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On Research Podcast – Consent in Clinical Research

Season 1 – Episode 8 – Consent in Clinical Research

Per the FDA, clinical trials aim to study medical products in people, emphasizing the importance of informed consent to clarify their role as research subjects rather than patients. Voluntary informed consent safeguards participants from potential research-related harm.


Episode Transcript

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Darren Gaddis: From CITI Program, I’m Darren Gaddis, and this is On Research. Today, consent and clinical research. I spoke with Linda Reuter from the Biomedical Research Alliance of New York. As a reminder, this podcast is for educational purposes only. It is not intended to provide legal advice or guidance. You should consult with your organization’s attorneys if you have questions or concerns about relevant laws and regulations discussed in this podcast. Additionally, the views expressed in this podcast are solely those of the guest and do not represent the views of their employer. Hi, Linda. Thank you for joining me today.

Linda Reuter: Thank you, Darren. It’s a pleasure to be here.

Darren Gaddis: To get us started today, what is consent, and how does consent in a clinical trial potentially differ from research done in the behavioral, social, or physical sciences?

Linda Reuter: So the term consent refers to a legally effective and informed agreement where a person voluntarily, and that’s really important, voluntarily agrees to be a participant in research. So it’s not a one-time event. There’s typically a consent document or form that a person actually signs before any research procedures are started. But there’s also an expectation that consent will be an ongoing communication, an ongoing process that really ensures that the person is continuing to be a willing participant in the research. So in other words, to keep the communication going and to give the person any new information that might come up that might affect their decision.

So how this actually looks depends on the nature of the study. There are times where the agreement may be verbal or even waived altogether. What’s important is determining what information to give at the beginning and also over the course of the research that may affect the person’s willingness to start the study and also to continue participating. A key aspect is that it’s made clear that participation is completely voluntary. I think I stressed that at the beginning too. For the researcher, it’s important to understand that consent is a process, not just the signature on the form, and that good communication is really important, not only at the beginning when you describe a study to someone the first time but also throughout the study as you describe things that might have changed.

Consent for social behavioral research or the physical sciences may look much different from a clinical trial because the nature of the research and the risks are often quite different. Because of these differences, the type of information the person would need to make an informed decision will be very different. Clinical trials generally aim to develop better medical treatments or better devices, better drugs. So very often a person’s health is affected. In a clinical trial, we’re dealing with someone’s personal health condition. They might worry most about, they meaning the subjects that are being asked to participate in a study, might worry most about, “What are the risks and the benefits to my own personal health?” And they’d want to know what other alternatives there are to treat their disease. “What’s known about all these options? What procedures will I have to go through? Who’s paying? Is my insurance covering this?” things like that.

So the focus for the clinical trial is typically physical risks and benefits and the involvement of a person in a clinical trial tends to be somewhat personal to the individual’s health. But consent for behavioral research or even the physical science, this is very different. There are still risks involved and it’s still really important that the potential participants be fully informed. We have to remember that in behavioral research there may be physical risks, but we have to remember that the focus is often on non-physical risks, things like psychological or even emotional risks.

Or it may just be that we’re doing a survey study, but is that going to trigger past emotional experiences or elicit some sort of fear or stress or confusion, guilt, things like that, or purely emotional risks that nonetheless are really important to consider? It could be social risks, things like social stigmatization of a particular class of people or an individual, a chance of being ostracized or shunned because of your responses to a particular research question, or even economic risks to employability or insurability.

So these are all very real risks that IRBs consider when they look at social behavioral research. And while some people may think there are no real risks involved, there really are and they need to be considered. While consent is important in all types of research that relies on people to participate in order to complete that research, the focus of the consent process may be very different between clinical trials and social behavioral research because there’s different concerns with each of them.

Darren Gaddis: When and why must consent be collected in a clinical trial?

Linda Reuter: Yes. So for clinical trials, the requirements for consent are pretty clear. There are federal regulations governing research with human subjects. These regulations very clearly stipulate that before involving a person in research, one must obtain the… And the term is legally effective informed consent of the individual or their legally authorized representative. And we’ll talk about legally authorized representatives. We’ll use the term LAR to refer to people who are authorized to consent for somebody else.

So these regulations also go on to the specific conditions under which consent should be sought. So things like allowing the right amount of time for discussion and consideration, making sure one is minimizing undue influence or coercion in the consent process, making sure the consent is in the right language for the subject to understand, getting translations when needed. The regulations are also very specific about the type of information that should be provided and even what the consent form should look like, how it should be formatted, what should be said first and specific elements that must be included.

So these regulations give us the parameters for designing a consent and a consent process, but they also give us parameters for waiving the requirements for consent or certain pieces of the consent in some circumstances. Since clinical trials typically involve some level of risk, a written consent is most often used, and the person needs to actually sign the form, or their LAR might sign it. As far as when consent must be obtained, consent must be obtained before any research procedure is performed. Even if you’re doing screening tests to see if someone’s eligible for a clinical trial, there has to be a level of consent before any research procedures are initiated.

Darren Gaddis: And can consent or parental permission ever be passive or implied during or in a clinical trial?

Linda Reuter: If a written consent is not obtained, it’s because the research qualified for a waiver or because consent wasn’t otherwise required. As an example, for certain survey studies, there may be a short introductory consent statement at the start of the survey which describes that there’s research being done, the person’s being asked to complete the survey for the research, et cetera, but there’s no signature or formal documentation of consent. The fact that the person was told about the research and then they actually completed the survey would imply that they consented to be a part of the research even though no formal consent process was documented. But that is because consent was not required by the regulations or the activity qualified for a waiver and not because implied consent is acceptable. The same goes with parental permission. If the parent’s signature is not being obtained, then the situation must have qualified for a waiver or the parent’s consent was not actually required.

Darren Gaddis: And with this information, what would happen to consent for a child who reaches a legal age during a clinical trial?

Linda Reuter: In general for research, there are certain instances where a formal reconsent is required, and one example of that is when the subject was initially enrolled in a study by parents or somebody else who was authorized at the time to enroll them because the subject was a minor, but now the subject has reached the age of 18, or I should say the age of majority in their state because this number can vary across different jurisdictions, different states have different ages for age of majority, so now this person can legally consent on his or her own behalf.

This is a lot like any situation where if a subject was incapacitated at the time of enrollment and has now regained capacity to consent. In the case of a child, it’s not exactly that they were incapacitated, per se, but they were not legally able to consent for themselves at the time they were enrolled, and now they are. The exact requirements may differ depending on the nature of the research, the ongoing procedures that are still occurring. But IRBs typically do consider what to do in these circumstances when a participant who’s a minor reaches the age of majority, and it would not be unusual to require a reconsent when somebody reaches the age of 18, especially when the person is still undergoing procedures for the research.

Darren Gaddis: Is it possible to receive legally effective consent during an urgent or emergency situation within a clinical setting?

Linda Reuter: Sure. This is a tough question, but yes, it is possible. IRBs will look at these types of situations really carefully to determine what’s appropriate as far as consent when we’re talking about an emergency situation. So first, there are times when research and emergency setting actually does allow for proper consent. It may be that even though it’s an emergency situation, the person is still competent to provide consent. It may also be that the IRB approve the use of an LAR in that particular situation, and it’s the type of situation where an LAR might actually be available to provide consent.

It’s also worth mentioning here, since we’re talking about emergency situations, that there’s also a very specific regulation for exception from the informed consent requirements for emergency research. This is a situation where the requirement for informed consent can be waived altogether, but there are very specific requirements for this classification. We call these the EFIC regulations or the Exception From Informed Consent for planned emergency research regulations. For an EFIC study, the protocol has to very specifically describe the population and the procedures to be followed and must include specific approvals from FDA for use of the products.

We’re talking only about life-threatening situations for this category of research where there’s no alternative standard treatment. The protocol has to document that it’s not possible to get consent because of the person’s medical condition and that consent by LAR is not really practical. Maybe these people are coming into the ER in an emergent situation in the midst of a stroke or something as an example. The IRB will also consider the risk-benefit ratio, and there has to be a potential benefit to the subject if they’re going to be enrolled in an emergency situation under an EFIC waiver. The protocol is required to have some other very specific details. But getting back to the question, is it possible to receive the legally effective consent during an urgent or emergency situation? It is possible to actually get the consent of the subject, but very often people will pursue…

Darren Gaddis: When could a legally authorized representative provide consent on behalf of an adult with diminished decision-making capacity within a clinical setting?

Linda Reuter: This is a great question, and there are a lot of layers here, so I’ll try to cover all the scenarios. First, the issue as to who can be an LAR is typically determined by local or state law. Some states have statutes or regulations or laws that specifically address consent by someone other than the subject for participation in research, but many states don’t have a specific regulation or rule about it. If there is no specific state law, any law in that state that addresses who is authorized to give consent for another person to specific medical procedures or generally to medical treatment, we’re not talking about research here, but just rules about who can consent for medical care, may be relevant in a research scenario if the research involves those same medical procedures or medical treatments.

Also, if a person has a healthcare proxy that specifically addresses decisions to be made for research, that would be allowable, but I don’t think it’s very common for people to have this specifically stated in their healthcare proxy. But it does happen, and it would be another way to allow for LAR. So the question on when an LAR could provide consent, it’s when state law allows or when the healthcare proxy identifies an individual who can actually make those decisions for the subject. But also, if the healthcare proxy is silent on the issue, surrogate consent or consent by an LAR may be allowed when certain conditions are met. So BRANY IRB, which is where I am coming from, uses specific criteria for this situation, and we distinguish between therapeutic research and non-therapeutic research. That would be different criteria that would have to be met for each.

So let’s talk first about research that has a potential therapeutic benefit. For example, the proxy is silent with respect to research. It is acceptable for healthcare proxy or other LAR to sign the consent for a study that holds out a potential therapeutic benefit, but these five conditions have to be met. And the conditions we look for are, first, as a potential benefit over standard treatment. The second is standard treatment is not being withheld. There’s no alternative standard treatment. Enrollment in the study is in the best interest of the patient that the participation in the research wouldn’t be contrary to any known wishes of the patient. So those are really the five things that our IRB would look at to determine if consent by an LAR is appropriate for a therapeutic research study. Of course, again, allowing state law, allowing that and the healthcare proxy not having anything contradictory to that.

So now for non-therapeutic research, when there’s no potential for the subject to perhaps improve clinically as a result of research interventions, the conditions the IRB would look for in order to approve use of an LAR are different five criteria, but they are, first, that the objectives of the trial can’t be met by means of a trial in other types of subjects. In other words, you have to include people that are in an emergency situation or that are not capable of consenting for themselves or you can’t do the research at all. The second would be that the risks are low. The negative impact on the subject’s wellbeing is minimized and low. The trial is not prohibited by law. And then the last criteria would be that the opinion of the IRB is sought in the inclusion of such subjects, and the written opinion covers this aspect, meaning the IRB has knowingly approved this way of getting consent.

Also, these types of non-therapeutic trials should always be conducted in people who actually have the disease or condition for which the investigational product is intended. And of course, these subjects should be particularly closely monitored and should be withdrawn if they appear to be unduly distressed. So that summarizes really quickly most of the scenarios that would allow for consent by an LAR or surrogate consent. As you can imagine, IRBs are very careful in evaluating these situations and will be very careful to approve a surrogate consent procedure only when it’s appropriate and allowable by law.

Darren Gaddis: What else should we know about consent and clinical trials?

Linda Reuter: As I’ve said before, and I’ll reiterate here, consent is an ongoing process. It’s not a one-time thing. Also, for clinical trials, we always need to be mindful of the issue of therapeutic misconception, making sure people don’t see the trial as a potential sure thing to treat their disease or condition, and that people are aware of the potential risks and benefits that are associated with whatever they’re going to be undergoing as part of the clinical trial, that these medical treatments are not yet proven to be effective. That’s why the research is being done. There may be a placebo arm as well where they’re not even getting an active intervention. So communication remains key. As consent documents themselves become longer and more complex, it will be even more important that during that process where we sit down and have discussions with people, we try to focus on the information that they really need to know to make an informed decision for themselves so that they understand exactly what it is they’re signing up for.

Darren Gaddis: Linda, thank you for joining me today.

Linda Reuter: Thank you, Darren.

Darren Gaddis: Thank you for listening to today’s episode and be sure to follow, like, and subscribe to On Research with the CITI Program to stay in the know. If you enjoyed this podcast, you might also be interested in other podcasts from CITI Program, including On Campus and On Tech Ethics. I invite you to review our content offerings regularly as we are continually adding new courses, subscriptions, and webinars that may be of interest to you, like CITI Program’s Effectively Communicating Research Results to Non-Scientific Audiences Webinar. All of our content is available to you anytime through organizational and individual subscriptions.


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Meet the Guest

content contributor linda reuter

Linda Reuter, MS, CIP – Biomedical Research Alliance of New York (BRANY)

Linda is the IRB Director at BRANY. She holds a BS in Biology and MS in Health Science. Over a 30 year career Linda has traveled the country providing IRB training/education, audit services, and general consulting to numerous IRB programs. She has also contributed to various publications in her field.


Meet the Host

Team Member darren gaddis

Darren Gaddis, Host, On Research Podcast – CITI Program

He is the host of the CITI Program’s higher education podcast. Mr. Gaddis received his BA from University of North Florida, MA from The George Washington University, and is currently a doctoral student at Florida State University.