Protecting Research Participants

By:  Heinrich Reagan Ochanda

Prior to the formulation of the Nuremberg code in 1949, there were revelations of atrocities performed on research participants, notable examples include the Tuskegee syphilis study where participants were forced to participate in the project by virtue of their condition (Pozgar, G. D., Santucci, N. M. & Pinnella, J. W. 2015).  The Nuremburg code documented the necessity for informed consent and voluntary participation in research.   The Helsinki Declaration by the World Medical Association stipulated good clinical practices; among them include the need to use human subjects only after carrying out laboratory and animal experimentation (Mandal, J., Acharya, S. & Parija, S. C. 2011). In addition, health research should be carried by scientifically qualified individuals, the risks should be more than the benefits and research protocols should be reviewed by independent committee before initiation of the research process.   The Nurenburg code and the Helsinki declaration explain the ethical principles for using human subjects in research.

It is important to protect human participants in the research because the success of the research depends on the trust and mutual respect between the participant and the researcher. In healthcare research, specifically psychological research, not all aspects of   human experience and behaviour can be experimented or observed (Oates, J., Kwiatkowski, R. & Coulthard L. M. 2010). Therefore, without mutual understanding, the findings of the research may be invalid.

In addition,  social and health related research involving human participants cover a wide range of topics  some of  them are sensitive and high-level  risk  while others cross national, professional and institutional boundaries. As such, the autonomy and dignity of individuals should be respected; in this case, people’s rights including self-determination, personal liberty and privacy must be respected (Oates, J., Kwiatkowski, R. & Coulthard,  L. M. 2010).  Based on this understanding it is important to protect human participants in research to reduce the psychological and physical suffering that they would otherwise experience.

Potential Risk of Participating in a Research

Human participants in research face unquantifiable risks; these risks are categorized as psychological, physical, socio-economic and legal. Psychological risk include,   short-term suffering arising from distress due to recalling of traumatic events.  Sometimes, the distress   maybe prolonged leading to reaction of fears and unhappy rumination; notable examples are remembering incidents of rape, torture or embarrassing moments.   In psychological research some participants may falsely identify themselves as having a disturbance, disorder or feel inferior. For instance, when a participant responds to a loneliness scale may conclude the he is lonely when in reality he is not.  In a research involving use of chemicals, physical risk include; suffering from allergies or environmental sensitivities,  burns and cuts; in extreme case, it may lead to death.   Socio-economic and legal risk arise from invasion of privacy by revealing information about family, income and use of illegal substance.

Vulnerability of Human Participants

Human participants are vulnerable due to their condition; for instance, children, the disabled, the old and the economically downtrodden   are more vulnerable human participants in research. Economically disadvantaged individuals can be coerced with incentives to participate in research without understanding its benefits. A case in point is the Tuskegee syphilis research participants who were selected on the basis of their race and low economic condition.  In Germany, Jews in concentration camps were used in medical research without their consent because of their race and for being prisoners.

Relationship between Law, Ethics and Morality

Law includes the duties stipulated by government that are necessary for  maintaining peace, resolving disputes, distributing resources  and maintaining social order. It is an enactment of the state that is backed by some form of coercion.  In philosophy, ethics is the study of values and justification of good or right actions. In health and social research, applied ethics uses ethical principles such as beneficence, respect for autonomy, justice and non maleficence in actual situations such as clinical or professional life. Morality is the widely shared, deeply held and relatively stable values held by a community. Morality and law are related because laws are based on existing moral principles; therefore laws are formulated to perfect the moral standards of a community.  Laws control and regulate the external conduct of a person while morals regulate the internal conduct of individuals (Horner, J. 2003)

Ethics Processes in the UK and How they Protect People

In United Kingdom, social care and healthcare research require approval from Ministry of Defense Research Ethics Committee- MoDREC.  The ethics review is prepared and submitted using integrated research application system- IRAS. The research ethics committee- REC reviews the application in full meetings. Certain research projects that meet certain criterion  that do not raise  material ethical issues  are not subjected to full meeting reviews.   Upon approval, the researcher can continue with the research involving human subjects.  RECs protect participants by safeguarding their rights, dignity, safety and well-being independent of the research sponsors.

The writer is an environmental consultant working in East African countries. He shares his views on pertinent issues around the world.

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