Voluntary Participation Show
Voluntary participation refers to a human research subject's exercise of free will in deciding whether to participate in a research activity. International law, national law, and the codes of conduct of scientific communities protect this right. In deciding whether participation is voluntary, special attention must be paid to the likely participants' socioeconomic circumstances in determining which steps must be put in place to protect the exercise of free will. The level of effort involved in clarifying voluntariness is not fixed and depends on several circumstances, such as the respondents' abilities to resist pressures like financial inducements, authority figures, or other forms of persuasion. Special care, therefore, must be taken to eliminate undue pressure (real and perceived) when research subjects have a diminished capacity to refuse. Basic ...locked icon Sign in to access this contentSign in Get a 30 day FREE TRIAL
sign up today! Code of EthicsEthical code has evolved over time, and changes are often spurred by media attention following an unethical experiment. Ethical codes for research now include specifications that may seem elementary, but were not always incorporated into studies. The Nuremberg Code, for instance, states that participation in research and experiments must be voluntary. This specification came after Nazi physicians routinely performed involuntary experiments in which the subjects were forced into participation. The inhumane nature of these experiments necessitated the inclusion of autonomy and voluntary participation into contemporary ethics codes.(1) Today, the Belmont Report is arguably the paramount code of ethics, used by the regulating agencies of many U.S. organizations.(2) The report highlights three main guidelines for human research: respect for persons, beneficence, and justice. The first emphasizes the need for human research subjects to be considered autonomous; those without sufficient autonomy (such as children) must be given certain protections and considerations. The second component, beneficence, refers to the need for the benefits of the study to outweigh any harm sustained by the participants. Although benefits and risks are not explicitly defined by the Belmont Report, the task of ensuring that the risks and benefits are appropriately balanced is left to the presiding ethics review board or the IRB (Institutional Review Board) to determine whether the research is justifiable. It is the researcher’s responsibility to describe, in detail, all associated risks and benefits of the research to avoid miscommunication between the review board and the investigator.(3) Last, the justice component of the report refers to considerations of vulnerable populations, and the benefits and findings of the research must be distributed equally. For instance, researchers may not use low-income populations for human research and then only utilize these findings to benefit a different population.(4) The Researcher in the CommunityResearchers occupy a position of respect and trust in the community. The Nuffield Council on Bioethics emphasizes this position in their report on research ethics in developing countries:
It is important for researchers to understand how to conduct their research in a manner that honors this trust, both for the sake of their research participants and for the sake of their study’s validity. Even the most well-intentioned and well-trained researchers can make mistakes in this area, so it is essential to think carefully about how to ensure that participants have given informed consent to participate in a research study. Informed ConsentAs described in the Belmont Report, informed consent allows for the confirmation of autonomy among all research participants. Informed consent, usually in the form of a document signed by the subject, relays all pertinent and relevant research information, such as risks and benefits, to the potential subject, allowing him or her to make an informed decision regarding participation.(6) Subsequently, the participant is given the opportunity to withdraw from the research or experiment at any time and for any (or no) reason.(7) This process is a basic legal and ethical standard by which all research must abide. According to Family Health International, “Informed consent is not merely a legal requirement or a document to be signed; it is a communication process between the researcher and the participant that starts before the research is initiated and continues throughout the study. It is essential that the information provided is understood by the potential participant and empowers that person to make a voluntary decision about whether or not to participate in the study”.(8) Researchers must take on the responsibility of making sure that the participants in their study are provided with, and fully understand, all of the following before consenting to take part:
The individual must know that participating is entirely voluntary.(9) Potential Difficulties with Informed ConsentAlthough these guidelines seem like common sense, there are several potential issues to informed consent that researchers must be especially concerned about when doing work in developing countries.
For a more exhaustive list of challenges and solutions to informed consent in developing countries, please click here to open the Nuffield Council on Bioethics report and refer to chapter 2, “Consent,” which begins on page 9. Oral Cultures and Informed Consent
Whether or not a community is largely literate, a cultural emphasis on oral contracts and the importance of the spoken word may be the norm. In these cases, researchers must be cognizant of the cultural differences between what they are used to and what the community deems appropriate. It is always the responsibility of the researcher to adapt his or her methodologies to fit the cultural context in which the study is taking place. Oftentimes, this means a fundamental reconsideration of what qualifies as “genuine consent” given the cultural context. Community Consent and Individual Consent
Cultural differences make up a large part of the potential difficulties to genuine informed consent, and researchers must be cognizant of the community structure in which they are conducting their research. Although it may be time and labor intensive to secure multiple levels of consent from both the community and the
individual participants, it is important for researchers to address these levels appropriately.
Informed Consent: Final ThoughtsInformed consent is required protection for the participant. Simply having a participant sign a form does not mean that they have given genuine consent. The burden of responsibility is always on the researcher to make sure that his or her participants are fully informed and therefore may freely choose to participate in the study. Potential participants must also be given adequate time to ask questions of the researcher, receive clear answers, and reflect on this information before choosing to participate. Case Study: Low birth weights in Madhya Pradesh, India(16)While traditional methods of obtaining consent use a standard written form (tailored to the specific experiment) to record a participant’s signature, in many low-resource settings, investigators are faced with poor literacy levels and various cultural factors that prevent the use of this method. A research study in Madhya Pradesh, India illustrates this particular challenge. In this study, investigators performed qualitative and quantitative research regarding the incidence of low birth weight, and reasons for not weighing a child at birth. The study involved extensive contact with human subjects, and informed consent was obtained. Because of the low literacy rates in the community, informed consent was obtained verbally. However, investigators did not account for educational and cultural contexts that reduced the efficacy of the informed consent. It is possible that the women did not fully understand the research procedures. In this culture, it is appropriate to be polite to those in positions of (perceived) authority, and this may have prompted the women to consent, despite reluctance. Fortunately, as researchers slowly gained a greater understanding of the cultural, they updated their methods of obtaining consent, and focus groups and surveys were conducted according to verbal and non-verbal cues from the participants. Although this is not necessarily a standardized methodology for obtaining consent, it helped to ensure that participation was voluntary. Overall, this case highlights a number of ethical issues that arise in the global health research arena. It is important for participants to understand the research goals and methods, and investigators must be sensitive to the local culture. Privacy and ConfidentialityOne of the conditions on which informed consent rests is that participants’ privacy will be respected. Privacy refers to “persons and to their interest in controlling the access of others to themselves,” and no participant should ever be forced to reveal information to the researcher that the participant does not wish to reveal.(17) Confidentiality is equally important and refers to information about the person that has been revealed to the researcher. Especially in medical research, researchers are in a position of responsibility and dealing with a great deal of very personal information that their participants have agreed to disclose. Safeguarding this information is a key part of the relationship of trust and respect that exists between the researcher and the participant. Depending on the type of study, personal identifiers such as names, birthdates, places of residence etc. may or may not have to be collected. In situations where these data are collected, researchers may take several steps to ensure the confidentiality of their participants’ information, including:
Go To Module 5: Culture, Language Barriers, and Interpreters >>Footnotes(1) Perlman, D. (2004). Ethics in clinical research: A history of human subject protections and practical implementation of ethical standards. SoCRA Source, 37. (3) National Institutes of Health. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. (4) Zucker, D. (2007). The Belmont report. Wiley Encyclopedia of Clinics Trials. (6) U.S. Department of Health and Human Services. (n.d.). Informed consent- FAQs. (7) World Health Organization (n.d.). Informed Consent Form Templates. Geneva, Switzerland: Research Ethics Review Committee. (8)“Research Ethics Training Curriculum: Responsible Conduct of Research: Informed Consent as a Process.” Family Health International. https://www.fhi360.org/. (9)“Research Ethics Training Curriculum: Responsible Conduct of Research: Essential Elements of Informed Consent.” Family Health International. https://www.fhi360.org/. (10) Bhutta, Z. A. “Beyond Informed Consent” Bulletin of the World Health Organization. Vol. 82, No. 10. (October 2004). (11) Nuffield Council on Bioethics. “The Ethics of Research Related to Healthcare in Developing Countries.” London, 2002. (13) Erinosho, O., ed. “Ethics for Public Health Research in Africa” Proceedings of an International Workshop in collaboration with the Special Programme for Research and Training in Tropical Diseases (TDR) of the World Health Organisation, with the support of the Federal Ministry of Health, Abuja, Nigeria, April 21-23, 2008. (14) Bhutta, Z. A. “Beyond Informed Consent” Bulletin of the World Health Organization. Vol. 82, No. 10. Page 774 (October 2004). (15) Marshall, P. A. “Ethical Challenges in Study Design and Informed Consent for Health Research in Resource-Poor Settings” Special Topics in Social, Economic and Behavioral Research No. 5, 2. (16) Marshall, P.A. (2007). Ethical challenges in study design and informed consent for health research in resource-poor settings. Geneva, Switzerland: TDR/World Health Organization. (17) Sieber, J. E. (2001). Privacy and confidentiality: As related to human research in social and behavioral science. Which of the following can satisfy the norm of voluntary participation?The norm of voluntary participation is usually satisfied through this: informing subjects about research procedures and then obtaining their consent to participate.
What scientific norm is threatened by the expectation of voluntary participation?norm of voluntary participation potentially works against certain scientific concerns or goals. the goal of generalizability may be threatened if experimental subjects of survey respondents are only the people who willingly participate.
Which type of research study project is designed to permit observations over an extended period of time?Longitudinal study
So, once again, researchers do not interfere with their subjects. However, in a longitudinal study, researchers conduct several observations of the same subjects over a period of time, sometimes lasting many years.
What are the three major aspects of the overall scientific enterprise?Science as an enterprise has individual, social, and institutional dimensions.
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