Tracking Federal Research Priorities

Notice of Proposed Rulemaking.

On September 9, 2015, sixteen federal departments and agencies released a Notice of Proposed Rulemaking (NPRM) to revise the main policy for the protection of human subjects in research (DHHS 45 CFR 46), typically referred to as "the Common Rule." There are significant implications for research with tribal nations and American Indian and Alaska Native peoples in these proposed revisions. And while this revision process has been ongoing since 2011, the federal government has not established a parallel process of tribal consultation. NCAI and its Policy Research Center have worked to ensure that the interests of tribal nations and peoples are recognized within the revision process by submitting comments in response to the 2011 Advance Notice of Proposed Rulemaking (NCAI Comments) and the 2013 National Institutes of Health Genomic Data Sharing Policy (NCAI Comments). We continued to build upon these efforts in response to the NPRM.

In late November 2015, following repeat requests from various institutions for a deadline extension, the U.S. Department of Health and Human Services announced that 30 days would be added to the comment period, with the final deadline set at January 6, 2016. On December 21, 2015, a Dear Tribal Leader Letter was distributed to announce a Tribal Consultation call on January 5 - one day prior to the final deadline. On the call, which included a presentation of the proposed Common Rule revisions by Dr. Jerry Menikoff from the Office of Human Research Protections, several tribal leaders expressed concern for the lack of tribal-specific language within the revisions and reiterated the need for full, meaningful consultation on the NPRM. Click here for a full transcript of the call.

NCAI's NPRM Comment Submission highlighted concerns related to consent for secondary research with biospecimens, including concerns for data belonging to those who have passed on; research oversight by tribal Institutional Review Boards (IRBs) and other tribal regulatory bodies; and revised rules concerning categories of research and activities important to tribal nations. Our comments were presented in relation to nine overarching themes, including:

·         Protection of human subjects being framed as countering the promotion of scientific innovation;

·         Proposed tradeoffs with principles of research ethics;

·         Autonomy rationale coupled with promotion of broad consent;

·         Responsibility placed on individual investigators more than research institutions;

·         Focus on risk, rather than benefit;

·         Commitment to tribal consultation;

·         Reliance on “majority rule” in determination of research policy rather than a reasoned process where minority voices can be heard on matters of ethics and research burden;

·         Acceptance of the “burden” of consent; and,

·         Inclusion of specific language regarding tribal research oversight and approval.

We were pleased to see several tribes and organizations engaged in research with tribal citizens participate in the NPRM process. The following tribal nations and entities gave us permission to share their comment submissions:

Choctaw Nation of Oklahoma Institutional Review Board

Sault Ste. Marie Tribe of Chippewa Indians 

Sisseton Wahpeton Oyate

Turtle Mountain Band of Chippewa Indians

Tribal Self Governance Advisory Committee

United South and Eastern Tribes

All public comment submissions are searchable here.

The Office of Human Research Protections (OHRP) provided an update on the NPRM process at the May 2016 Secretary’s Advisory Committee on Human Research Protections (SACHRP) Meeting. A summary of the comment review process and themes was provided, followed by a brief Q&A. An archived webcast of the presentation is available here, with the NPRM update occurring from approximately 10min-1hr30min. Additionally, the Association of Public & Land-Grant Universities (APLU) and Council on Governmental Relations (COGR) partnered on a preliminary analysis of the NPRM comments. Information on their analysis can be found here, and the comments they summarized relative to Tribal Nation responses is located here.

On June 29, 2016, the National Academies of Sciences, Engineering, and Medicine called on Congress to withdraw the Notice of Proposed Rulemaking to revise the Common Rule and create a commission to examine the protection of human participants in research. More information on the National Academies’ stance can be found here.

NCAI will provide additional updates on the NPRM as they unfold. For further information, please contact Dr. Deana Around Him at daroundhim@ncai.org



Notable Trends.


On April 10, 2013, the White House Office of Science and Technology Policy co-hosted an historic briefing with the American Association for the Advancement of Science on the President’s Research and Development Budget for Fiscal Year 2014. Leaders of the National Institutes of Health (NIH), the National Science Foundation, the National Aeronautics and Space Administration, the National Oceanic and Atmospheric Association, the Department of Defense, the Department of Energy’s Office of Science, and the National Institute of Standards and Technology were represented. The President’s FY14 budget totals nearly $143 billion budget for research and development, representing an almost $2 billion increase from the FY13 proposed budget. The President and agency leaders also announced a range of new research initiatives, including those involving:

  • BRAIN initiative (or Brain Research through Advancing Innovative Neurotechnologies) that includes an effort to map the human brain; 
  • BIG DATA to Knowledge (BD2K) initiative at NIH (and subsequent Open Data Policy issued by the President on 5/9/2013) that sets a national expectation related to data sharing;
  • STEM goal to graduate 1,000,000 new STEM graduates and to produce 100,000 new K-12 STEM teachers in the next 10 years, which requires a consolidation of federal STEM programs;
  • DIVERSITY initiatives established to increase biomedical workforce diversity, yet funding to “research centers at minority institutions” was diminished as the NIH proposed budget increased. 

Mechanism

Number

FY 2012 Enacted

Number

FY 2014 Request

Number

Change

RC in minority institutions

22

$58,994

20

$52,405

-2

-$6,589

TOTAL NIH

 

$30,860,000

 

$31,331,000

 

$471,000

 Dollars in millions; see National Institutes of Health Budget Request Main Page for more information.



Each of these priorities has major implications for Indian Country, and Native people should be at the table as implementation of these initiatives is developed and as new priorities are set. For example, the new STEM and workforce diversity goals could engage tribal communities, Native institutions like tribal colleges and universities, and others engaged with research and job training toward a shared vision and agenda. Also, where the BRAIN and related National Plan to Address Alzheimer’s Disease
set research goals that could benefit Native elders, veterans, and others struggling with brain-related illnesses, there are concerns that this research agenda will require the collection of human brains and tissue, which may have cultural implications for some Native people. In addition, there is an emphasis on mapping the brain in order to understand (and potentially modify) human behavior, which runs the risk of pathologizing Native communities as has been the case historically.
 
Finally, the Big Data efforts have the potential to create new access to data sets that could guide community planning. Yet, we have to also be aware that policies about open access should acknowledge tribal sovereignty over tribal data and help curb the tendency toward surveillance where tribes are asked to share their data but are not provided equivalent access to national datasets or databases.

Just as these priorities are relevant to Indian Country, tribal leaders are calling for research leaders to develop research that is relevant to our needs. Specifically, we have heard a demand for research on a range of topics including those listed in the Research Priorities section of the Website, and especially for health research that explores co-occurring conditions like diabetes and depression and for research that explores the relationship between human and environmental health. This sort of research often requires interdisciplinary coordination, mixed and multiple methods, and complex research design.

At the same time there has been an increase in federal research funding, there is a demand for a return on this investment. This often takes the form of requiring that research findings be published in academic journals. NCAI is working to ensure that there is also clear benefit back to tribal communities and a broad focus on outcomes like health services, replication and adaptation of successful interventions in a culturally-based way, and expanded research training and capacity building for community-based researchers. We are also working to challenge the narrative that research developed in partnership with tribal communities takes too much time and costs too much money. We believe research can add value to tribal contexts when conducted in an appropriate manner. Specifically, there are four areas where NCAI hopes to engage federal research agencies to advance policy that supports tribally-based research, namely:

  • Tribal consultation by federal agencies on research priorities, funding, and administration;

  • Active approval by tribes of research taking place on tribal lands and with tribal citizens;
  • Alternative data sharing agreements that acknowledge tribal sovereignty over data; and
  • Training for scientific review panels responsible for granting federal funding to applicants.

We recognize that we are highlighting these issues at a time when others, including Congressional leaders, are raising questions and concerns about research rigor, funding, and policy. We hope it is clear that this dialogue comes out of a desire to advance research policy and outcomes through meaningful engagement with tribal leaders and communities. At the same time, the experiences and insights of tribal nations engaging with research have much to offer other communities. We have seen that most clearly in what tribes have to offer in terms of how to protect small populations in research and in relation to advancing the discussion of measurement in small populations – issues communities around the globe continue to struggle with. NCAI looks forward to engaging with federal research agencies to advance meaningful policy and to hearing from tribal leaders, Native research organizations, and others working on these issues to develop effective approaches for addressing the complexity of research that benefits Native people.