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Saturday, April 19, 2014

Medical Research on Humans: Scandal and Protectionism


Research Ethics: ?born in scandal and reared in protectionism?
In 1988 Carol Levine, in an article which asked whether AIDS has changed the ethics of human subjects research, said the following about ethics in human research: “born in scandal and reared in protectionism” (Levine 1988:167). In this essay I will critically analyse this statement and support its veracity by showing how human research abuses continued even while codes and declarations on human research were being developed. I will argue that there has been a paternalistic protectionism on the part of scientists and researchers to protect or defend their perceived right to conduct research on human subjects and that this protectionism has to an extent been validated by Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) by nature of the make up of their membership. I will argue for greater representation of participant communities in RECs and IRBs
Table of Contents
  1. Introduction
  2. Current and past debates regarding human research
2.1.  Hippocrates
2.2.  19th Century
2.3.  20th Century and vulnerable populations
2.3.1       Second World War and German abuses.
2.3.2.     United States abuses
2.3.3.     Japanese abuses
2.3.4.     Attitude of Superiority in experimenters towards their human subjects
2.3.5.     South Africa
      3. Codes, Declarations and Guidelines
3.1. Defining codes
3.2. Beaumont’s Code
3.3. 20th Century Codes
3.3.1. The Nuremberg Code
3.3.1.1. Criticisms of the Nuremberg Code
                        3.3.2. The World Medical Association and the Helsinki Declaration
                        3.3.3. WHO/CIOMS Guidelines
      4. Research Ethics Committees
      5. Key Ethical theories
             5.1. Respect for persons
             5.2. Beneficence
             5.3. Justice
       6. Conclusion
       7. Bibliography
       8. Declaration



1. Introduction

In 1988 Carol Levine, in an article which asked whether AIDS has changed the ethics of human subjects research, said the following about ethics in human research: “born in scandal and reared in protectionism” (Levine 1988:167). In this essay I will critically analyse this statement and support its veracity by showing how human research abuses continued even while codes and declarations on human research were being developed. I will argue that there has been a paternalistic protectionism on the part of scientists and researchers to protect or defend their perceived right to conduct research on human subjects and that this protectionism has to an extent been validated by Research Ethics Committees (RECs) and Institutional Review Boards (IRBs) by nature of the make up of their membership. I will argue for greater representation of participant communities in RECs and IRBs. (From this point on I will use the term REC and IRB interchangeably, favouring REC as it is the term used in South Africa). By examining current and past debates with regard to human experimentation and its history, particularly in the 20th century, I will show how various codes, declarations and guidelines have come into being and I will examine various key ethical theories which ought to guide human research ethics.

I will come to a conclusion that indeed ethics in human research was “born in scandal and reared in protectionism” and that it is now a growing child that continues to be threatened by scandal and that the protectionism now required is one that needs more than ever to be directed towards the research participants.

2. Current and past Debates regarding Human Research

A perusal of the literature on human research and experimentation could lead one to believe that Nazi Germany was the first or worst culprit in this area and that once the German atrocities were dealt with, everything could return to normal. Many writers on the subject begin with an account of the research/experimentation carried out on inmates of the concentration camps during World War II (Lott: 2005; Schuklenk: 2005; Pedroni & Pimple: 2001).

Now there is no doubt that the research conducted in the concentration camps was unethical and inhumane, but it was neither the first nor the last unethical and inhumane research carried out on humans.

         2.1. Hippocrates
Experimentation in medicine seems to be as old as medicine itself. McNeill (1993:17 -36) begins his account of unethical experimentation with Hippocrates who, while removing splinters of bone from the exposed cortex of a boy is said to have gently scratched the surface of the cortex with his fingernail and observed the corresponding movements on the opposite side of the boy's body. His most recent examples occurred just before the publication of his book and include an example in New Zealand from the 1980s where treatment was withheld from women with carcinoma in situ as part of an experiment. He also includes as an example of unethical research the mother of the first “test tube” baby, who had not been told that she was the subject of an experiment. He concludes from his survey of human experimentation that it is the socially powerless and disadvantaged who are most likely to be subjected to unethical research and suggests that this has always been the case. McNeill refers to Scutt (1988:1-11) who has argued that it is lower class women who have been experimented on for the development of new reproductive technologies and new contraceptive measures because they were less likely to complain if something went wrong. Yet women at this socio-economic level, having been subjected to the risks, were unlikely to benefit from new and expensive reproductive technologies.

         2.2. 19th Century
Some 19th century scandals include purposefully infecting healthy subjects with syphilis, gonococcus and typhoid fever in Dublin. In the same century, in the United States, physicians put slaves into pit ovens to study heatstroke, poured scalding water over them as an experimental cure for typhoid fever, and there are records of amputating fingers of slaves, some with anaesthesia and some without in order to test the effectiveness of anaesthesia (McNeill 1993:19).

McNeill concludes that there was considerable abuse of the subjects of experiments in the 19th and early 20th centuries and that “research ethics was not a subject of widespread concern” (1993:19).
 
2.3. 20th Century and vulnerable populations
Research ethics has since certainly become a subject of “widespread concern.” Writing in 2005, Lott (2005:31) writes about human research participants that are already disadvantaged or vulnerable to harm independent of their participation in clinical trials. Included in this group are the mentally disabled, abjectly impoverished persons, prisoners, refugees and ethnic minorities. He suggests that these vulnerable populations are “particularly attractive for clinical research precisely because of their vulnerability.” Dhai (2005:73) states that South Africa, being home to a large number of vulnerable groups of poor populations that have limited or no access to health services and education and who accept authority without question, is a country that many researchers are drawn to.

It thus seems that the “scandal” that Carol Levine refers to continues to be a problem even in the 21st-century and particularly for vulnerable populations. Lott (2005:32) states that “it is no surprise then that the majority of sensationalised research ethics cases in the past 60 years have involved vulnerable persons - indeed the entire field of research ethics has, in an important way, been built upon and refined according to examples of “extreme” clinical research that have dotted modern history.”

2.3.1 Second World War and German abuses
Certainly one of the largest “dots” in modern history was the Second World War which represented a turning point in experimentation on human subjects. “War, it seems, justifies all sorts of inhumane treatment of human beings” (McNeill, 1993:20). McNeill highlights some research atrocities committed by the United States, Germany and Japan.

2.3.2. United States abuses
In the US there was debate around the fact that soldiers were being drafted into the army to risk their lives and by extension it was accepted that the institutionalised, retarded, incarcerated and mentally ill should contribute to the war effort and accept some of the risks involved in research designed to alleviate the diseases of soldiers, whether or not they were capable of consent. Because of the greater good that was served, the research without consent was justified. And so it was, for example, that research subjects drawn from mental asylums and state penitentiaries were infected with malaria and given experimental antidotes to test therapeutic effectiveness, relapse rate and side effects. The effect of the association between the war and medical research was to undermine any concern for the welfare of research subjects. After the war, research practices established during the war “profoundly influenced researchers’ behaviour in the post-war era” (1993:21) and the public's perception of science in service of society was successfully employed to argue for increased funding and to perpetuate an ethic that “subordinated subject’s interests to those of science on the implicit assumption that this was also in the interest of society” (1993:21).

Still in the US, the Tuskegee syphilis study, which started in 1932 and ended in 1972, and which Lott (2005:34) refers to as the most well-known example of unethical experimentation after the Nazi concentration camp experiments, is an example of the “scandal” within which research ethics was being born. This study spans the period during which the earliest ethical codes (see next section) were being debated, developed and applied, but only came to an end following the publication of a front-page New York Times article describing the study and its effects.

2.3.3. Japanese Abuses
German atrocities and the debates around them are well-known. Less well-known are the atrocities committed by the Japanese. Between 1930 and 1945, Japan conducted trials of biological warfare through the use of various diseases including anthrax, cholera, typhoid and typhus. The principle testing site, Unit 731, was on mainland China where there were installations for germ warfare, a prison for the human experimental subjects and a crematorium for the human victims. There was also an airfield and special planes for dropping germ bombs. At least 11 Chinese cities were subjected to biological warfare attacks. McNeill records that “documents obtained by freedom of information applications revealed that the United States agreed to give the Japanese experimenters immunity from prosecution in exchange for information about biological warfare. One of the American government documents acknowledged that ‘because of scruples attached to human experimentation’ it was not possible to conduct such experiments in the US. It went on to express the hope that the individuals involved would be ‘spared embarrassment’. It was a delicate show of concern considering that they had used humans as guinea pigs in lethal experiments and executed any who survived. Far from being embarrassed many of them have become influential and respected figures in modern Japan” (1993:24). It would seem that the command of the American occupation forces in Japan decided that the value of gaining access to the results of the Japanese experimentation was greater than the value of prosecuting the experimenters. The US therefore offered immunity from prosecution in exchange for the results of the research and did this, according to McNeill “on the grounds of national security.”

When one bears in mind that this was going on at the same time that the Americans were conducting the Nuremberg trials which resulted in Germans being hanged for being criminally culpable and in breach of a universal standard of ethics, one gets a further example of Carol Levine's “scandal” in which modern research ethics was birthed.

McNeill goes on to highlight unethical experiments carried out in countries like the US, Britain and Australia. The last one he mentions involves the US Food and Drug Administration and Department of Defence approving the use of investigational drugs and vaccines on American troops without their consent in late 1990.

2.3.4. Attitude of superiority in experimenters towards their human subjects
The common thread in all these examples is the attitude of superiority in the experimenters toward their human subjects. Thieren and Mauron (2007:8) make the following comment regarding the Nazi researchers but I would argue that it applies to all the examples I have mentioned: “rather than being the result of a coercive state, Nazi medicine illustrates how medical researchers and their representative bodies co-operated with and even manipulated a totalitarian state and political system relying on expert opinion in order to gain resources for the conduct of research without any moral and legal regulation. The Nazi doctors followed the intrinsic logic of their scientific disciplines and used the legally and ethically unrestricted access to human beings created by the context of the political system.” I would argue that researchers today are similarly tempted and where they have sought to protect their right to experiment (Levine's “protectionism”), it is more than ever necessary to ensure the protection of the participant.

This is borne out by the final example of ‘scandal’ that I would like to introduce before moving on to discuss the various codes, guidelines and declarations that have been developed at the very same time that these ‘scandals’ have been unfolding.

2.3.5. South Africa
Jason Lott (2005:34) discusses an HIV-related clinical trial carried out in South Africa which came under intense criticism in the New England Journal of Medicine. Without discussing the details of the study, I wish to draw on Lott's comments which tie in with much of what I have discussed above. He points out that the study could never have been conducted in developed world countries and that the study was rightly accused of being “exploitative, capitalising on the poor of the developing world who had no alternative treatment to prevent HIV transmission” (2005:35).

The scandal and protectionism continues. A quote attributed to Carl Leopold, although in a different context, could be used to describe the situation in human research before the development of specific codes regarding human research. Simon and Hersh (2002:43) quote Leopold as describing a particular situation as one of “science saturation and ethics starvation.” I turn now to the various efforts that have been made to inject ethical codes into the ‘ethics starved’ science of human research.

3. Codes, Declarations and Guidelines
3.1. Defining Codes
Simon and Hersh (2002:41-44) define ethical codes as instruments which formalise the structures that guide practice, especially within a profession. They point out that codes are subject to multiple interpretation. There may, for example, be a generally accepted social meaning; a specialised official meaning; a distinct meaning within a given working environment; and also unique individual shadings of meaning. The meaning of a code is always context dependent. The observance of given ethical norms may reflect a consensus. However when ethical norms and codes are not disseminated, they are not internalised and may end up serving only a symbolic function. They therefore stress (2002:44) that ethical direction must also come from outside the profession as well as from its leadership. Together, informal and formal sources can create an ethically-conscious environment, “as valuable as any formal code of ethics.”

In the discussion which follows it will become evident how important an “ethically conscious environment” is, and how good codes of conduct in an environment which is not ethically conscious become worthless.

3.2. Beaumont Code
The oldest known American code of ethics is William Beaumont's code of 1833. Ronald Numbers (1979:113-135) points out that he recognised the importance of experimentation on humans but considered that the voluntary consent of the subject was necessary. His code required abandoning the experiment if it caused the subject distress or if the subject became dissatisfied. While Numbers finds much to criticise in Beaumont's code he describes it as an important step in the history of bioethical codes and says: “William Beaumont may not have been a pioneer in the history of bioethics, but neither was he a villain” (1979:135).

3.3. 20th Century codes
The 20th century saw the development of national and international codes of ethics applying to experimentation on human beings. According to McNeill (1993:40) “Germany provided both the nursery for the early development of research and its commercial application. It was the first country to formulate a national code of ethics. Paradoxically, German atrocities during the Second World War in contravention of its own codes, led to the first international statement on the ethics of research: the Nuremberg Code.”

3.3.1. The Nuremberg Code
Udo Schuklenk (2005:11) regards the Nuremberg code as the first and historically most important international research ethical guideline. It was the international community's response to the crimes Nazi scientists committed in German concentration camps. The court drew up the code as a statement of a universal standard of ethics in research against which to measure the behaviour of the accused. According to McNeill (1993:42ff) the court ordered two of its expert witnesses to advise it on universal standards of ethics in experimentation on human subjects. With the endorsement of the American Medical Association, they presented three basic principles of human experimentation: (1) voluntary consent; (2) previous animal experiments to investigate the risks of each experiment; and (3) responsible, medically qualified management.

The court took these three points and expanded them into ten principles of the Nuremberg Code. Emanuel et al (2003:2-3) point out that although it is now recognised as a landmark document, the Nuremberg code did not provoke much of a response at the time it was issued. They put this down to the fact that in the United States the German misdeeds were considered an anomaly attributable to a totalitarian regime of unquestionable brutality. The unspoken assumption was that researchers working in democratic countries would never do such things. “Thus the Nuremberg code was viewed as a document that was needed to restrain barbarians but was not applicable to ‘the rest of us’ ” (2003:3)

It needs to be remembered that the Nuremberg trials and code were taking place at the same time the Japanese researchers were being spared exposure and punishment - another example of Levine's “scandal and protectionism.”

McNeill (1993:43) highlights the fact that the Nuremberg trial itself received little press coverage and that before the 1970s there were few discussions of the Nuremberg code and fewer citations in medical journals. Furthermore it had little judicial application. He too puts this down to a tendency to dismiss the atrocities, revealed in the Nuremberg trials as the work of morally bankrupt or deranged Nazi doctors. He goes on to say “this was a political and defensive reaction that blinded the medical profession and medical bureaucracy to the ethical and humanitarian concerns inherent in medical research. It took revelations of unethical medical research in the United States itself, to shake this complacency” (1993:43).

Writing on the 60th anniversary of the Nuremberg code, Thieren and Mauron (2007:573) suggest that although the Nuremberg code evokes a dark time for medicine, yet it remains a powerful symbol in inspiring the medical profession to stand up for its Hippocratic values and protect individuals from harmful medical experiments. They refer to the fact (which I will still discuss) that the Nuremberg code was the first in a number of ethical codes designed to control human research, but ask an important question, “whether modern ethics and its binding instruments can always secure full protection to experimental subjects and beyond them, to the recipients of health care.” In the context of this essay, they seem to be aware, in 2007 that the “scandal and protectionism” continues.
           
3.3.1.1. Criticisms of the Nuremberg Code
Before moving on to later codes, I would like to point out some criticisms of the Code (summarised from McNeill 1993:42-43). One of the strongest criticisms is that it was an exercise in moral indignation by the victor over the actions of the vanquished and did not take into account that breaches of moral codes were condoned on both sides. This is a valuable criticism, but need not detract from the overall importance of the Code.

Much contention surrounding the code arose because of the emphasis given to the principle of consent. Pedroni and Pimple (2001:2) highlight this in their statement: “the code begins simply, with one statement set apart from all the rest: ‘the voluntary consent of the human subject is absolutely essential’…… clearly the principle of informed consent predominates.” McNeill points out that before consent becomes an issue, the scientific validity of the proposed study, the acceptability of potential risks to subjects and the competence of the investigator to conduct the study, need to be established. None of these are adequately dealt with by the Nuremberg code, but are addressed in later codes and guidelines.

3.3.2. The World Medical Association and the Helsinki Declaration
Goodyear et al (2008: 1067) refer to the Declaration of Helsinki[1] adopted in 1964 as the “cornerstone of research ethics” and that its periodic revision provides an opportunity for debate about its purpose and effectiveness.

McNeill (1993:44) suggests that the Helsinki declaration has been more influential because it is perceived to be a guide to researchers rather than a legal document and because it is less restrictive of research.

The declaration was “birthed” over a long period of time which was put down to the desire to produce a truly useful and practical document. McNeill suggests however that there was disagreement within the Association on the need for a code. “Indeed, resistance to the adoption of guidelines for researchers within an organisation that had previously placed its confidence in the responsibility of the investigator was hardly surprising” (1993:44). This is surely another example of Levine's “protectionism”. Having undergone several amendments, the most recent version was approved in 2008[2]. Some of the important elements of the Declaration of Helsinki include the allowing for proxy consent by others for research on those who are incapable of giving informed consent, and a distinction between therapeutic research and non-therapeutic research (which remains a contentious issue). In 1975 an amendment was introduced that research projects be considered by specially appointed independent committees. Up to this time all research had relied on the conscience of the individual investigator and the consent of the research subject. One senses here a move from the “protectionism” of the profession that I have referred to earlier, to a “protectionism” more aimed at the research subject.

Commenting on the latest revision, Puri et al (2009:131-134) point out that where previous versions of the declaration emphasise the fact that it is the duty of the physician to promote and safeguard the health of patients, the current version clearly specifies that this is also applicable to the “researcher physician.” When a medical professional conducts research, the primary responsibility as a physician must not be in conflict with the scientific curiosity to find research answers, thus the responsibility to safeguard participants health and well-being is significantly enhanced. The latest revision also indicates the need to perform research among populations that otherwise would always enter the “exclusion criteria.” For example, pregnant or lactating women, children and the elderly are often left out as they may be vulnerable. The latest version also requires the protocol to have provisions for treating or compensating participants who are harmed as a consequence of participation in the research study.

3.3.3. WHO/CIOMS guidelines
Other international guidelines have followed the Helsinki Declaration. The World Health Organisation (WHO) and the Council for International Organisations of Medical Sciences (CIOMS) published International Ethical Guidelines for Biomedical Research Involving Human Subjects[3]  in 1993. According to McNeill (1993:48) the issuing of these guidelines was prompted by concern that research might be conducted in developing countries to avoid restrictions and to minimise expense. Other factors, like investigations serving external rather than local interests and no long-term commitment to participants are also dealt with. The guidelines also give a strong endorsement to independent, impartial prospective review of all protocols by a committee of the investigators’ peers that might also include lay people qualified to represent community, cultural and moral values.

4. Research Ethics Committees
The idea of peer review of research protocols is one which I have shown is built into both the Helsinki declaration and the CIOMS guidelines. As a product of the very guidelines that are meant to ensure good research ethics, I want to suggest that they have the potential to be a source of the “scandal and protectionism” which this essay has sought to identify. In 1975 Robert Veatch claimed that there was no rationale for ethics review committees composed of expert and lay members (1975:32). He correctly identifies that RECs are composed of some members who are there because of their expertise and other members who are there as representatives of the community without any special expertise. In his view, this split reflects the lack of any clear rationale “of what these committees are supposed to do, of what purposes they are to serve, and what skills their members ought to have.” He suggests that there is a need for a theory to clarify the ambiguities and for changes to be made to committees to make them consistent with that theory. He believes it is impossible for RECs to fulfil their task successfully without these changes, but he does acknowledge that participants are better protected by committees than by reliance on a researcher’s judgement alone. His solution is to have two committees, one of professional members, and one of community representatives.

Dhai (2005:82), commenting on South African guidelines points out the RECs should (amongst other things) be independent, have a membership of at least nine, with at least two lay people not affiliated to the institution, preferably from the community. I would suggest that 2 out of 9 does not reflect a fair representation of the community, and bearing in mind that the other seven (or most of them) will probably be from the institution, and therefore have a vested interest in it and its research, one can question whether research ethics is entirely free of the risk of scandal and protectionism on the part of scientists and scientific institutions. Commenting on unequal power relations between committee members, McNeill (1993:188) says “the difference between professional and lay members on committees is part of a general difference in the power and status between professionals and non-professionals in society. A power difference on committees of review means in practice that those with a vested interest in research are the most influential in decision-making.”

George Annas  commented on the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research decision to endorse the status quo which placed primary reliance on local IRBs for subject protection as follows: “this was predictable because of the commission's researcher-dominated composition which permitted it to assume that (1) research is good; (2) experimentation is almost never harmful to subjects and (3) researcher dominated IRBs can adequately protect the interests of human subjects. The successor Presidential Commission can learn much by re-examining these premises” (1980:84).

It seems many fear ongoing “scandal and protectionism” in research.

Lawrence Baer (2005:7) fears that when it is made known that funding for research will be made available subject to IRB approval, two things might happen. A committee might believe that a research proposal has overall credibility if an outside agency, especially a government one, has approved the funding. Secondly, he suggests that with the prospect of funds flowing into the institution for research, the committee might be biased in favour of the institution.

All the above indicates how important it is to balance the interests of science with the interests of participants in research. As I have shown, science has given (and often continues to give) the public reason to be wary of it. RECs are the ideal place for trust to be restored and renewed and developed, but I suggest they need to be better balanced between scientists and the community in which science wishes to do its work. This would require better representation of communities on RECs, perhaps by NGOs, perhaps by other means. This means RECs need to take on a more “political” nature. In South Africa this might mean that an organisation like the Treatment Action Campaign and others like it, need to take up positions on RECs. George Annas (1994:21) believes that “bioethics, being applied ethics, has always sought to deal with the real world. As this world is dominated by politics and as the manner in which health care is delivered becomes more and more a function of politics, bioethics will have to learn more about politics to be effective in influencing medical research. The challenge for bioethics is to influence politics and policy without corrupting itself by making it seem that ethical principles and practice are the result of compromise and majority vote rather than reason and virtue.”

Thus the ongoing realisation that research ethics was not only born in scandal and reared in protectionism, but continues to be threatened by scandal and protectionism should lead to the realisation that human research is still on a journey toward maturity. Stephen Toulmin (1981:38) gives some good advice for this journey. Discussing method in ethics he mentions a bad example that is so often followed today, namely that of “assuming that we must withdraw discretion entirely when it is abused and impose rigid rules in its place, instead of enquiring how we could adjust matters so that necessary discretion would continue to be exercised in an equitable and discriminatory manner.” He calls for the recognition of the truth that a morality based entirely on general rules and principles and codes is tyrannical and disproportioned, and that only those who make equitable allowances for subtle individual differences have a proper feeling for the deeper demands of ethics.

Thieren and Mauron (2007:573) ask whether modern ethics and its binding instruments can always secure full protection to experimental subjects and beyond them to the recipients of health care.

I would suggest the answer is a humble: “No.” However, we can believe that with the use of key ethical theories and the ongoing development of our various codes, declarations and guidelines we can move further away from the scandal and protectionism into which research ethics was born and continues to be reared.

5. Key Ethical Theories

Schuklenk (2005:3) claims two fundamental objectives for ethics: “to tell us how we ought to act in a given situation and to provide us with strong reasons for doing so.” Dhai (2005:75) points out that while there are various codes and declarations that guide ethical research, most of them lack a systematic and coherent framework for evaluating research studies that incorporate “all requisite ethical considerations.”

Many commentators on the key ethical theories which should underlie research ethics begin by referring to principle-based ethics, with its emphasis on Autonomy, Beneficence, Non-Maleficence and Justice. Others first look at deontological ethics (with its emphasis on motive) and utilitarian ethics (with its emphasis on maximum utility) and conclude that a utilitarian approach is more useful for problem solving in research ethics. Stephen Toulmin (who served on the National Commission for the Protection of Human Subjects which led to the drawing up of the Belmont report) says that in almost every discussion the commissioners came close to agreement even about quite detailed recommendations. He says (1981:32) “even when the commission's recommendations were not unanimous, commissioners were never in any doubt what it was they were not quite unanimous about. When the eleven individual commissioners asked themselves what principles underlay and supposedly justified their adhesion to consensus, each of them answered in his or her own way: the Catholics appealed to Catholic principles, the humanists to humanist principles, and so on. They could agree; they could agree what they were agreeing about; but, apparently, they could not agree why they agreed about it.”

With this in mind I conclude this essay with some key ethical principles which should permeate, guide, define and nurture human research ethics, which was born in scandal and raised in protectionism.

5.1.Respect for Persons
This includes classical ideas associated with autonomy, but also ethical notions about the need to protect those with diminished autonomy. Autonomy includes the idea that an individual is free to choose and to act. Respect for Persons includes respecting the decisions of individuals and giving them the information needed to be able to make rational decisions. Respect for autonomy translates into the requirement for informed consent based on the provision of all necessary information, ensuring that the information has been understood, honouring objections and insisting that all consent is voluntary.
5.2. Beneficence
Ryan (unknown year from Research Ethics Binder: 524) describes beneficence as an obligation to do no harm and to maximise possible benefits and minimise possible harms. According to McNeill (1993:146) this principle includes the duty to consider the proper design of research, its value and validity, and whether the risks to participants are justified.
5.3.Justice
Powers (1998:147) points out that where in the past emphasis of justice in research was applied almost exclusively to the need for protection of vulnerable populations, it now refers to an increased concern that members of disadvantaged populations (both individually and as a group) have greater access to the potential benefits of medical research and increased opportunities to participate as research subjects.

6. Conclusion

Research ethics was born in scandal and reared in protectionism and these two issues remain threats in modern research. The ongoing development and application of codes and declarations is essential for the development of ethical research. RECs have been a very important step in the regulation of research but more needs to be done to establish a fair balance between all the parties involved in research. Respect for persons, beneficence and justice need to undergird all human research.

7. Bibliography

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Annas, G. J. 1994. Will the Real Bioethics (Commission) Please Stand up? Hastings Centre Report 24(1): 19 to 21. Available:
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Baer, L. J. 2005. Influences on IRB Decisionmaking. IRB: Ethics and Human Research, Vol. 27(3):7. Available:
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Dhai, A. 2005. Implementation of Ethics Review. In: Developing World Bioethics. Vol 5 No.1. Oxford: Blackwell Publishing. [from Research Ethics 7011 Binder]

Emanuel, E.J., Grouch, R.A., Arras, J.D., Moreno, J.D., Grady, C., (Eds). 2003. Ethical and Regulatory Aspects of Clinical Research. Baltimore: Johns Hopkins University Press. [from Research Ethics 7011 Binder]

Goodyear, M.D.E., Eckenwiler, L.A., Ells, C. 2008. Fresh thinking about the Declaration of Helsinki. British Medical Journal Vol 337:1067-8. Available:
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Levine, C. 1988. Has AIDS changed the ethics of human subjects research? Law, Medicine and Health Care. Vol. 16, no.3-4, Fall/Winter: 167 [this reference from McNeill 1993:205]

Lott, J. 2005. Vulnerable/Special Participant Populations. In: Developing World Bioethics. Vol 5 No.1. Oxford: Blackwell Publishing. [from Research Ethics 7011 Binder]

McNeill, P.M. 1993. The Ethics and Politics of Human Experimentation. Cambridge: Cambridge University Press.

Numbers, R.L. 1979. William Beaumont and the Ethics of Human Experimentation. Journal of the History of Biology Vol 12 (1): 113-135. Available:
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Pedroni, J.A., Pimple, K.D. 2001. A Brief Introduction to Informed Consent in Research with Human Subjects. [from Research Ethics 7011 Binder]

Powers, M. 1998. Theories of Justice in the Context of Research. In: Beyond Consent. Kahn, J.P., Mastroianni, A.C., Sugarman, J. (Eds) [from Research Ethics 7011 Binder]

Puri, K.S., Suresh, K.R., Gogtay, N.J., Thatte, U.M. 2009. Declaration of Helsinki, 2008: Implications for stakeholders in research. Ethics Forum. Vol.55 Issue 2:131-134. Available: http://www.jpgmonline.com/article.asp?issn=0022-3859;year=2009;volume=55;issue=2;spage=131;epage=134;aulast=Puri
Accessed 18/05/2010


Ryan, K.J. Unknown Year. Ethical Principles & Guidelines for Research Involving Human Subjects. [from Research Ethics 7011 Binder]

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[1] World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research involving human subjects. Available from: http://www.wma.net/e/policy/b3.htm. Accessed: 18/05/2010 13:43
[2] 7th Revision of the Declaration of Helsinki: Good News for the Transparency of Clinical Trials
Accessed: 18/05/2010 14:03


[3] Council for International Oganizations of Medical Sciences [CIOMS]. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: CIOMS, 1993. Available: http://www.cioms.ch/frame_1993_texts_of_guidelines.htm.

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