by Deanne Dunbar Dolan, PhD
I write today to encourage ELSI scholars to deposit their published and unpublished research tools into the Research Tools repository on ELSIhub.
Since 1990, the ELSI Research Program at the National Human Genome Research Institute (NHGRI) has contributed meaningfully to the formation of a field of study focused on the ethical, legal, and social implications (ELSI) of genetics and genomics. Beyond investigator-initiated grants, NHGRI has supported training programs, Centers for Excellence in ELSI Research (CEERs), and most recently, the Center for ELSI Resources and Analysis (CERA), charged with developing “a more synergistic and integrated ELSI research community” by convening transdisciplinary projects and meetings and providing a platform for ELSI researchers to “share their research tools and products.” According to Google Analytics, the CERA platform, ELSIhub, has logged over 13,000 visitors since it launched in November of 2020. Over 170 ELSI researchers have contributed a profile to the ELSI Scholar Directory and some have contributed to the listings of ELSI-related jobs and events.
The CERA responds to calls to streamline the ELSI field like international genomic science, which has instituted common research platforms, open access policies to support data sharing, and other enhancements to collaboration. Advocates of extending this collaborative approach to ELSI hoped a common online platform would liberate ELSI from its national silos; improve the responsiveness of ELSI researchers to developments in genetics research and society; enhance translation by offering advocates and the public direct access to ELSI research products; reduce isolation of ELSI researchers who may find themselves adrift of traditional disciplinary and regional support structures; and integrate localized inquiries into a single, “effective, economical, [and] efficient” ELSI field.
So why research tools? In the 1990s, an intensely competitive environment that impaired collaboration among human genome researchers led to a call from the National Institutes of Health (NIH) Working Group on Research Tools (an advisory committee to then NIH Director, Harold Varmus) for the agency to “use its full moral and legal authority to promote the freer sharing of research tools between scientists”. The Working Group recommended that the NIH require grant recipients to license patentable inventions on reasonable terms and exercise its legal right to use without charge or permission any patented research tool arising from research that it funds. The recommendations were intended to end the common practice of protracted negotiations over materials usage terms between investigators, universities, and industry, some of which included a right of approval before publication and even “reach-through” legal provisions intended to claim the right to all future discoveries created with the shared materials.
Unlike in genome science context of the 1990s, where the “research tools” of concern were life science staples like reagents, monoclonal antibodies, and transgenic mice, the materials to be traded in the ELSI universe include validated and yet-to-be validated survey instruments, qualitative interview guides, and consent form templates. Not only is there no ethical justification for the inefficient use of research resources—for example, asking taxpayers to pay for the remake of any research materials—but ELSI research, which can claim many normative investigators taking their first steps into the empirical world, has much to gain from facilitating work with expertly crafted research tools. Imagine the impact on the ELSI knowledge base if investigators were supported to sort out a set of validated surveys on oft-explored issues (e.g., psychosocial or behavioral responses to genetic risk information, genetics literacy, etc.) and encouraged to reuse them to firmly establish central tenets of ELSI knowledge or, at least, find out exactly how local particularities may undermine universal truths. While there are significant differences between ELSI research and genome science, if patents on and secrecy about research materials constituted a barrier to the advancement of genetic science in the 1990s, might neglecting to share research tools do the same in the ELSI context?
The modern day result of the above efforts by Varmus and others is the Sharing Research Resourcessection of the current NIH grants policy statement (applicable to ELSI grants) which states: when “resources are developed with NIH funds . . . it is important that they be made readily available for research purposes to qualified individuals within the scientific community”. This statement applies to all tools with the exception of those that qualify as a patentable invention arising from a federally funded research project, per the Bayh-Dole Act. Recent NHGRI ELSI funding opportunity announcements reference this Sharing Research Resources policy and ask grant reviewers to comment on the reasonableness of applicant Resource Sharing Plans for research data sharing, genomic data sharing, and model organisms, but not research tools. Without increasing applicant burden by requiring that ELSI researchers deposit research tools in the NHGRI-funded Research Tools repository on ELSIhub, when applicable, grant peer-reviewers could identify and reward this service to the field as a welcome enhancement to applicants’ data sharing plans.
In the absence of a mandate, there are also many good reasons why ELSI researchers might volunteer to contribute research tools to ELSIhub. Shared ELSI research tools promise benefits to both the field of study and individual ELSI scholars. Among benefits to the ELSI field are:
1) the ability to compare results across studies,
2) the ability to pool data to construct larger sample sizes,
3) enhanced ability to synthesize published findings,
4) improved methodological transparency and study reporting, and
5) more efficient use of research resources, including public money and academic labor.
Further, depositing research tools into a centralized repository, offers direct benefits to individual researchers, such as:
1) the ability to see what exists and use it instead of developing new instruments,
2) citations by those who use your published instruments,
3) enhanced visibility for your scholarship, and
4) the possibility of having your results confirmed by others.
If you would like to donate published or unpublished research tools to ELSIhub to advance empirical ELSI work at this important moment—the start of the fourth decade of ELSI inquiry—please visit the Research Tools FAQ page or contact the CERA at firstname.lastname@example.org.
COI: The author is funded by the CERA, which is sponsored by NHGRI.