Margaret Henderson gave a presentation on the role medical librarians can play in helping researchers comply with data management policies and plans. She discussed several examples of data issues in published research that led to retractions or controversy. Her presentation covered investigating local and funding agency policies on data, creating guides to data resources, conducting reference interviews to understand researchers' data practices, and focusing on key elements like data description, sharing, and preservation when developing data management plans. The overarching message was that by learning policies and helping navigate resources, librarians can reduce administrative burdens for researchers and help ensure compliant and reproducible research.

1. MIS Webinar 2016 – Margaret Henderson
1. Good afternoon. Thank you to the Medical Informatics Section for the invitation to speak
with you today. I have been working with many researchers throughout my university for
the last three years, and over the last year and a half, I’ve been doing more with the
School of Medicine and our Center for Clinical and Translational Research in the area of
data education for clinical trials and quality improvement research. Since this talk is
short, I have knowingly added quite a bit to my presentation and included helpful URLs,
so you can get it from the MLA website or slideshare later and read more about what I
was covering.
2. First, I like to point out why it can be helpful to have a knowledgeable person to help.
There are many disaster stories involving data. This story is about the data from a trial
on treatments for chronic fatigue - (PACE = Pacing, graded Activity, and Cognitive
behaviour therapy; a randomised Evaluation). An outside researcher sued to see the
data after a subset of the main trial was published in PLOS ONE, which has a data
sharing requirement. The study researchers and university didn’t want to share and it all
ended up going to trial, and a court would not agree to the university’s attempt to prevent
the release of data.(DWP = Department of Work and Pensions)
3. This controversy has called into question all the study data. Commentators have pointed
out many flaws in the study methodology, even without being able to see the dataset.
The original trial was in LancetOpen, and you can see there have been many comments
published in Lancet, as well as continuing, new comments in PubMed Commons.
4. All types of research can have problems, in many cases because of missing data. In this
cancer research, a paper has been retracted because the authors can’t supply the
original images to prove there was no image manipulation. Of note with this case is the
fact that the retraction came 10 years after the paper was published, which, as we shall
see, is past the federally required limit for data retention.
5. So with all these problems what can a librarian do to help, especially one with no
biomedical research experience. Even though we know our jobs are more than the

2. students who wrote this realize, the final point, talk and communicate with people, is very
important.
6. I think Medical Librarians can do the most good if they learn about policies, resources,
and data management planning, and then help researchers navigate through these
things, especially the policies. After reading the Cornell report on streamlining research
administration, I think that policy and resource knowledge can be considered shadow
work - work that is done by a researcher that was probably done by somebody else in
the past - and helping with policy compliance and keeping abreast of research resources
can help reduce the administrative burden most researchers are dealing with.
7. So, you need to start with the basics. Investigate local policies that might apply to the
researchers you are trying to help. For instance
8. What is Data? What is your local definition,
9. This is from my institution - quite extensive - but you need to find out what your
institution considers data. And you’ll need to learn what funders consider data as well.
10. And make sure you know who owns the data and who is responsible for it. Grant funded
research is usually owned by the institution but for clinical trials, the sponsor might be
the the owner of the data.
11. There may be other local policies as well - such as these examples from Duke.
12. Be sure to know outside policies, especially in relation to funding agencies,
13. For most NIH funded biomedical research you need to know about the NIH public
access policy
14. The NIH data sharing policy, which will soon apply to all grants, not just the large ones,
15. The NIH genomic data sharing policy

3. 16. And of course the one policy to rule all the federal agencies,
17. Most OSTP policies have some variation on providing public access to data that
supports peer reviewed publications, as well as public access to the articles.
18. As Kevin has, NIH is working on various ways to make funded data available, but it is
important to note, that they have withheld funds when PIs aren’t in compliance with the
public access policy, so it will be important to comply with the data policy when it is
finalized.
19. FDA will have similar requirements to the NIH
20. This new SPARC website can help you keep up with them all.
21. As a side note, given this week’s election, even if there is no OSTP memo in the future,
we still need to do these things for good science.
22. There is a new Final Rule for clinical trial reporting that needs to be followed - and the
ClinicalTrials.gov website provides information, tutorials, and access to webinars.
23. As you can see in the yellow box, there will be new requirements in January. There are
so many new policies in so many areas, knowing about policies can be of great help in
many institutions.
24. Clinical trials now must be registered and summary results must be posted, and there
needs to be plan on how results will be shared
25. There are many other guidelines and policies from different agencies and organizations
26. that can apply to clinical trials and quality improvement research.
27. So you can see, policies cover a lot of area.

4. 28. While many research labs have a Research Associate or some other personnel who
runs trials, it can still be helpful for biomedical librarians to understand what researchers
need to do for these policies.
29. Make sure all peer reviewed articles can be put in the appropriate repository for public
access
30. All grants will need a DMP, even if it just states why data can’t be shared.
31. And digital data needs to be shared in the way the grant or agency requires.
32. And as we’ve mentioned, clinical trials need to be registered and final data submitted.
33. And ClinicalTrials.gov has a list of reasons why if researchers are uncertain.
34. Understanding something like these data element definitions, which are very similar to
fields used in cataloging or database indexing, is one area librarians could be of help to
researchers.
35. So once we learn some policy, what can we do next to support biomedical research.
36. I suggest, that in order to help facilitate research at our institutions, we make sure we
know what resources are available to researchers.
37. I conducted an institutional inventory to bring together resources from around my
university. We had a listing of registered core facilities that worked under various grants,
but no central listing of resources.
38. So I pulled together local, licensed, and free resources into a LibGuide that can be used
by everyone. Computing resources are especially important - everyone is looking for
somewhere to store their data. I talked to people providing these services as well so I
can send researchers to the right person.

5. 39. It may be that your institution already has a similar resource, like this one at Duke.
40. And as I mentioned, don’t forget free resources such as DMPTool for data management
plans,
41. Or YODA for those who want to reuse clinical trial data.
42. Once you learn about the resources, it becomes easier to help with planning.
43. I’ve said this before in other talks, but we really need to make sure we conduct a good
reference interview before starting on a data management plan. Getting researchers to
explain how they are collecting data, where they are putting it, how they are using it, and
why they need it can help you understand what they are doing, but talking through things
with somebody new can also help the researcher discover things that could be an issue
in the future.
44. When working on a data management plan that will become part of a grant, I try to focus
on these 6 elements.
45. As mentioned earlier, policy might dictate who is responsible for the collected data.
46. There are many types of data, and there are many ways to insure data security. Your IT
security office should be able to help with this.
47. Describing data is one role librarians can be very helpful with.
48. The IOM (link will be shown later) recommends common data elements for clinical trial
protocols which will be a big help when doing metadata analysis in future.
49. Sharing data is common to most policies.
50. Before researchers get worried about having to share all raw data, it is important to find
out what actually needs to be shared. NIH expects something different than the OSTP

6. memo, and other agencies have requirements..
51. ClinicalTrials.gov has a nice table about why summary data should be shared and who
benefits.
52. And many journals have specific expectations when an article is published.
53. There are many ways to share data. This is a short list of general, open resources, but
there are many subject repositories, institutional repositories, and government
collections that could be used. Again, check to see what the grant requires or find out
the disciplinary norm for sharing.
54. And remind researchers to be cautious when signing contracts for publication, to be sure
data is not being signed over to a publisher.
55. No, we aren’t done with sharing yet.
56. The best resource for learning about sharing clinical trial data is the IOM report that
provides recommendations for when and what needs to be shared during trials.
57. Basically, there are two main ways to share trial data. A registry that requires an
application to access the data, with IRB approval. Or protecting personal information in
some way and then providing public access to the data.
58. But even when data must be shared, most researchers will want some control over what
is done with it,
59. Despite the fact that data reuse can be very important.
60. There are a couple of ways to license data, and the IOM report says…”Employ data use
agreements that include provisions aimed at protecting clinical trial participants,
advancing the goal of producing scientifically valid secondary analyses, giving credit to
the investigators who collected the clinical trial data, protecting the intellectual property

7. interests of sponsors, and ultimately improving patient care.”
61. The final part of the plan is preserving the data
62. Preservation involves all the data, not just the data that must be shared. As noted at the
beginning, even though the state or grant might require a specific amount of time for
saving the data, it is good to keep data supporting tables and figures in an article as long
as possible in case there are questions about that results.
63. And in cases where there are print records, make sure security, storage, and destruction
of records are considered. Contact archives or records management at your institution if
you aren’t sure.
64. So, in summary,
65. And if you want more in depth information on research data management or policies, I’ve
done a couple of other talks that cover these things.
66. And I’m always happy to answer questions.