Guidance for Collaboration with the Private Sector
CIO Contact: CDC Associate Director for Management and
Operations
Material Superseded: None
Manual Guide, General Administration CDC-81, 2/18/97
- SUMMARY
- INTRODUCTION
- COLLABORATION WITH THE PRIVATE
SECTOR
- PRINCIPLES OF PUBLIC HEALTH AND
CDC
- CRITERIA FOR ASSESSING POTENTIAL
COLLABORATIONS
- GENERAL RECOMMENDATIONS FOR
COLLABORATIONS
- REFERENCES
I. SUMMARY
The Centers for Disease Control and Prevention (CDC)(1)
has developed guidance for employees to help evaluate the suitability of
potential collaborations with the private sector. This guidance is based on
several principles: public health decisions must be based on sound science
and public good; benefits to society must be a higher goal than benefits to
either partner in the collaboration; the agency must be a diligent steward
of public trust and funds; and the agency and its employees should conduct
business according to the ethical standards that govern the agency. Criteria
used to determine whether to collaborate include: fit of collaboration to
mission, independence of scientific judgment, effect of the potential
collaborator's product(s) or service(s) on health, and the potential
collaborator's behavior. General recommendations for collaboration address:
consistency of potential collaborator's broad mission with agency's mission,
use of indirect relationships, public nature of collaboration, and openness.
II. INTRODUCTION
Broad societal goals for health promotion and disease prevention cannot
be achieved without widespread change in individual behavioral practices;
optimal utilization of preventive services; improvement in diagnostic,
treatment, and prevention technologies; and increased knowledge about and
understanding of public health problems. The assistance of both public and
private organizations is required if societal change is to be achieved. The
Centers for Disease Control and Prevention alone rarely has the resources
needed to achieve large-scale implementation. Thus, the agency periodically
considers partnerships, including ones with private sector organizations, to
carry out its mission.
For purposes of this Guidance, a collaboration is defined as an
interaction between CDC and one or more private sector organization in which
both parties work together to carry out their missions. The interaction is
voluntary and the basis for the interaction is not found in statutory
authority or other law. Situations in which CDC is mandated to work
with the private sector are not subject to the criteria and recommendations
in this Guidance. For example, interactions with the private sector that CDC
carries out as part of its Congressional authority such as responses to
emergencies (e.g., epidemics, toxic spills, etc.) and health hazard
evaluations or interactions covered by other laws or regulations (such as
grants, cooperative agreements, contracts, and CRADAs) are not considered to
be collaborations subject to the criteria and recommendations in this
Guidance. Situations in which CDC is mandated to work with the private
sector are also excluded. However, the principles in this guidance apply to
all CDC activities.
The types of collaborations possible are many. For professional
organizations, public grantees, and individual practitioners, the ethics and
appropriateness of collaborations with private organizations have been
greatly debated.1-5 These debates generally
concern issues of conflict of interest and duty to patients, workers, and
the public. The responsibilities associated with using public funds and
being public employees also affect what might otherwise be reasonable
interactions.5
A dearth of literature is available on the ethics of, or the practical
approaches to, such collaborations from which CDC can develop policy. The
approach described here began with a series of discussions within CDC's
National Center for Chronic Disease Prevention and Health Promotion and with
outside experts on how best to assess and encourage partnerships with
private organizations6 and how to assess the
suitability of public/private collaborations. This approach was originally
developed to guide industry collaborations within one CDC Center, but now
has been broadened and modified for agency-wide use. (For
further information, see Section VII, References.)
This document identifies principles that underlie the public health
mission and sets forth guidance for evaluating potential collaborations.
This document concentrates only on collaborations with private
organizations, both for-profit and not-for-profit. Even with this guidance,
the decision of whether to collaborate may still be unclear in some
circumstances; no set of precepts can adequately cover all situations. Only
if such collaborations were arbitrarily prohibited could judgment and
oversight on a case-by-case basis be suspended.
III. COLLABORATION WITH THE PRIVATE SECTOR
Private sector organizations are not-for-profit or for-profit.
Not-for-profit organizations include voluntary associations, foundations,
civic groups, professional associations, universities, unions, and other
similar types of groups. For-profit organizations include corporations,
partnerships, proprietorships, and others intended to generate financial
gain for their owners. The agendas and missions of private organizations may
overlap to a greater or lesser degree with those of CDC. Even where such
overlap exists, it is likely there are fundamental differences between CDC
and private organizations.
Collaborations with the private sector may involve, but are not limited
to:
- Technology transfer. Examples of technology transfer activities
include the development and evaluation of commercial products such as
vaccines, diagnostic tests, computer software, and media tools.
- Public education. Examples of public education activities include mass
media campaigns, production and dissemination of educational materials,
and direct client or patient intervention programs.
- Professional education. Examples of professional education include
conference sponsorship and publication of proceedings, recommendations, or
other materials.
- Applied research or evaluation. Examples of research and evaluation
include development or assessment of the effectiveness of various
commercial or pharmaceutical products and efficacy of nonpharmacologic
interventions, investigations of etiology, evaluation of health protection
and promotion activities, engineering control measures, and dissemination
of results.
- Provision of public health services.
For purposes of this Guidance, collaborations are not considered to
include interactions with the private sector that would occur as part of
CDC's routine conduct of business such as responses to emergencies, health
hazard evaluations, surveillance, and technical assistance. However, the
principles undergirding this guidance should generally apply to all CDC
activities.
Reasons for considering collaboration include access to private sector
skills and enhancement of the program by involving outside partners.
Exemplary organizations in an industry can set an example for other
organizations. Organizations often possess information or technology that is
useful to the public. Organizations provide access to at-risk worker
populations. Engaging the private sector may be helpful in reaching a large
segment of the public, generating broad societal support or winning over
potential opposition. However, limited public resources or the expectation
of gaining private resources alone should not be considered sufficient
reason for collaborating with private organizations.
What the health agency and the private sector partners bring to the
collaboration are often similar. Both may have resources to commit, and each
may have access to specific populations or professional groups that the
other cannot easily reach. In the best collaborations both groups bring
credibility with selected segments of the population on certain issues
and/or special technical expertise.
IV. PRINCIPLES OF PUBLIC HEALTH AND CDC
The mission of CDC is to prevent premature death, disease, injury and
disability; to protect against hazardous environmental and occupational
exposures; and to promote health. Other organizations may share much or part
of this mission, but rarely is it central to a private organization's
mission. Because much of the concern about collaborations arises from CDC's
potential conflict of interest between its societal responsibility and
responsibilities growing out of the collaborations, the agency must have its
mandated mission clearly in mind when considering a collaboration. The
following principles are presented to help insure that CDC is attending to
its primary mission and to govern the assessment of the potential
collaboration.
A. Public health decisions must be based on sound science
and the public good.
B. The benefits to society must be a higher goal than
benefits to either partner in the collaboration.
C. The agency must be a diligent steward of public trust
and funds.
D. The agency and its employees should conduct business
according to the ethical standards that govern the agency.
A number of issues should be addressed in deciding whether to enter into
a potential collaboration. The relative contribution of each issue to the
decision will depend upon the specific circumstances of the potential
collaboration. The decision of whether to collaborate with a given private
partner should be based on the preponderance of evidence gathered by
addressing the issues.
The agency should execute, in advance, a concise, written agreement with
the collaborating partner(s). The agreement should identify key elements of
the project including: goals and intended benefits; the role and
responsibilities of each partner; the resources each commits to the project;
the rights to any property, goods, services, or other products of the
project; the individuals acting as lead for each partner; and any reporting
plans or requirements. The agency should review the agreement periodically
as the project is implemented and update it as needed.
V. CRITERIA FOR ASSESSING POTENTIAL COLLABORATIONS
A. CDC should be clear how the potential collaboration
fits within its overall mission and priorities and the private partner's
mission and priorities.
If CDC originated the project, then it is likely to fit well with the
agency's mission and goals. If the project was the partner's idea, the
agency should assess whether the project is central to the agency's goals
and priorities. The agency should consider the following questions:
- Why does the organization want to work with the agency?
- How does the project relate to the organization's mission and goals?
- Will the potential collaboration have a reasonably large impact
relative to the resources required?
B. CDC should address independence and objectivity of
scientific judgment in the potential collaboration. Further, mechanisms
should be identified that will ensure such objectivity and independence
during the collaboration.
The agency should consider the following questions:
- Will the project be designed so that it is scientifically defensible?
- Will CDC be able to review and approve any public statements about the
project, its findings, and its implications?
- Will the agency have a say in data analysis, publication, and
dissemination of results and materials?
- Will the agency or the private sector partner have unilateral veto
power over what can be disseminated?
- Can either party halt the project because they become uncomfortable
with the results or interpretations?
Answers to these questions should be agreed on in advance and put in
writing.
Independence and objectivity are particularly critical when examining an
issue surrounded by controversy. The fact and appearance of independent
judgment can be protected in many ways, including establishing independent
review boards of public health professionals and scientists who are not part
of the project.
C. CDC should assess the effect of the private partner's
products or services on health and whether they are compatible with CDC's
mission.
The agency should consider the following questions:
- What is the overall impact of the organization's products or services,
their distribution, mode of delivery, and their use on health?
- Do the organization's products or services harm the public's health
when used as intended?
- What is the impact of the potential collaboration on the public's
health?
Some organizations produce products that have aspects both harmful and
beneficial to the public's health. When deciding to collaborate with these
entities, the potential harm the product or service causes should be
compared to the potential benefit of the product or service; the benefit to
the public of the product or service should outweigh harm and be easily
articulated.
By working with CDC, organizations producing harmful products or
delivering harmful services can gain a measure of respectability. At the
same time, CDC can open itself up to criticism by others in the health
community and a potential loss of credibility. The collaboration should
address the product's or service's harmful effects and it should clearly
state how the collaboration fits within CDC's overall mission and
priorities.
In negotiating the collaboration, the potential
partner can be asked to provide a list of products or services. Common
knowledge should suffice to determine the extent to which a product or
service has a harmful component. If there is doubt about a product's safety,
a more thorough review should be conducted.
D. CDC should assess the behavior of the private partner
in conducting business and determine whether the partner's behavior is
consistent with CDC's mission and the principles guiding private sector
collaboration.
Questions regarding a variety of aspects about the organization's
behavior should be asked.
- What is the history of the organization's previous collaborations with
CDC or another public health agency?
- Do the organization and CDC adhere to similar scientific, ethical, and
legal principles and practices?
- Will the organization comply with CDC's policy and regulations?
- What are the organization's practices in promoting its products or
services and its interests?
- Could CDC stand behind the organization's practices?
- Does the organization's motivation for pursuing the collaboration fit
with CDC's mission and priorities?
- How has the organization behaved in the past when its product or
service was found to be harmful?
Generally, it is considered good business practice for commonly owned
organizations to support each other's interests. In the specific case where
an organization is owned by another (e.g., subsidiaries owned by a parent
company) and either the parent company or one of the subsidiaries produces a
product or delivers a service that is harmful, the issue of whether the
organization supports the interests of the parent company or other commonly
owned organizations should be addressed. The independence of the potential
partner and whether the interests of the other commonly owned organizations
will be supported by the collaboration should be addressed. Questions to ask
include:
- Is there evidence that the potential partner has conducted activities
that support the interests of other organizations?
- How independently is the organization able to conduct its business
from the parent organization and affiliated organizations?
Most of these questions about partner's behavior in conducting business
can be asked directly of the partner or assessed during the negotiation
phase of the collaboration. In addition, a media search could be made to
determine whether there have been press reports about the partner's
behavior.
VI. GENERAL RECOMMENDATIONS FOR COLLABORATIONS
A. CDC should assess not only the specific area of mutual
interest but the public impact of the partner's broad public mission and
image. For highly controversial issues, multiple collaborators should be
sought that represent a broad spectrum of opinions and interests.
In any collaboration, partners should share a common goal. But CDC should
also be aware of the unshared aspects of the partner's activities. Areas of
similarity of mission and interest are often well described in planning
meetings, since these similarities are the basis for potential
collaborations. However, the overall perception of the partner will
inevitably color the public's view of the appropriateness of the
collaboration. Will the collaboration enhance or detract from the agency's
mission, image, and credibility?
Many potential partners hold public positions on controversial issues.
Working on issues with such collaborators may compromise the agency.
Findings or activities favorable to the collaborator's position could be met
with public skepticism. One way to avoid this skepticism and the agency
being too closely tied to an individual organization's position is to
collaborate with multiple partners.
B. CDC should avoid participating in indirect
collaborations unless it would participate in a direct relationship with the
partners.
A direct relationship is one in which the agency and private partners
execute a project agreement. The most direct relationship is with a single
organization. An indirect relationship occurs when the agency collaborates
with an organization through an intermediary partner with whom the agency
executes an agreement. Indirect relationships vary; for example, the agency
may serve as a member of an advisory group for a project or may be a member
of a large group conducting a project through a third party, such as a
professional association.
Indirect relationships should not be established solely to distance CDC
from a specific partner, thereby avoiding an external perception of an
inappropriate collaboration. An indirect relationship often provides
relatively little protection from the perception that the agency is
inappropriately working with a private organization. This is especially true
when a third party is the intermediary between the agency and a single
organization.
C. Private partners should be informed that the existence
of the collaborative relationship will be made a matter of public record.
How this will occur should be worked out early, especially if implied
endorsements are likely. No direct endorsement of a product or service is
permitted by the agency.
Both CDC and the partner should be willing to make public the existence
of a collaboration. For CDC the standard should be whether the agency could
defend a collaboration about which the details were published on the front
page of the local newspaper. Although publication of minutes from meetings
is rarely required, private organization should be aware that all meetings
are subject to public disclosure.
CDC should ensure that any stand taken on issues of public health
importance is supported by the interests of the partner, the public, and the
agency. This responsibility must be borne out in fact and in appearance
because of the importance of the public's trust in the agency. The
appearance of compromised principles may limit CDC's ability to carry out
its public health mission as much as actual compromise.
Except where specified by law (e.g. the National Technology Transfer and
Advancement Act) for public employees, no appearance or fact of personal
gain should result from the collaboration. This responsibility becomes
critical when collaborations are with a single organization or concern
controversial subjects. Appearing to "do wrong" while "doing right" is
really "doing wrong." Officials who appear to be doing wrong erode
confidence in government and give citizens reasons to believe the government
can not be trusted. Citizens often have no other way to judge actions other
than by appearance. Public disclosure of the relationships can help reduce
concerns about potential conflicts of interest.
CDC should assess how its name and participation in a collaborative
project will be used and whether such usage is consistent with the agency's
public role. A private partner may be eager to link its name with CDC. Both
partners should understand how the collaboration might be publicized, and
the agency should have the chance to review and approve how its name and
participation will be used.
CDC should assess whether the partner will attempt to use its name to
endorse a product. Implied endorsement could occur, for example, if the
agency tested a specific product in a research project and did not include
all possible products in the test. Collaborating with one organization
(among several that provide the same product or service) may, in addition to
possibly implying endorsement of that organization or its product, give a
real or perceived (by its competitors) competitive advantage to the
collaborator. No direct endorsement of a product or service is permitted by
the agency.
At times, CDC is mandated to evaluate a product to determine
whether it performs as intended. While it can certify performance, CDC does
not endorse one product over another. For example, the National Institute
for Occupational Safety and Health certifies selected worker protection
equipment as meeting specified performance criteria.
D. CDC should maintain a process of openness and fairness
in developing collaborations with partners on similar projects or projects
with similar intent.
Openness to participation means CDC is willing to consider all potential
partners for similar projects or projects with similar intent. Any
organization can approach CDC regarding a potential collaboration. At the
same time, CDC is sensitive to the need to protect private sector interests.
Under certain circumstances, particularly those involving proprietary
information, knowledge, or technology, CDC can appropriately enter into
exclusive partnerships with private organizations. Examples include
Cooperative Research and Development Agreements (CRADAs), contracts,
cooperative agreements, and grants. Establishment of these exclusive
partnerships is generally preceded by a public announcement indicating
openness to considering applications from any organization capable of
providing the products or services necessary for a successful collaboration.
Under other circumstances, a collaboration may be most appropriate and
successful when it includes many partners, especially when the idea was
originated by the agency. One of the best ways to avoid potential criticism
of exclusive partnerships is to offer to collaborate with all appropriate
partners and collaborate with all of those who express interest. Under such
an arrangement concerns about exclusivity are usually avoided since any
organization could have participated.
E. Within each Center, Institute, and Office (CIO), a
formal review and advisory process should be established for examining
potential collaborations according to the principles, criteria, and
recommendations described in this document.
The criteria for assessing potential collaborations and
the recommendations outlined here are open to interpretation, and the
characteristics of individual projects can affect the relative weight and
interpretation of specific criteria and recommendations. Because any one
unit within a CIO is unlikely to accumulate extensive experience with
assessing potential collaborations, a review process should be established
and provide advice on potential collaborations to the CIO Director. The
implementation of the review process should be determined by each CIO; for
example, it may be established as a separate process from the CRADA review
or it may include the process to review CRADAs.
Individuals not directly involved in a potential collaboration should
formally review the proposal at some stage in the negotiation process. This
review serves several purposes. It ensures that agreements are open and
disclosed, and that potential conflicts of interest are formally assessed.
Through comments and summaries, the review ensures that key individuals are
kept informed about projects. Formal review also requires that the criteria
and recommendations outlined here are addressed early in discussions with a
potential collaborator. Such a process also allows a body of experience to
develop over time that can be used to sharpen decisions, identify potential
problems, and assess the outcomes of projects. A potential collaboration
that is viewed as controversial or as not meeting all of the criteria for
collaboration outlined in this guidance should be reviewed by the Director,
CDC before a final decision is made by the CIO.
Following review, a record should be kept of the decision for
documentation and learning purposes. At a minimum the record should include
the name of the potential collaborator, the CIO contact for the
collaboration, the purpose of the collaboration, the reason for disapproval
(if disapproved), and the results of the collaboration (successful,
partially successful, or unsuccessful). If the collaboration was less than
successful, the reason for the lack of complete success should be recorded.
A specific person should be assigned responsibility for maintaining these
records. Progress of the collaboration should be reviewed annually. Each CIO
should send semi-annual reports to the CDC Ethics Officer who will maintain
a records file and distribute a report to the CIOs. CRADAs are excluded from
these reports because they are reported through another mechanism.
F. Employees who will be developing collaborations with
the private sector should receive orientation and guidance from the CDC
Ethics Officer concerning the agency's principles, criteria, and
recommendations for collaborating with the private sector.
These principles, criteria, and recommendations provide general guidance
for collaborating with the private sector. Their success in implementation
is dependent upon consistent use by all employees. Because they are open to
interpretation, employees who are likely to develop collaborative
relationships should become familiar and conversant in the principles,
criteria, and recommendations. The CDC Ethics Officer shall serve as a
consultant to employees developing private sector collaborations. The Ethics
Officer will involve others (e.g., Office of the General Counsel) as
dictated by the specific details of the collaboration.
VII. REFERENCES
1. Margolis LH. The Ethics of Accepting Gifts from
Pharmaceutical Companies. Pediatrics 1991;88:1233-1237.
2. Marshall E. When Commerce and Academics Collide. News and Comment.
Science 1990;248:152-156.
3. Page L. Funds from Alcohol, Tobacco Firms Raises Concerns. AMA News,
December 21, 1992.
4. Blumenthal D. Academic-Industry Relationships in the Life Sciences:
Extent, Consequences, and Management. JAMA 1992;268:3344-3349.
5. Thompson DF. Paradoxes of Government Ethics. Public
Administration Review 1992;52:254-259.
6. Adams MM, Harris J, Ericksen MP, Trowbridge FL,
Marks JS, Koplan JP. The Ethics of Collaboration between Public Health
Agencies and Tobacco-Affiliated Companies. (In preparation)
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1. References to CDC
also apply to ATSDR
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