Updates from the NIH Advisory Committee to the Director’s December Meeting ?>

Updates from the NIH Advisory Committee to the Director’s December Meeting


The National Institutes of Health’s Advisory Committee to the Director convened Dec. 13 to provide recommendations on the agency’s efforts to address foreign influences on research integrity, discuss the Next Generation of Researchers Initiative, and provide updates on policies to prevent and address sexual harassment.

NIH director updates

NIH Director Francis S. Collins discussed the agency’s budget and highlighted recent activities and discoveries.

Collins addressed the European Union’s General Data Protection Regulation. Implemented in May, this regulation strengthens privacy rights in the EU and protects data derived from academic research.  The NIH has found it difficult to comply with GDPR provisions such as conducting internal audits and reporting results due to U.S. regulations that restrict federal agencies from providing sensitive information to foreign countries.  Committee members remarked that the vagueness of the regulation has created significant confusion.

Collins also talked about the U.S. Department of Health and Human Service’s audit of federally funded fetal tissue research.  While the audit is underway, the NIH has been ordered to not award any new research projects that use fetal tissue.  Ongoing research should not be affected.

Also of note: Neil Shapiro, NIH budget director, provided an update on funding for fiscal 2019. The NIH has received an increase of $2 billion, or 5.6 percent, above FY18. Included in the budget is a general increase of 3 percent for institutes and centers across the NIH. The only funding that was not covered in the FY19 appropriations is the NIH’s superfund program, which is under a continuing resolution.  The NIH’s budget has increased by $9 billion in 3 years, restoring more than half of the agency’s purchasing power since fiscal 2003.

Additional highlights from the meeting are below.  You can watch a recording of the meeting here (day 1/day2). Timestamps for highlighted references are included.

Foreign influence on U.S. research integrity – 1:48:51

Members of a working group addressing foreign influence on NIH-funded research presented their recommendations (detailed below).

As background, violations that have been identified include undisclosed foreign financial conflicts, conflicts of commitments, intellectual property theft and unauthorized dissemination of grant proposals by peer reviewers.

Recommendations for the NIH include:

  • Increase communication of the NIH’s policies on foreign affiliations.
  • Reduce risk by updating foreign affiliation disclosure policies and implementing restrictions on peer reviewers.
  • Develop clear consequences for individuals and organizations found to be in violation.

Recommendations for NIH-funded organizations include:

  • Increase education on foreign affiliation disclosures and scientific topics prone to intellectual property piracy.
  • Increase guidance and policies for hosting foreign scientists.
  • Identifying potential opportunities for breaches to internal systems;
  • Strengthen policies for vetting potential employees and travel for faculty and staff to foreign countries.

The committee approved the recommendations, and the NIH leadership will determine effective implementation strategies in FY19.

Finally, rest assured, Collins emphasized that the vast majority of foreign scientists do not violate conflict of interest policies, and that the agency is working to not demonize foreign talent.

Next Generation of Researchers Initiative – 4:25:23

For the past year, the NIH Next Generation of Researchers Initiative working group has been developing recommendations for NIH institutes to address biomedical research workforce problems and provide better support to the next generation of researchers.

Recommendations from the working group had five broad themes:

  1. Modify the original NGRI policy.
  2. Develop methods to identify and support at-risk and early-stage investigators.
  3. Promote sustainable training opportunities that incorporate diversity and inclusion.
  4. Monitor outcomes and optimize workforce stability through improved metrics and further research.
  5. Continue transparency efforts and engagement with scientists across career stages to inform policy decisions.

Collins mentioned that some of the strategies proposed by the working group have been used to increase the number of early-stage investigators funded by the NIH in FY18.

The working group also provided suggestions to address pivotal issues facing early career researchers. Because the definition of independent investigator varies by institution, the working group recommended that the NIH ESI classification not be contingent upon an investigator’s first independent position.

Working group members also discussed how the lack of salary support by universities and institutions promote hyper-competition for obtaining grants and thus incentivize research misconduct. The working group recommended that universities increase salary support of their research faculty.

The ACD approved the recommendations. The NGRI working group will provide advice on the policy implementation.

ASBMB’s Public Affairs Advisory Committee is largely supportive of the suggestions and will provide comments to the NIH leadership on the final recommendations.

Policies to prevent and address sexual harassment – 5:38:20

Internally, the NIH has created a number of tools to empower employees to report harassment. Extramurally, however, the NIH has been less proactive, unlike the National Science Foundation, which has moved quickly to change its extramural policies for reporting sexual and gender harassment.

NIH Principal Director Lawrence A. Tabak said that regulations prevent the agency from asking questions that don’t directly pertain to NIH-funded work and from unilaterally removing grants from institutions. However, Tabak said the NIH can audit a grantee institution for compliance with Title IX or remove an investigator from an award.

The NIH released a notice in the Federal Register about its internal policies for harassment. The notice also encourages grantee organizations to act similarly.

The Advisory Committee to the Director has created a working group to assess the current state of sexual harassment, provide advice on oversight and reporting requirements for awardee institutions, and develop policies and best practices to prevent harassment and gender discrimination.

Carrie Wolinetz, associate director for science policy and acting chief of staff, said that the NIH should look at its role in incentivizing culture change. Wolinetz highlighted that the agency should utilize its power of the purse to make change.

The working group plans to solicit the research community’s input on harassment policymaking and will present its preliminary recommendations in June.

Additional presentations included updates on the HEAL (Helping to End Addition Long-term) initiative; the High-Risk, High-Reward Research program; and the second phase of the BRAIN initiative.

View slides and reports from the meeting here.

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