Justice – Ethical Principles in Human Subjects Research

by Mark Hughes, MD, MA

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    00:01 The third principle to consider when we're thinking about clinical research is justice.

    00:06 So there are two ways that justice is going to be considered, both in terms of how we select research subjects, and also what we do with the results of research once it's been conducted.

    00:18 So let me talk to you a little bit about, you know, fairness in the selection of a research subject.

    00:23 So the main goal, you know, the main thing that should drive how we decide who a research subject is the scientific goals of the research, you know, how will it best answer the research question? We have a hypothesis, who is the population that's best going to answer that hypothetical question.

    00:45 We should not rely on, you know, we can choose people that are vulnerable, or people that are privileged, or other social factors to decide who the research participants are going to be.

    00:56 It really should be the scientific goals that drive recruitment and enrollment.

    01:01 And then subject selection really should depend on the inclusion and exclusion criteria, you know, so the parameters that we've set for who should be a research participant, what's our research population, define that clearly.

    01:15 And then use recruitment strategies to try to get those that population into the study.

    01:21 Those are the potential groups that we should be targeting for enrollment rather than just going to one segment of the society.

    01:32 Because of historic examples, it's important to consider vulnerability.

    01:37 You know, people when they have a medical condition, especially are vulnerable in some way.

    01:42 But when we're thinking about clinical research, there are other vulnerabilities we need to consider of whether or not to have them be research participants.

    01:51 The three I'd like to focus on are consent-based vulnerability, harm-based vulnerability and wrong-based vulnerability.

    02:00 So in consent-based vulnerability, these are individuals where there's concern that they will be incapable of protecting their own interest, especially in regard to the informed consent process.

    02:13 So we may have individuals that either lack decision-making capacity or have fluctuating decision-making capacity, or, you know, we're concerned that they're going to lose capacity in the future.

    02:27 So for example, you know, a person that might have fluctuating capacity would be person with bipolar disorder.

    02:35 When they're in the midst of their mania or the depths of their depression, they may lack judgment about making sound decisions.

    02:43 Once they're stable with their mental illness, they might be able to have capacity to make decisions, but to do mental health research on individuals with bipolar disorder can be tricky because you need to know, do they have the capacity to be doing the informed consent process and agreeing to be a research participant? For prospective, you know, vulnerability, we might think of a patient with Alzheimer's disease.

    03:07 So in the early stages of dementia, they might be able to make their own decisions.

    03:12 But as the dementia progresses, they lose their cognitive abilities.

    03:16 They may not be able to give voluntary informed consent on their own.

    03:20 They need somebody to speak for them.

    03:22 Are we going to enroll them as a research participant, especially for questions about Alzheimer's disease or about treating the dementia have to make those considerations for consent-based vulnerability.

    03:35 And then they're going to be individuals where they never have capacity or they've completely lost capacity.

    03:42 In those cases, should they even be research participants.

    03:47 There might be particular conditions where it's going to be helpful to learn information about that condition.

    03:53 But again, they will need somebody to speak on their behalf a proxy decision maker to say this is in their best interest.

    04:00 A second kind of vulnerability is harm-based vulnerability.

    04:03 So here, we're concerned that because of the person's personal situation, they're going to be susceptible to additional harm if they are a research participants.

    04:13 So one example might be that they have other comorbidities, they have other medical conditions.

    04:18 They're entering the study, you know, for diabetes, but they also have heart disease.

    04:23 Now, as a research participant, they have additional harms that affect their diabetes, that may be a vulnerability that the researcher needs to consider.

    04:34 Or, you know, there might be psychosocial features of the person's personal situation that puts them at risk for additional harm.

    04:41 So they enter into a clinical research study on a surgical intervention.

    04:48 They don't have insurance, that's their personal situation, they have a complication from their participation in this surgical research.

    04:56 But they now have no means of paying for the additional medical care that came as a result of the research that makes them vulnerable, more susceptible to additional harm.

    05:07 The third kind of vulnerability is going to be wrong-based vulnerability.

    05:11 So here, there's concerns that the person will not be able to protect their rights as a decision maker.

    05:17 So the issue here would be whether there's going to be exploitation or infringement of that person's rights based on their personal situation, perhaps, you know, they're poor, and they're entering research, in order to get medical care.

    05:33 But really, that's going to be exploitative of their situation to be a research participant.

    05:39 All of these kinds of vulnerability needs to be considered as a clinical researcher when you're debating whether or not to enroll certain populations.

    05:50 Also said that justice is about, you know, what do we do with the results once we've conducted the research, so there needs to be a fairness in the application of those results.

    05:59 So a general caveat is, you know, the results of the research should be generalizable to the populations who will eventually use that intervention if it does prove effective.

    06:09 What that means is, who you select as your study group, the study population should include all those people that might potentially use this intervention in the future.

    06:19 So you wouldn't want to, you know, restrict women from being research participants, if you know, in the future that women might, you know, take advantage of this intervention if it proves effective.

    06:30 You know, historically, that was the case, women were denied access to being research participants.

    06:36 So we need to have a broad based population in our study group, knowing if they're going to get the intervention in the future, we need to have answers of how it works in that population.

    06:48 The other caveat, you know, when we're thinking about justice is groups recruited to bear the risks and the burdens of research should also be in a position once the research is done, to share in the benefits if that intervention proves effective.

    07:03 So the stark example here is resource poor countries, they might have populations that are used as research participants.

    07:12 But if they don't have the resources after the fact, if it proves successful, they won't have the means of actually paying for that intervention.

    07:21 That's in a way exploiting that population.

    07:24 So we need to make sure that there are processes and systems in place to make sure they can get the benefits of research if they've been exposed to the burdens and the risks of the research.

    About the Lecture

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

    Included Quiz Questions

    1. Fairness in the distribution of benefits and burdens across society
    2. Vulnerability of people across society
    3. The privilege of a class of people in society
    4. Maximizing the benefits within society
    5. Minimizing the risks within society
    1. A person incapable of protecting their own interests
    2. A person unable to remember their childhood
    3. A person susceptible to additional harm because of research participation
    4. A person with a comorbidity
    5. A person with limited ability to avoid exploitation of their rights
    1. The results should be generalizable.
    2. The results should be accurate.
    3. The results should be peer-reviewed.
    4. The results should be concise.
    5. The results should be relevant to a specific group of people.
    1. By scientific goals
    2. By research of a vulnerable population
    3. By recruitment of upper-class population
    4. By exclusion of wealthy individuals
    5. By exclusion of patients with government-based health insurance

    Author of lecture Justice – Ethical Principles in Human Subjects Research

     Mark Hughes, MD, MA

    Mark Hughes, MD, MA

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