Research In Epidemiology And Biostatistics
Epidemiology and Biostatistics
Introduction
Research is important for the advancement of many things especially health and science. The experiments that researchers conduct must be reviewed and the group that does the review is known as the Institutional Review Board or IRB. The IRB committee is not involved directly with the research but they assess the research studies to make sure that ethical standards are upheld. Research that involves human participants should be fair and they should be aware of what is going to take place in the study (HHS.gov, 2019). Involvement in research studies is to be done without coercion or trickery. Informed consent needs to be given and ethical principles observed. Institutions such as universities use institutional review boards to prevent wrong actions from happening.
The IRB
The Institutional Review Board’s responsibility is making sure that the regulations and policies of federal, local, state and institutions are being followed. For any research that has human participants to be approved, the Institutional Review Board has to be satisfied that the intended participants are suitable, the participants are not under duress, the risks of the study are minimal, the way the study is made up is solid, benefits of the study are extensive and the benefits outweigh the risks to the participants (HHS.gov, 2019). The IRB also makes sure if the participants are being paid that it is done in fairness and without duress, privacy and confidentiality is kept, informed consent was done ethically and legally and that the researchers are suitable and qualified, have the credentials and the proper place to do the study (Georgia Fouka1, Marianna Mantzorou2. (2011). The Institutional Review Board is made up of about five people who are members that are from different backgrounds. One of the members must be a scientist, one of them should be non-scientific and one should not be associated with the institution. There are atrocious examples of unethical issues in the past that affected men, women, and children. There were the Nazi “medical” experiments which were conducted in concentration camps and from those war crimes came the Nuremberg Code that gave standards of how research that involves human beings should be handled. Even after the Nuremberg Code, here in the U.S. unethical studies were carried out. The Tuskegee Syphilis study that was conducted used illiterate black sharecroppers who had syphilis, but the men did not get treatment for the disease. The Willowbrook State School experiments where children were infected with Hepatitis on purpose (NIH.gov, 2009). Mentally disabled children at The Fernald State School were fed cereal that was laced with radioactive tracers without any consent of the parents to do so. A study was done at Jewish Chronic Disease Hospital on elderly patients, they were unknowingly injected with living cancer cells (Margaret R. Moon, MD, MPH, and Felix Khin-Maung-Gyi, PharmD, MBA, 2009). These studies brought light to the necessity for ethical guidelines, policies and review boards. Institutional review boards help to prevent unethical studies like those mentioned above from occurring. The Institutional Review Board protects the rights, welfare, and safety of the participants. The committee reviews and approves research to make sure that the participants are not exposed to anything unethical or harm.
Principles
The IRB makes its determination by using the principles of respect, beneficence, justice, and non-maleficence. In respect for persons, participants should not be treated as a means to an end for the sake of others. The participants have the right to volunteer or withdraw from any study, unbiased selection for participation, privacy, compensation, and feedback. The welfare and interests of any participant should be protected. Participants that are impaired and cannot make decisions for themselves and need protection because they can easily be misled or manipulated. Informed consent is needed for participation in a study. An ethical research study makes for better decisions to be made in the design of the study and how the people involved are treated. Respecting their privacy, religious and ethnic background, keeping their confidentiality safe and secure ensures that the study is ethical. To respect someone is to value their dignity. All people have the right to be treated with dignity and as individuals (Georgia Fouka1, Marianna Mantzorou2, 2011). In healthcare, having respect plays an important role in the interactions between healthcare professionals, patients, and their families. In 1951, a poor black woman by the name of Henrietta Lacks died from ovarian cancer and her cells were collected and used in research without any inform consent from her or her family. Henrietta and her family autonomy were not given the respect that they deserve (Beskow, L.M., 2016). From the staff at the front desk to the volunteers, they all make a difference in the way that they interact with the patients. Being respectful is showing consideration of the patients feeling and it is a reflection of the service provided in that setting.
Beneficence is doing good to the individual. The study should maximize the benefits and minimize any risks like in drug study the purpose is to find out if the drug is safe and beneficial but in the study, participants will be subjected to risks. Participants have to be made aware of the possible effects, risks, and benefits of any treatments they will be exposed to. Conduct research that in the end benefits society (Mandal, J., Acharya, S., & Parija, S. C.,2011). Any good research design involves an experienced competent experimenter and making sure there is a good balance of benefits and risks, sometimes the experiment may have to be canceled to keep the participant or society safe. In every situation, healthcare professionals have to do what is beneficial for the patient, whatever the treatment or procedure is, it must be done for the benefit of the patient.
Justice is to treat participants in a way that follows what is morally right and give them what is due. The research needs to be fair across the board and all involved should be treated equally. Suitable participants should not be exempt from a study because of their ethnic background or gender. If there is a treatment that studied to be used in the adult population then it must be studied on women and men, not just one gender. If participants are harmed in any way during the research they must be paid (Mandal, J., Acharya, S., & Parija, S. C., 2011). Who reaps the benefits of the research and who bears the burden? Justice in healthcare says that there should be fairness in every decision that is made. If twenty people have the same disease then all twenty people should be given the same available treatment.
In research, there will be risks, and harm can happen in various ways and be unpredictable. Harm can be physical, financial, and social. Non-maleficence is to not intentionally inflict harm onto someone (Mandal, J., Acharya, S., & Parija, S. C. 2011). If a patient is found unconscious on the restroom floor by the nurse aide, it is their responsibility to give or get medical attention for the patient. Not providing a medication that is known to have life-threatening side effects is an example of non-maleficence. Doctors are supposed to provide effective care and not intentionally inflict harm.
Before any funding, the Institutional Review Board will review the project and its procedures. Any surveys, questionnaires and other materials will be given to the IRB by the experimenter. After the materials are reviewed and the IRB is satisfied that the participants are protected and the risks are minimal, they will give their approval. If the project needs some changes to be made the IRB will request that the experimenter does so (HHS.gov, 2019).
Conclusion
Health and scientific advancements are made possible because of the research and studies. The Institutional Review Board makes sure that the research that is done, is done ethically. Human participant protection standards of any institution are set by the Institutional Review Board and those standards need to be upheld by the institutes and researchers. In the history of research, there have been many unethical studies and institutional review boards were created because of what took place many years ago. Having ethics plays an important part in research because in doing so, boundaries are set, ethics makes the difference in whether the research is legal or illegal. In research, those who participate in the studies should be treated with respect and the ethical guidelines should be followed. When the participants are treated with respect it builds trust among those who participate, the researchers and the community. Principles such as respect for persons, beneficence, justice, and nonmaleficence assist the researchers in developing and conducting unbiased research studies and trials. Ethics is something people learn in their home, church, or other setting but each person has their interpretation of those ethics. Ethics can be a bit confusing for some because one thing could seem ethical to do but to do so would be illegal, for example, a mother that steals food or money to provide meals for her children so that they will not starve. In my opinion, if it was not for committees and advocates like the Institutional Review Board history would surely repeat itself and participants would be exposed to all sorts of inhumane and unethical situations in the name of health research.
References
- Beskow L. M. (2016). Lessons from HeLa Cells: The Ethics and Policy of Biospecimens. Annual review of genomics and human genetics, 17, 395–417. DOI:10.1146/annurev-Genom-083115-022536 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5072843/
- Georgia Fouka1, Marianna Mantzorou2. (2011). What are the major issues in conducting research? Is there a conflict between research ethics and the nature of nursing? Retrieved from http://www.hsj.gr/medicine/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.pdf
- HHS.gov. (2019). The Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
- Margaret R. Moon, MD, MPH, and Felix Khin-Maung-Gyi, PharmD, MBA. (April 2009). The History and Role of Institutional Review Boards. Retrieved from https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2018-06/pfor1-0904_0.pdf
- Mandal, J., Acharya, S., & Parija, S. C. (2011). Ethics in human research. Tropical Parasitology, 1(1), 2–3. DOI:10.4103/2229-5070.72105. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3593469/
- NIH.gov (2009). Willowbrook Hepatitis Experiment. Retrieved from https://science.education.nih.gov/supplements/webversions/bioethics/guide/pdf/Master_5-4.pdf
