Informed Consent in Clinical Research

This document discusses the concept of informed consent in clinical research and highlights the critical factors to consider when drafting an informed consent in an IRB application. It explains the purpose of informed consent, the requirements set by the IRB, and the importance of providing clear and understandable information to participants. The document also includes two examples of informed consent for different research projects.

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

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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).

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 Participation rules- Your participation is voluntary, and may stop or withdraw from the
research at any time. No benefits or loss of opportunities if would occur under such
circumstances5.
 Objective- The study will help us to compare the efficacy of rapid HIV test and ELISA in
detecting HIV.
 Procedure- We seek your permission to collect blood, urine and saliva, and store them for
future research. We will code your sample so that the researcher who uses it for other
purposes does not know your identity. We will tell you about the final conclusions derived
from the research.
 Duration- 8 months.
 Confidentiality- No information will be disseminated, unless required by the law. All
information will be kept confidential and private4.
 Benefits- Determining the test that helps in early detection of HIV will prove a
breakthrough in the treatment of AIDS.
 Risk or Discomfort- The research will be conducted at minimal risk and no additional
discomfort is associated with the study.
OR
2. Use your hypothesis from Assignment 1, “Conducting a Literature Search” as the basis
for your project (identify the question you want to study) and draft an informed consent
for your IRB application.
Template informed consent documents can be found at:
https://arc.research.usf.edu/Prod (Links to an external site.)Links to an external site.
Choose:
Institutional Review Board --> Consent Form Templates
Application-
You are being requested to participate in a research study.
 Total participants- 100 community dwelling patients who meet the diagnostic criteria for
Alzheimer’s disease
 Purpose- The purpose of the study is to determine the effectiveness of behavioral
management techniques, combined with home based physical exercise programs in
lowering functional dependence of the Alzheimer’s disease patients
 Why participate- You are being asked to take part because Alzheimer’s disease has been
identified to be a major factor that results in functional dependence of the affected
patients on their family members and caregivers.
 Participation rules- Your participation is voluntary, and may stop or withdraw from the
research at any time. No benefits or loss of opportunities if would occur under such
circumstances5.
 Objective- Reduction of functional dependence will increase the quality of life among the
Alzheimer’s disease patients and will also increase their capability to conduct activities of
daily living.
 Procedure- We seek your permission to randomly assign you to two intervention groups,
namely routine medical care (RMC) and the combined behavioral management and
exercise programs. We will tell you about the final conclusions derived from the research.

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 Duration- 4 months and 2 months follow-up.
 Confidentiality- No information will be disseminated, unless required by the law. All
information will be kept confidential and private4.
 Benefits- Determining efficacy of the combined program in reducing functional
dependence will also enhance physical health among the community-dwelling adults and
uplift their mental health.
 Risk or Discomfort- The research will be conducted at minimal risk and no additional
discomfort is associated with the study.

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Bibliography
1. Faden, Ruth R., Tom L. Beauchamp, and Nancy E. Kass. Informed consent, comparative
effectiveness, and learning health care. N Engl J Med. 2014; 370(8):766-768.
http://www.cmtpnet.org/docs/resources/20140220_nejm_CER_Consent_Kass.pdf
2. Tam, Nguyen Thanh, Nguyen Tien Huy, Le Thi Bich Thoa, Nguyen Phuoc Long, Nguyen Thi
Huyen Trang, Kenji Hirayama, and Juntra Karbwang. Participants’ understanding of
informed consent in clinical trials over three decades: systematic review and meta-
analysis. Bulletin of the World Health Organization. 2015; 93:186-198H.
https://doi.org/10.2471/BLT.14.141390
3. Grady, Christine. Enduring and emerging challenges of informed consent. New England
Journal of Medicine. 2015; 372(9): 855-862.
4. Check, Devon K., Leslie E. Wolf, Lauren A. Dame, and Laura M. Beskow. Certificates of
confidentiality and informed consent: Perspectives of IRB chairs and institutional legal
counsel. 2014; IRB 36(1):1.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4076050/pdf/nihms582610.pdf
5. IRB Institutional Review Board. General Requirements for Informed Consent.
Northwestern University. https://irb.northwestern.edu/process/new-study/informed-
consent/general-requirements-informed-consent Published November, 2016. Accessed
February 08, 2019.