Classmate Response (2): Topic 8 DQ 2 -Application and interpretation of research data in Public health-
QUESTION-Discuss an ethical challenge you might face as a researcher when collecting and analyzing data from human subjects. What is an IRB and why is it necessary?
Classmate (Chayah’s) response-There are multiple potential ethical challenges that may be faced as a researcher working with human subjects. Some general examples could include dignity, bodily integrity, autonomy, and privacy factors. Our country has checks and balances in place to provide safety, informed consent, and confidentiality (Kapp, 2006). The lack of informed consent is a huge potential pitfall of ethical standards with any study with humans. Historically there have been many instances of harm coming to persons because they did not know at all or fully understand what they were signing up to do. Examples such as the Tuskegee study or Puerto Rico birth control trials unfortunately shows the harm that can come to people when they are not informed in order to actually give consent. There is much room for harm to do be done potentially and safety protocols need to be in place. Current regulations are that participants consents must be documented, they must be informed of risks and benefits or participation, alternatives to participate, that they have the right to stop being involved in the study at any time, knowledge of the purpose, and what is the expected nature of inventions (Kapp, 2006). Ethics can become more complicated in this area when dealing with persons that have potential to be taken advantage of such as prison inmates, children, or the developmentally delayed. Other people such as pregnant women may inherently be at more at risk in any study. The researchers and oversight need to carefully evaluate that such persons are indeed giving informed consent without coercion or misinformation. Any study that the Common Rule (rule of ethics) or FDA regulation apply to must be reviewed by an IRB or institutional review board that is recognized as one by the federal office of Human Research Protections (Kapp, 2006). A study then can have continued IRB oversight or minimally an annual report (Kapp, 2006). The primary purpose of an IRB is to examine, prior to and as needed, that participants in a human study are protected and their rights are being respected (U.S. Food and Drug Administration, 2019). The research body has a duty to take steps to meet these premises and the board ensures that this is happening. There is a group process to examine the protocols in place for a study that works to ensure that it follows current regulations. An IRB has authority to grant approval, provide feedback concerning needed modifications, or to reject a research plan (U.S. Food and Drug Administration, 2019).
References
Kapp M. B. (2006). Ethical and legal issues in research involving human subjects: do you want a piece of me? Journal of clinical pathology, 59(4), 335–339. https://doi.org/10.1136/jcp.2005.030957
U.S. Food and Drug Administration. (2019). Institutional Review Boards Frequently Asked Questions. Guidance for Institutional Review Boards and Clinical Investigators. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
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Solution
QUESTION-Discuss an ethical challenge you might face as a researcher when collecting and analyzing data from human subjects. What is an IRB and why is it necessary?
A common ethical challenge when dealing with human subjects in research includes informed consent, autonomy, confidentiality, etc. Informed consent refers to the process where the participant is given all the relevant information about the trial, which is important in making an informed decision. After studying all the provided information, the participant willingly and voluntarily confirms his/her willingness to participate in the study. Informed consent is founded on the legal and moral premise of patient autonomy, that the patient has the right and the responsibility to make decisions that concern their health and medical conditions (Reiss, 2019). It is based on four principles, including the capacity to make decisions; this includes the ability to understand the options and the consequences of each provided decision, including the cost and benefits associated with each. Disclosure requires that the researcher provides all the relevant information concerning the trial/research. Documentation of the consent and competency; which indicates that an individual has the ability to make a decision and be held responsible. Failure to ensure that informed consent is observed can have serious consequences on the participants, for example, the Puerto Rico birth control trials, which resulted in the deaths of 3 participants while others experienced extreme side effects, including blood clots (Reiss, 2019).
The Institution Regulation Board (IRB) was formed to ensure informed consent and is charged with protecting human research subjects’ rights and welfare. The board comprises at least five members from different backgrounds to ensure a comprehensive review of human research. It has the authority to approve, monitor, disapprove or request modifications to the research activities as required by the federal laws and institution policy (U. S Food and Drug Administration, 2019).
References
Reiss, A. J. (2019). Conditions and consequences of consent in human subject research. In Regulation of Scientific Inquiry (pp. 161-184). Routledge. https://www.taylorfrancis.com/chapters/edit/10.4324/9780429304279-15/conditions-consequences-consent-human-subject-research-albert-reiss
- S Food and Drug Administration, (2019) Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions