Beneficence – Ethical Principles in Human Subjects Research

by Mark Hughes, MD, MA

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    00:01 The second ethical principle is going to be beneficience.

    00:05 So this is all about having a favorable risk-benefit ratio.

    00:10 So that means that the potential risks that you envision that might happen to subjects, they are minimized as much as possible.

    00:17 The potential benefits to the individual subjects are enhanced as much as possible.

    00:22 And that you're really trying to make sure that whatever the benefits are, they might be to the individual, they might be to society as a whole, because you're increasing knowledge.

    00:31 But those potential benefits are proportionate to or even outweigh whatever the risks are involved in having this person participate as a research subject.

    00:43 The way you figure out this risk-benefit ratio is going to be based on the existing data.

    00:48 So previous studies, previous clinical care, helps to inform what the potential benefits might be, what the potential harms might be, how likely it is that those are going to occur, and also what the potential long term consequences might be.

    01:02 So if there is a benefit, how long lasting will it be if there's a risk or harm happens, Is it a permanent harm? Is it something that might only be for a short term? You're going to be informed by your knowledge of clinical medicine, prior research, to know the benefits, the risks, the likelihood, and the longer term consequences? So let's talk a little bit more about benefits.

    01:30 So in general, a benefit is something that is a value.

    01:34 And when we're thinking about clinical research, that's generally going to mean value related to health or well-being or the welfare of the individual.

    01:43 There may be physical benefits.

    01:45 So you know, medical care, you know, if you're having an investigational surgery or investigational device or investigational drug, there may be a tangible physical medical benefit in terms of their participation.

    02:01 Some people would also say, well, there's just a benefit of being included in a research study, that the person will feel like they are contributing to science, they're contributing to other people with the same condition that might have some benefits to them.

    02:17 There may be these aspects of hope, you know, so perhaps standard of care has not worked for them.

    02:24 And they're hoping that this investigational study is going to provide some hope for treatment of their condition.

    02:32 Another psychological benefit to participating in research is altruism.

    02:37 So again, feeling like you are contributing to society, contributing to other people with a condition and it also gives you a sense of kinship that you're in this with other people.

    02:49 There may be times where you might think about a benefit in terms of economic.

    02:53 So here, you know, just getting access to medical care could be a benefit.

    02:59 People might certainly have availability to clinical care.

    03:02 But now, as a research participant, there might be a little bit more closer monitoring of their condition that might be seen as a benefit.

    03:10 And then in some cases, we may actually pay research subjects.

    03:14 So there may be monetary benefits.

    03:16 When we're thinking about the benefits in terms of enrollment and informed consent, we generally think of the monetary benefits as something separate.

    03:27 It's something that we're doing is compensation, either for the person's time, for the inconvenience, for reimbursing them for the cost associated with being a research participants.

    03:38 But it is, you know, one of the benefits to consider.

    03:43 Now, let's think about risks.

    03:44 So there are a few concepts to consider when we're thinking about risks.

    03:49 One is that there's always going to be uncertainty, you know, risk is all about probabilities.

    03:55 So there's, you know, you don't know if a harm is going to actually happen.

    03:58 So some amount of uncertainty, and some amount of things that are unanticipated, you don't know what's going to happen to the research participant, there might be unforeseen risks and you only learn about those as a result of doing the research.

    04:13 For individuals, there's also this idea of risk perception.

    04:16 So it's always in the eye of the beholder as to you know, how risky or not risky something is.

    04:23 So there might be some general agreement about, you know, what a risk is or probabilities of it happening.

    04:31 But, you know, if it's a very serious risk, people may take that you perceive that differently, based on what their condition is, you know, if they've got a devastating medical condition, maybe they're willing to take higher risks in order to have something good come from the research.

    04:50 And the other important concept when we're thinking about risk is relative risk.

    04:53 So what is this being compared to.

    04:56 So is it, you know, what the risks are that we encounter in everyday life, just crossing the street or, you know, riding in mass transit, is it...

    05:07 you know, what you experienced just in terms of getting general clinical care going to see a physician and, you know, getting blood tests taken.

    05:16 What is the risk relative to the everyday experience of either an individual that's healthy, or a person that has a particular condition, and their usual medical care? Then when we think about risks, they're going to be, you know, physical, psychological, social, or economic, just as we were thinking about for benefits.

    05:38 So for the physical risks, obviously, there could be bodily injury, so harm to the body.

    05:45 There may also be the notion of, you know, if you are wanting to enroll in a study, you have to delay your own treatment in order to be enrolled in the study.

    05:56 So there might be a lag period, where you're waiting for that to happen.

    05:59 Whereas if you had gone with standard of care, you might have been able to start your treatment sooner.

    06:05 So that might be a physical risk.

    06:08 Psychological risks could be stress, you know, just being a research participant, the uncertainty of how the research is going to play out for you that may lead to heightened anxiety.

    06:21 There may be concerns about disclosure of medical information.

    06:24 So if you're, the researchers collecting information about you, obviously need to try to protect that private information.

    06:31 But there might be times where that gets disclosed.

    06:36 So that's a psychological harm to you.

    06:39 There may be kinds of research where there's actually deception of the research participants.

    06:43 So you try to, you know, mask what you're doing with the underlying aim of the research.

    06:49 Because if you if they had full knowledge, like for instance, you know, whether they're getting a placebo or not, that might alter, you know, the results that you get.

    06:59 So learning that they might have been deceived, as part of the research could be a risk unto itself.

    07:06 In terms of social risks, there is the inconvenience factor of just being a research participant and having to go to, you know, study visits and making sure you're being monitored correctly.

    07:20 There might potentially be wrongs to personhood.

    07:23 So, if information is being collected about you, depending on the kind of research that might be damaging to your reputation, there might be stigmatizing information learned.

    07:33 If that gets disclosed, that may be a social risk.

    07:37 And also, you know, there may be economic risks.

    07:40 So if you're a research participant, you may not be able to, you know, engage in your usual employment, you may have loss of income, there may be cost of transportation to get to the research.

    07:52 There might be issues of you know, if you're, you know, research participant for a particular condition, and they learn information about you that may affect your insurability in the future.

    08:04 So now you've got a existing condition that hadn't been known about before.

    08:10 It's only as a result of the research that may affect you economically.

    08:16 So anytime we're thinking about risks, we have to think about, you know, what are the ways that we can prevent that harm from happening? And if the harm actually happens, if it actually occurs, how will we address it? How will we try to mitigate the effects of that harm? So we have to put those two things together, you know, consideration of the benefits, consideration of the risks, and put that as a ratio, it's going to be a gestalt, that you know, a judgment by the researchers in conversation with the research participant.

    08:50 And they have to decide, you know, is this worth pursuing? Sometimes we're going to have external bodies, like an institutional review board that will review these things.

    09:00 And they have to say, is it justifiable to seek these benefits despite the risks involved? Or, you know, should we just forego these benefits, because it's too risky.

    09:12 So somebody has to weigh in on this risk benefit ratio.

    09:16 And then for society as a whole, it has to weigh in of, you know, we're hoping for improvements in health and healthcare and well-being of individuals.

    09:25 When we're trying to seek those longer term benefits, knowing that there might be risks involved, you know, you know, how important is for us to, you know, seek improvement and knowledge, seek the development of new interventions? Is it worth pursuing the research, knowing that there might be risks to actual individual research participants?

    About the Lecture

    The lecture Beneficence – Ethical Principles in Human Subjects Research by Mark Hughes, MD, MA is from the course Clinical Research Ethics.

    Included Quiz Questions

    1. Favorable risk–benefit ratio
    2. Maximized risk
    3. Societal risks being greater than environmental risks
    4. Small likelihood of benefit
    5. Long-term consequences
    1. Certainty of treatment success
    2. Bodily injury
    3. Delay in treatment
    4. Stress
    5. Deception
    1. Likelihood of an event occurring during research versus that of the event occurring without research participation
    2. Likelihood of an event occurring during treatment versus that of the event occurring without treatment
    3. Likelihood of a death occurring during treatment versus that of death occurring without treatment
    4. Uncertainty of potential benefits from treatment on a research protocol
    5. Perceived social risk of participating in a research protocol
    1. Altruism
    2. Uncertainty
    3. Disclosure of medical information
    4. Wrongs to personhood
    5. Inconvenience

    Author of lecture Beneficence – Ethical Principles in Human Subjects Research

     Mark Hughes, MD, MA

    Mark Hughes, MD, MA

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