Study Design in Clinical Research Report

Running Head: Study Design in Clinical Research
STUDY DESIGN IN CLINICAL RESEARCH

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Study Design in Clinical Research
Table of Contents
Introduction................................................................................................................................3
Requirements of informed consent in terms of clinical research...............................................3
Potential limitations and challenges to obtain informed consent for clinical registry...............3
Explanation of context where the opt-out approach can be considered.....................................4
Explanation of context where the waiver of consent approach can be considered....................5
International and Australian guidelines of waiver of consent and opt-out approach.................5
Criteria that HREC needs to consider before approving the opt-out approach for research......6
Criteria that HREC needs to consider before approving the selection of waiver of consent for
research.......................................................................................................................................7
De-identification of the information of the patient....................................................................7
Additional discussion.................................................................................................................7
Conclusion..................................................................................................................................8
Reference list..............................................................................................................................9

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Study Design in Clinical Research
Introduction
Informed consent is essential for providing the participants of clinical research with
adequate information and allowing them to make an informed decision. Informed consent is
necessary before any clinical trial. In this assignment, waiver and opt-out consent approaches
are discussed and different information about those approaches is provided.
Requirements of informed consent in terms of clinical research
Detail information regarding protocol and purpose of the research that can be easily
understood by target human subjects. It is important to allow adequate time for participants to
consult with their family members before providing informed consent (IC) to researchers. On
the other hand, Hardcastle & Hansoti (2016) have mentioned that participants need to enter
into a voluntary agreement if they agree to take part in the concerned research. However, it is
important for the participants to be competent in making decisions on their own
(Health.vic.gov.au, 2020). Participants cannot be forced to take part in the research process.
Before collecting information, it must be ensured that participants have not indicated the
intention to withdraw consent. Through the IC, participants must be informed about the terms
of maintaining the confidentiality of data. A clear statement of potential risks associated with
the information gathering process must be included within the IC.
Potential limitations and challenges to obtain informed consent for clinical registry
There are different limitations and challenges for obtaining informed consent include
language barriers. As opined by Nijhawan et al. (2013), it is very difficult to assess the
viewpoint of participants about the trial. This is because there is no established procedure to
measure the extent of understanding that a participant must have about the information
provided. Hence, it is assumed that the participants sign the consent with a full understanding
of what has been stated in the form. Another barrier is religious influence and it was seen

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Study Design in Clinical Research
that participants sign the consent form due to religious belief (Harris & Porcellato, 2018).
However, this process is framed to provide every participant the liberty to make decisions
regarding their participation.
The false expectation of participants is a major limitation of informed consent.
Misunderstanding can occur due to inappropriate communication between researchers and
participants, which can give rise to false expectations among participants Rich & Katheria
(2017). For example, participants can fear being treated as an experimental model for
different studies and they can refuse to take part. Another limitation of informed consent is
related to children. It is necessary to take permission from the parents of children who are
potential participants. However, collecting child assent is also necessary for participants
above 7 years of age (Dickert et al. 2017). Confusion can occur if a parent gives consent but
the child refuses to assent.
Explanation of context where the opt-out approach can be considered
An opt-out approach for recruiting participants to research is appropriate if it is
possible to contact all or at least some of the participants. However, in large scale projects
gaining explicit consent are not feasible neither is it practical.
While conducting research by involving the hospital patient population, an opt-out
approach can be used. This method is suitable when a diverse population is involved in the
research such as in a hospital (Ballantyne & Schaefer, 2018). Moreover, this approach can be
applied to gain consent, if it is required to encourage participants. This approach helps
participants to gain information about the research. Thus, information about a good topic of
study and less or no harm to participants can encourage them to take part and give consent.
This approach provides a chance for participants to withdraw consent, which encourages
them to participate in the research.