Tag: Biosecurity

Staying Ahead of the Curve on Chimeras

Posted on

One of the truisms of science policy is that developments are often reactive, in response to external events or breakthrough leaps forward in science and technology.  Thoughtful, deliberative policymaking on emerging fields of science and biotechnologies is challenging, particularly since unpredictability is inherent in the very nature of scientific discover.  Simply put, the wheels of science often turn faster than the wheels of policy.

Today, NIH published a notice in the NIH Guide for Grants and Contracts announcing the agency would “not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos” while we consider a possible policy revision in this area.   As described in the Guide notice, this is an exciting area of science that is rapidly progressing, but in which ethical and animal welfare considerations might merit additional guidance to move forward.  This is a unique opportunity to take a deep breath, look at the state of the science, and think about current policies and consider whether any additional policies are needed to promote the responsible conduct of this promising science.

Of course, thinking about the ethical considerations related to the formation of these types of animal-human chimeras is not new.   In 2005, the National Academies Guidelines for Research on Human Embryonic Stem Cells urged caution for experiments in which human embryonic stem cells were introduced into non-human embryos, suggesting both restrictions and additional consideration might be necessary.  NIH adopted several of those provisions in the 2009 NIH Guidelines for Human Stem Cell Research. While the Academies report pre-dated the discovery of the ability to create induced pluripotent stem cells, the ethical considerations raised remain resonant.   Advances in cellular technologies and gene editing present opportunities to address interesting scientific questions and propel progress in regenerative medicine.  They also illustrate that the time is ripe to proactively consider whether additional ethical considerations should be put into place to guide the science moving forward.

Moving forward, NIH will bring together experts in the field to discuss the state of the science: what are the aims of research involving early stage chimeras and what are the advances on the horizon?  This discussion will help serve as a foundation to consider policy needs going forward.  In other words, thoughtful, deliberative policymaking at its best.

Blog Roll

Genomic Data Sharing: Part II – Playing by the Rules

Posted on

The discussions surrounding the Precision Medicine Initiative (PMI) have highlighted some of the policy challenges inherent in balancing the sharing of valuable research data with the protection of participants whose data is being shared. How do you ensure that researchers, and even participants themselves, have appropriate access to data while making sure that the data is not inadvertently or deliberately released or misused in a way that might present a risk to participants?

As mentioned in the last blog post: Part I – Enhancing Consent through the NIH Genomic Data Sharing Policy, the NIH is not new to this, of course, and has had success in developing policies that support the sharing of data that also harbors information about the disease status of research participants.  The NIH Genomic Data Sharing (GDS) Policy, which became effective on January 25, 2015, and its predecessor, the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS) have enabled the sharing of potentially sensitive genomic and phenotypic data from NIH-funded studies.  The ethical principles and privacy safeguards incorporated in the GDS Policy enable secondary use of NIH genomic data while respecting participant autonomy and protecting privacy.

These protections have been built into both the submission and access stages of the genomic data sharing process.  When investigators submit data, their institution must assure, through submission of an Institutional Certification, the appropriateness of the data submission as well as the secondary use of the data, based on the consent of the participants.  When qualified investigators seek access to the  data, they must describe how they intend to use the data through a Data Access Request (DAR) in the database of Genotypes and Phenotypes (dbGaP) and promise, through a  Data Use Certification (DUC) Agreement, to adhere to the GDS Policy’s ethical principles, terms of data access, and privacy safeguards.  Before access is granted, each request is reviewed by an NIH Data Access Committee (DAC) for consistency with the appropriate data uses, as outlines by the data submitters, and Policy expectations.

Since 2007, and under the GWAS Policy, approximately 3,700 datasets have been submitted and made available in dbGaP for secondary research, and nearly 21,000 access requests from over 3,300 investigators from 46 countries, have been approved by NIH.  Of the large number of approved requests, we can say that approved users of the data have adhered to the terms of Policy most of the time, and that only 27 violations of the Policy (out of the 21,000 approved requests) have been reported.  The figure below provides a schematic of this, as well as the general categories that these violations fall under.  Policy compliance violations, also known as data management incidents, have occurred in both the submission and access processes as well as in data security.  For example, in one case, an investigator accidentally reversed the labels for two datasets in a data submission, such that a dataset meant only for disease-specific secondary research was made available for general secondary research use and vice versa.  Fortunately, the mistake was discovered before the data were improperly used.  The datasets were then reconfigured with the appropriate use categories and made available again to the research community.  NIH has also made a similar mistake in handling the data once it was received.

In all Policy compliance violation cases, NIH has worked cooperatively with the violator to remedy the situation.  Most importantly, however, and to the best of our knowledge, none of the 27 Policy compliance violations have resulted in harm to the research participants from which the data were generated.  Additional information on Policy compliance violations and specific cases, as well as other statistics on data submission, access, and use, are available on the Facts & Figures section of the GDS Policy website.

In order to advance our understanding of how the myriad of genetic, environmental, and behavioral factors interact to play a role in human health and disease, we must continue to enable the responsible sharing of genomic and associated data broadly within biomedical research community, while at the same time respecting the wishes of study participants.    NIH’s policies for sharing of genomic data have led the way and set a precedent for culture changes in sharing all types of data, including sharing of data though groundbreaking initiatives such as PMI.

For more information on the GDS Policy please visit the GDS website.

Blog Roll

Genomic Data Sharing: A Two-Part Series

Posted on

NIH is committed to both the responsible stewardship of participants’ biospecimens and data.  Meeting our commitments protects the interests of research participants and ensures public trust in the biomedical research enterprise.  For biomedical research in general, policies and practices must strike a careful balance between the benefits of research and any potential risks to the study participants.  This balance will be covered in two separate blog posts about genomic data sharing:  Part I addresses promoting participant trust and permission for research and Part II, next week, will delve into the responsible sharing of genomic data for research.

Part I

Enhancing Consent and Participant Trust through the NIH Genomic Data Sharing Policy

One way to promote trust is to ensure that participants’ biospecimens, tissues and cells, and the information derived from them, are used in research only with their permission (consent).  Efforts to modernize federal regulations (i.e., the Advanced Notice of Proposed Rule Making to update the Common Rule) are focusing on the need to enhance research protections and reduce regulatory burden.  Some of the proposed reforms apply to research using specimens and data and include important changes to informed consent requirements.  NIH supports these reforms because seeking consent is respectful to participants and facilitates sharing of biospecimens and data in order to maximize the public benefits of research.

In fact, NIH is taking steps at a policy level to enhance consent in the context of NIH-funded large-scale genomic research.  In August 2014, NIH issued its Genomic Data Sharing (GDS) Policy, which outlines expectations for obtaining participant consent.   According to the GDS Policy, investigators who intend to generate large-scale genomic and phenotypic data from new collections of biospecimens and/or cell lines may only do so with the consent of the participants who provided those biospecimens and/or cell lines, even if the data generated are de-identified.  Further, NIH strongly encourages investigators who seek consent for research participation to also request consent for future research use and broad sharing of genomic and phenotypic data generated from the biospecimens or cell lines.

Last month, NIH released NIH Guidance on Consent for Future Research Use and Broad Sharing of Human Genomic and Phenotypic Data Subject to the NIH Genomic Data Sharing Policy, to provide guidance on consent expectations and information that can be tailored to individual studies and conveyed to prospective participants during the consenting process.  NIH has also posted a series of Frequently Asked Questions on consent for broad sharing (see Section H).

Why is NIH taking this approach to consent for sharing of human genomic data? First, studies of research participants’ preferences have taught us that participants expect to be asked for permission to use and share their de-identified specimens for research, and it is understandable why people might want to have some say in the use of their biospecimens. To preserve and even bolster public trust in research, it is critically important for the research enterprise to begin to respect the wishes of participants in this way.  Moreover, as has been well-documented, the risk of re-identification of genomic data is no longer a theoretical possibility.  As such, it is no longer tenable for us to hold that anonymization is still achievable or to allow the use of “de-identified” biospecimens without consent on the premise that such use is without some risk to the donor.  The evolution of genomic technology and analytical methods require us to acknowledge the risk of re-identification.

We believe that NIH’s expectation for consent under the GDS Policy is a step in the direction of continuing to earn the trust and respect of research participants.

For more information on the GDS Policy please visit the GDS website.

Stayed tuned for Part II – Genomic Data Sharing – Playing by the Rules to learn more about responsible sharing of data from NIH-funded genomic research.

Blog Roll

Let’s Talk About DURC: A Workshop Invitation

Posted on

It is almost universally acknowledged that life science research is fundamentally important and is the basis for advances in medicine, agriculture, environmental quality and a strong national economy.  However, over the past several years, the U.S. Government has recognized that some information generated by important life science research could be misused by those with the intent of harming public health or other aspects of national security.  This is the dual use dilemma: good science could be put to bad uses.

The NIH Office of Science Policy, in association with its Federal partners, has been actively involved in the discussion of how to best address research with this potential, known as ‘Dual Use Research of Concern, or (DURC).  In recent years, the U.S. Government has issued two policies on the oversight of DURC, both with the goal of preserving the benefits of important life sciences research while minimizing the risk that such research could be misused to cause harm.  The first Policy was issued in March 2012 and required Federal departments and agencies to review their life science research portfolios to determine if any research projects had potential DURC implications.

The second U.S. Policy, United States Government Policy for Institutional Oversight of Life Sciences DURC, was issued in September 2014.  The institutional policy outlines the procedures for the oversight of DURC at the local level and describes the responsibilities of Principal Investigators and research institutions.  The institutional policy must be implemented by institutions subject to its scope by September 24, 2015.

In advance of the implementation date, the White House Office of Science and Technology Policy and the National Institutes of Health are co-hosting a public workshop to discuss and solicit feedback from the community on the implementation of the institutional policy.  The workshop will take place at the NIH on July 22, 2015, and will include a series of panels where institutional representatives will share their experiences, challenges, and innovative practices in identifying research which is subject to the policy, developing risk mitigation plans, and raising awareness and educating about DURC.  The event will also feature an interactive case study that will highlight issues that investigators and institutions need to consider when determining whether research is subject to the policy.  This is a unique opportunity for the research community to provide feedback on the policy, and I hope stakeholders will take advantage of it and will come to share their thoughts.

I hope to see you on the 22nd!  In the meantime, you can contact staff in the NIH Office of Science Policy with questions about DURC by emailing [email protected].

Blog Roll