Informed Consent and Human Subject Activity

Introduction

When carrying out research especially the one involving human subjects, codes of ethics must be adhered to strictly because without ethical standards and guidelines, obligations and concerns will be raised. When rules and regulations are not followed then harm is caused in the lives of the human subjects. Clearly stipulated ethical standards and guidelines are put in place so as to avoid causing of harm to the human subjects involved.

Harmful practices carried out in Tuskegee Syphilis Study

In Tuskegee Syphilis Study, the human subjects that were told that they are treated for “bad blood” on the contrary were just examined, given meals and the burial insurance. They were not fully informed about the kind of the research they are participating, the purpose and how they are participating.

The projected time of the study was six months which was not correct because it took over 40 years and the study did not end well. This means that the projected time, indicated during the approval and issue of certificate was not correct and they did not apply for extension; this is contrary with the regulations with IRB and Nation Institutes of Health.

The human subjects involved in the study were told that they were to be treated but they were not treated and when the Penicillin was used in the treatment of Syphilis, the subjects were not given it. This posed the human subjects with more risks which led to death due to the lack of treatment despite early diagnosis during the onset of the study. Thus, the human subjects’ risks and benefits were not clearly explained as it is required by the IRB guidelines.

The human subjects in a research should be allowed to make a voluntary consent to take part on the research and the choice to quit should be given whenever the human subject feels like. However, in this case, the human subjects were neither informed nor given the choice to quit no matter the effect they felt. This is also wrong and not required by the standards and guidelines given.

Ethical standards of practice today and what they safeguard

Ethical standards must be maintained to uphold integrity and avoid causing harm to human subjects and enable research to be conducted safely and successful. Some research conducted may not require some of them but they must comply with the standards and the guidelines given by IRB. They include the following: privacy and confidentiality, informed consent, risk and benefits among others.

Informed consent is an ethical requirement which ensures that the potential human subjects understand well what is required of them in relation to the nature of the study, the purpose, expected duration and the description of the procedures to be carried during the research. The potential human subjects must be informed of the possible risks and any discomfort that may be experienced during and after the study and the benefits they get from this research.

Privacy and confidentiality of the information obtained from the subjects should be maintained during and after the research to ensure that the human subjects are safeguarded from any vices and outcome if they are exposed. The human subject’s reputation, financial state, health status and any information that may trigger their credibility must be safeguarded during and after the research and the consent must be obtained in case the information will be used in a manner that the subject will be known.

Human subjects should be given the incentives for participating and not used as a way of enticing them to participate. They should be informed of the awards, certificates and may be cash. In case with students, award will present their participation and their achievements during their study. The ethical issue here is to appreciate their consent to participate and not to bribe or entice them to participate in a research that has different outcomes.

Evaluation of human subject consideration in Tuskegee case

In Tuskegee case, most of ethical requirements were ignored posing harm to the subjects during the study. The researcher in this case could have addressed the issue of consent from the subjects by clearly informing them about the procedures that will be undertaken and explain everything to them in a language that they will understand. Secondly, the researchers were to make clear to the subjects information about the risks and effects that may occur and way to treat them. At the same time, benefits may be obtained through participating like treatment, medicine provision and support from their families. The subjects’ information was to be treated with privacy and confidentiality in order their reputation was to be maintained and integrity upheld.

Ethical research practices help in preventing of causing harm to the subjects by the researcher not following the standards and ethical regulations that are in place. National Institutes of Health is responsible in issuing certificate of confidentiality which ensures that the researchers have satisfactory complied everything in accordance with regulations and guidelines as indicated in the IRB. The informed consent document must be provided, timeframe clearly indicated and possible risks indicated with incentives given indicated.

Conclusion

The research team should well understand the regulations and ethical standards required for research especially one involving living human subjects to avoid harm and to uphold integrity of the research and make it a success.

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