The members selected to serve on an advisory committee can affect the integrity, perception, credibility, and acceptance of the work performed. Membership selection, therefore, is a critical initial step in the overall process. In general, an agency or organization that convenes an advisory committee has the authority to decide how the members are identified, screened, vetted, and appointed. This has led to the implementation of a variety of approaches. Some of the differences are institutional, as not all convening entities have the infrastructure or resources needed to execute the same protocol. The specific committee’s function can also be a source of variability. Committees with charges that differ in scope and intended audiences may use different techniques to optimize the composition of membership. Because the wide variety of methods, purposes, and outcomes makes it challenging to conduct systematic evaluations of best practices, this National Academies of Sciences, Engineering, and Medicine (the National Academies) committee was not able to identify a set of best practices. Instead, it found that the heterogeneity offers a range of options to consider for enhancing the Dietary Guidelines Advisory Committee (DGAC) selection process.
Determining the usefulness of alternative committee selection approaches is challenging, as the applicability of a specific process is circumstantial. To contextualize the approach used to select members to the DGAC and to consider opportunities for improvement, this National Academies committee explored different membership selection processes across a variety of disciplines and organizations. The analysis contained
in this chapter exclusively highlights examples of committees whose processes differ from those used to select the DGAC. Committees whose processes are similar to the DGAC are purposely not discussed in this report. The sections that follow summarize key differences in advisory committee selection processes. Inclusion of a selection process herein does not reflect this National Academies committee’s endorsement, but rather describes an environmental scan of the variability and options that exist.
Federal advisory committees are underpinned by the same key legislation, namely the Federal Advisory Committee Act (FACA), which governs the establishment, operation, oversight, and termination of advisory committees within the executive branch of the federal government (see Chapter 2 for additional details). Because each agency is required to develop its own administrative procedures describing how it will implement FACA while being consistent with the law and the 2001 Final Rule, an assessment of other federal advisory committees offers insight into processes that are considered permissible under the same general confines.
This National Academies committee used the FACA database and a review of other reports to search for federal advisory committees with unique selection processes that were also different from the process used for the DGAC (CRS, 2007; GAO, 2004; GSA, 2016). Advisory committees that were current, chartered, and active across a range of agencies were considered. With approximately 1,000 federal advisory committees active at a given time, this committee was unable to comprehensively explore the breadth of all possibilities. This assessment, therefore, was not intended to be systematic or exhaustive, but rather exploratory, to help identify components of the selection process that could be adapted or modified to enhance the transparency, minimize bias, and incorporate a range of viewpoints and expertise into future DGACs.
The DGAC selection process was compared to the 11 illustrative examples listed in Table 3-1. An initial review of the FACA database and reports from the U.S. Government Accountability Office and the General Services Administration were used to identify federal advisory committees with innovative and unique processes related to the selection of members. These examples were selected for their procedural differences from the DGAC process related to membership designations; methods for soliciting nominations; and the steps taken to screen, vet, and appoint members. Specific details were identified in the committees’ charters, membership balance plans, websites, and Federal Register notices. This National Academies committee recognizes that processes are more
TABLE 3-1 Federal Advisory Committees Chosen to Illustrate Variability in Membership Selection Processes
|Advisory Committee||Sponsoring Agency||Individual or Entity Being Advised|
Advisory Committee on Agriculture Statistics (ACAS)
Chemical Safety Advisory Committee (CSAC)
FDIC Advisory Committee on Economic Inclusion (FDIC ComE-IN)
Homeland Security Information Network Advisory Committee (HSINAC)
National Advisory Committee on Racial, Ethnic, Other Populations (NAC-REOP)
Advisory Board on Toxic Substances and Worker Health (ABTSWH)
Arthritis Advisory Committee (AAC)
Health IT Policy Committee (HITPC)
Healthcare Infection Control Practices Advisory Committee (HICPAC)
National Vaccine Advisory Committee (NVAC)
Physician-Focused Payment Model Technical Advisory Committee (PTAC)
NOTE: CDC = Centers for Disease Control and Prevention; U.S. DHS = U.S. Department of Homeland Security; DOC = U.S. Department of Commerce; DOL = U.S. Department of Labor; EPA = U.S. Environmental Protection Agency; FDA = U.S. Food and Drug Administration; FDIC = Federal Deposit Insurance Corporation; HHS = U.S. Department of Health and Human Services; IT = information technology; USDA = U.S. Department of Agriculture.
involved and nuanced than what can be provided for in descriptive summaries, and that sponsoring agencies may deviate from what is initially planned. This assessment, however, must assume agencies fully implement the procedures as outlined. The DGAC procedures included in this section are discussed in more detail in Chapter 2. Detail extending beyond what was included in previous charters and membership balance plans are included, but are noted as such. Across the illustrative examples, key differences were noted in types of members sought, the process for soliciting nominees, and the review of candidates and appointments.
Advisory Committee Composition—Membership Designation
As part of the chartering process, sponsoring agencies are asked to provide a description of how members will be designated. Federal advisory committee members can be designated as a special government employee, representative, regular government employee, or ex officio members. Some advisory committees have also made use of nonvoting members, including those considered ex officio, industry representatives, and liaisons to special interest groups. A member’s designation indicates the perspective he or she is expected to bring to the advisory committee (i.e., individual or representing a particular bias). The designation may have implications for which ethical standards and laws regarding conflicts of interest are applicable. Importantly, as noted in Box 2-2, representative members are not subject to criminal financial conflict of interest laws, while all other members are. Another difference among membership designations is that members may be eligible to receive compensation for their work if approved by appointing authority, while employees and officers of the federal government are not eligible.
The DGAC includes only special government employees, which was found not to be an uncommon practice. However, the illustrative examples demonstrate that there is no single approach to composing an advisory committee, with respect to membership designation, and that some committees use a blend of special government employees, representatives, regular government employees, and ex officio members (see Table 3-2).
Solicitations for Nominations
Sponsoring agencies can describe how candidates will be identified in the membership balance plan, which is required for discretionary committees and encouraged for nondiscretionary committees. Although dependent on the structure and function of the advisory committee, agencies tend to seek nominations from a range of individuals and groups including, but not limited to, professional, scientific, and medical societies
and organizations; stakeholder and advocacy groups; current and former committee members; and relevant federal agencies or staff. One approach to announcing the public call for nominations, common across the illustrative examples, is publishing a notice in the Federal Register. The notices can include information about the advisory committee (e.g., authority, purpose) and about how nominations can be submitted. Other dissemination channels are also used. The Advisory Board on Toxic Substances and Worker Health, for instance, planned to use “existing outreach tools, such as email groups and social media tools, to publicize vacancies and identify as many potential candidates as possible” (DOL, 2015d).
The materials collected during the initial phase of advisory committee formations have implications for the screening of nominees. For example, some sponsoring agencies will only consider individuals with complete applications. As presented in Table 3-3, there are common items requested, such as the nominee’s curriculum vitae or résumé, but no standard set of materials is used across agencies or advisory committees.
Evidence from the illustrative examples indicates that sponsoring agencies have the ability to tailor their nomination solicitation approach. The extent to which agencies receive input and guidance on their customized strategy is not well characterized. One example, however, was identified. The membership balance plan for the Chemical Safety Advisory Committee, which is convened by the U.S. Environmental Protection Agency (EPA), noted that the designated federal officer was to consult with EPA’s Office of Diversity, Advisory Committee Management and Outreach, to develop an approved outreach plan for identifying committee members (EPA, 2015d). This National Academies committee could not identify an oversight step of the nomination process in its review of the other illustrative examples.
Although this National Academies committee was unable to assess the effectiveness of different nomination solicitation models (e.g., reach of announcement, nomination information, transparency), it did identify one example of enhanced transparency. As outlined in a 2015 Federal Register notice, nominations for the Chemical Safety Advisory Committee (CSAC) could be delivered by hand, sent by mail, or submitted through the Federal eRulemaking Portal (EPA, 2015b).1 Nominations capture the name of the commenter and the materials submitted, and they are openly available online for review (EPA, 2015c). Across the illustrative examples, this was the only federal advisory committee in which nominees were recorded in a publicly accessible platform.
TABLE 3-2 Membership Designations for Select Federal Advisory Committees
|Special government employee||X||Xa||X||X||X||Xb||X||X||Xa||X|
|Regular government employee||X||X||X||Xc|
NOTES: An X indicates the member type was described in the advisory committee’s charter, balance plan, or other associated materials. A blank indicates such a member was not explicitly permitted or anticipated. Members of the Physician-Focused Payment Model Technical Advisory Committee (PTAC) “have been determined to be neither employees of the executive branch of the federal government nor ‘special government employees’” (HHS, 2016c). As such, PTAC is not included in this table.
AAC = Arthritis Advisory Committee; ABTSWH = Advisory Board on Toxic Substances and Workers Health; ACAS = Advisory Committee on Agricultural Statistics; CSAC = Chemical Safety Advisory Committee; DGAC = Dietary Guidelines Advisory Committee; FACA = Federal Advisory Committee Act; FDIC = Federal Deposit Insurance Corporation; FDIC-ComE-IN = FDIC Advisory Committee on Economic Inclusion; HICPAC = Healthcare Infection Control Practices Advisory Committee; HITPC = Health Information Technology Policy Committee; HSINAC = Homeland Security Information Network Advisory Committee; NAC-REOP = National Advisory Committee on Racial, Ethnic, and Other Populations; NVAC = National Vaccine Advisory Committee.
a The charter includes language about inclusion of special government employees, but none of the members in the FACA database for this committee are currently or have historically been designated as such.
b May include one technical qualified individual who identifies with consumer interests and is nominated by a consortium of consumer-oriented organizations.
c Based on search of current and historical membership in the FACA database. From 2009 through 2011, committee membership included regular government employees. Thereafter, all members were designated as either representative or ex officio.
d Voting status of the ex officio members is not specified in the charter.
e Ex officio members are nonvoting members.
f May include one nonvoting industry representative.
g Includes federal representatives and liaison representatives from a range of associations and stakeholder groups.
h Nonvoting members include those designated ex officio and liaison representatives of organizations and interest groups.
TABLE 3-3 Materials Requested to Nominate an Individual to Serve on Select Federal Advisory Committees
|Letter of nomination||X||X||X||X|
|Letter(s) of recommendation||Xb||Xc||Xd|
|Statement from nominee||X||X||Xb||Xe||X|
|Nominator’s contact information||X||X|
|Nominee’s contact information||X||X||Xf||X||X|
|Nominee’s curriculum vitae or résumé||Xg||Xh||X||X||X||X||X||X||X|
|Nominee’s short biography||X|
|Summary of nominee’s qualifications||Xi|
|Membership background information form||Xj|
|Articles authored by nominee||X|
|Nominee’s active participation in organizations||Xb,k|
|Nominee’s familiarity with the program||Xl|
|Completed OGE Form 450m||X|
NOTES: An X indicates the material was requested of a nominator, while a blank indicates the material was not specifically requested. This National Academies committee did not find evidence of a call for nominations for the FDIC Advisory Committee on Economic Inclusion, and as such it has been omitted from the table.
AAC = Arthritis Advisory Committee; ABTSWH = Advisory Board on Toxic Substances and Workers Health; ACAS = Advisory Committee on Agricultural Statistics; CSAC = Chemical Safety Advisory Committee; DGAC = Dietary Guidelines Advisory Committee; FDA = U.S. Food and Drug Administration; FDIC = Federal Deposit Insurance Corporation; HICPAC; Healthcare Infection Control Practices Advisory Committee; HITPC = Health Information Technology Policy Committee; HSINAC = Homeland Security Information Network Advisory Committee; NAC-REOP = National Advisory Committee on Racial, Ethnic, and Other Populations; NVAC = National Vaccine Advisory Committee; OGE = Office of Government Ethics; PTAC = Physician-Focused Payment Model Technical Advisory Committee.
a Only accepts applications directly from the candidate.
b These materials are requested in the FDA Advisory Committee Membership Nomination Portal, but not explicitly requested in the Federal Register notice.
c At least one letter of recommendation must come from someone outside of the U.S. Department of Health and Human Services.
d Two letters of support are required.
e Nominees must acknowledge they are aware of their nomination, consent to having their name published in the Federal Register, are willing to actively participate, and verify they have no financial conflicts of interest.
f Includes the nominee’s current employment or position.
g Limited to 10 pages or less.
h Limited to 2 pages or less.
i Nominators are also asked to specify which membership category the nominee is suited to represent.
j Candidates are asked to complete Form AD-755, “Advisory Committee or Research and Promotion Background Information.” The form requests the individual to report his or her contact information, demographic characteristics (optional), current employment, specific expertise, affiliations with organizations, and sources of income other than primary employment.
k Only requested for individuals seeking a consumer representative appointment.
l The Advisory Board on Toxic Substances and Worker Health provides guidance on claims under the Energy Employee Occupational Illness Program Act (EEOIPA) program. The request for nominations asks for information about the nominee’s experience with the EEOIPA program or one as technically complex.
m OGE Form 450 is a confidential financial disclosure form that asks filers to report their assets and income; liabilities; outside positions; agreements and arrangements; and gifts and travel reimbursements from the previous 12 months. Assets, income, and liabilities of the spouse and any dependent children must also be reported.
Review of Candidates and Appointments
FACA does not stipulate how members should be appointed to federal advisory committees. Instead, the head of the agency establishing the federal advisory committee has the sole authority in appointing members, unless otherwise provided for in statute, presidential directive, or other establishment authority.2 Agency heads are also responsible for ensuring the interests and affiliations of advisory committee members are reviewed for conformance with applicable conflict-of-interest statutes and other federal ethics rules.3 Materials reviewed describing the 11 illustrative examples varied in their level of detail concerning agency-specific processes. Differences were identified in how nominees are initially screened, how candidates are vetted, and who has the authority to appoint members. Although screening and vetting are not always operationalized as distinct procedures, this National Academies committee uses the terms to connote two aspects of the selection processes. Screening is used to describe the initial appraisal of nominees’ qualifications, generally in relation to their expertise unless otherwise noted. Vetting is used to describe a more comprehensive or thorough investigation into the candidates’ background, including their affiliations, personal biases, personal and imputed financial conflicts of interest, and nonfinancial conflicts of interest (see Box 3-1).
Initial Screening of Nominees
Five of the illustrative examples described a preliminary screening of the nominees, prior to conducting an extensive background investigation or selecting a slate for final approvals. The designated federal officer and/or a team of program staffers were responsible for this initial narrowing of the candidate pool (see Table 3-4). Across the examples, screening generally involved an assessment of relatively subjective characteristics, such as expertise and leadership qualities. For the CSAC nominees, EPA also noted considering financial conflicts of interests and impartiality during this preliminary screening stage. The other illustrative examples described evaluating conflicts of interest later in the appointment process, if described at all (see “Vetting of Candidates” section). One unique process was noted for the National Vaccine Advisory Committee. The director of the National Vaccine Program is required to consult with the National Academy of Sciences (NAS) to determine if the candidates are qualified based on the criteria outlined in the Federal Register notice. This
2 41 C.F.R. § 102-3.130.
3 41 C.F.R. § 102-3.105.
is the only federal advisory committee this National Academies committee reviewed that uses a nongovernment entity to participate in the screening of nominees.
Vetting of Candidates
Vetting refers to a thorough review of candidates’ backgrounds. Vetting procedures are often cited as a means for assessing candidates’ biases and conflicts of interest (see Box 3-1).
As presented in Table 3-5, the illustrative examples have taken different approaches to vetting candidates. One broad approach is to seek approval of several offices or various positions within the agency. This presumably allows for the slate of candidates to be considered from individuals who may offer different perspectives. Other vetting procedures are specific to the appraisal of conflicts and other ethical considerations. These have included background checks and financial disclosures. While most of the vetting procedures are described as taking place after a slate of candidates is selected, the CSAC described considering financial conflicts and lack of impartiality as considerations that inform the development of the slate.
Assessment of financial conflicts of interest is at the forefront of the vetting of special and regular government employee candidates. Officers or employees of the executive branch of the U.S. government (which includes those designated as special government employees) may be charged under criminal law for participating in any government matter in which they have a financial interest. The federal U.S. Office of Government Ethics (OGE) provides overarching guidance for how executive branch agencies prevent conflicts of interest. Included are tools for identifying and managing conflicts of interest of those who serve on federal advisory committees (OGE, 2000). Based on an assessment of the regular government employee’s position, rate of pay, and the regulations put forth by OGE, the appointee may be required to complete either an OGE Form 450 (Confidential Financial Disclosure Report; see Box 3-2) or OGE Form 278 (Public Financial Disclosure Report), in order for the agency to assess the potential for personal and imputed financial conflicts of interest.4 Appointees designated as special government employees typically complete OGE Form 450. However, alternative procedures may be used in lieu of filing OGE Form 450.5 Information submitted on OGE Form 450 is confidential and
4 Imputed interests includes those of the candidate’s spouse, minor child, general partner, outside employer, and persons or organizations with whom the candidate is negotiating or has an arrangement for employment.
5 5 C.F.R. § 2634.905.
TABLE 3-4 Initial Screening of Nominees for Select Federal Advisory Committees
NOTES: The following committees were omitted from this table because a description of how the nominee pool was narrowed was not included in their charter or membership balance plan: Advisory Board on Toxic Substances and Worker Health, Advisory Committee on Agriculture Statistics, Federal Deposit Insurance Corporation Advisory Committee on Economic Inclusion, Health IT Policy Committee, Homeland Security Information Network Advisory Committee, and Physician-Focused Payment Model Technical Advisory Committee.
AAC = Arthritis Advisory Committee; CSAC = Chemical Safety Advisory Committee; DGAC = Dietary Guidelines Advisory Committee; HHS = U.S. Department of Health and Human Services; HICPAC; Healthcare Infection Control Practices Advisory Committee; HITPC = Health Information Technology Policy Committee; NAC-REOP = National Advisory Committee on Racial, Ethnic, and Other Populations; NVAC = National Vaccine Advisory Committee; USDA = U.S. Department of Agriculture.
a In recent revisions, the program staff have been the co-executive secretaries appointed by Office of Disease Prevention and Health Promotion (HHS); Food, Nutrition, and Consumer Services Center for Nutrition Research (USDA); and the Research, Education, and Economics Agricultural Research Service (USDA). See Chapter 2 for additional details.
b Term used in the 2016 membership balance plan.
c As described in the 2015 membership balance plan.
d Under 42 U.S.C. § 300aa-5, the director of the National Vaccine Program appoints NVAC committee members in consultation with the National Academy of Sciences.
TABLE 3-5 Process Used to Vet Candidates for Select Federal Advisory Committees
NOTES: The following committees were omitted from this table because a description of how the candidates were vetted was not included in their charter or membership balance plan: Arthritis Advisory Committee; Federal Deposit Insurance Corporation Advisory Committee on Economic Inclusion; Health Information Technology Policy Committee; Homeland Security Information Network Advisory Committee; National Advisory Committee on Racial, Ethnic, and Other Populations; and Physician-Focused Payment Model Technical Advisory Committee.
AAC = Arthritis Advisory Committee; ABTSWH = Advisory Board on Toxic Substances and Workers Health; ACAS = Advisory Committee on Agricultural Statistics; CDC = Centers for Disease Control and Prevention; CSAC = Chemical Safety Advisory Committee; DGAC = Dietary Guidelines Advisory Committee; FACA = Federal Advisory Committee Act; FNCS = Food, Nutrition, and Consumer Services; HHS = U.S. Department of Health and Human Services; HICPAC = Healthcare Infection Control Practices Advisory Committee; NAC-REOP = National Advisory Committee on Racial, Ethnic, and Other Populations; NCEZID = National Center for Emerging and Zoonotic Infectious Diseases (CDC); NVAC = National Vaccine Advisory Committee; OGE = Office of Government Ethics; REE = Research, Education, and Economics; SGE = special government employee; USDA = U.S. Department of Agriculture.
a The proposed slate is compiled after two stages of screening. The initial screening identifies potentially qualified candidates, based on the criteria listed in the charter. This smaller pool is further narrowed by considering a range of factors, including potential intellectual conflicts of interest.
b Vetting by senior-level officials includes comprehensive personal and professional background checks, which encompasses but is not limited to an assessment of the candidate’s criminal history, affiliations and associations, and prior involvement with the department.
c Background checks are used to assess whether candidates have a conflict of interest that would rise to the level of a criminal or ethical violation, and therefore disqualify them from serving on the advisory committee.
e NAC-REOP uses the FACA membership process outlined by the Office of the General Counsel of the U.S. Department of Commerce.
g Used in the assessment of committee members’ point of view and overall committee balance.
h Used in the final determination whether the candidate is sufficiently qualified to be appointed to the advisory committee.
cannot be released, even through a Freedom of Information Act request. Special government employees serving on federal advisory committees may be granted a waiver if it is determined that the need for their service outweighs the potential conflict.6
Capturing and evaluating biases and nonfinancial conflicts of interest poses a challenge for any organization convening a committee (GAO, 2004) (see Box 3-3). Indeed, this is reflected in the illustrative examples, which did not provide extensive descriptions of such assessments. One example for capturing nonfinancial conflicts was identified. EPA has adapted the standard confidential financial disclosure form for special government employees and added Section 6, which includes supplemental ethics questions for the potential committee member to complete (EPA, 2016). Questions ask the candidate to report anything that would be perceived as jeopardizing their impartiality, whether they had been involved in any of the documents that will be reviewed, what other committees on which they have served, and if they have made any public comments
6 18 U.S.C. § 208(b)(3).
on the topics under consideration. While the burden of disclosure remains on the individual candidate, EPA Form 3110-48 represents one approach to documenting and assessing biases and nonfinancial conflicts of interest.
The vetting process is not restricted to background investigations conducted by the agency. One example incorporated public feedback as part of the vetting process. A 2015 Federal Register notice listed the names, credentials, and affiliations of each candidate for the Advisory Board on Toxic Substances and Worker Health, and gave the public 14 days to provide comment before final appointments were made (DOL, 2015b). Public comment on the list of candidates, however, was not a process seen in any of the other illustrative examples.
The presence of conflicts of interest is not always an automatic disqualifier. Members of the Physician-Focused Payment Model Technical Advisory Committee (PTAC), for example, operate under bylaws that explicitly outline how conflicts of interest will be managed (HHS, 2016c). The legislation authorizing the formation of the PTAC states that for the
purposes of filing financial disclosures, members are treated as employees of Congress. This means that members are not classified as special government employees and are not subject to the same rules regarding conflicts of interest and ethical standards. Instead, each committee member is responsible for disclosing at the beginning of each meeting any involvement with the materials to be discussed. It is then up to the other members of the advisory committee to collectively decide the extent to which the potentially conflicted member may participate in the meeting. Both the potential conflict and the advisory committee’s decision on the
member’s involvement in the discussions and voting on the topic are disclosed to the public. This model engages members in managing conflict of interest and promotes transparency.
Unless directed otherwise by statute or presidential directive, the head of the agency establishing the federal advisory committee has the sole authority to appoint federal advisory committee members. Mandates have been put forth assigning appointing authority to political appointees and other leaders. For example, members of the nondiscretionary Health IT Policy Committee are appointed by the secretary of health and human services (3 members); the majority leader of the Senate (1 member); the minority leader of the Senate (1 member); the majority lead of the House of Representatives (1 member); the minority leader of the House of Representatives (1 member); the Comptroller General of the United States (13 members); and the President (relevant representative members) (HHS, 2009).
Committees That Operate Under Section 15 of the Federal Advisory Committee Act
Section 15 of FACA mandates specific procedures for committees appointed by the NAS and the National Academy of Public Administration that provide advice to a federal agency under an agreement with it. Section 15 requires the two academies to “provide public notice of the names and brief biographies of individuals that the Academy appoints or intends to appoint to serve on the committee” and to “provide a reasonable opportunity for the public to comment on such appointments before they are made.”7 This requirement is in contrast to the noted procedures for federal advisory committees that operate under the other provisions of FACA.
Other selection approaches are used by groups that do not operate under FACA. This National Academies committee explored the processes of organizations whose recommendations, guidelines, and policies have national or international implications. Many convening entities that do not operate under FACA publish documentation of their processes by posting procedure manuals online or publishing the information as jour-
7 Federal Advisory Committee Act Amendments of 1997, § 15(b)(1).
nal articles. There is no standard set of information that must be included in such descriptions, making it almost impossible to assess and compare processes. Furthermore, there is no central repository of the different processes, as there is with federal advisory committees. As such, this National Academies committee was limited in its ability to comprehensively explore the range of processes used to compose non-FACA committees. This appraisal, therefore, is not intended to be exhaustive. The procedures to select non-FACA committee members largely differed from federal advisory committees with respect to documenting how financial and nonfinancial conflicts of interest are identified and managed. Based on a review of the literature and the experiences of this National Academies committee, a large number of governmental and nongovernmental organizations—both domestic and international—were studied. The processes developed by governmental organizations tended to be more transparent and have more explicit rules to follow than nongovernmental organizations. Five examples with unique conflict of interest procedures are described below.
U.S. Preventive Services Task Force
The U.S. Preventive Services Task Force (USPSTF) is an independent committee that makes evidence-based recommendations about health promotion and clinical preventative services in the primary care setting. Although the members are appointed by Agency for Healthcare Research and Quality, USPSTF does not operate under FACA. The USPSTF Procedure Manual explicitly outlines how members’ financial and nonfinancial conflicts of interest are identified and managed (USPSTF, 2015b). Briefly, potential conflicts are graded as levels 1, 2, or 3. The conflict’s level corresponds to recommended actions regarding public disclosure of the conflict and the extent to which the member should participate in discussions and voting on the specific matter. The period of disclosure for conflicts is the 36 months prior to completing the form, which is in contrast to the previous 12 months asked for on OGE Form 450. All publications related to the topic under consideration must be disclosed, regardless of when they were published. The USPSTF website lists all conflicts classified as level 3, along with the action taken because of the disqualifying activity (USPSTF, 2015a).
European Food Safety Authority
The European Food Safety Authority (EFSA) is an independent agency funded by the European Union to serve as a source of scientific advice and communication on risks related to the food chain. The proce-
dure for identifying and handling potential conflict of interests delineates how financial and scientific interests are managed, while a separate guidance document provides definitions and instructions on what needs to be declared (EFSA, 2009a,b). A general declaration of interests must be completed annually, while a specific declaration must be submitted before each meeting that is tailored to the specific topic to be discussed at that meeting. Members, the chair, hearing experts, and staff are all asked to submit declarations, which are all made available to the public.
EFSA notes that scientific expertise is necessary to fulfill its mission and tasks and that requisite experiences are understood to be part of being an expert; interests are therefore not necessarily considered a conflict of interest. The disclosure period is the 5 years prior to completing the declaration. The forms ask members to state (1) ownership or other investments, (2) member of a managing body or equivalent structure, (3) member of a scientific advisory body, (4) employment, (5) consultancy/advisory, (6) research funding, (7) intellectual property, (8) other membership or affiliation, and (9) interests of close family members (EFSA, 2009b). Interests are graded as levels A (nonexistent), B (possible), or C (existent). Level B conflicts are managed by limiting the person’s involvement (e.g., respond to specific questions, but cannot actively participate in final decision making). Level C conflicts require the person to be excluded from the activity and be replaced by another expert, but in exceptional cases a waiver can be granted (EFSA, 2009a).
World Health Organization Global Advisory Committee on Vaccine Safety
The Global Advisory Committee on Vaccine Safety is a standing committee that advises the World Health Organization (WHO). Members serve as individuals and cannot be affiliated with industry (WHO, 2016). Before serving on the advisory committee, members must complete the “Declaration of interest for WHO experts” form (WHO, 2014). The form asks the member to report employment and consulting appointments (previous 4 years), research support (previous 4 years), investment interests (valued at more than $5,000), intellectual property, and public statements and positions (previous 3 years). The form notes that a conflict does not necessarily disqualify an individual from service. The WHO secretariat may apply one of the following three measures for members with potential or significant conflicts: (1) publicly disclose the conflict and allow the member to fully participate; (2) prohibit the member’s participation in portions of the advisory committee’s work related to the conflict; and (3) total exclusion from the advisory committee’s work. Members are required to disclose significant conflicts to other participants in the
activity. The advisory committee’s reports and publications all publish disclosed conflicts and remedies.
Australian Government National Health and Medical Research Council
The National Health and Medical Research Council (NHMRC) is commissioned under Australian law to develop evidence-based guidelines in population health, ethics, and clinical practice, and carries out this task through appointing expert task-based committees (NHMRC, 2014a).8 The NHMRC’s process for vetting candidates includes (1) identifying and disclosing potential conflicts of interest, including financial, intellectual, and organizational; (2) determining whether a conflict of interest exists; and (3) putting procedures in place to manage any conflicts of interest (NHMRC, 2012). Financial activities to be reported include employment (previous 3 years), ownership interests (for the member and his or her immediate family), and consulting fees, honorarium, grants, travel support, meals and beverages, entertainment, gifts and gratuities, and any other financial interest (for the member and his or her immediate family; previous 3 years and anticipated in the 12 months that follow). Candidates are also asked to report relevant professional and organizational experience (e.g., publications, speeches or lectures, expert testimony, development of related guidelines and materials) and any other affiliations, relationships, or associations that could be perceived as a potential conflict. Conflicts are disclosed in writing to the chief executive officer or delegate, and they are disclosed verbally in a discussion with the membership, upon which the presiding individual determines appointment and appropriate management procedures if necessary. The NHMRC’s chief executive officer is responsible for overseeing this process, but he or she has the authority to delegate this responsibility to a committee member or NHMRC staff member (NHMRC, 2012). The committee chair, who also must be free of conflicts of interest, is responsible for overseeing the compliance to any management plans. Committee member declarations of conflicts and any management plans put in place are published on the NHMRC website on an ongoing basis (conflict declarations are updated every meeting), unless an exception is granted by the chief executive officer, as well as published in the final guidelines (NHMRC, 2014b).
8 National Health and Medical Research Council Act, Act No. 25, 1992, Australian government.
American College of Chest Physicians Antithrombotic Guidelines, Ninth Edition
Professional organizations also offer examples of differing selection processes, although not always in the context of an advisory committee. While many professional organizations put together advisory committees, not all have a strong record on conflicts of interest. Many professional organizations follow generally similar processes, including not hosting a public comment session and requiring committee members to be a member of the host organization. This National Academies committee identified one example notable for its unique process: the development of the ninth edition of antithrombotic guidelines, convened by the American College of Chest Physicians. Specifically, this professional organization explicitly reviews intellectual conflicts of interest. In composing this committee, the conveners developed management strategies to balance conflicts of interest with the expertise needed to develop the guidelines. Each committee member disclosed both financial and intellectual conflicts in writing for each recommendation, and the conflicts were reviewed and graded as either primary or secondary by the American College of Chest Physicians Health and Science Policy Committee. Primary conflicts, such as consultancies or authorship of original studies directly related to the recommendations in question, were considered serious and required management plans, including recusal from voting on recommendations (Guyatt et al., 2012). Secondary conflicts, such as consultancies not directly related to the recommendations in question, or participation in previous guidelines panels, were considered less serious and did not require a management plan. The Health and Science Policy Committee did not enforce the recusal of conflicted experts throughout its deliberations; this was managed by a nonconflicted methodologist who co-led each content area with a relevant, but generally conflicted, content expert (Guyatt et al., 2012). In this example, although conflicts were identified in the committee selection process, the Health and Science Policy Committee relied on the management plan in place to produce guidelines free of undue influence from conflicts of interest (Akl et al., 2014). Conflicts for each recommendation were published in the final guidelines.
This National Academies committee’s review of selection processes revealed profound variation across several steps of selection processes, including membership types, methods for soliciting nominations, and the ways in which candidates are screened, vetted, and appointed. Among committees that are required to abide by FACA, practices were found to range widely by agency. Even less agreement was
identified in the development of nonfederal advisory committees. Because this committee could not identify valid measures of success and a lack of standardization, no set of best practices were recognized. Instead, interesting examples were identified for promoting transparency, as well as for including a range of viewpoints and expertise in an advisory committee.
There are many methods to broaden committee membership and enhance transparency not used by the DGAC. For example, one approach is to use different types of committee member designations (i.e., special government employee, regular government employee, representative, ex officio, nonvoting members). Committees have enhanced their transparency through documentation and public release of information. Stages of the process where this has been accomplished includes the solicitation of nominations from the public and procedures for identifying and managing conflicts of interest. While the assessment of financial conflicts is standard, evaluating nonfinancial conflicts appears to pose a greater challenge. Some groups have created forms and questionnaires in an effort to capture and document these relatively subjective potential influences. The selection authority and process typically resides with the convening entity, although outside offices or organizations have been consulted in the appointment process.
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