Valid consent is necessary and sufficient for moral transformation.
In medical context, pressure exerted by illness itself does not undermine the voluntariness of patient’s consent to treatment = easy to explain on FT but not on LK/AA. Fairness is a quality of the interaction between the two parties, not the nature of the background condition. Criteria of moral transformation must also reflect the choice among potential decision makers

Question 28

What is optimism bias and why might it be concerning?

Answer 28

It is optimism bias and why might it be concerning?
Unrealistic optimism/optimism bias = bias in which person believes he/she more likely to experience positive outcomes (or less likely to experience negative outcomes) than others similarly situated. Unrealistic expectations could have positive effects (inverse relationship with depression), but other studies show associated with higher risk, poorer knowledge of and attention to health risk information, more risky behavior, etc.

Question 29

Is therapeutic misconception common and can it be reduced?

Answer 29

Believing that research will help the subject in particular. You can help by giving someone other than the researcher the task of explaining the study. (Appelbaum)

Question 30

What is the role of trust in the patient-subject, physician-investigator relationship?

Answer 30

Patients become subjects because they trust hospitals, researcher, physician’s recommendations. We usually assume that informing patients of risks and benefits is the necessary condition for sound research choices. In fact, interviews with patient/subjects illustrated that they tend to trust their physician to guide their decisions more than their understanding of risks and benefits.

Question 31

Why is ‘soft paternalism’ in research acceptable? Is hard paternalism ever acceptable?

Answer 31

An appeal to group soft paternalism for research subjects does not necessarily conflict with the liberal values of respect for individual autonomy. What is not widely recognized is that the current system of regulating human subjects research with competent adults is paternalistic at its core because it places a variety of restrictions on permissible research. Soft paternalism is warranted if a person’s judgment is substantially nonvoluntary, even if we disagree as to when a person’s judgment is substantially nonvoluntary. 2 reasons thinking that soft paternalism must be defended:
1. depends on valid or reasonable judgment that substantial decisional defects are likely to impair the voluntariness of conduct:
2. There are numerous good reasons to eschew paternalistic interference with competent adults even if their decision-making is impaired
The regulatory system is not justified by nonmaleficence or exploitation.
-Yes, when the risks are too high, ex. An educated, health person wants to undertake high risk research for altruistic purposes—artificial heart

Question 32

Distinguish: Direct paternalism, indirect paternalism, soft paternalism and hard paternalism

Answer 32

Soft paternalism: limitation of liberty on grounds that person’s decisionmaking is impaired
Hard paternalism: limitation of liberty of someone whose decisionmaking is NOT impaired
Direct paternalism: limiting the liberty of the person whose interest we are trying to protect
Indirect paternalism: limiting the liberty of one person(s) to offer choices to another person(s), to protect the interests of the latter person

Question 33

Who comprises IRBs?

Answer 33

1974 DHEW regulations: committee must be composed of not fewer than five persons and must include capacity to judge the proposal in terms of community attitudes. IRBS must include persons whose primary concerns lie in these areas of legal, professional, and community acceptability (committee cannot consist entirely of employees of organization where research conduction, no committee shall be composed of a single professional or lay group)

Question 34

Describe the types of IRB review and types of approval.

Answer 34

Exempt: IRB deems studies that fall under certain categories exempt form further review (unless they change)
Expedited: IRB deems studies that fall under certain categories appropriate for review by one reviewer rather than a board, in order to expedite the review
Full board: all research that is more than minimal risk, and some minimal risk that doesn’t fall under previous categories must be reviewed by full board.
Describe 3 different critiques of IRBs. How can we modify IRBs to account for problems?

Types of Approval:
Full approval; approval with contingencies (most all); tabled/deferred; disapproved
___

Question 35

Are risk and benefit not analogous terms?

Answer 35

Risk is about the possibility of future harm that might occur. Benefit is a certain value that is gained or will be gained. In research, benefit means certain and tangible advantage, not hoped for gain.

Question 36

What counts as a community? Why and when should researchers engage communities in their research?

Answer 36

Community = group that has organizational structure and leadership regardless of research. In doing community based research, researchers need to develop partnerships (community consult or consultation is not enough). To develop a partnership, researchers may work with a community based organization that serves as a conduit.

Question 37

How does the assessment of researchers differ from regular folk?

Answer 37

(Slovic: “Perceptions of Risk”) Factors that affect risk perception for regular folk: Benefits perception, voluntariness of activity, familiarity of activity, catastrophic potential of activity, fairness/unfairness of activity, level of uncertainty about the activity, delayed or immediate effect, risk to future generations, old vs. new risk, individual vs. group risk
“Expert” risk assessment based on: amount of injury, amount of death, amount of damage, magnitude of society impact – should they consider this?

Question 38

Is confidentiality a prima facie or absolute standard in research?

Answer 38

Prima facie. There are times when breaching confidentiality is necessary e.g. Abuse, direct threat.

Question 39

What have been some of the problems with HIPAA for research?

Answer 39

Overly complicated and complex. It has no regulations for specimens. HHS did not integrate or harmonize HIPAA with the Common Rule, thinking they were separate. HIPAA forms has practically discouraged subjects from enrolling in trials. Under HIPAA we have gained no privacy protection for human subjects but offer many obstacles harmful to recruitment and selection bias. Not everyone agrees on the privacy rule, which makes multicenter research tough.

Question 40

What are the requirements of the Privacy Rule?

Answer 40

Under privacy rule, covered entity may disclose phi in a limited data set only if recipient signs agreement that info will only be used limited purposes. The privacy rule goes into great detail about requirements for deindentification, 17 provisions (name, zip code..)

Question 41

What did the Duke Case tell us about NIH Confidentiality Certificates?

Answer 41

They don’t always work and the NIH doesn’t involve itself in upholding the certificate. In negative case, 2004, prosecution witness was study participant at Duke, were used without knowledge of certificate, but then again in appeal; only lawyers and judge allowed to see, but was proven to be unhelpful in case

Question 42

What is problematic about the way the Common Rule and other regulations address vulnerabilities?

Answer 42

It is vague, don’t define vulnerability or define characteristics of vulnerable groups or offer suggestions on how to prevent harm; vulnerability is about populations, some believe it should be situational.

Question 43

What does Coleman see as the three conditions for IRB approval of research, and how do they help clarify vulnerabilities?

Answer 43

1. Risks reasonable in relation to benefits (both to subject and society), 2. Risks minimized to extent possible, 3. Informed consent

Question 44

What are the six vulnerabilities that Kipnis identifies?

Answer 44

Cognitive: does the C-S have the capacity to deliberate about and decide whether or not to participate in the study?
Juridic: Is the C-S liable to the authority of others who may have an independent interest in that participation?
Deferential: Is the C-S given to patterns of deferential behavior that may mask an underlying unwillingness to participate?
Medical: Has the C-S been selected, in part, because he or she has a serious health-related condition for which there are no satisfactory remedies?
Allocation: Is the C-S seriously lacking in important social goods that will be provided as a consequence of his or her participation in research?
Infrastructural Vulnerability: Does the political, organizational, economic, and social context of the research setting possess the integrity and resources needed to manage the study?

Question 45

According to Kipnis, what are the deficiencies of the subpopulation approach to vulnerabilities (pt 1) and how does an analytic account help? (Pt. 3)

Answer 45

-Not clear what characteristics are common to groups, what to do when confronted with vulnerable group; problem vulnerability is a trump card. (Pt. 1)

Question 46

What are the current research regulations regarding pregnant women?

Answer 46

1977: FDA mandates exclusion of women of childbearing potential from Phase I and early Phase II trials. Common Rule: Does not speak to women of childbearing age, but of pregnant women, fetuses, and neonates. DHHs regulations, therefore, are founded on principle of exclusion of pregnant women from clinical research. 1993: mandated inclusion of women and members of minority groups in clinical research supported by NIH (follow FDA rules on pregnant women).

Question 47

How are the current regulations harmful to women, according to Kass, et al.?

Answer 47

1. HIV infected pregnant women are denied access to potential benefit of participation in clinical trial
   
   2. They are denied access to scientific advances (principle of justice)

Question 48

What did the IOM conclude about the DHHS Subpart C?

Answer 48

1. Expand the definition of prisoner: parole or probation
   
   2. Ensure Universal, Consistent Ethical Protection: need uniform application of regulations, need a central database for how many prisoners are involved in research
   3. Shift from a Category-based to a risk-benefit approach to research review (disallow phase 1 and 2)
   4. Update the Ethical Framework to Include Collaborative Responsibility
   5. Enhance systematic oversight of research involving prisoners

Question 49

Why does Chwang take issue with the IOM’s recommendation to shift to a risk-benefit approach for prisoner research?

Answer 49

Makes sense for children who can’t give rational consent, but prisoners aren’t children; most prisoners issue not lack of competency but coercion, undue inducement, exploitation and paternalism; 4 issues people concerned about.

Question 50

What are 3 responses to the question of whether paying research subjects constitutes undue inducement?

Answer 50

Yes:
Denny et al. (Economically disadvantaged groups should be considered vulnerable subjects because decision impairing inducements render subjects “relatively or absolutely incapable of protecting their own interests”, the very definition of vulnerability and they are liable to exploitation)
McNeil (Research volunteers must clearly understand the extent and nature of risk, and financial reward can induce participants to disregard and/or downplay risk. )
No:
Wilkinson and Moore (Money is not an undue inducement, because it is not coercing/forcing anyone to participate in research. ‘Freedom requires the presence of more than one acceptable option’)
Emanuel (masks other concerns abotu independent review, poor informed consent, and unfair subject selection);
Festinger (study shoes payment did not effect perception of coercion);
Lemmens and Elliot (Healthy human subjects should be treated like laborers to receive a fair wage and legal resources available to high-risk workers.

Yes but its ok:
Dickert and Grady (We can address the ‘undue inducement’ problem 3 ways: market model, wage payment model, reimbursement model.)
Wertheimer (It is hard to justify interference with trials that exploit the poor for the benefit of the poor. )

Question 51

What are some alternative models for payment for research subjects?
Dickert et al.

Answer 51

1. The market model: (Pay well, be competitive with payments) Pros: it is likely to ensure a sufficient number of subjects who complete the study, make money while making a socially beneficial contribution, reduces or eliminates financial sacrifice of participation. Problem is that payment may be so high that all of other factors become irrelevant to subjects decision to participate or to remain in recent studies.
   
   2. Wage payment model (pay like its a job): Pros: inducement or explication is lessens, standardization of payment, reduces financial sacrifice of participation; paid for work that is valuable to society. Cons: Not as many people will participate, too attractive to the poor; commercial participation.
   3. Reimbursement model (for expenses incurred): Pros: Alleviate concern of undue inducement; no incentive to conceal information; does not induce vulnerable populations; lessens the financial sacrifice of participation. Cons: insufficient numbers.

Question 52

What is exploitation in human subjects research and how is it connected to undue inducement. What are the arguments for and against the claim that the two are linked?

Answer 52

Wertheimer: Exploitation has 2 meanings, one negative one neutral. Exploitation can be harmful (exploiter gains by harming exploitee) and mutually advantageous (both parties reasonably expect to gain, the advantageousness is mutual, not the exploitation.) Need to distinguish consensual and nonconsensual exploitation. Two distinctions not equivalent, can be mutually advantageous but nonconsensual. We have a prima facie reason not to interfere with person’s autonomous choice to be exploited. We must prohibit harmful and nonconsensual exploitation.
Lemmens, Elliot: Healthy subjects should be in kind of labor relation to protect them from exploitation
Denny et al.: Economically disadvantaged groups should be considered vulnerable subjects because decision impairing inducements render subjects “relatively or absolutely incapable of protecting their own interests”, the very definition of vulnerability and they are liable to exploitation.

Question 53

What is genetic exceptionalism and what are the arguments for and against it?

Answer 53

The belief that genetic information is categorically different from other kinds of medical information.
Pro: because it is predictive, linked to others, open-ended, has the potential for discriminatory research, and is highly personal and creates special duties and obligations
Con: Manson, O’Neill: There may sometimes be prudential reasons for taking account of the feelings that people have about genetic information, but they offer no basis for a general argument for the intrinsic ethical significance of genetic information, or to establish rights to genetic privacy. Informed consent is about an interaction between two or more agents, not a transfer of a thing (data) from one person to another. Genetic information is heterogenous, it requires extensive interpretation, it can be used in ways that are general and does not need to implicate individuals, non-genetic information can lead to genetic conclusions. “it is intrusive action rather than distinctive informational content that may call for special measures.’

Question 54

What are the arguments for and against offering people the results of DNA biobanking?

Answer 54

Yes:
Some studies show that participants want to receive these results
Way of recognizing contributions
Genetic results constitute important information about oneself
Genetic results can enhance self-determination
-can enhance clinical care, quality of life, reproductive decisionmaking, life planning.
-genetic results can gain self-knowledge

No:
Research does not entail individual benefit/clinical obligations
Results of research often tentative and inconclusive (not CLIA certified like hospitals, not as much quality control)
-do no harm doesn’t entail a positive duty to promote participants’ interests

In between: Haga and Beskow: offer aggregate results

Question 55

What are some models for consent to genetics research

Answer 55

Broad/general consent’ approach: Under this approach, consent processes are designed to describe the biobank’s practices with regard to future use and then ask prospective participants whether they wish to contribute to the biobank under those conditions.
‘specific consent’ : any researcher collect biospecimens for a specific purpose, which means that individuals give consent to use their biospecimens for a specific purpose, which means that individuals give consent to use their biospecimen only for that purpose
Tiered consent system: Permitting use of the specimen in the current study only; Permitting use of the specimen in the current study only, but allowing contact to request consent for future studies; Permitting identified versus unidentified future use.
Waive Consent: May be allowed if: no more than minimal risk; could be practically conducted without a waiver; could not be practically conducted without PHI

Question 56

What is the interaction principle? What does Wertheimer think of it?

Answer 56

Interaction Principle (IP): one can have obligations or moral reasons to provide super-contractual benefits to those with whom one engages in mutually beneficial and consensual transaction. Even though A has no obligation to provide any benefits to B if A chooses not to interact with B, A nonetheless can acquire an obligation to provide benefits that go beyond that to which A and B would otherwise have agreed if A chooses to interact with B. Even if IP is defensible with respect to some interactions, not true of every interaction. t is arguably better to regard certain types of interaction as wrong even when they yield a morally superior state of affairs in a particular case. It may be best to regard certain research interactions as wrong even if they yield a better state of affairs than non-interaction in a particular case. The fact that we benefit from the use of each other does not create additional obligations.

Question 57

How does the Quinacrine Affair exemplify Macklin’s thesis?

Answer 57

Quinacrine affair (promotes sterilization): question is it acceptable to use experimental treatment in developing country when same treatment not approved in developed countries? It had become standard therapy in some countries 
The real question is whether the assessment of risks and benefits, against a backdrop of poverty and lack of access to medical benefits can justify lower standards of safety in disadvantaged parts of the world. Some argued can’t do in other countries if you can’t do in ours, the counter argument was (1) that the standard of care in other counties was no treatment, (2) placebo controlled trials shorter and easier (3)AZT  can’t be use in other countries because of cost (4) cheaper drug developed will help pregnant women in developing countries

Question 58

When is a waiver of consent permissible in research?

Answer 58

1996 – “Final Rule” – Waiver of Informed Consent Requirements in Certain Emergency Research in the DHHS regulations and the Emergency Exception to Informed Consent in the FDA Regulations

Question 59

What are the primary ethical issues in BSS research?

Answer 59

Confidentiality and Privacy
Consent: consent vs. Assent for minors; passive vs. Implied consent
Reinforce stereotypes
Deception

Question 60

What are the differences and implications between innovative therapy and medical experimentation?

Answer 60

A novel therapy is trying something new for the patient’s benefit when no standards of care exist.
Experimental treatment is trying something you think may be better than what exists. (NOTE: If no standard treatment exists, innovation is not experimental. If standard treatment exists, departing from it is experimental or negligent. )

Question 61

What is an institutional conflict of interest?

Answer 61

Conflicts between the primary missions of a health care institution and its other interests like profit.

Question 62

What are some of the problems with finder’s fees in research?

Answer 62

Patients may lose trust in their physicians if they are being paid to recommend them for research. Physician researcher may propose research that is unnecessary or less beneficial than the standard treatment. Recruiters might enroll ineligible individuals into a trial

Question 63

What is a bounty hunting fee?

Answer 63

Bounty Hunting fees: large sums of money paid by pharma, manufacturers of medical devices, for the purposes of testing their products. Companies pay clinical researchers to test their products.

Question 64

What is the Bayh-Dole Act?

Answer 64

Bayh- Dole Act (1980)- passed with the intention of promoting researching by providing institutions with a commercial incentive, even though research was publicly funded. Publicly funded research could still be privately owned at the institutional level. Ex. Of problem: Myriad genetics, was suing research institutions that wanted to use BRCA genes in research, but funding for the gene discovery came from public funds.