W3 Exploring Informed Consent

Post#2 by Rolando Gonzalez Arias - Exploring Informed Consent

The purpose of Informed Consent is to notify the probable subject about the facts about the research or clinical trial they will be undergoing. The subject should also be informed about the possible risks and benefits before agreeing to participate in the research or clinical trial (Nnebue, 2010). Because of the importance of informed consent, this part is an ethical and legal requirement needed before research (Nijhawan et al., 2013).

An informed consent form should include the disclosure of information of the probable candidate, the competency and appropriateness of the probable candidate relative to the target audience of the study, and the voluntary nature of the subject’s decision (Shah et al., 2020). Nine basic elements should be included in an informed consent form. These are: (a) Research statement; (b) Risks and Discomfort; (c) Benefits; (d) Alternatives; (e) Confidentiality; (f) Compensation; (g) Contact Details; heart Voluntary Participation; (i) The right to withdraw (University of Hospitals, 2000).

When appropriate, the following additional information may be included in the Informed Consent form depending on the nature of the research or the clinical trial. Additional information includes: (a) Unknown risks to participants; (b) Termination of Participation; (c) Costs involved; (d) Consequences of Withdrawal; and (e) New findings to be given to subjects.

An actual example of an Informed Consent form from the Psychology Department of Wagner College talks about the objective and importance of having an Informed Consent as part of their research’s legal and ethical requirements. The Informed Consent also explicitly educates the subject on the activities they need to perform within the study or clinical trial, including the estimated time duration required of the subject. It also offers the opportunity for the subject to withdraw from the study if need be. The researcher’s contact details are provided, together with the commitment to share the study results with the subjects. A reminder that the subject’s participation is completely voluntary is reiterated at the end of the form. Lastly, there is an area where the subject can sign at the end of the form to signify their willingness to participate in the study (Wagner College, n.d.). For a sample of the Informed Consent form of the Psychology Department of Wagner College, refer to this link.

References:

Nijhawan, Lokesh & Janodia, Manthan & Krishna, Muddu & Bhat, Kishore & Bairy, Laxminarayana & Udupa, Nayanabhirama & Musmade, Prashant. (2013). Informed Consent: Issues and Challenges. Journal of Advanced Pharmaceutical Technology & Research. 4. 134-140. 10.4103/2231-4040.116779.

Nnebue, Chinomnso. (2010). Informed Consent In Research.

Shah, P., Thornton, I., Turrin, D., & Hipskind, J. (2020, August 22). Informed Consent. Https://Www.Ncbi.Nlm.Nih.Gov/Books/NBK430827/. https://www.ncbi.nlm.nih.gov/books/NBK430827/

University of Hospitals IRB Policy. (2000). Nine Basic Elements of Informed Consent Form. Https://Www.Uhhospitals.Org/. https://www.uhhospitals.org/-/media/Files/For-Clinicians/Research/informed-consent-elements-basic-and-additional.pdf

Wagner College. (n.d.). Sample Informed Consent Form (HERB). Https://Wagner.Edu/Psychology/Informedconsent/. Retrieved May 17, 2021, from https://wagner.edu/psychology/informedconsent/