Responsible Conduct of Clinical Research

00:01 In this lecture, we're going to talk about responsible conduct of clinical research.

00:06 There are two main considerations when we're thinking about the responsible conduct of clinical research.

00:12 First, you know, like any kind of research, not just clinical research, it's important to maintain the integrity of the researcher and the validity of the results.

00:23 A second consideration when we're thinking about clinical research is that we also have to think about the human subjects.

00:28 So we need to protect the rights and interests of that research participant.

00:35 Trust is at the core of responsible conduct of research.

00:39 So trust in the research endeavor is enabled by a few different things that are done either externally or internally.

00:46 There may be professional codes that ensure that researchers are acting responsibly.

00:52 So for instance, there's the Declaration of Helsinki, which was developed by the World Medical Association in the 1960's and has been revised over the years.

01:01 There's something called the Council for International Organizations of Medical Sciences (CIOMS).

01:07 And they've created an international ethical guideline for health-related research involving subjects or humans.

01:13 And there's also the International Conference on Harmonization.

01:17 And they've come up with something called Good Clinical Practice GCP.

01:20 So these are sort of professional codes or guidelines that tell a researcher the things they need to pay attention to, to be a responsible clinical researcher.

01:30 There may also be government regulations, an external body that makes sure that researchers are acting responsibly.

01:37 So for instance, in the United States, we have something called the common rule.

01:40 So any institution that receives federal funding to conduct research has to abide by the common rule.

01:48 For investigators that work with drugs and devices, they may also have to follow the Food and Drug Administration or FDA regulations.

01:57 So again, it's means of making sure that the government is allowing researchers to do research, but that are adhering to certain rules.

02:05 If a researcher is at an institution, there may also be institutional policies or guidelines about proper conduct and conducting clinical research.

02:13 And then lastly, there may be personal convictions.

02:16 So the internal motivators that have a researcher make sure they are acting responsibly conducting research in an appropriate way.

02:28 So what are the ethical foundations for scientific integrity? So if we think about science in general, what is the aim of science? It's to create knowledge.

02:38 So the actual research endeavor itself, you know, creates knowledge, we learn from it.

02:43 But also, science, as you know, broad discipline, we get all this accumulated knowledge over time, that's reflected in the scientific literature.

02:53 So, all of that is what science is seeking and creating knowledge.

03:00 So, when we think about the ethics of that, the first thing is deontology, which is duty based ethics.

03:06 So the idea of we need to uphold honesty and transparency in conducting our research, we have to follow rules that we are actually perpetuating and fostering knowledge rather than obscuring or deviating from truthfulness and transparency.

03:24 So a knowledge base is only useful if it is accurate.

03:27 So one of the aims of being a scientist, the ethical foundations for that is we present things accurately and truthfully.

03:36 You could also use virtue theory as an ethical foundation for scientific integrity.

03:41 So here, if you recall previous lectures about virtue theory, this is habits of character that disposed person to do the right action.

03:50 So in this case, if our aim of science is to increase knowledge, and the role of the scientist in society is the knowledge maker, then you're virtuous as a scientist if you have habits of character that always have you conduct research properly.

04:08 Now, there are certain concepts we need to think about for clinical research.

04:13 First, is that the science itself the research has to have social and/or scientific value.

04:21 So when we're thinking about clinical research, in particular, and in some way has to lead to improvements in health and well-being so we're pursuing it with that aim in mind.

04:31 Now, maybe that a particular research project, you know, it does generate knowledge but it may not lead to immediate practical application.

04:39 But nonetheless, that might be foundational to understanding how the body works, so that eventually there might be treatments or other things that do improve health and well-being.

04:50 So another reason that we need to think about the social or scientific value of research is because they are only finite resources in allowing research to happen, so we need to make sure we use those resources wisely.

05:04 Make sure you know, especially when it's use of human subjects that we're avoiding any kind of exploitation.

05:10 So we need to know that the research is going to be valuable in improving health and well-being at some point in the future.

05:16 We could say that research is not a value if one it has either substantial overlap with what's already known or we already have proven results about or the results are unlikely to actually be disseminated or the intervention that's proposed in the research could never be practically implemented, even if it were proven effective.

05:36 So it has to have value in and of itself but then have value downstream in terms of improving health and well-being.