7 thoughts on “Module 1”

1. We really want you to please send us your reflections!

   Reply

2. applying ethical principles that should guide the conduct
   of research involving human subjects as set in the Declaration of Helsinki could be
   effectively applied particularly in developing countries given their socioeconomic
   circumstances, culture, laws, regulations, and administrative arrangements my comments as following:
   1- Interprets Nuremberg Code for research that involves
   patients who are receiving medical care. here in trovan case in Nigeria clinical trials Clinical trials, especially in developing countries,
   should address problems that are relevant to the
   community.
   2- Some risks justified by “potential therapeutic or
   diagnostic value for the patient”. in that case the research is unethical because it is lack of value
   • In case of legal incompetence, informed consent should
   be obtained from the legal guardian. in that case there is no consent, which means the research is invalid, it is been done underpowered.
   • Review of research by an independent review
   committee. in the case of trovan vulnerable group been selected (children), in addition to this choosing groups based solely on easy
   availability.
   points to the conclusion that It is difficult, and some maintain that it is impossible, to be free from bias, but Scientific objectivity should be maintained (or attained as nearly as
   is practical). If you can see any reason for a possibility of bias in any aspect
   of the research, it should be acknowledged and explained.

   Reply

3. I WOULD LIKE TO SHARE WITH RELAVANCE CASES IN ETHICAL CONSIDERATION WHICH REGRAD HONSET AS PERNCIPLES IN ETHICS ISSUE.

   “the most influential liar of the 20th century’ story:”

   Jung developed a theory that humanity shares archetypal images in its collective unconscious, and asserted that this was supported by evidence collected by one of his assistants, J.J. Honegger, in 1909. According to Honegger, a male patient he interviewed, known now as Solar Phallus Man, reported that he saw a vision of the sun with a phallus. This image was similar to those found in the ancient Greek cult of the god Mithras, thus proving, according to Jung, that this archetypal image had persisted throughout the ages. Knoll claims that Jung deliberately falsified the research notes in order to substantiate his claims. Because the mythology of Mithras was being popularized at that time in Germany, Jung changed the dates on the notes to before the publication of popular books on this subject in order to counter any possible assertions that the man had read about the solar phallus and recalled it during the interview. This makes Jung, according to Knoll, ‘the most influential liar of the 20th century’.
   I find out that from Nicolas Willimans work book “your research project: step by step guide for the first time research, 2001:p115”
   my question here.
   How could take consider to sensitive about issues of ethical behaviour?

   Reply

4. The Trovan Case in Nigeria is a forward case of the socioeconomic state of non-developed countries and the nonethical exploitation of some companies under the umbrella of “benefits” and developing new drugs that will benefit human beings, human beings in any country shouldn’t be treated as Guinea pigs at all.

   Reply

5. In the Trovan Case in Nigeria, the following principles were breached:
   1- Equitable Selection of Subjects:
   they chose vulnerable groups, based solely on easy availability or compromised position, also they did not ensure that the benefits and risks of research were distributed fairly among all groups in society.
   2- A favorable Risk-Benefit Ratio was absent.
   3- Informed Consent was lacking, and the trial was conducted on children who are considered individuals who can’t decide by themselves (their parents or legal custodian should sign informed consent)
   4- Independent Review: there was the absence of a functional ethics committee,
   5- Respect for Enrolled Subjects: it does not end with a signed consent document, respecting enrolled subjects includes: giving them the right to permit withdrawal
   at any time of the trial, protecting their privacy, informing them of new risks & benefits of the trial, Informing them of results of clinical research, and Maintaining the welfare of subjects (e.g. treatment of the adverse effect).

   Reply

6. • The Nuremberg Code established the foundation of voluntary participation and informed consent.
   • The Thalidomide tragedy emphasized the need for ethical standards, leading to the Declaration of Helsinki.
   • The Tuskegee study highlighted exploitation and the importance of laws like the National Research Act.
   • The Trovan case in Nigeria revealed challenges in applying ethical principles in developing countries with varying socioeconomic and legal frameworks.

   How can we ensure these ethical guidelines are effectively implemented worldwide?

   Reply

7. 1/ Nazi Trials and the Nuremberg Code: this represent a real initiative in advocating for voluntary participation
   2/ The Tuskegee syphilis: elaborate the importance of protecting human subjects
   3/ Nigeria and CIOMS guidelines: demonstrate the importance of ethical principles in biomedical research.
   All these collectively reflected over human research

   Reply