This document discusses the ethics involved in phase 1 drug trials. It notes that phase 1 trials test new drugs on healthy volunteers to observe pharmacokinetics and biological effects, after preclinical testing on cells and animals. Key ethical principles for clinical trials include doing no harm, informed consent, and fair subject selection. Phase 1 trials raise specific ethical issues around potential dangers of objectification of participants, coercion, and unqualified investigators. While monetary compensation could be attractive, fully informed consent addressing risks and benefits is needed. Participants should also be protected by insurance in case of adverse events. Overall ethical acceptability would depend on the risk-benefit ratio and adherence to oversight board requirements.

1. Obumneke_Amadi- Onuoha, Dr.PH, MPH,MSHS, MS.Pharmacol(c)
The ethics involved in phase 1 drug trials.
I understand that prior to phase 1 trial in humans using healthy volunteers to observe the
Pharmacokinetics and biologic effects of the developed drug, the preclinical phase of the drug
development have been conducted to evaluate the drug to be tested through in-vitro test followed
by live animal testing and is approved for new drug investigation by the Food Drug
Administration. In clinical research, there are set principles and rules that guides the conduct of
any clinical trial which involves human subject e.g. do no harm to protect participant volunteers,
included, are the ethics of good clinical practice established to preserve the integrity of the
science e.g. scientific validity, social & clinical value, favorable risk ratio, informed consent, fair
subject selection and others (NIH Clinical Center, 2020). These set of ethical issues are
paramount surrounding the start of phase I drug trails to certify the adherence to the Institutional
Research Board(IRB) overseeing the protocol of the Trail study.
Moreover, I believe that a study volunteer approved to informed consent prior to the study
initiation, but, in Phase 1 drug trails these ethical issues should to be taken into
consideration,1)danger of objectification -not to treat participants as objects, 2) the danger of
direct or indirect coercion-that may include exploitation of vulnerable people, 3) the problem of
Investigators not professionally & personally qualified and responsible to uptake accountability
of the study outcomes(Fakruddin, Chowdhury, Hossain, & Mannan, pp.17-18, 2012).
Phase 1 drug trails : agree or disagree are ethically questionable and why
Phase 1 drug trails are ethically questionable because, A) it is the first stage of human to new
drug components and effect test observation, B) the concerns about the safeness of the risk
attached to the uncertainty surrounding the impact of the developed drug that may result once
administered to the experimental participants by the investigators and c) the potential remedy to
the patient volunteer in case of adverse effects. Moreover, there may be uncertainty whether the
investigators followed precautions towards the planning, implementation and follow up plans of
the study, and that the trail is in accordance with the Board of Research Ethics committee
requirements for all investigators research study.

2. As a healthy adult, would you participate in a phase 1 trial if the compensation for
participation were $3000 for 10 days of inpatient stay?
Though the monetary value is attractive, I would place great emphasis on the risk-favorable ratio
of participating in the trail to ensure the benefit outweighs the risk showing that am not been
exploited for the purpose to gain participants to enroll into the drug trail by the
investigators. Also, I will emphasis on clear and valid study disclosure to the participants
showing that the clinical trial meets approved IRB requirements, including a confirmed
obligation of insurance cost-sharing in the case of the drug adverse events of research
subjects. Having this in thoughts, as a healthy adult I would participate in phase 1 trial of above
stated criteria.
Reference
Fakruddin, M., Chowdhury, A., Hossain, M. N., & Mannan, K. S. B. (2012). Ethics in clinical
research. Bangladesh Journal of Bioethics, 3(3), 16-20.
NIH Clinical Center(2020). Patient Recruitment: Ethics in Clinical Research- Ethical
Guidelines. Retrievevd from https://www.cc.nih.gov/recruit/ethics.html