Nova Southeastern University Belmont Report Discussion

I HAVE TO REPLY TO THESE 3 POST 15–250 WORDS PER POST.

FIRST POST

Thank you for your thoughts on the opportunities and challenges of the Belmont report. I concur with your sentiments on the report protecting human rights in trials and research (Millum, 2020). It is an integral role in protecting humans involved in biomedical and behavioral research is spot on. It functions to guide the ethical principles that researchers ought to consider as they conduct research or clinical trials. Your analysis of the various Belmont report ethical principles is commendable and spot on. The three principles include respect, beneficence, and justice. I do agree with you that beneficence involves risk minimization while maximizing benefits. On the other hand, justice fairly distributes burdens and benefits to the participants while respect entails researchers seeking informed, consent maintaining autonomy, and ensuring participants fully understand.

References

Millum, J. (2020). International Clinical Research and Justice in the Belmont Report. Perspectives in Biology and Medicine, 63(2), 374-388.

SECOND POST

Protection of patient information is important in Big Data as most patient information is now stored online. I found an interesting article exploring corporate wellness programs, big data and informed consent. According to Ajunwa et al., (2016) patient information in relation to wellness programs are not subject to government regulations because wellness information is not actually considered medical information. Wellness programs are similar to obtaining a gym membership in that they can ask for personal health information for safety reasons but are not regulated by privacy laws. Most wellness programs ask for a wealth of information from participants like medical history, allergies and current medications (Ajunwa et al., 2016). These programs typically only ask for a general consent to join the program and then store large amounts of patient data online where it is not protected or regulated (Ajunwa et al., 2016). Even though this information is not regulated, it is still private patient information and should be protected. Ajunwa et al., (2016) found that many wellness programs actually sell the data they collect to other companies like pharmaceutical companies. A lot of the same information is given to wellness programs as it is given to medical entities and for that reason should be subject to privacy regulations and informed consent laws.

Ajunwa, I., Crawford, K., & Ford, J. S. (2016). Health and big data: An ethical framework for health information collection by corporate wellness programs. Journal of Law, Medicine & Ethics, 44(3), 474-480. https://doi.org/10.1177/1073110516667943

THIRD POST

The Belmont report is composed of three sections. The first section defined research and practice, the section identified three principles of ethics as it pertains to human participants, and the third section combines the three principles as it relates to humans. “The content of the Belmont Report reflects the committee’s fears that research subjects would continue to be deceived, harmed, or otherwise exploited by investigators, a point that has often been overlooked by critics. As one Belmont author explains, the Belmont Report was meant to be “a proclamation that had to ring true in the ears of scientists, policymakers, politicians, ethicists, journalists, and judges” (Friesen, 2017).

As you stated big data is a collection of patient information for the use of research purposes. Big data can be collected from numerous sources but as it relates to patient specific it can be collected from the electronic health records. The biggest risk from big data is the possibility for information to be traced back to patients after it has been de-identified.

Reference

Friesen, P., Kearns, L., Redman, B., & Caplan, A. L. (2017). Rethinking the Belmont Report? American Journal of Bioethics, 17(7), 15–21.