Human Experiments Developing an Informed Consent Form Analysis Essay

Please select a clinical trial currently posted on the website. This can be a trial investigating a new drug, device, or biologic in adults or children.

Students are encouraged to use the appropriate template below to develop an Informed Consent Form (ICF) for the trial you selected.

References must be listed on a final separate page.

Pages should be about 10, all included.

Expert Solution Preview

Clinical trials are an essential tool in developing new drugs, devices, and biologics in children and adults. As a medical professor, it is my responsibility to provide medical college students with the necessary tools and knowledge to create informed consent forms for clinical trials. In the following answer, I will provide an example of a clinical trial posted on and give instructions on how to create an Informed Consent Form (ICF) for the selected trial.

Let us choose a clinical trial investigating a new drug in adults that is currently posted on, such as “A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib and Dexamethasone (B-Vd) Compared with the Combination of Placebo, Bortezomib and Dexamethasone (Placebo-Vd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM-6).”

To create an ICF for this trial, the following template can be used:

1. Introduction
a. Purpose of the study
b. Explanation of the clinical trial
c. Volunteer participation request

2. Procedures
a. Eligibility criteria
b. Study procedures
c. Duration and frequency of visits

3. Risks and Benefits
a. Possible risks
b. Potential benefits
c. Alternative treatments information

4. Confidentiality
a. Data and Information confidentiality
b. Permitted use of information

5. Rights and Responsibilities
a. Right to withdraw
b. Study team contacts
c. Compensation

6. Conclusion
a. Consent Acknowledgment

In each section, the ICF should use clear language that is easy to understand for potential study subjects.

References must be listed as a final separate page using the correct citation format (APA, AMA, etc.)

The ICF should be approximately 10 pages in length, including all sections.

In conclusion, creating an ICF for a clinical trial is an essential part of conducting ethical research, and medical college students must learn how to create these documents correctly. The provided template and instructions can be used as an example to guide students in making informed consent forms accurately.

Table of Contents

Calculate your order
Pages (275 words)
Standard price: $0.00

Latest Reviews

Impressed with the sample above? Wait there is more

Related Questions

Saudi Vision 2030

 Description Why is it important to understand the concepts of inflation, present value, and future value as Saudi Arabia moves toward Saudi Vision 2030? What

New questions

SEU Random Sampling Discussion

Reply to this post: In arrange to choose an arbitrary test, a subset of subjects must be picked so that each subject within the populace

SEU Risk Assessment Tools Discussion

Reply to this post: Examine the quality improvement that occurred, including the background and the process changes. Hospital-acquired pressure injuries are commonly seen in patients

SEU Tertiary Hospital Discussion

Examination of the Quality improvement The available pharmacists’ roles are thought to have evolved dramatically during the last few decades. The general public believes that

Don't Let Questions or Concerns Hold You Back - Make a Free Inquiry Now!