Ethics in Series
Informed consent and research Jharna Mandal, Subhash Chandra Parija Department of Microbiology, JIPMER, Puducherry, India
ABSTRACT
KEY WORDS Autonomy, informed consent, research
Informed consent is the central doctrine to any research based on the principles of autonomy and self‑determination. For it to be genuine and effective, it should be in simple regional language catering to the cultural and psychological and social requisites of the participant. The information entailed in the consent form must be true, should cover all the relevant aspects, and no fact should be hidden however seemingly important or unimportant. Every research volunteer puts his or her health and life at risk for the sake of science, and this must be respected at all times during the research.
undergoing a medical intervention. Every research volunteer puts his or her health and life at risk for the sake of science. This must be respected at all times during the research.[1,2]
INTRODUCTION “We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own treasures, with its own sources of anguish, and with some measure of triumph.”
The principle of consent is closely related to the principle of autonomy, self‑determination and the affirmation of human rights and respect for human dignity and this is well addressed and an integral part of the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. [2,3] The concepts of autonomy and self‑determination imply the freedom and the responsibility of the individual to take decisions. Since this acceptance of responsibility underlies the fact that the person involved accepts the consequences of the details entailed in the research, it is imperative that the person understands all the facts and risks involved in the process. It is important that the research/healthcare personnel explain the benefits and the risks involved in the research process. The researcher, therefore, needs to establish a channel for the dialogue with the participants who will ensure that they feel secure at all times and can make decisions freely knowing that their confidentiality will be maintained.[3]
‑Elie Wiesel Informed consent is the bond of trust which is the foundation and the central stone to any research involving human subjects. It is the central doctrine and is probably the most important part of any research. It constitutes one of the fundamental principles of research that researchers must comply with. The purpose of informed consent is intended to protect the subject’s well‑being throughout the trial/research by ensuring that a person understands the nature, purpose and risks involved in giving a biological sample or Address for correspondence Prof. Subhash Chandra Parija, Dean- Research, Senior Professor, Department of Microbiology, JIPMER, Puducherry, India. E‑mail: [email protected] Access this article online Quick Response Code:
Website:
To ensure that the participant understands the contents of the informed consent and is willing to make free decisions, the researcher needs to ensure that the informed consent form be in the regional language catering to the cultural and psychological and social requisites of the participant. The information must be true, should cover all the relevant
www.tropicalparasitology.org DOI: 10.4103/2229-5070.138533
Jul 2014 | Volume 4 | Issue 2 |
78
Tropical Parasitology
Mandal and Parija: Informed consent and research
aspects, and no fact should be hidden however seemingly important or unimportant. If the participant is underage, then the parents or the legal guardians need to provide their assent on their ward’s behalf and provision for the same should also be made. Informed assent can be obtained in addition to informed consent in the case of children who can understand the nature of the research work and are willing to enter into the agreement knowingly, but this is only a supplemental measure and should not be allowed to replace the original informed consent obtained from the parents/guardians.[3‑5]
the consent is applicable to any changes in the protocol/research project made later. This process should be made a continuous process which should be available to the participants as and when they wish to access e.g. can be made as an online electronic update which can be viewed by the participant even through a mobile phone • During the project, the researcher should make an interim contact so that the participant is aware about the progress of the project work • In case of illiterate participants, presence of a third witness and recording of the consent being taken need to be included instead of a “thumb impression” • In case of research work where genetic testing is included, instead of using the traditional informed consents it should be renewed and re‑consulted time and again considering the loopholes in the former system to maintain population DNA databases.
Consent must be acquired by a health professional, and the participant must be provided with sufficient time to make their decision, and calm environment in which to reflect on the information they receive. The consent procedure must always contain a written report of the intervention in question and what will be involved in participating. Stress should be laid on the comprehension of the participant about contents of the informed consent. If a person is illiterate, it is advisable to collect witnessed informed consent in the presence of a third party or a representative from the community.[1,3,4]
REFERENCES 1. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. New delhi, India: ICMR; 2006. 2. Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol 2011;1:2‑3. 3. Council for International Organization of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 2002. 4. Kulkarni NG, Dalal JJ, Kulkarni TN. Audio‑video recording of informed consent process: Boon or bane. Perspect Clin Res 2014;5:6‑10. 5. Hoeyer K. ‘Science is really needed – That’s all I know’: Informed consent and the non‑verbal practices of collecting blood for genetic research in northern Sweden. New Genet Soc 2003;22:229‑44. 6. Bhutta ZA. Beyond informed consent. Bull World Health Organ 2004;82:771‑7.
Exemptions of informed consent There are many conditions wherein informed consent is not mandatory, but the final decision for this exemption should be taken by the Institute Research Body based on the existing national guidelines.[1] Further needs [1,6] • Auditing of all ongoing research by a central investigating team independent of the institute/organization should be made mandatory in all research projects involving human subjects to ensure the safety of the volunteers. In such audits, the principal investigator and the study co‑ordinator should be interviewed independently • Since the consent is taken only once in the beginning, researchers tend to breach this by assuming that
How to cite this article: Mandal J, Parija SC. Informed consent and research. Trop Parasitol 2014;4:78-9. Source of Support: Nil. Conflict of Interest: None declared. DOA: 11‑07‑2014, DOP: ***
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Jul 2014 | Volume 4 | Issue 2 |
Copyright of Tropical Parasitology is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Informed consent and research Jharna Mandal, Subhash Chandra Parija Department of Microbiology, JIPMER, Puducherry, India
ABSTRACT
KEY WORDS Autonomy, informed consent, research
Informed consent is the central doctrine to any research based on the principles of autonomy and self‑determination. For it to be genuine and effective, it should be in simple regional language catering to the cultural and psychological and social requisites of the participant. The information entailed in the consent form must be true, should cover all the relevant aspects, and no fact should be hidden however seemingly important or unimportant. Every research volunteer puts his or her health and life at risk for the sake of science, and this must be respected at all times during the research.
undergoing a medical intervention. Every research volunteer puts his or her health and life at risk for the sake of science. This must be respected at all times during the research.[1,2]
INTRODUCTION “We must not see any person as an abstraction. Instead, we must see in every person a universe with its own secrets, with its own treasures, with its own sources of anguish, and with some measure of triumph.”
The principle of consent is closely related to the principle of autonomy, self‑determination and the affirmation of human rights and respect for human dignity and this is well addressed and an integral part of the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. [2,3] The concepts of autonomy and self‑determination imply the freedom and the responsibility of the individual to take decisions. Since this acceptance of responsibility underlies the fact that the person involved accepts the consequences of the details entailed in the research, it is imperative that the person understands all the facts and risks involved in the process. It is important that the research/healthcare personnel explain the benefits and the risks involved in the research process. The researcher, therefore, needs to establish a channel for the dialogue with the participants who will ensure that they feel secure at all times and can make decisions freely knowing that their confidentiality will be maintained.[3]
‑Elie Wiesel Informed consent is the bond of trust which is the foundation and the central stone to any research involving human subjects. It is the central doctrine and is probably the most important part of any research. It constitutes one of the fundamental principles of research that researchers must comply with. The purpose of informed consent is intended to protect the subject’s well‑being throughout the trial/research by ensuring that a person understands the nature, purpose and risks involved in giving a biological sample or Address for correspondence Prof. Subhash Chandra Parija, Dean- Research, Senior Professor, Department of Microbiology, JIPMER, Puducherry, India. E‑mail: [email protected] Access this article online Quick Response Code:
Website:
To ensure that the participant understands the contents of the informed consent and is willing to make free decisions, the researcher needs to ensure that the informed consent form be in the regional language catering to the cultural and psychological and social requisites of the participant. The information must be true, should cover all the relevant
www.tropicalparasitology.org DOI: 10.4103/2229-5070.138533
Jul 2014 | Volume 4 | Issue 2 |
78
Tropical Parasitology
Mandal and Parija: Informed consent and research
aspects, and no fact should be hidden however seemingly important or unimportant. If the participant is underage, then the parents or the legal guardians need to provide their assent on their ward’s behalf and provision for the same should also be made. Informed assent can be obtained in addition to informed consent in the case of children who can understand the nature of the research work and are willing to enter into the agreement knowingly, but this is only a supplemental measure and should not be allowed to replace the original informed consent obtained from the parents/guardians.[3‑5]
the consent is applicable to any changes in the protocol/research project made later. This process should be made a continuous process which should be available to the participants as and when they wish to access e.g. can be made as an online electronic update which can be viewed by the participant even through a mobile phone • During the project, the researcher should make an interim contact so that the participant is aware about the progress of the project work • In case of illiterate participants, presence of a third witness and recording of the consent being taken need to be included instead of a “thumb impression” • In case of research work where genetic testing is included, instead of using the traditional informed consents it should be renewed and re‑consulted time and again considering the loopholes in the former system to maintain population DNA databases.
Consent must be acquired by a health professional, and the participant must be provided with sufficient time to make their decision, and calm environment in which to reflect on the information they receive. The consent procedure must always contain a written report of the intervention in question and what will be involved in participating. Stress should be laid on the comprehension of the participant about contents of the informed consent. If a person is illiterate, it is advisable to collect witnessed informed consent in the presence of a third party or a representative from the community.[1,3,4]
REFERENCES 1. Indian Council of Medical Research. Ethical Guidelines for Biomedical Research on Human Participants. New delhi, India: ICMR; 2006. 2. Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol 2011;1:2‑3. 3. Council for International Organization of Medical Sciences. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: CIOMS; 2002. 4. Kulkarni NG, Dalal JJ, Kulkarni TN. Audio‑video recording of informed consent process: Boon or bane. Perspect Clin Res 2014;5:6‑10. 5. Hoeyer K. ‘Science is really needed – That’s all I know’: Informed consent and the non‑verbal practices of collecting blood for genetic research in northern Sweden. New Genet Soc 2003;22:229‑44. 6. Bhutta ZA. Beyond informed consent. Bull World Health Organ 2004;82:771‑7.
Exemptions of informed consent There are many conditions wherein informed consent is not mandatory, but the final decision for this exemption should be taken by the Institute Research Body based on the existing national guidelines.[1] Further needs [1,6] • Auditing of all ongoing research by a central investigating team independent of the institute/organization should be made mandatory in all research projects involving human subjects to ensure the safety of the volunteers. In such audits, the principal investigator and the study co‑ordinator should be interviewed independently • Since the consent is taken only once in the beginning, researchers tend to breach this by assuming that
How to cite this article: Mandal J, Parija SC. Informed consent and research. Trop Parasitol 2014;4:78-9. Source of Support: Nil. Conflict of Interest: None declared. DOA: 11‑07‑2014, DOP: ***
Announcement
iPhone App A free application to browse and search the journal’s content is now available for iPhone/iPad. The application provides “Table of Contents” of the latest issues, which are stored on the device for future offline browsing. Internet connection is required to access the back issues and search facility. The application is Compatible with iPhone, iPod touch, and iPad and Requires iOS 3.1 or later. The application can be downloaded from http://itunes.apple.com/us/app/medknow-journals/ id458064375?ls=1&mt=8. For suggestions and comments do write back to us. Tropical Parasitology
79
Jul 2014 | Volume 4 | Issue 2 |
Copyright of Tropical Parasitology is the property of Medknow Publications & Media Pvt. Ltd. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
