|RESEARCH METHODOLOGY AND ETHICS
|Year : 2015 | Volume
| Issue : 2 | Page : 183-185
Informed consent in clinical research
Saurabh R Shrivastava, Prateek Shrivastava, Jegadeesh Ramasamy
Department of Community Medicine, Shri Sathya Sai Medical College and Research Institute, Kancheepuram, Tamil Nadu, India
|Date of Web Publication||16-Mar-2015|
Saurabh R Shrivastava
Department of Community Medicine, Shri Sathya Sai Medical College and Research Institute, Ammapettai Village, 3rd Floor, Thiruporur, Guduvancherry Main Road, Sembakkam Post, Kancheepuram - 603 108, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Worldwide, the goal of clinical research is to develop knowledge that improves human health or augments understanding of human biology. In biomedical research, two pillars have been identified - informed consent and independent review by an Ethics Committee. Informed consent is a consent given by a competent individual, who is willing to participate in a specific study after being informed about the study, and having made the decision without being subjected to force, undue influence or intimidation. The informed consent form consists of multiple elements, which should be incorporated in the form, and the completeness of the same should be assessed by the Ethics Committee. In conclusion, the practice of obtaining informed consent plays a crucial role in clinical research to safeguard the interests of the study subjects.
Keywords: Assent, informed consent, research
|How to cite this article:|
Shrivastava SR, Shrivastava P, Ramasamy J. Informed consent in clinical research. CHRISMED J Health Res 2015;2:183-5
| Introduction to clinical research|| |
Worldwide, the goal of clinical research is to develop knowledge that improves human health or augments understanding of human biology, in accordance to their social and natural environment.  The research work should be done with the intention to not only maintain ethical values and principles, but also ensure the safety and well-being of the study participants. 
| Ethics in clinical research|| |
Ethical guidelines for performing clinical research were formulated for the first time after discovery of unethical practices involved in research experiments conducted by the German medical practitioners during the Second World War. , A set of 10 research principles under the Nuremberg Code, namely absolute necessity of obtaining a voluntary consent from the human subjects before including them in studies; conducting only those studies which are good for the society; developed on the results of animal experiments; avoid physical and mental suffering and injury; refraining from research if there is a reason to believe that death or disabling injury will occur; assess the degree of risk involved in research in comparison to the anticipated benefits; taking appropriate steps to avoid any untoward incidence; performed by scientifically qualified persons; right to withdraw from the study at any stage by participants; and termination of the trial at any stage if the researcher believes there are obvious reasons for human harm, was proposed for the first time. , In fact, in biomedical research, two pillars have been identified - informed consent and independent review by the Ethics Committee. ,
| Informed consent|| |
Informed consent is a consent given by a competent individual, who is willing to participate in a specific study after being informed about the study and after having understood all aspects of the studies, and having made the decision without being subjected to force, undue influence or intimidation. , In other words, it is considered as a communication process between the investigator and the participant, which begin before starting the research and extends throughout the duration of the study.  Informed consent is obtained with the help of a single document comprising of two parts: Patient/participant information sheet (viz. provides only the information), and the informed consent form (viz. used to record consent). 
| Informed consent form|| |
The informed consent form consists of multiple elements that should be incorporated in the form to ensure completeness of the form, namely:
- Trial involves research - mentioning clearly that it research, there is additional protection for vulnerable groups, and in a language that is easy to understand for a lay person
- Voluntary participation/right to withdraw - the informed consent form stresses on the voluntariness of the study participants and assures that they can withdraw at any time during the study
- No coercion/undue influence - the study participants are not enrolled just on the basis of giving any monetary benefits or any other undue favors
- Nature and purpose of study - the exact nature of the study (observational or interventional study) and purpose (anticipated benefits to a specified category or whole human population) should be explained to the study participants
- Description of study procedures and treatment options - the precise methodology of the proposed study and needed investigations should be explained to the study subjects prior to the start of the study in a language they can understand
- Number of participants - mention to the study participant that other than him/her, the study will include another (for instance - 100) participants
- Duration of study - the subject will remain one of the participants for a specified period and that should be informed to the patients well-in advance
- Associated risks and benefits - the risks (viz. state adverse events noted so far, if possible provide frequencies or group them into common, rare etc., mention the number of individuals treated, and always state that unexpected/unreported side-effects could occur) and benefits (do not exaggerate, be circumspect), should be explained to the subjects
- Alternative options - explain the additional options available and allow the subjects to make an informed choice
- Responsibilities of the subjects - the subjects should be informed about the do's and the don'ts during the study duration so that any study-related adverse consequence can be averted
- Clause of withdrawal - the study subjects should be allowed to withdraw from the study at any stage and that there will be no loss of benefits despite withdrawal from the study
- Circumstances under which subjects participation can be terminated - the situations in which subjects participation in the study can be discontinued has to be clearly explained, so that compliance to the study protocol can be ensured right from the beginning
- Management of study-related injuries - the study subjects are informed well-in-advance about what they are supposed to do if they experience a study-related injury, who will pay for such an injury, and can they avail treatment from other hospitals in case of an emergency and will that be paid for by the sponsor
- Compensations for study-related injuries - nature of compensations, and who will decide if payment is warranted and if so, its quantum
- Any compensation for participation - it has to be informed to the study subjects prior to the start of the study regarding any form of compensation available for mere participation in the study
- Clause of confidentiality - it is one of the most important aspect of informed consent form and the researcher should take all the study subjects in confidence that none of the study-related findings or their identities will be revealed to anyone in future
- In special circumstances - studies that involve genetic analysis, or testing of HIV status, the researchers should ensure that compliance with all the national standard procedures/guidelines is done
- Whom to contact in case of study-related queries - the contact details of the principal investigator and chairperson of the Ethics Committee are provided to each of the study participants to clear their doubts or to bring to their notice any of their concerns during the study; and
- Storage of records and biological samples - the duration of storage of study-related records/biological samples is also informed to the subjects and a choice is being offered to participants regarding refusal for storage, subsequent use of sample, etc. ,,,,
| Role of ethics committee|| |
It is the responsibility of the Ethics Committee to ensure that the language of the form is easy to understand (viz. simple and nontechnical-layman friendly language); consists of all essential elements; emphasizes on voluntariness; and offer additional protection for vulnerable groups (viz. persons who may not be able to make free and informed decisions about their participation in research or medical care like children, prisoners, pregnant women and fetuses, cognitively impaired, illiterate subjects, etc.), so that the welfare and safety of the research participants can be ensured. ,
| Informed consent process|| |
The informed consent document has to be brief in content highlighting that it is given voluntarily after understanding the consequences (viz. risks and benefits) of the research, freedom to withdraw without loss of routine care benefits, and confidentiality of the recorded responses.  Informed consent is obtained to ensure that the research is conducted without compromising autonomy of individuals, and at the same time to encourage the documentation of the provided information. ,
It is generally recorded by means of a written, signed/thumb impression (illiterate) and dated informed consent form.  In studies where signed/thumb impression cannot be obtained, a verbal consent should be obtained after ensuring its complete documentation by an unrelated witness. In special circumstances, consent can be obtained through audio-visual methods provided permission from Ethics Committee is obtained in advance.  In-fact, since 2013 the government of India has made it mandatory for the audio-video recording of the informed consent process of clinical trials. 
The informed consent is given by either the study participant or by the participant's legally acceptable representative (viz. if subject unable to give consent - children <7 years, dementia etc). In case, the study subject is a child (7 years or more), two consents should be obtained-one from the parents/legally acceptable representative and one from the child (assent). , However, subjects should be informed to the extent compatible with their understanding and consent sought and documented. , In addition, a copy of the participant/patient information sheet should be given to the participant for their record. 
| Waiver of informed consent|| |
Although, obtaining a voluntary informed consent is essential for every research proposal, it can be waived provided, research involves not more than minimal risk; when the participant and the researcher do not come into contact; and in emergency situations (viz. research on sensitive areas such as HIV/AIDS, or research on publicly available reports, etc.), when no surrogate consent possible provided protection is in place for both privacy and confidentiality and there is no violation of the rights of participants. ,,
| Conclusion|| |
In conclusion, the practice of obtaining informed consent plays a crucial role in clinical research and thus it is the responsibility of both the investigators and members of the Ethics Committee to ensure that all essential elements are incorporated in the informed consent form to eventually safeguard the interests of the study subjects.
| References|| |
Council for International Organizations of Medical Sciences (CIOMS), World Health Organization. International Ethical Guidelines for Biomedical Research Involving Human Subjects; 2002. Available from: http://www.cioms.ch/publications/layout_guide2002.pdf
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