Though enveloped by challenges, informed consent is an important tool in clinical trials, which facilitates the entry of new therapeutic interventions into the market. No research activity involving human subjects can be conducted and proceed unless informed consent is completely sought. The responsibility of conducting trial ethically and genuinely lies in the hands of those involved in it. Everyone must understand their obligations and should not misuse their power for own benefit.
Rights, safety and well-being of trial subjects should always prevail over the interest of science and society, so that a layman never feels being deceived off in name of a social cause.
The issue of informed consent in India is a challenge on the part of investigator as a lot of complexities arise. Further, regulations are based on the western guidelines, which do not necessarily reflect the requirements of India. The guidelines on informed consent in India should be based on complex factors such as culture, level of education, demographics and risks involved during the study. Source of Support: Nil. Conflict of Interest: Nil. National Center for Biotechnology Information , U.
J Adv Pharm Technol Res. Lokesh P. Nijhawan , Manthan D. Janodia , 1 B. Muddukrishna , 2 K. Bhat , 2 K. Bairy , 3 N. Udupa , 1 and Prashant B. Musmade 2. Manthan D. Prashant B. Author information Copyright and License information Disclaimer. Address for correspondence: Dr. E-mail: moc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3. This article has been cited by other articles in PMC.
Abstract Informed consent is an ethical and legal requirement for research involving human participants. Keywords: Human subjects, informed consent, institutional review board.
Open in a separate window. Table 3 Informed consent and obligations. Table 2 Classification of informed consent. Figure 1. Religious Influence The informed consent process is designed to give every participant the liberty to decide whether to accept or refuse the recommended medical treatment. False Expectations Even when there are no language barriers or religious impediments to hinder the communication relationship between researcher and participant, misunderstanding can still occur due to participants false expectations of the experiment outcome.
Patient Perceptions Most patients believe that, trials will put extra burden on them. 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.
For instance, researchers may not use low-income populations for human research and then only utilize these findings to benefit a different population. Researchers 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:. This may be especially true if the healthcare practitioners have been trained in Western countries. It is questionable whether researchers from developed countries are well prepared for the enormous responsibility that this attitude of respect and trust places upon them.
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.
As 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. The individual must know that participating is entirely voluntary. Although 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.
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.
While the process of going through such community gatekeepers does not take away from the importance of the individual's understanding of and willingness to participate in the research, it adds an element of security in traditional societies where communal consciousness and living is the norm.
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.
In some settings, sensitivity to local cultural context requires that investigators provide opportunities for individuals to seek advice or permission from a third person, such as a spouse or head of household. Researchers also may need to consult with local community leaders before implementing a study.
Do not be afraid to ask about questions about the trial and make sure you voice your concerns before enrolling for a study. Here at Avail Clinical Research we strive to live up to the highest industry standards for operating clinical trials. If you are interested in participating in a clinical trial, check out are enrolling clinical trials here. You could qualify for one of our upcoming clinical trials!
As a participant in one of our studies, you are not expected to pay for any medication or medical care that you receive. You are also eligible to enroll in a clinical trial if you do not have health insurance. Some studies may also offer monetary compensation for the participants who complete the study. If you would like to enroll in one of our studies, please take a look at our patient resource center , or call us at Careers Contact Us Privacy Policy.
Skip to content. What is the Informed Consent Process? It must contain the anticipated duration of the subjects participation. A detailed account of any procedures or experimental procedures the participant must complete over the course of the trial. It must explain any potential risks involved with the trial.
Any discomforts the participant may experience must be disclosed, such as injections. Expected benefits from research and information on alternative options that could also benefit the participant.
It needs to explain clearly if any medical treatments or compensation are provided in the event of injury. Word General outline to create and post a flyer seeking participation in a human subjects study. Includes instructions. Word Two sample letters for site approval cooperation between U-M and other institutions, organizations, etc. Letters of cooperation must be on U-M letterhead and signed by an appropriate official. For use by U-M Dearborn faculty, staff, and students conducting exempt human subjects research using subject pools.
Phone: Fax: irbhsbs umich. Skip to main content. If the human subjects are part of a vulnerable population e. If the human subjects are children , in most cases you must first obtain the permission of parents in addition to the consent of the children.
Contact the IRB Office for more information. Informed Consent Process Informed consent is the process of telling potential research particpants about the key elements of a research study and what their participation will involve.
Projects which collect biospecimens for genetic analysis must obtain documented signed informed consent.
0コメント