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A New NIH Resource on the Lasting Legacy of Henrietta Lacks

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The amazing and tragic story of Henrietta Lacks became part of the public’s consciousness in large part thanks to Rebecca Skloot’s 2010 book “The Immortal Life of Henrietta Lacks,” which spent 75 weeks on the New York Times Best Seller’s list.  Prior to her untimely death at the age of 31 from an aggressive form of cervical cancer, Henrietta’s doctors at Johns Hopkins extracted cells from her tumor and were able to keep those cells alive and replicating.  These cells, thereafter known as HeLa cells, have helped enable some of the most important advances in biomedical research over the past 65 years.

In 2013, researchers in Germany published a paper that described the full sequence of the HeLa genome.  This publication immediately raised privacy concerns with respect to the Lacks family because of the potential to identify the family’s potential disease risk.  In response to this, NIH partnered with the Lacks family to provide a mechanism for whole genome sequence data generated from HeLa cells to be used to advance research, while respecting the family’s privacy and wishes.

In subsequent conversations with NIH, members of the Lacks family have emphasized how much they value learning about the nature and progress of HeLa cells in research.  This got us here at NIH thinking “how can we quantify the impact of HeLa cells over the past six decades?”

To answer that question, the NIH Office of Science Policy (OSP), in collaboration with the NIH Library recently put together the first ever systematic and comprehensive literature review on the contributions of HeLa to biomedical science.  We have taken the results of this review and have added several new pages to the OSP website that display the data in a powerful, interactive and interesting way

The new pages feature:

  • A timeline of significant research milestones that were enabled by the use of HeLa cells;
  • An interactive world-map where users can scroll to see the number of publications there have been in each of the 142 countries with a publication since 1953;
  • A relational chord chart that shows the interconnectivity between HeLa cells and many essential areas of biomedical research; and
  • Links and information on the most highly cited papers relating to HeLa cells from 1953-2017.

This resource can be accessed at: https://osp.od.nih.gov/scientific-sharing/hela-cells-landing/. While there, you can take a deep dive into how HeLa cells have contributed to the development of the polio vaccine, the advent of recombinant DNA technology, nanotechnology treatment for cancer, and many other impactful applications over the past 65 years.

I invite everyone to take a look at this new resource so that they can get a sense of how important Henrietta and the Lacks family’s contribution to biomedical research has been.  OSP will continue to update the information on the site as necessary so that the site will remain a living testament to Henrietta.  The generosity of the Lacks family has ensured that Henrietta’s legacy will continue to be one of scientific progress and hope for a healthier world.

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The Protocol Template for Behavioral and Social Sciences Research Involving Humans: A New Community Resource!

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A few months ago, back in August 2018, we authored a blog letting the community know that we were working on a new resource for behavioral and social science researchers to prepare research protocols for human studies measuring a behavioral or social outcome or testing a behavioral or social science based intervention. We are now happy to report back that the template has been finalized and is ready for researchers to utilize.  Even better news is that the template has been fully integrated into the NIH’s Clinical e-Protocol Writing Tool!

As you may recall from our previous post, the Behavioral and Social Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template but was adapted to include terminology and approaches used by behavioral and social scientists. While use of the template is not required, we would like to share a few of the reasons why we encourage investigators to take advantage of the benefits it affords.

TOP REASONS TO USE THE NEW BEHAVIORAL AND SOCIAL SCIENCES RESEARCH TEMPLATE

  • The template is an effective resource for communicating the science, methods, and operations of a clinical trial thus allowing for standardization of procedures and guiding replication studies.
  • Consistent use of the template will reduce the chance for inaccuracies in study procedures that could potentially result in null or spurious findings.
  • It fosters training and accountability of study staff and allows for efficient review by peers and oversight bodies.
  • It assists investigators who are less familiar with the information and level of detail expected in a clinical protocol and fully adheres to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.
  • Utilizing the template through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information directly to clinicaltrials.gov.

These are just a few of the reasons that we are excited about this template and why we believe that it is such a valuable resource to the research community.

We also recognize that many researchers involved in clinical behavioral and social sciences research already prepare protocols, whether they be for submission to an IRB or for an operations manual aimed at research staff.  This template can also be an important tool for preparing those documents.

While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation it can be an effective tool to help anticipate decision-points and potential challenges before a study launches, thus helping avoid delays down the road.

We encourage all of our clinical behavioral and social sciences stakeholders to take a look at both the template document and the associated e-protocol writing tool.  We think once you start using these resources you will see the value they offer.  Also, we would appreciate any feedback users have on their experiences with the template and tool.  These resources are meant to be “living” tools that will evolve based on feedback so that they are of maximum utility to the community.

This blog was co-authored by Dr. William Riley, Director of the NIH Office of Behavioral and Social Sciences Research (OBSSR). More information about OBSSR can be found at https://obssr.od.nih.gov.

William Riley
Director of the NIH Office of Behavioral and Social Sciences Research
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GDPR: Crossing the Data Sharing Bridge, One Regulation at a Time

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Like most of you, my personal email last summer was filled with fun invitations, the latest news….and tens to hundreds of emails from companies highlighting new privacy policies, notices, and updates. Behind the immense number of notifications that “we’ve updated our privacy policy” was a new regulation and one of the defining science policy issues of the last decade: the tension between participant privacy and open data sharing.

When it comes to data sharing and biomedical research, most of us have a horse in both races. We want to know and have some control over how our personal data is accessed and shared, and we understand that open science—where researchers share data as freely as possible with other researchers—can skyrocket our ability to find better treatments and cures for patients, which helps us all. Balancing and respecting these different values is complicated. NIH has spent a lot of time and resources staying attuned to participant interests in privacy and autonomy while charting a path that allows for responsible open science and data sharing.

The European General Data Protection Regulation (GDPR) enacted in May last year is the latest regulation on the privacy and data policy block, As Europe’s answer to navigating today’s data-filled, breach-full and not-always-regulated online and business world, GDPR mandates a high level of personal data protection and autonomy for people in the European Economic Area (EEA). GDPR defines personal data broadly—from name and email address to special categories such as health and genetic data—and provides people in the EEA with control over when and how their personal data is collected, retained, passed along, and used. So, given that GDPR was written to protect people in the EEA from data and privacy breaches, and not intended to target biomedical research—where significant protections for individual privacy and the concept of explicit consent already exist—why has the onset of GDPR created barriers for critical research collaborations between NIH grantees and their European research partners?

Not surprisingly, the answer has to do with both GDPR itself and with individual reactions to GDPR. GDPR is not directed at biomedical research, but it does regulate the use, processing, and transfer of personal data collected in the EEA for clinical and observational research. There are legal pathways under GDPR for data collected in the EEA to be transferred to, used and processed in other countries. Unfortunately, understanding how to translate the legalese of these pathways into practice has been confusing, and the costs for non-compliance are high—most recently €50 million for Google in France. As a result, risk-adverse interpretations of GDPR have dominated collaboration discussions between EEA and U.S. research partners and led to delays in EEA-U.S. collaboration. In the absence of an official recognition that U.S. laws ensure an adequate level of protection (an “adequacy decision”), and with the NIH unable to use standard, GDPR-approved data protection clauses (as they conflict with U.S. law for federal agencies), the NIH is exploring GDPR’s other legal options for data sharing. These include relying on explicit consent from participants, defining data transfer as being in the “public interest,” and adherence to an approved, sector-specific code of conduct (to date unwritten). A code of conduct is particularly compelling, as it should serve as an implementation manual, providing clear, concise guidance to EEA and non-EEA researchers and research institutions on how to ensure GDPR protections for personal data when collaborating.

Given the current uncertainty, and the likelihood that any “solutions” to GDPR for biomedical research will take time, what does all this mean for NIH-funded researchers now? Fundamentally, it means that it is never too early to begin the time-consuming but necessary data privacy and data sharing discussion with potential collaborators in the EEA. While such discussions are leading to glimmers of light at the end of tunnels for currently halted collaborations, it sure would be preferable to resolve issues before research is scheduled to begin. We are interested in hearing from you about any GDPR-related problems or resolved issues and will certainly keep you updated on our experiences. In the midst of all this work, I am reminded that GDPR presents us with great opportunities as well as challenges. If we can harmonize consent and data sharing between U.S. and EEA researchers, we will be able to pool analysis of genomic and other health data and tissue samples, powering new and innovative trials and advancing the science of the future.

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Investing in Bioethics Research to Inform Science Policy

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I am a big believer in policies based on evidence. I am also a big fan of ensuring that all of the research that NIH funds upholds the highest ethical standards. Where those two interests collide is in the funding of bioethics research. To that end, NIH has published advanced notice of an upcoming funding opportunity announcement that will give NIH-funded researchers the opportunity to apply for administrative supplements that would advance our knowledge of bioethical issues, which could then be used to inform policy endeavors.

The scope of the funding opportunity announcement will be broad and would support expanding grants that already include bioethics research efforts. It would also allow for the addition of a bioethics component to a grant in which bioethics was not the primary focus. Potential research topics that may be funded through this opportunity include, but are not limited to, new and emerging technology development and use, clinical and non-clinical data sharing, and research privacy and security. Through this program, NIH intends to fund at least 10 awards.

While applications for this funding opportunity announcement are not currently being accepted, we wanted to provide the research community with plenty of notice of our plans so that they could begin thinking of ways and places where bioethics could substantially impact research and policy. We anticipate that NIH will publish the funding opportunity announcement in early 2019.

Supporting development of an evidence base to ensure that our ethical responsibilities are not outpaced by our science isn’t a novel idea. NIH has proudly supported bioethics-related projects and programs over the last two decades.  For example, NIH funded a robust literature survey on participant preferences for using deidentified biospecimens for future studies, and a large survey of prospective research participants views on broad consent. This research was cited in comments on the 2015 Notice of Proposed Rule Making (NPRM) to revise the Common Rule.

What are your ideas for research questions that can help deepen our understanding about bioethics and build the foundation for future policy considerations or discussions on ethical issues related to biomedical research? We are excited to see your innovative proposals.

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