Research on alternative treatments for fever due to infectious diseases

Mary admires the NIH-funded work of her postdoctoral advisor, Henryk, who pioneers research on alternative treatments for fever due to infectious diseases. Mary is one of many co-workers who has assisted Henryk in compiling the most comprehensive database ever assembled, tracking many different infectious agents, species of animals, and different interventions and their outcomes. Henryk’s interpretation of this rich dataset suggests that some “alternative medicines” are highly effective in certain species, but have no therapeutic value in others. He is completing his analysis and interpretation, and is preparing a manuscript for submission. Mary will be a co-author because of her part in collecting data for the study.
Mary is preparing to seek an Assistant Professor position and wants to build on her postdoctoral work. She asks Henryk for permission to use the dataset to develop her own project. However, she plans to use a different methodology for analysis and interpretation of the dataset to address a different aspect of the outcomes of treatment. At that point, she will develop a career development proposal to submit to the NIH.
Henryk is unwilling to share the entire dataset prior to publishing his interpretation of these data. However, Mary has access to the database as part of her current project, and therefore she decides that it is ethical for her to look more closely at the data. Mary spends quite a lot of time looking at the data and Henryk’s analysis, and realizes that he has excluded specific datapoints that impact his interpretation. Henryk’s draft manuscript carefully justifies the exclusion of these data in the methods section so that there is no issue with data falsification.
Mary realizes that if she includes these datapoints, an entirely new understanding of therapies to treat fever could emerge. Mary is excited about her impending grant proposal, but is concerned about how to broach the discussion of her use of the data with Henryk.
Discussion Questions

  1. Must Henryk share his database with Mary before publication? After publication? Must he share it with others, outside his lab, and if so, when?
  2. Who owns the database at this point: Henryk? The institution? NIH? The public?
  3. Why is sharing a dataset beneficial to the person who collected it? How is it potentially risky?
  4. Is Henryk obligated to document how datapoints were included or excluded in the methods section of his paper?

Full Answer Section

      Henryk is not obligated to share his database with others outside his lab, unless the research was funded by a public agency, such as the NIH. In that case, he would be required to share his data with other researchers who request it, after a reasonable embargo period. The embargo period is a period of time after publication during which the PI is given exclusive access to the data. This allows the PI to publish their findings first and to get a head start on future research. The embargo period for NIH-funded research is typically 12 months. Who owns the database at this point: Henryk? The institution? NIH? The public? The ownership of the database depends on a number of factors, including the source of funding, the employment agreements of the researchers involved, and the policies of the institution where the research was conducted. In general, the institution where the research was conducted is the owner of the database. However, the PI may have some rights to the data, such as the right to publish the results first and the right to get a head start on future research. If the research was funded by a public agency, such as the NIH, the public may also have some rights to the data. For example, the NIH requires that all data from NIH-funded research be shared with other researchers after a reasonable embargo period. Why is sharing a dataset beneficial to the person who collected it? How is it potentially risky? Sharing a dataset can be beneficial to the person who collected it in a number of ways. First, it can help to accelerate scientific discovery by allowing other researchers to build on the work of the original researcher. Second, it can increase the visibility and impact of the original researcher's work. Third, it can help to ensure the transparency and reproducibility of the research. However, sharing a dataset can also be risky. For example, the researcher may lose control of the data and it may be used for unintended purposes. Additionally, the researcher may be criticized for their methods or their interpretation of the data. Is Henryk obligated to document how datapoints were included or excluded in the methods section of his paper? Yes, Henryk is obligated to document how datapoints were included or excluded in the methods section of his paper. This is important for transparency and reproducibility. It also allows other researchers to assess the validity of the study and to determine whether the results can be generalized to other populations or settings. Additional Considerations In the case of Mary and Henryk, there are a few additional things to consider. First, Mary has already had access to the database as part of her current project. This means that she has a good understanding of the data and has already spent a lot of time analyzing it. Second, Mary plans to use a different methodology for analysis and interpretation of the dataset to address a different aspect of the outcomes of treatment. This suggests that her findings are unlikely to be the same as Henryk's findings. Third, Mary plans to develop a career development proposal to submit to the NIH. This means that she is serious about her research and is committed to making a contribution to the field. Conclusion Henryk is not obligated to share his database with Mary before publication or after publication. However, there are a number of factors that suggest that it would be in his best interest to do so. First, Mary is a co-author on the study and has already had access to the database. Second, Mary plans to use a different methodology for analysis and interpretation of the dataset to address a different aspect of the outcomes of treatment. Third, Mary plans to develop a career development proposal to submit to the NIH. If Henryk shares his database with Mary, he could benefit from her expertise and insights. Additionally, he could help to accelerate scientific discovery and promote collaboration within the field.  

Sample Answer

   

Must Henryk share his database with Mary before publication? After publication?

Henryk is not obligated to share his database with Mary before publication. He is the principal investigator on the study and has the right to decide when and how to publish the results. However, it is customary for PIs to share their data with their co-authors before publication so that they can review the analysis and provide feedback.

After publication, Henryk is still not obligated to share his database with anyone. However, he may be required to do so if the research was funded by a public agency, such as the NIH. The NIH has a policy requiring data sharing for all research that receives funding from the agency.