Question

There is a considerable history of how medical research has been conducted in morally inappropriate, even devastatingly inappropriate ways. People have forced into serving as human subjects in research projects, deceived, risks not being disclosed or at least not fully disclosed to get people to volunteer but in the absence of full disclosure of risks, informed consent is not fully informed. But what to do if full disclosure of risks would scare people away from volunteering? The dilemma is that research is vitally important for continued progress in terms of medical technology and break-throughs while at the same time abiding by the strictest of ethical standards in terms of how research is carried out -- can we have it both ways? Does the importance of progress in terms of combating illnesses outweigh the importance of taking ethics seriously in terms of risks to the human subjects which are part of the means of reaching the goal of such progress -- a sure conflict between the utilitarian standard of doing what benefits the greatest number versus the Kantian ideal of respecting people and not simply using them to achieve a desired end. To those ends, do we offer incentives to get people to volunteer as human subjects of research projects; is that putting unfair pressure on the less affluent to agree; do we say let respect for the individual be damed given the importance of eradicating disease; do we put animals into service -- who cares if animals are put at risk so long as we humans derive a benefit in terms of finding treatments and cures for what ails us; do we make use of the findings of research immorally conducted -- why waste possibly important findings even though such was obtained in ethically improper ways or would doing so encourage further improperly conducted research to be undertaken again? Discuss these important issues raised by considerations of the ethics of medical research.

Answer 1

In discussing ethical issues relating to conduct of medical research we have given primary consideration to the protection of human study participants. Two other ethical issues also desreve mention: the treatment of animals in reserach and research misconduct.

Ethical considerations are clearly different for animals and humans. For example, the concept of informed consent is not relevant for animals. The United States, Public Health Service has issued a policy statement on the human care and use of animals which was amended in 2002

The guidelines articulates 9 principles for the proper care and treatment of animals used in research.

These principles cover issues concerning the following areas

• the transport of research animals,
• alternatives to using animals,
• pain and distress in using animals
• researcher qualifications
• Use of appropriate anaesthesia
• Euthanising animals under certain conditions during or after the study

A study conducted by Holtzclaw and Hanneman (2002) found out certain additional considerations while using animals for the study. Their recommendations include

• A compelling reason for using animals should not be simply based on convenience or novelty
• The study procedures should be well-planned,well-funded and humane
• Studies related to animals are not necessarily less costly and require serious ethical and scientific consideration to justify their use

Research Misconduct

According to U.S.Public Health Service regulation research misconduct is defined as , is fabrication, falsification,or plagiarism in proposing, conducting,or reviewing research or in reporting research.

Fabrication: involves making up data or study results and reporting them

Falsification: involves manipulating research materials,equipment or process;it includes changing or vomiting data or distorting results such that results are not accurately reported

Plagiarism: involves the appropriation of someone's ideas,results or words without giving due credit including information obtained through confidential review of research articles

Other issues covered by research misconduct include

• Improprieties of authorship
• Poor data management
• conflicts of interest
• Inappropriate financial arrangements
• Failure to comply with government regulations
• Unauthorized use of confidentila information