Informed Consent in Clinical Research

Running head: NURSING
Informed consent- Clinical Research
Name of the Student
Name of the University
Author Note

1NURSING
Answer these questions under each one with black letters:
What is an informed consent? What are the critical factors one needs to consider in
drafting an informed consent in an IRB application?
Informed consent refers to the procedure for obtaining permission, prior to the
conduction of a healthcare based intervention on any individual, or prior to revealing
personal information1. Healthcare providers often ask patients for their informed consent
as well, before administering any treatment2. Informed consent is gathered during
research on human participants, based on the framework and guidelines of research
ethics and human ethics. In other words, it refers to a vital document that provides
evidence for voluntary agreement of the participants for the investigation and is a
comprehensive process that increases awareness of the participants on the potential risks
and advantages of the research3. Some of the general requirements for informed consent
as per the IRB are cited below:
1. Human participants cannot be involved in a research unless legally effective
informed consent are obtained by the researchers.
2. The participants must be offered adequate opportunity for considering their
involvement under circumstances that reduce probability of coercion.
3. The information must be provided in an understandable language5.
4. No informed consent should contain any exculpatory language that makes the
participants waive their legal rights, or release the sponsor, investigator, agents or
institution from liability for negligence.
500 words total
bibliography in JAMA format 5 to 10 sources
Use the main book too: Designing Clinical Research 4th Edition stephewn B
Hulley
1. Draft an informed consent for your IRB application on the following project: You intend
to conduct a clinical study which aims to evaluate the sensitivity and specificity of a
fourth-generation rapid HIV test compared to the standard ELISA. Your study subject
population is 500 HIV positive and 500 HIV negative subjects and your collected samples
will be finger-prick blood, saliva and urine.
Application-
You are being requested to participate in a research study.
 Total participants- 500 HIV positive (case) and 500 HIV negative (control)
 Purpose- The purpose of the study is to evaluate the sensitivity and specificity of a fourth-
generation rapid HIV test, in comparison to a standard ELISA.
 Why participate- You are being asked to take part because you have been diagnosed to be
either HIV positive (infected with the virus) or HIV negative (not infected with the virus).