Summary of the April 17 – 18, 2012 NCVHS Subcommittee on Privacy, Confidentiality and Security Hearing – National Committee on Vital and Health Statistics

All official NCVHS documents (including meeting transcripts) are posted on the NCVHS website (http://www.ncvhs.hhs.gov)

Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Privacy, Confidentiality and Security

“NEXT STEPS FOR COMMUNITY DATA USE”

April 17 – 18, 2012

Doubletree Hotel
8727 Colesville Road
Silver Spring, MD 20910

Meeting Synopsis

The National Committee on Vital and Health Statistics Subcommittee on Privacy, Confidentiality and Security was convened on April 17 – 18, 2012 at the Doubletree Hotel in Silver Spring, MD. The meetings were open to the public.

Present:

Committee members:

Leslie Pickering Francis, J.D., Ph.D.
Linda A. Kloss, M.A., Co-Chair
John J. Burke, MBA, MSPharm.
Vickie Mays, Ph.D., MSPH
Sallie Milam, J.D., CIPP/G
Paul Tang, M.D.

Absent:

Walter Suarez, M.D., M.P.H.

Staff and Liaisons

Maya Bernstein, J.D., ASPE, Lead Staff
Nicole Cooper, NCHS
Gail Horlick, M.S.W., J.D., CDC
Debbie Jackson, NCHS/CDC
Katherine D. Jones, NCHS/CDC
Hetty Khan, NCHS
Marjorie S. Greenberg, NCHS/CDC
Iliana Peters for Susan McAndrew, OS/OCR Privacy Liaison
Marietta Squire, NCHS/CDC

Absent:

Amy Chapper, J.D., CMS
Kathleen Fyffe, ONC
Sarah Wattenberg, SAMHSA

Others:

Natalie Gonzalez, CDC

Presenters (April 17, 2012)

Kelly Edwards, Ph.D.
Dave Kaufman, Ph.D.
Cyd T. Lacanienta, M.S.W.
Bradley Malin, Ph.D.
Jerusha Nelson Peterman, Ph.D.
Linda Silka, Ph.D.
Phillip Smith, M.D., M.P.H.
Ryan Spellecy, Ph.D.
Paul Spicer, Ph.D.
Malia Villegas, Ph.D.

Note: The transcript of this meeting and speakers’ slides are posted on the NCVHS Web site, http://www.ncvhs.hhs.gov. Use the meeting date to locate them. For final versions of NCVHS documents discussed in the meeting, see “Reports and Recommendations.”

MEETING SYNOPSIS

ACTIONS

The goal is to complete a draft letter within several weeks. To accomplish this, development of a high-level outline was suggested.
SharePoint will be used to allow for Subcommittee member input. Further thoughts should be sent to Maya Bernstein, who will circulate rough draft notes of the meeting to Subcommittee members.
A conference call will be scheduled for mid-May 2012.

DAY ONE: TUESDAY, APRIL 17, 2012

(Note: For further information, please refer to transcripts, presenter statements and PowerPoint materials)

OPENING REMARKS AND INTRODUCTIONS Leslie Francis, J.D., Ph.D., Co-Chair

This hearing is a follow-up to the 2011 publication of “The Community as a Learning System for Health,” a report about how data can be advantageously used by communities. The report was issued following a series of relevant hearings held by the Population and Privacy Subcommittees and the full Committee.

PANEL I Beyond Data Use Agreements: Governance Models

Kelly Edwards, Ph.D., University of Washington
Bradley Malin, Ph.D., eMERGE Consortium, Vanderbilt University
Phillip Smith, M.D., M.P.H., Chair National Institutional Review Board, IHS

The hearing began with introductory comments by Dr. Edwards, Dr. Malin, and Dr. Smith. Please refer to transcripts, statements, and powerpoints.

Discussion

The public must be educated about how data will be used in their communities. Building trust is important as is maintaining the integrity of the science. Within the Native American community, trust must be earned not only from individuals and families but also at the community/nations level. Although community advisory boards help to ensure that data use is “for and by the people,” they are often not included in research endeavors, possibly because of an overreliance on IRBs and regulatory bodies. Small investments in the integrity of the system pay off.

Discussion ensued about the following questions: How does a community come to appreciate the value of community engagement? How are sustained relationships developed in settings where vital health statistics are collected? How does one assess who speaks for the community and how the community is defined? Individuals who consistently show concern for their communities over long periods of time emerge as the interface to the outside world. Sometimes to be effective in the Native American community, one must be “less efficient” according to modern day management principles (i.e., value is placed on listening rather than talking). Trust is a basic human element that is learned early on but must be developed over time.

In diverse communities, a broad approach to sharing intent about what will be done with collected data is helpful. Accountability should be discussed as a shared function between the community and researchers. It is important to respond to those who have contributed input or voiced concerns; and to discuss the future relative to beneficial uses of the data for the community. An ombudsperson (representative of the research organization who is available to the community) was recommended.

Discussion followed about how to identify appropriate community advisory board members; and how to build upon trusting relationships that community members develop with local organizations (some of which, in turn, interact with the federal government). It is easier for people to be vocal about dissatisfactions than to voice the positive. Suggestions ranged from developing clear opt-out models; 1-800 numbers to answer questions; and websites that describe what happens with data collection. People connect best to research when it is personally relevant to their lives. Community and research stories humanize the process. A question was raised about how best to prepare people for scientific realities.

An example of a successful NIH-funded collaboration between Vanderbilt University and a Navajo reservation was described, components of which included a researcher presence in the community; training of tribal members in research methods; and helping local youth further their education in public health. Other universities (e.g., U. of Washington, Arizona and Colorado; Johns Hopkins, Harvard) have also worked well with tribes in developing research programs with training components. Educated community members teach other community members, which helps to create an informed decision-making process.

Relationship-building and community trust were further discussed. Potential exists for community advocates (especially those directly connected to their communities) to be coercive about study participation (although mostoften, advocates have a vested interest in protecting the communities’ best interests). A process for determining appropriate advisory group participants must consider different structures, values and belief systems as well as principles of sociology and organizational behavioral modeling. Broad inclusion of community members was recommended. In many research projects, community member consent is provided by people entrusted with representing others, such that individuals often don’t know what they have consented to. In response to a question about how to incentivize local participants, carrot and stick approaches were articulated. What must be done to maintain the collection of data and what does the community gain? It is difficult to conduct a linear scientific process within a three-dimensional environment.

Community advocates should discuss funding for public health services research. It would be useful to establish policies and procedures for what scientists should communicate directly with community advisory boards and vise versa. More training for scientists on ethics was recommended. Those involved in research must go beyond the transactional, mechanical acceptance of consent to develop trusting relationships. Informed consent works best when researchers explain why such data are being collected. Investigators and their teams must be vigilant about enacting policies and procedures for how information is used, disseminated and audited. A question was raised about how to slow down the consent process to ensure that people understand what they are agreeing to. Those who steward data have ample opportunity to establish user requirements and dissemination plans.

Funders and data accessing groups must help researchers meet their obligations and frame productive research environments. CITI training should be updated to include more community health database issues. At present in the United States, insufficient transparency in the use of de-identified data means that often, people do not understand how information gets shared or used (OCR should examine this). A test run was recommended for broad data collection for secondary analysis.

PANEL II Protecting Small Groups

Paul Spicer, Ph.D., Center for Applied Social Research, University of Oklahoma
Malin Villegas, Ph.D., National Congress of American Indians (NCAI)

The hearing opened with brief presentations by Dr. Spicer and Dr. Villegas. Please refer to transcripts, statements, and powerpoints.

Discussion

Within Native American communities, individual and tribal consent must be obtained for research participation. The benefits of research in small communities were noted as well as the need to protect participants. A requirement for only one IRB of record for multi-site studies should not be imposed (example given) yet the complexities of managing different IRBs for a multi-site project were also recognized. Recommendations honor tribal consultation. Studies of specific tribes in urban areas should be differentiated from more general urban Indian health studies. Questions were raised about the negotiation of reporting-out/publishing conflicts. Co-authorship is a more collegial, respectful collaborative arrangement with communities (example given). In a tribal setting, it is not an option for a researcher to publish without tribal approval. NCAI advocates involving tribes with research early on; developing their own research; and considering different dissemination approaches.

Discussion ensued about intra-group disagreement. NCAI prioritizes formal tribal processes of decision-making (examples given). It is trickier to negotiate in communities without the formal authority of a tribal council, noting that the parameters of a study’s participants must be clearly defined. Researchers should be sensitive to the risks of collected data and to the fact that often, information is not adequately developed to delineate risks to the community (example given). While tribes are not often engaged in national studies, information gathered from small tribal communities provides an opportunity to consider issues in new ways. Tribes often assert ownership of data. A standard operative in American Indian and Alaska Native health research is community confidentiality, which protects specific communities but may create more general stigma. In protecting particular communities, there are challenges to information usefulness and diversity between tribes.

Specific consent forms should be developed for research projects rather than generalized use of a standardized consent form. Options should be available to research participants on informed consent forms (example given).Waiving consent is not acceptable for research involving collection and study of existing data and biospecimens. Secondary data use must require additional consent. Limited datasets should not be shared outside the originalresearch team without additional permission. The major research risk to small communities relates to how information gets reported. Individual risks associated with participating in small community research were also noted.

Reuse of “de-identified” data poses ethical challenges (example given). Under the HIPAA rule, once data are de-identified, the concern is that they are no longer governed by HIPAA and thus it is possible that they can be re-identified for any purpose. The issue may be less about de-identification and more about purpose, role and ultimate impact. There are considerable costs to data quality, the ability to draw relevant inferences and usefulness to participants when specific tribes are not identified in research. As everyone belongs to a small community, the discussion as it pertains to Native American tribes has broad relevance.

An inherent conflict exists between individual confidentiality and identifying small groups for research purposes. There are times when data cannot be presented back into a tribal community because they are too identifiable; and/or consent forms must first be reissued. There are also times when individuals want to be identified. Questions of reporting research results to whom and to what end are ongoing. For the sake of resources, one model creates local research capacity.

NCAI is developing a policy research brief with tribes about the definition of sampling, to include benefits and limitations. New geoinformatics tools help determine what communities to include in what research. Regionalapproaches to data collection are important. NCAI would like more information about what is being collected and greater access to data. A different approach considers available indicators and how to develop equity indices, noting that wellness and well-being are goals along with equity. A third approach uses culturally-based measures of success, looking at more local, defined measures (example given). The federal, state and tribal governmentsmust be held accountable for what they collect; how they report; and how they provide access. Important lessons can be learned by engaging tribal communities in what kinds of data matter. The broker for data access must be considered trustworthy.

PANEL III Using Results to Improve Community Health

Jerusha Nelson Peterman, Ph.D., School of Public Health and Health Sciences, University of Massachusetts in Amherst
Linda Silka, Ph.D., Director, Margaret Chase Smith Policy Center and School of Economics, University of Maine

The hearing began with introductory comments by Dr. Peterman and Dr. Silka. Please refer to transcripts, statements, and powerpoints.

Discussion

A question was posed about involving community participants in designing data use collection. Notable in a study about community partnerships in Maine was the marked difference between what university faculty wanted and what the community wanted. In addition, the assumption that all Maine cities and towns were same was proven wrong; and levels of trust varied greatly. Maintaining confidentiality verses sharing information was again raised (examples given) [note paper entitled, “Creating Community-Based Participatory Research in a Diverse Community: A Case Study”; Silka, L; Cleghorn, G. Dean; Grullon, M.; Tellez, T, in collaboration with the Lawrence Research Initiative Working Group; Journal of Empirical Research on Human Research Ethics; April 2008]. Community members are far more responsive when they understand what they gain from research. Researchers can learn from an educational model/presentation developed in Lawrence, MA that uses a partnership approach to effectively engage with communities. An infrastructure with institutional research memory that identifies problems is also needed.

An ongoing challenge is how to involve the “right” research partners and ensure that researcher and community needs get met (example given). Such a process is more effective when a designated person oversees the partnership. It is useful to think in terms of creative cost benefit analysis. To engage, it is helpful to talk about research rigor in community terms, relative to what is important to its members. Effective strategy involves entering into the culture; connecting rigor to places of concern in people’s lives; and then helping people understand the fit with research and how that research will make a difference (examples given).

A tiered release of data results can help determine who should have the information and who should act first. Such thinking could be translated into a standard with a series of decisions about when to make tiered data results. Methodology has been developed to link other data with health data (e.g., the Economic Research Service links GIS data to locations of food availability and examines nutritional outcomes). Ethical concerns about data collection and use were further discussed. The complexities of identifying community leaders within refugee immigrant communities were raised (examples given). The importance of cultural awareness and generational differences by researchers was emphasized (examples given). Different cultures respond differently to trusting the federal government (examples given). In many instances, people generally do not trust state or federal government but do trust providers.

PANEL IV Consumer Attitudes about Community Health Initiatives

Dave Kaufman, Ph.D., Director, Research and Statistics, Genetics and Public Policy Center, Johns Hopkins University
Ryan Spellecy, Ph.D., Medical College of Wisconsin

The hearing began with introductory comments by Dr. Kaufman and Dr. Spellecy. Please refer to transcripts, statements, and powerpoints.

Discussion

Bio banks and genetic researchers wrestle with problems that have already been addressed by researchers and American Indian and Alaskan Native communities. The Office for Human Research Protections (OHRP) takes the view that IRBs should not consider long-term research effects, including negative community impact. The gaps in human subject protection in community-engaged research are addressed within an article by Dr. Lainie Friedman Ross and others, which offers a collaborative model between researchers, the IRB and community.

Adequate training for community members in IRB’s role in regulations is needed (note U. of Michigan’s pilot of a new education and training program for community-based research). A discussion ensued about the Collaborative Institutional Training Initiative (CITI), an on-line training program in research ethical and regulatory conduct, which doesn’t work well with community partners. If a community partner does something that violates regulations, the PI is responsible. To date, methods of educating consumers about what will happen to their information vis-à-vis research have not been effective (examples given). Dr. Kaufman reported that in focus groups, people seemed satisfied with a relatively shallow description of the research (although more thought the research should be done than were initially willing to participate; and there was further discussion aboutwhy). Significant questions by consumers included what would be learned; when would results be shared with participants; and who would see the data.

Sampling bias can occur when people opt out of research participation but in some cases such as bio banks, a representative sample is not necessary. In other situations, opt-outs can bias the data. There is a need for interaction between being asked and being told, that is, if a researcher explains the project upfront and shows good faith while giving people the opportunity to weigh in and opt out, that can “buy (the researcher) a lot.” Broad community buy-in as opposed to individual consent might work for some projects.

Established community organizations sometimes need help with integrating research into their infrastructure, noting that new partnerships take time to build. More face-to-face time is needed for relationship-building within community-engaged research. It is helpful to have community members participate in the work, especially recruiting. The IRB does not act as a scientific review committee that checks adherence to components of community-based participatory research (CBPR). Rather, its role is to weigh research risks and benefits. A report should be made to OHRP when non-compliance occurs often. The degree of freedom within research depends upon the funder. Current talk of returning a minimum set of genetic results to adults in a clinical genetics study indicates broader movement toward obligation for return.

With regard to the DOJ process for Certificates of Confidentiality, researchers can be subpoenaed but their response is to uphold the Certificate. Data is protected but the researcher might not be. The question of whether universities can be a source of community infrastructure (e.g., data and research skills) was further discussed (examples given). Problems can be avoided when researchers respectfully engage the community from the start. When this happens, the community is less likely to veto use of data for requested uses. If the community vetoes data release, results should not be disseminated. It is helpful to ask the community upfront whether they want this type of research done and to move away from it if the answer is “no.” Especially for large-scale federal projects, focus groups help ascertain where the public stands; and can be a useful forum to discuss whether the research will proceed.

STATEMENTS FROM THE PUBLIC

None

SUBCOMMITTEE WRAP-UP

Suggestions were made about how to organize the next day’s meeting. One idea was for each subcommittee and staff member to identify an issue for the Secretary’s recommendation letter with regard to next steps for community data use. Review of the CHIP report was also suggested in order to tease out framework issues (that would include general community guidance and specific recommendations). It would be useful to draw out principlesthat advance trust in how data are used and to identify gap areas. Discussion followed about reconsidering certain aspects of IRBs and CITI training; and about what the federal government’s role should be (e.g., facilitate and provide resources to strengthen community data collection capacity).

Is the Subcommittee interested in gathering more information before making recommendations? A break-out session at the full Committee meeting or a webinar could be arranged. Should the community engagement section of theStewardship Primer be updated? The status of the Advanced Notice of Proposed Rulemaking was delineated. It was suggested that recommendations about the rulemaking process be made to the Secretary soon; and that the consumerperspective be considered.

Additional suggestions were made about how to approach the letter, noting linkages to the Quality Subcommittee’s work and letter (which will be emailed to Subcommittee members for review).

The meeting was adjourned at 5:15 p.m.

DAY TWO: WEDNESDAY, APRIL 18, 2012

INTRODUCTIONS AND OPENING REMARKS

Leslie Francis, J.D., Ph.D., Co-Chair and Linda L. Kloss, M.A., RHIA, FAHIMA, Co-Chair

SUBCOMMITTEE DISCUSSION

Work session to formulate ideas for a recommendation letter about next steps for community data use for the Secretary of HHS.

WRAP-UP AND NEXT STEPS

A draft letter should be completed within a few weeks. SharePoint will be used to allow for Subcommittee member input. Development of a high-level outline was suggested. Further thoughts should be sent to Maya Bernstein, who will circulate rough draft notes of the meeting to Subcommittee members. A conference call will be scheduled for mid-May 2012.

The meeting was adjourned at 1:00 p.m.

To the best of my knowledge, the meeting synopsis is accurate and complete.

/s/ June 12, 2012

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Co-Chair Date

/s/ June 12, 2012

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Co-Chair Date