Informed Consent

Introduction

Informed consent is, first and foremost, a continuous process. It involves a person voluntarily agreeing to participate in a research study after being fully informed about it through verbal discussion with study staff, followed by documentation in a written, signed, and dated informed consent form. Consent from participants will be continually sought during the course of the study, and they should be notified of any changes to the study or any other patient information that may influence their decision to remain in the study. Researchers must ensure that the process of obtaining informed consent from study participants not only conforms to federal, state, and local regulations but also respects each individual's right to make a voluntary informed decision.

Purpose

The purpose of informed consent is not only to obtain a participant's signature but also to provide participants with information related to a clinical trial. Informed consent means that the purpose of the clinical trial is explained to the subjects, including their role and how the trial will be conducted.

Elements of Informed Consent

The elements of informed consent are as follows:

Essential elements:

a) Purpose

b) Risks

c) Benefits

d) Confidentiality

e) Compensation

f) Contact information

g) Voluntary participation

Additional elements:

a) Withdrawal criteria

b) Additional costs to subjects

c) Statement that there may be unforeseeable risks

d) Approximate number of subjects in the study

e) Statement that participants will be informed of new findings

Contents of the Investigator's Brochure

The Investigator's Brochure (IB) should contain the following sections, each with literature references where appropriate:

The Informed Consent Document

The informed consent document must contain the following:

Study purpose: It should state that the trial involves research and the purpose of the trial.

Study treatment and randomization: It should explain the trial treatment and the probability of random assignment to each treatment.

Study procedures: It should outline the trial procedures and the participants' responsibilities.

Risks of taking part in the study: It should state the reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant.

Benefits of taking part in the study: It should state the reasonably expected benefits. If there is no intended clinical benefit to the participant, they should be made aware of this.

Alternatives to taking part in the study: It should state the alternative procedures or courses of treatment that may be available to the participant, along with their important potential benefits and risks.

Costs of participation and compensation in the event of injury: It should state the compensation and treatment available to the participant in the event of a trial-related injury, as well as any anticipated expenses for participating in the trial.

Voluntary nature of the study: It should state that the participant can withdraw from the trial at any time without penalty or loss of benefits.

Confidentiality of personal information: It should state that the monitor, author, Institutional Review Board (IRB), and regulatory authority may be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, while respecting the confidentiality of the participant as permitted by applicable laws and regulations.

New information that may affect study participation: It should state that the participant or their legally acceptable representative will be informed if any information becomes available that may be relevant to their willingness to continue participating in the study.

Study contacts: It should provide contact information for further inquiries about the trial and the rights of trial participants in the event of trial-related injury.

Duration of participation and number of people taking part in the study: It should indicate the expected duration of participation in the trial and the approximate number of participants involved.

Documentation of Informed Consent

Documentation of informed consent marks the conclusion of the initial consent process. The individual responsible for documenting the obtainment of informed consent must be qualified to attest that the subject has provided legally effective informed consent. While several qualified research personnel can and should be involved in the consent process, it should be remembered that the principal investigator (PI) is ultimately responsible for all aspects of the research and informed consent. Therefore, the PI should be involved in both the process and documentation of informed consent, particularly in studies involving investigational drugs or devices under an Investigational Device Exemption (IDE).

Conclusion

Respect for persons demands that legally effective informed consent be obtained from subjects before they participate in research. Informed consent is a crucial protection for human subjects participating in clinical trial studies.

References

Genome.gov - Informed Consent: https://www.genome.gov/about-genomics/policy-issues/informed-consent

National Center for Biotechnology Information - Informed Consent: https://www.ncbi.nlm.nih.gov

U.S. Department of Health and Human Services - Informed Consent FAQs: https://www.hhs.gov/ohrp/regulation-and-policy/guidance/faq/informed-consent/index.html

FDA - Informed Consent for Clinical Trials: What Patients Need to Know: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials

ScienceDirect - Informed Consent: https://www.sciencedirect.com/topics/medicine-and-density/informed-consent

Code of Medical Ethics - Informed Consent: https://code-medical-ethics.amassn.org/ethics-opinions/informed-consent

Student Name: Taddi Raja 

Student ID:044/032023

Qualification: M.sc Microbiology

e-Mail ID: taddiraja143@gmail.com