Important for Protection of Research Subject

Important for Protection of Research Subject essay assignment

Important for Protection of Research Subject essay assignment

(1) Explain why it is important for the protection of the research subject.

(2) Explain what activities/responsibilities the investigator must do to meet that commitment. Reference appropriate FDA regulations to support your work.

The success of a clinical trial is dependent on the volunteer participation of human subjects and their retention through the entire process of the clinical trial however, human history indicates it was not too long ago when people were subjugated to unethical experiments. According to McMahon, 2022, it is also important to note that between 1932 and 1972, the Tuskegee Syphilis Experiments continued to exploit the use of human subjects with the lack of informed consent forms, unfair subject selection, and more. According to Allen-Kinross, 2021, the first sentence of the Nuremberg Code written in 1947 is that voluntary consent of human subjects is essential, and this marked a new era in the conduct of research.

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Despite the dramatic events of history, the ethical time clock has been slow yet steady. As we fast forward to 2022, ethical compliance in clinical research is mandatory. A lack of ethical compliance following the federal regulations mandating the conduct of clinical research using human subjects can blacklist a clinical investigator based on failure to comply with biomedical ethics. The purpose of ethical compliance is to ensure the safety of human participants volunteering to participate in a clinical trial for the good of research. Ethical governance is for all participants, however, for the vulnerable population, such as women, children, veterans, and the mentally unstable, additional protection is available. For some research participants, clinical trials may be the only way to afford the expensive drug that could prove helpful for their condition and offer a chance to survive or battle the health condition. On the other hand, for those who are at the terminal point of their condition, this may be a way to contribute to the good of humanity. Either way, those who offer themselves to help promote research need to be appreciated, respected, and treated with equality.

According to Berry et al., 1996, establishing and maintaining the informed consent process is a multidisciplinary effort that researchers and investigational clinicians are ethically obligated to abide by while treating participants. The investigator is responsible to ensure that he or she goes through the inclusion and exclusion criteria of the study with each subject participant to confirm that the participant is aware of the impact the investigational product may have on the participant’s health. The investigator needs to discuss the expected adverse events, AE or serious adverse events, SAE, which could result from being part of the trial. Any side effects that could impact the participant’s health need to be disclosed. In addition, if the study is an efficacy and safety study, and it could be double-blind, then the investigator needs to explain that the subjects for the study will be chosen randomly. It is the investigator’s responsibility to discuss the length of the study term, the dietary restrictions or implications expected because of the process, and any medications that could react with the investigational product being administered. The researcher must clarify that participation in the clinical trial is exclusively voluntary and the subject is not obligated to continue until the end of the study if they wished to drop off the study. In cases, regarding control subjects who are healthy and volunteer for the study, the health-related concerns increase since the IP could result to be toxic and therefore it becomes important for the participant to get a chance to evaluate their reasons for participating in a clinical trial.

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When an investigator agrees to provide his or her oversight for a clinical trial, they agree to abide by the requirements of the Food and Drug Administration, FDA’s form 1572, Statement of the Investigator. One of the agreements based on this form is for the investigator to inform any patient or person used as controls in a study that the drugs are being used for the investigational purpose as a requirement of the informed consent process governed by 21 CFR 50 and the institutional review board, IRB, under 21 CFR 56. According to FDA, the federal regulation, 45 CFR 46, also referred to as the Common Rule, is monitored for compliance by the department of health and human services, DHHS, and it protects the participation of humans, particularly vulnerable populations who participate in clinical studies. According to the International Conference for Harmonization under Good Clinical Practices, GCP-ICH, the informed consent process is required to ensure that the research subject, is protected under 21 CFR 50, is aware of all aspects of the trial that is needed to make a comprehensible, voluntary decision to participate in a clinical trial using the investigational product, IP. The agreement is bound between the research organization and the participant using a written format of a signed and dated form with the understanding that participation is voluntary, and the subject can withdraw from the study at any time. According to Pfeiffer and Wells, 2017, informed consent states that individuals should not be included in a study without freely giving their permission in a language that is understandable to them. Pfeiffer and Wells, 2017, further add additional exceptions to the informed consent applied in the use of investigational new drugs in connection with military operations and study in emergency research which would include more than minimal risk to subjects. For example, during the initial phases of COVID19 trials, trials were conducted based on emergency research needs which posed ethical concerns. The IRB, which is regulated under 21 CFR 56, is obligated to ensure ethical compliance is maintained through the conduct of the clinical trial as documented based on the informed consent process. According to Moroney, 2020, the IRB is responsible for approval of the informed consent forms as it reviews the safety documents to determine the risks associated with the trial that could impact the patient health. The purpose of the IRB is to safeguard the welfare of participants in clinical trials.

Based on the regulatory requirements, the investigator site must document the informed consent process, and review it to ensure it is signed and dated based on the voluntary agreement of the participant to be part of the study. In the case of a vulnerable population, additional caution is taken to ensure compliance with HHS regulations. For example, if a child was to participate in a clinical trial, then the legal guardian of the child is responsible for the decision-making criteria to have the informed consent documented. In addition, if a person was not capable of signing their name or signing the informed consent, then in the presence of their legal guardian, the informed consent process is recorded, and the documents associated with the process are filed with the recorded version of the agreement. The investigator must ensure all the required documents for the informed consent process are signed and dated before the participant leaves the site during the documentation process. In addition, the documents need to be submitted to the IRB for review to ensure compliance and completion.

Reference

Allen-Kinross, P., 2021., Why is the Nuremberg code being used to oppose covid19 vaccines?., Full Fact: Health/Coronavirus., 13 May., Cited: Why is the Nuremberg Code being used to oppose Covid-19 vaccines? – Full Fact (Links to an external site.)

Berry, D. L., Dodd, M. J., Hinds, P. S., Ferrell, B. R., 1996., Informed consent: process and clinical issues., Oncology Nursing Forum., April 23; (3): 507-12., Cited: Informed consent: process and clinical issues – PubMed (nih.gov) (Links to an external site.)

McMahon, M., 2022., What was the Tuskegee experiment., United States Now., March 09., Cited: What Was the Tuskegee Experiment? (with pictures) (unitedstatesnow.org) (Links to an external site.)

Moroney, B., 2020., The importance of IRB approval., AMD., January 7.,  Cited: The Importance of IRB Approval | A Major Difference: A Major Difference (Links to an external site.)

Pfeiffer, J. and Wells, C., 2017., A practical guide to managing clinical trials., CRC Press., pp 42-44.

Alisha

Investigator Commitment #3: “I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met.”

This commitment has two significant implications. First, the investigator commits to upholding clinical research ethics and protecting the rights of human subjects in research. Each study participant has the right to autonomy. This Belmont Report (1979) principle requires potential research participants to be given the freedom to make their own informed decisions. Withholding information about the investigational nature of the drug prevents study participants from exercising their right to autonomy. Next, nondisclosure that the drug being used is for investigational purposes also perpetuates the therapeutic misconception. A therapeutic misconception arises when research subjects mistakenly believe that participation in clinical research is similar to or equivalent to receiving medical care. The investigator needs to make this distinction as research participation does not always yield clinical benefit and research subjects require this information to provide informed consent.

To meet the commitment, the investigator must obtain informed consent from the research participant or their legal representative in compliance with federal regulations. The Protection of Human Subjects (1980) outlines several requirements for obtaining informed consent, including explaining any reasonably foreseeable risks and anticipated benefits to the research subject. However, in general, informed consent requires the investigator to give the participant sufficient information to make an informed decision in language understandable to them and absent of any language that releases stakeholders from liability (Protection of Human Subjects, 1980).

References

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html (Links to an external site.)

Protection of Human Subjects, 21 C.F.R. § 50 (1980). https://www.ecfr.gov/current/title-21/chapter-I/su…

Ryan

Commitment

I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64. I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the drug.

1.  Explain why it is important for the protection of the research subject.

The need to report to the sponsor on adverse experiences over the course of a clinical trial are of importance to protecting researcher subjects.  Not only due to the regulations surrounding this commitment, but also due to the nature of adverse events.  These events can be categorized, according to Philips, et al. (2019) as either not having the drug be the cause of a reaction occurring, which are classified as just adverse events, or if the drug can be determined as the likely cause of the adverse event it is referred to as an adverse drug reaction (p. 1).  This commitment ensures that the adverse events are reported to the sponsor and are appropriately logged for the study record and further investigation.  If there is a commitment to understanding the risks and side effects of the study drug, then the individuals overseeing the study will be able to promptly understand and report on these events, ensuring that participants are treated appropriately and withdrawn from the study, if necessary.

2.  Explain what activities/responsibilities the investigator must do to meet that commitment. Reference appropriate FDA regulations to support your work.

The investigator is responsible for the immediate reporting and assessment of any serious adverse events that occur during the clinical trial, according to 21 CFR 312.64 section on safety reports (ecfr.gov, 2022).  The study protocol and the investigator brochure include some serious adverse events, but all serious adverse events are to be reported (ecfr.gov, 2022).  Adverse events that are not serious are to be reported to the sponsor according to the study protocol (ecfr.gov, 2022).  All adverse events, regardless of whether related to the study drug administered, must be reported (ecfr.gov, 2022).  It is the responsibility of the investigator to ensure that adverse events are reported to the sponsor to ensure participant safety.

References

Ecfr.gov. (2022).  Title 21 CFR Section 312.64 Investigator reports.  Accessed April 4, 2022 from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.64 (Links to an external site.)

Philips, R., Hazell, L., Sauzet, O., Cornelius, V. (2019).  Analysis and reporting of adverse events in randomized controlled trials: a review.  BMJ Open, 9:e024537.  DOI: http://dx.doi.org/10.1136/bmjopen-2018-024537