Scientific Validity and Authorship in Clinical Research

by Mark Hughes, MD, MA

My Notes
  • Required.
Save Cancel
    Learning Material 2
    • PDF
      Slides Scientific Validity and Authorship in Clinical Research.pdf
    • PDF
      Download Lecture Overview
    Report mistake

    00:01 Another important concept in the responsible conduct of clinical research is scientific validity.

    00:07 So this is using accepted scientific principles and methods, you know, how we do science is we generate a hypothesis, we create a design to try to answer that hypothesis.

    00:20 And then once we collect the data, we analyze that to come up with results.

    00:25 So that as part of the scientific validity of performing research.

    00:30 We have to make sure that the statistical techniques that we use are appropriate to the type of research that we're conducting.

    00:37 And we have to ensure the integrity of the data.

    00:40 So, the way it's been collected, stored, and analyzed, has to ensure that there's accuracy, reliability and validity to that data.

    00:54 Another important thing that has gained increasing attention in recent years is the concept of reproducibility.

    01:01 So we need to know that something is valid by the fact that it can be repeated.

    01:07 Certainly in basic science, you know, bench research, you can repeat experiments and prove reproduce but in that way by experiment after experiment.

    01:16 A little harder in clinical research but you have to have a study design that shows that a result could be reproducible if done again.

    01:26 And also, you know, it's important for the researcher, once they have generated this knowledge once they wish to, you know, promulgate their results, they need to put that in the context of what is already existing in the scientific literature.

    01:40 So what are the significance of these findings relative to the existing knowledge.

    01:46 One way they are going to do that is through publication.

    01:49 So there are also things we need to think about in terms of being an author, if you're a clinical researcher and going to publish your work.

    01:56 There are four concepts for responsible authorship.

    02:00 The first is the idea of credit.

    02:03 So this is called contributorship.

    02:06 So if you've contributed to the research, if you have, you know, helped with the creation of the research and the results, and the analysis of the results, then you should be given credit for your work and becoming an co-author, for instance, on a publication.

    02:24 An author also has to have demonstration of responsibility that they guarantee the work.

    02:29 So they will stand behind the work, they will say that I've done this and you know, proven scientific method, my results are valid, I guarantee the work, and that when they put their name on it, that's a demonstration of their responsibility to defend the work.

    02:47 As mentioned, there has to be transparency.

    02:49 So if our aim is increasing knowledge, one of the core concepts there is truthfulness.

    02:54 So reporting things honestly, being transparent in how you've performed the research, not hiding things, not obscuring things, really being transparent in how you're reporting.

    03:07 And then lastly, there needs to be accountability.

    03:09 So if there are questions, you know, there could be, you know, rigorous scientific debate about how you design your study, or how you analyze the data.

    03:20 You know, that's part of, you know, being in the scientific community, people will question the work and want to understand it.

    03:27 So you have to be accountable to the work.

    03:29 If there are concerns that there's been some sort of misconduct, that also means that there needs to be accountability.

    03:36 And we'll talk about that.

    03:37 The other ways that it's important to think about accountability in especially clinical research, is what are we doing in terms of accountability to the research subjects.

    03:47 So editors of journals, we want to make sure that there's been adequate protection of research subjects, that there's been an informed consent process, that there has been means to protect the identity or the personal information of research subjects, so issues of confidentiality and privacy.

    04:04 And the you know, the biggest one is just the integrity of the work and the integrity of the researcher.

    04:10 That also speaks to accountability.

    04:13 So the International Council for Journal Medical Editors, something called the ICJME, has created guidelines for who should get authorship credit.

    04:24 And a lot of journals adhere to these four criteria.

    04:28 Again, I would refer you to your own institution, your own jurisdiction, about how to think about things, it may be a little bit discipline specific about how these things are done.

    04:38 But in general, these are the four criteria you should be thinking about in order to receive credit as an author.

    04:45 First of all, you need to have substantial contribution to the conception and design or the acquisition of the data or the analysis and interpretation of the data.

    04:54 So in some way, an intellectual contribution to that research.

    05:00 Second, so it's an actual manuscript that's being developed that's going to be published with, you know, authors attached to it.

    05:07 You have to draft the article or revise it critically for important intellectual content.

    05:13 Third, you're going to make sure that you have sufficiently participated in the work to take public responsibility for it, that's part of the accountability.

    05:21 So whatever portion of the work that you were responsible for, that you are going to be accountable for it and take public responsibility for it.

    05:29 And then fourth, once it is published, you know, once a journal decides to publish this manuscript, you need to give final approval of the version to be published.

    05:41 So to be an author, you have to fill all four criteria.

    05:46 Now, there are also things that, you know, are going to be discipline specific about how you give credit to people.

    05:53 One way that's done might be authorship order.

    05:55 So how your name appears on a byline that really decisions about authorship order should be discussed at the outset of a project, you know, determining what the criteria going to be for fulfilling a particular designation, whether you're the first author, the second author, the last author, all of that needs to be negotiated with your co-authors, your co-researchers.

    06:18 And it also means that, you know, as a project evolves, it might change over time, your responsibilities might change.

    06:25 Your authorship order might also change based on your contribution to the manuscript and to the research.

    06:32 There are other things about being a responsible member of the scientific community.

    06:36 So one is giving them credit for the work that they've done, and the contributions they've made to this knowledge-based that we all rely on.

    06:44 So one is allocating credit.

    06:46 The other is this idea of collegiality that we should all be working together as scientists, as researchers, that we're all trying to increase knowledge in an effort to, you know, enhance health and well-being that should be a collegial atmosphere, not a competition between scientists.

    07:05 It's also important to think about the next generation of scientists and researchers, that there should be opportunities for advising and mentoring.

    07:14 And when a person is a mentor, that they have certain responsibilities to their trainee to make sure that they learn science well, and learn the ethical principles that undergird that science.

    07:26 And lastly, being a responsible member of the scientific community means that you have interaction with the larger community, the larger society, that you are communicating your results, trying to make them understandable to the non-scientist, especially when it has implications either for public health, for medical care, for future medical care.

    07:49 All of these things need to be communicated in a way that makes science tangible for everybody, not just the scientific community, but all people in society.

    07:59 So there are lots of things to consider in being a responsible researcher, especially responsible clinical researcher.

    08:06 Again, the three most important things are going to be make sure you earn the trust that has been put in you to be a researcher.

    08:15 Make sure that you are adhering to your own integrity and to the integrity of the data and the research enterprise.

    08:21 And making sure if you're a clinical researcher and you're involving human subjects that you are protecting the rights and interests of those participants in research.

    About the Lecture

    The lecture Scientific Validity and Authorship in Clinical Research by Mark Hughes, MD, MA is from the course Clinical Research Ethics.

    Included Quiz Questions

    1. Scientific principles and methods
    2. Inappropriate statistical methods
    3. Data storage
    4. Unique findings
    5. Singular finding
    1. Memorization
    2. Credit
    3. Responsibility
    4. Transparency
    5. Accountability
    1. Informed consent process
    2. Release of personal data
    3. Patient integrity
    4. Patient longevity
    5. Morality of patients

    Author of lecture Scientific Validity and Authorship in Clinical Research

     Mark Hughes, MD, MA

    Mark Hughes, MD, MA

    Customer reviews

    5,0 of 5 stars
    5 Stars
    4 Stars
    3 Stars
    2 Stars
    1  Star