|Year : 2016 | Volume
| Issue : 3 | Page : 262-263
What is the process of obtaining informed consent in a clinical trial? Is it ever justifiable to include someone in a clinical trial without prior informed consent from the individual?
Akosua Adom Agyeman1, Richard Ofori-Asenso2
1 Superintendent Pharmacist, Septal Chemist, Accra-North, Ghana
2 Public Health Consultant, Health Policy Consult, Weija, Accra, Ghana
|Date of Web Publication||22-Jun-2016|
Akosua Adom Agyeman
Superintendent Pharmacist, Septal Chemist, Accra-North
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Agyeman AA, Ofori-Asenso R. What is the process of obtaining informed consent in a clinical trial? Is it ever justifiable to include someone in a clinical trial without prior informed consent from the individual?. J Pharm Bioall Sci 2016;8:262-3
|How to cite this URL:|
Agyeman AA, Ofori-Asenso R. What is the process of obtaining informed consent in a clinical trial? Is it ever justifiable to include someone in a clinical trial without prior informed consent from the individual?. J Pharm Bioall Sci [serial online] 2016 [cited 2019 Jun 26];8:262-3. Available from: http://www.jpbsonline.org/text.asp?2016/8/3/262/174231
The fundamental requirement for any research involving human subjects is a free and informed consent (IC). The features of such consent are the disclosure of research information to trial subjects by the investigator, the understanding of the given information by the participant, and the capacity of the participant to make informed decisions under free and voluntary conditions. However, some problems may arise with the IC process such as lack of understanding of trial purpose and design by subjects. The proceeding paragraphs discuss the process of obtaining IC by highlighting key features of the IC as well as certain situations which may pose a challenge to obtain the IC from a clinical trial participant.
The IC process begins with prior approval of the written certificates on the financial statements (CFs) by an appropriate European Commission (EC). Subject to this, the investigator presents all the written information [Table 1] on the CF and additional information to subjects and efforts must be made to improve the comprehension of participants. Such efforts include allowing more time for discussion and inviting feedback. Particular attention ought to be given to participants who are vulnerable or lack decision making capacity. Subsequently, the investigator ought to assess the decision making capacity of the participant by employing, for example, a questionnaire. Finally, the subject, the legal representative, or consultee must be allowed to make a free and voluntary decision to participate or withdraw by minimizing possible coercion or undue influence. The IC is formally sealed with the signature of the subject, the legal representative or consultee and the investigator who carried out the process.
|Table 1: Examples of information an investigator must disclose to trial participants during the informed consent discussion|
Click here to view
Regarding ethical issues, it is unjustifiable and unlawful to include any individual in a trial without prior IC. Yet, it is a reality that certain circumstances deny subjects the ability to give personal IC which present ethical dilemma for inclusion in trial. Such circumstances include adults lacking decision making capacity (e.g., dementia, learning disability, and drug overdose), minors, and intensive care and emergency subjects. However, the decision making capacity in such circumstances must not be assumed and efforts must be made to explain the trial features to the level of their capacity. Nonetheless, inclusion may be justifiable in the absence of personal IC when appropriate principles and regulations are followed to serve the best interest of the subject. Surrogates such as a legal representative, consultee, or nominee under the appropriate legislation may endorse the consent form on behalf of the subject. In emergency situations, where subjects are unable to consent and surrogates are not available, subjects may be enrolled in research in accordance to procedures approved by an independent EC.
| Conclusion|| |
The IC process should aim at improving the understanding of the trial subject concerning the research and obtaining a free and voluntary response to participate, not participate, or withdraw at any time during the trial without having to suffer any repercussions. Consent from subject must always be sought prior to enrolment. However, where personal consent is impracticable, subjects may be enrolled under conditions which are justifiable in principles and regulations to protect the best interest of the subject over that of science and society.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Lo B. Ethical Issues in Clinical Research. Philadelphia: Lippincott Williams and Wilkins; 2010.
Berg JW, Lidz CW, Appelbaum PS. Informed Consent: Legal Theory and Clinical Practice. 2nd
ed. New York: Oxford University Press; 2001.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guidelines for Good Clinical Practices E6 (R1); 2015. Available from:
. [Last accessed on 2015 Sep 23].
Flory J, Emmanuel E. Interventions to improve research participants' understanding in informed consent for research: A systematic review. J Am Med Assoc 2004;292:1593-601.
Legislation.gov.uk; 2013. Mental Capacity Act; 2005. Available from:
. [Last accessed on 2015 Sep 23].
University of Leicester (UL) and University of Bristol (UB). Adults Lacking Capacity to Consent to Research; 2010. Available from: https://www.connect.le.ac.uk/alctoolkit. [Last accessed on 2015 Sep 23].