Clinical Research: Informed Consent, Opt-Out, and Waiver Approaches

This report delves into the critical aspects of study design within the realm of clinical research, with a specific focus on informed consent procedures. It thoroughly examines the nuances of both opt-out and waiver consent approaches, elucidating their respective contexts, advantages, and limitations. The report outlines the essential requirements for informed consent, addressing potential challenges such as language barriers, religious influences, and participant expectations. It explores situations where opt-out and waiver approaches are most appropriate, considering international and Australian guidelines. Furthermore, the report details the criteria that Human Research Ethics Committees (HRECs) must consider when approving these approaches. It also discusses the crucial process of patient data de-identification to maintain confidentiality. The report concludes by emphasizing the importance of ethical data collection and adherence to guidelines to ensure participant safety and privacy.

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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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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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.

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Explanation of context where the waiver of consent approach can be considered
This approach can be considered in the case of research projects that are able to
ensure no more than the low risk for participants. According to Rebers et al. (2016), this
approach can be granted by a research process that does not affect the legal rights and welfare
of the participants. Additionally, this approach can be granted if researchers can agree to
share information about participation with participants. There are some data collection
processes associated with minimal risk and these kinds of research projects can have the
opportunity to consider waivers of consent. For example, if a person conducts a survey or
interview through online websites or through telephone, there is no need to collect informed
consent documents from the participants, as participants are communicating from their own
choice. As mentioned by Boulos et al. (2018), research projects that ensure not breaching
confidentiality at any situation that can harm participants, can be allowed to consider waiver
of consent.
International and Australian guidelines of waiver of consent and opt-out approach
Australian guideline
● For considering the opt-out approach, participants need to have detailed information
about the aim, objectives, and protocol of the research and the researcher is bound to
maintain security standards while collecting the data. It is important to ensure minimal
risk and privacy of data needs to be maintained (Nhmrc.gov.au, 2020).
● For waiver of consent, research needs to be associated with the minimal risk, the
confidentiality of data needs to be protected, participants must access the outcome
after completion of the research if it is significant for them, participants must have the
financial benefit if applied.
International guideline

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● For considering a waiver of consent, researchers must have social value, no more
than minimal risk needs to be ensured and the research cannot be conducted without a
waiver (Cioms.ch, 2016).
● For the opt-out approach, participants need to be informed about the existence of the
research process, they must know that they can withdraw their information at any time
and the researcher must offer a reliable possibility to object.
Criteria that HREC needs to consider before approving the opt-out approach for
research
HREC needs to consider different criteria before approving the opt-out approach. This
includes the
● Involvement of participants in the research should involve low risk. Approval must
not be granted if the research involves high risk.
● The public interest in the proposed activity needs to outweigh the protection of
privacy (Nhmrc.gov.au, 2020).
● The level of participation is another criteria, which need not be compromised for
gaining explicit consent. A low level of participation can impact on the objectives of
the research.
● Researchers need to make proper attempts to provide information about the research
to participants. This can be done through the help of plain and clear language, which
explains the nature and type of information that will be collected from participants.
● The procedure to withdraw participation is explained clearly.
● A proper time period is provided between the provision of information to participants
about the research and utilizing collected data. This can help participants to make
decisions about withdrawing from research.

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Criteria that HREC needs to consider before approving the selection of waiver of
consent for research
The following criteria are considered by HREC to approve the waiver of consent for
the research. These criteria have been developed based on legal and ethical guidelines.
● Participating in the research will not face more than low risk and the benefit of the
project will justify associated minimal risk (Nhmrc.gov.au, 2020).
● There will be no reason that can cause reluctant participants to be involved and the
researcher will protect the privacy of participants.
● If the result of the research will be significant for participants, they must get the
opportunity to access the information arisen from the research.
● The research will not deprive participants if they are entitled to some financial
benefits due to their participation in the research.
● The HREC neither will nor grant a waiver of consent if any objection comes from the
end of international, state and federal laws.
De-identification of the information of the patient
De-identification of patient data is a process of segregating PII (Personal Identifiable
Data) from different protected information about health. This protected information is
generally stored in the system of healthcare organizations. The process of De-identification
helps to become compliant without compromising technical flexibility. However, it is
necessary to store PII in a secured system to become compliant. This is an invisible process,
which is not essential to inform patients (Kayaalp, 2017).
Additional discussion
If a waiver is issued then the consent documentation can be of any type, which
includes notes written in the research record or medical record. Moreover, it can be a form

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created specially at consists of a page for documentation about verbal consent and place for
signature.
On the other hand, opt-out is more acceptable among both general practitioners and
patients, which has helped to achieve a high level of participation (Ncbi.nlm.nih.gov, 2015).
This process is more effective than a waiver because it has helped to empower participants by
giving them the option to decline participation.
Conclusion
From the entire discussion of this study, it can be concluded that researchers need to
follow the guidelines for both cases of considering a waiver of consent and opt-out approach.
The process of data collection must be ethical in any situation and the confidentiality of data
must be maintained. On the other hand, it has been understood that it is the responsibility of
researchers to ensure low risk for the involved participants.

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Reference list
Cioms.ch. (2016). International Ethical Guidelines for Health-related Research Involving
Humans. Retrieved on 8th April 2020, from
https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
Dickert, N. W., Eyal, N., Goldkind, S. F., Grady, C., Joffe, S., Lo, B., ... & Wendler, D.
(2017). Reframing consent for clinical research: a function-based approach. The
American Journal of Bioethics, 17(12), 3-11. Retrieved
from:https://nett.umich.edu/sites/default/files/docs/1-17-18_article_1.pdf
Hardcastle, T. C., & Hansoti, B. (2016). HIV, trauma and the emergency departments: The
CDC opt-out approach should be adopted in South Africa. South African Journal of
Bioethics and Law, 9(2), 57-60. Retrieved
from:https://www.ajol.info/index.php/sajbl/article/viewFile/150124/139690
Harris, J., & Porcellato, L. (2018). Opt-out parental consent in online surveys: ethical
considerations. Journal of Empirical Research on Human Research Ethics, 13(3),
223-229. Retrieved from:http://researchonline.ljmu.ac.uk/id/eprint/8588/1/Opt%20out
%20parental%20consent%20in%20online%20surveys_deposited%20version.pdf
Health.vic.gov.au. (2020). Informed consent. Retrieved on 8th April 2020,
fromhttps://www2.health.vic.gov.au/mental-health/practice-and-service-quality/
mental-health-act-2014-handbook/recovery-and-supported-decision-making/
informed-consent
Rich, W. D., & Katheria, A. C. (2017). Waiver of consent in a trial intervention occurring at
birth—how do parents feel?. Frontiers in pediatrics, 5, 56. Retrieved
from:https://www.frontiersin.org/articles/10.3389/fped.2017.00056
Nijhawan, L. P., Janodia, M. D., Muddukrishna, B. S., Bhat, K. M., Bairy, K. L., Udupa, N.,
& Musmade, P. B. (2013). Informed consent: Issues and challenges. Journal of

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advanced pharmaceutical technology & research, 4(3), 134. Retrieved from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3777303/
Boulos, D., Morand, E., Foo, M., Trivedi, J. D., Lai, R., Huntersmith, R., ... & Le, S. (2018).
Acceptability of opt‐out consent in a hospital patient population. Internal medicine
journal, 48(1), 84-87. Retrieved from: https://scholar.google.com/scholar?
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&hl=en&as_sdt=0,5&scillfp=14740365092829219153&oi=lle
Ncbi.nlm.nih.gov (2015), Opt-out as an acceptable method of obtaining consent in medical
research. Retrieved on 10th April 2020 from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3079702/
Kayaalp, M. (2017). Modes of De-identification. In AMIA Annual Symposium Proceedings
2017, 1044 Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977668/
Nhmrc.gov.au (2020), Waiver, opt-out guidelines. Retrieved on 10th April 2020 from
https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-
human-research-2007-updated-2018#toc__296
Rebers, S., Aaronson, N. K., van Leeuwen, F. E., & Schmidt, M. K. (2016). Exceptions to the
rule of informed consent for research with an intervention. BMC medical ethics,
17(1), 9. Retrieved from: https://link.springer.com/article/10.1186/s12910-016-0092-6
Ballantyne, A., & Schaefer, G. O. (2018). Consent and the ethical duty to participate in health
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