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Code of Research
Ethics
A
Position Paper of the Society for Adolescent Medicine
Code of Research Ethics: A Position Paper of the Society for
Adolescent Medicine - Journal of Adolescent Health:
1999; 24:277-282
Rationale
Why
Does a Professional Society Need a Code of Research Ethics?
Because the professions
possess a body of abstract knowledge and a service orientation,
they therefore occupy a distinctive niche in public life,
securing certain privileges not accorded other occupations.
One of the privileges granted by the public is self-governance,
since the extended specialized professional education in both
abstract knowledge and practical application precludes regulation
of individual professionals by any one other than peers. In
fact, it is how this regulation of practice is conducted in
the public interest that represents the effective service
orientation or ethicality of a profession1.
The public has
granted a certain level of autonomy to professional societies
based on trust in the individual professional's responsibility
and conscientiousness and on the profession's claim of self-regulation.
Nonetheless, there continues to be a "tension between the
acquisition of new knowledge and the fear of that knowledge
(which) remains widespread in society" 2. The public
certainly desires the benefits of new knowledge and usually
wants these benefits without their attendant risks. At a minimum,
though, the public demands assurances that knowledge is accurate,
ethical conduct is assured, and subjects are carefully protected3.
As researchers work to learn new insights into treating illness
and improving health, the public expects that they will conduct
their work ethically and maintain as their highest priority
the protection of research subjects. This constitutes the
basis of the social contract through which the public participates
through volunteerism and supports research through government
funding. Professional societies based on their responsibility
and conscientiousness are empowered to encourage, enhance,
and protect ethical standards that are attentive to the societal
concerns regarding research.
Self-regulation
can take a number of forms. Much self-regulation focuses on
admission criteria such as educational preparation and proficiency,
and is therefore administrative or proscriptive. Yet, Frankel
noted that "(T)he scientific disciplines... are a prominent
normative reference group, whose values and standards of appropriate
research practices serve as guides by which individual scientists
organize and perform their work and by which outsiders can
understand and evaluate their performance"4.
In this light, he maintained that the societies should address
common values and "by appealing to moral consciences and collective
commitment to ensuring the integrity of science, ...seek to
evoke from scientists a higher standard of behavior than that
which can be commanded through regulation"4.
A
code of ethics reflects a collective professional conscience
committed to promoting ethical behaviors based on the collective
experiences and distinct traditions of the scientific discipline.
A code constitutes a basis for evaluating behavior and holding
individual professionals accountable, and thereby creates
a system in which individual professionals assume responsibility
for the collective integrity of the society. A code of ethics
also contributes to the socialization of new professionals,
providing guidance on expected behaviors. Finally, a code
of ethics establishes standards that may be used by legislative,
administrative, and judicial bodies in adjudicating allegations
of misconduct4.
Why
Does the Society for Adolescent Medicine Need a Code of Research
Ethics?
The Society for
Adolescent Medicine (SAM), a multi-disciplinary organization,
is devoted to the delivery of comprehensive acute, chronic,
and preventive health care to youth and to the institution
and execution of imaginative scientific research regarding
all aspects of adolescence5. SAM has committed
itself to the establishment of a code of research ethics and
its broad dissemination. It is hoped that by example,
it will influence other organizations to do likewise.
The Society for Adolescent Medicine adopts
a code of research ethics to identify the norms and values
by which its members should act and with which it will initiate
new members into the research life of its society. In so doing,
SAM reaffirms its contract with the general population to
seek knowledge through research in an irreproachably ethical
manner.
A
code of research ethics will be of particular value to SAM
because research with adolescents presents many challenges.
Adolescence itself is a period of profound cognitive, physical,
social, and moral development, none of which adheres to a
perfectly predictable course. During this time, adolescents
experience a compelling need for privacy and develop a sense
of identity apart from their parents. Parents, particularly
those ill-prepared for these changes in their children, need
reassurance from professionals that their parental role will
be honored and their children protected. Establishing knowledge
to promote healthy transitions from the dependency of childhood
to a fully mature and capable adulthood is a noble endeavor,
but one that requires clear vision, sensitivity, and integrity
in the researchers attempting it. By providing the standards
of responsible practice, a code of research ethics should
foster trust and enlist both youth and their parents as collaborators
in the effort.
While professional societies such as SAM
can assume responsibility for defining, establishing, and
disseminating ethical standards among their members, professional
societies are generally remote from the institutions in which
research is conducted and lack administrative mechanisms to
enforce standards of conduct. In general, these institutions
are often better able to enforce ethical standards. SAM will
focus its efforts on the formation and continuing education
of its members in the ethical conduct of research. Codes are
absolutely necessary, although not sufficient, for the ethical
well being of all concerned. The Society and its members must
strive to promote the strong personal commitment of the individual
researcher to the values, rights, and principles outlined
in the code.
Code
of Research Ethics for the Society for Adolescent Medicine
This Code is based firmly on the Global
Ethic6 and the principles outlined in the Report
of the National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research, known as the
Belmont Report7.
The
Global Ethic, which seeks to identify those ethical elements
common to the world's community of religions and traditions
of honor, states:
Every
human being without distinction of age, sex, race, skin
color, physical or mental ability, language, religion, political
view, or national or social origin possesses an inalienable
and untouchable dignity, and everyone, the individual as
well as the state, is therefore obliged to honor this dignity
and protect it. There is a principle which is found and
has persisted in many religious and ethical traditions of
humankind for thousands of years: What you do not wish
done to yourself, do not do to others. Or in positive
terms: What you wish done to yourself, do to others!
Scientists
and researchers must not give themselves over to morally
questionable ideological or political programs or to economic
interest groups nor should they justify research which violates
fundamental ethical values. In the great ancient religious
and ethical traditions of humankind is the directive: You
shall not lie! Or in more positive terms: Speak and
act truthfully!
Mutual
respect and consideration must be cultivated so as to reach
a reasonable balance of interests instead of thinking only
of unlimited power and unavoidable competitive struggles.
In the great ancient religious and ethical traditions of
humankind is the directive: You shall not steal!
Or in positive terms: Deal honestly and fairly!
The
Belmont Report establishes three principles as the
guiding spirit of ethical conduct: respect for personhood,
beneficence, and justice. The application of these principles
must be an integrated one, for on occasion situations may
arise when dogged adherence to one principle invites violation
of another. Consequently, easy answers and absolutism are
to be avoided; acting ethically demands continual self-examination,
discernment, and a willingness to approach ambiguity by consulting
colleagues and others knowledgeable about the dilemma.
Principle
1: Respect for personhood. Honoring the dignity inherent
in every human requires the acknowledgment of the right
of self-determination. It rests on the principle of subsidiarity
in which freedom of choice and action rests in the smallest
unit of society with the capacity to exert it. In research
activities, individual autonomy over personal decisions
is to be respected and assiduously protected. There is also
dignity to be respected in the families of subjects
and the communities in which they live. Members of professional
societies have additional responsibilities to their colleagues,
especially those in training, for honoring their personhood,
welfare, and development.
Principle
2: Beneficence. The principle of beneficence builds
on the ancient dictum, First, do no harm, by requiring
that research efforts must equally attend to doing good.
Honoring the principle of beneficence demands that researchers
commit themselves to advancing the common good, contributing
to the welfare of humanity by establishing and disseminating
new knowledge, and maximizing benefits while minimizing
harm to subjects in their own research effort.
Principle
3: Justice. Justice demands that we give to all
persons what is their due. Distributive justice requires
that persons receive the benefits to which they are entitled.
Investigators must scrutinize subject selection practices
to ensure that all persons eligible for the research effort
may have the opportunity to participate and potentially
gain from research offering potential benefit. Subjects
should be selected equitably with appropriate racial and
sexual representation. Contributive justice requires that
the burdens of research participation be not imposed in
a way that affects some people unfairly. In addition, the
requirement to act justly extends to one's colleagues and
collaborators in honoring their work and contribution.
The
Code of Ethics in Research Development
Creation
of the Research Question and Design
- Society for
Adolescent Medicine member scientific investigators should
maintain basic competence in research methods and seek competent
methodologic and analytic support when it is indicated.
The principle of beneficence demands that the contribution
of research subjects be honored and optimized so that the
objective of improving health and welfare is achieved.
- Research efforts
involving human subjects should be scientifically sound
and feasible, while all attendant risk to
subjects be made proportional to their particular circumstances.
- Research projects
with little statistical probability of achieving study objectives
should be avoided. Investigators are duty bound to ensure
that the research experiences contributed by study subjects
in good faith be evaluated and reported as understood by
the subjects in the consent process.
- Society for
Adolescent Medicine members should consider the effect of
study results on identifiable communities in which studies
are conducted. Communities should be understood to be sponsors
and consumers of research. SAM members should make efforts
to elicit and respond to community concerns during the development
of research projects.
- Investigators
conducting sponsored research must maintain independence.
This extends to study design, conduct, interpretation, and
reporting of study results. Investigators must always be
aware of their moral obligation to hold the public interest
above the interest of sponsors if a conflict arises.
- Investigators
should undertake animal experimentation only to advance
knowledge, when known alternatives are scientifically inadequate,
and when scientifically valid conclusions will be possible.
Study design must ensure respect and due concern for animal
health and welfare.
Formal
Review Process
- Society for
Adolescent Medicine members should strive for honest appraisal
of their own limitations, seeking peer review of research
initiatives, making efforts to learn from critical evaluation,
and assuming good faith on the part of colleagues. No member
should discriminate against or harass colleagues who have
offered criticism nor should a member retaliate against
a colleague who raises concerns about a member's misconduct.
- Investigators
must obtain objective ethical review of proposed projects
before contact with human subjects. These reviews are generally
conducted by institutional review boards (IRBs). Researchers
should adhere to requirements imposed by IRBs.
- Investigators
must be alert to conflicts of interest, prudently engage
in relationships that might precipitate such conflicts,
and disclose such conflicts to the affected parties. Investigators
are required to disclose all relevant financial, personal,
or professional relationships that might lead to a conflict
of interest, for themselves and their family members, to
their institutions, in their writings and public speeches,
and to the sponsors of their research funding.
Consent
Process
- Society for
Adolescent Medicine members must honor the role of parents
or guardians in the lives of adolescents and carefully balance
the developing maturity of the adolescent with the benefits
of adult engagement in the research process8.
Adult involvement becomes increasingly important if adverse
consequences are possible from research with higher levels
of inherent risk.
- Society for
Adolescent Medicine members, in their work with adolescent
research subjects, should respect the adolescent's
evolving intellect, judgment, and experience. The adolescent's
capacity for independent decision making should be respected
in a careful balance of the individual adolescent's experience
and personal circumstances with the inherent research risks.
The adolescent's right to autonomy must be honored in the
research process with clear, patient, and complete explanations
of the research and implications which can be readily understood
by the adolescent8.
Management
of Study Data
- The investigative
team is obligated to honor the consent agreement related
to the confidentiality of subject information. Consent agreements
should explicitly note the circumstances in which there
are limits on confidentiality in the professional-client
relationship (e.g., child abuse reporting requirements).
SAM investigators should ensure that there is a written
confidentiality policy understood and adhered to by the
full team which addresses both verbally shared and recorded
information collected on subjects. The principal investigator
is responsible for the integrity of the system.
- In general,
information maintained in study databases should not include
personal identifiers. In special circumstances, viz. database
linkage requiring personal identifiers, investigators assume
greater responsibility for providing additional protections
for the confidentiality of the information. Under
no circumstance may databases which include direct or potential
personal identifiers be made available to investigators
external to the original IRB-reviewed investigator team
and project unless specific subject consent for that practice
has been expressly obtained.
- Research records
should be maintained for a minimum period of 5 years after
publication for reference purposes should questions arise.
The integrity of the scientific process rests on the capacity
to challenge and question and the existence of the primary
data source makes the process possible. Investigators must
keep in mind that the end of the process is not publication,
but the advancement of knowledge.
Authorship
- Primary or
submitting authors assume responsibility for the contents
of the manuscript and the accuracy of all primary data,
for determining all legitimate coauthors, and specifying
the order in which the authors' names appear4.
- Legitimate
coauthors are those who make significant scientific contributions
to the work and who share responsibility for the results.
An author is first of all a writer and the criterion of
merit is the advancement of knowledge6.
Authors must substantially contribute to each of three activities:
(a) conception and design, or analysis and interpretation;
(b) drafting the article or revising it critically for important
intellectual content; and (c) approval of the final version
to be published10 .
- Granting honorary
authorship is an unacceptable practice. Individuals with
contributions not meriting coauthorship should be acknowledged;
such contributions include clerical assistance, arranging
for research subjects, and computer programming.
- The scientific
contributions of students must be acknowledged.
- Scholars are
obligated to acknowledge the use of the intellectual property
of others.
- Teachers and
mentors are not to appropriate the work of students as their
own.
Responsibility
to Disseminate Study Results
- Researchers
must truthfully report study data. Lying, misrepresenting,
falsifying, and selectively reporting only favorable data
are all reprehensible practices.
- After
the original investigator has completed analysis and all
prior rights to publication are satisfied, and unless specifically
prohibited by provisions of the subject consent process
or the proprietary nature of the data, investigators
should open access to research databases to competent
and qualified researchers. The original IRB-reviewed investigator
must ensure that no personally identifying data exist in
shared databases including the capacity to link database
information with other sources to identify subjects. It
is expected that the requesting investigator will bear the
expense of the project. This practice of data-sharing furthers
the advancement of knowledge by expanding the scope of the
original study question through ancillary analyses and optimizes
the societal benefit to be derived from the contributions
of study subjects.
- If datasets
are particularly complicated or the conditions under which
the data were collected may affect the interpretation of
results, it is appropriate for the original investigator
to suggest a collaborative relationship in order to fully
share all aspects of the research design, data collection
procedures, and unique features of the database for the
purpose of ensuring accuracy. This collaborative relationship
does not imply automatic authorship on resulting publications;
the criteria for authorship must be met.
- Society for
Adolescent Medicine members should decline participation
in peer review if it poses a conflict of interest for them.
Conflicts of interest should not be narrowly defined by
institutional or financial relationship but should extend
to any situation in which a reviewer knows s/he cannot deliver
a fair and objective review. No reviewer should use the
review process to further his/her own research by unnecessarily
delaying the publication timetable or appropriating the
work of others entrusted for review.
- Society for
Adolescent Medicine members should consider the effect of
study results on the communities in which studies are conducted.
SAM members should make efforts to insure that study results
are provided to guide and support relevant community programmatic
initiatives. SAM members should be committed to the improvement
of the communities in which adolescents live. Communities
which have provided support, volunteer time, or accepted
intrusion into their privacy should be provided with a thorough
review of research findings.
Particular
Responsibilities
- All SAM members,
whether they are involved in a formal institutional training
program, should consider mentorship and the training of
junior investigators a professional responsibility. All
members are obligated to act as exemplary role models adhering
to the highest standards of conduct.
- Society for
Adolescent Medicine members who function within training
and educational programs should ensure that values and ethical
principles governing research are understood by trainees
and students. This process should be formal and systematic,
not haphazard or assumed.
- Effective
and beneficent mentoring is premised on respect for the
junior partner. It elicits initiative and independent thinking
while providing guidance and supervision. Mentors must assiduously
avoid acting in their self-interest at the expense of their
junior partners.
- Society for
Adolescent Medicine members must hold each other accountable
in the conduct of research. Preserving the integrity of
the research process and thereby maintaining and enhancing
the goodwill of our larger society demands vigilance and
engagement from us all. SAM members must be willing to advise
and confront and, failing resolution, report concerns to
appropriate authorities for private investigation. SAM members
should approach this duty respectfully and confidentially
and never exploit the situation for character assassination
or personal gain.
This document
relies heavily on the work (Reference 4) of Mark S. Frankel,
Director of the Scientific Freedom, Responsibility and Law
Program at the American Association for the Advancement of
Science in Washington, DC, who summarized key tenets of codes
adopted by other professional societies.
References
1. Freidson, E. The Test of autonomy:
Professional self-regulation, In: The profession of
medicine: A study of the sociology of applied knowledge.
New York: Harper and Rowe, 1970:137-40.
2. Olson, S, for the Board on Biology,
National Research Council. Science and scientists from the
public's perspective. In: Shaping the future: Biology and
human values. Washington, DC: National Academy Press, 1989:28-32.
3. Kass NE, Sugarman J, Faden R, and
Schoch-Spana M. Trust: The fragile foundation of contemporary
biomedical research. Hastings Center Report 1996; 26(5):25-9.
4. Frankel, MS. Professional societies
and responsible research conduct. In: Responsible science:
Ensuring the integrity of the research process. Vol. II.
Washington, DC: National Academy of Sciences, National Academy
of Engineering, and Institute of Medicine, 1992-1993:26-49.
5.
Society for Adolescent Medicine. Aims and scope. Masthead
of the Journal of Adolescent Health, the Official
Publication of the Society.
6. Declaration toward a global ethic.
Parliament of the world's religions. Chicago IL: Global
Ethic Foundation, Tubingen, Germany, September 4, 1993.
7. National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research.
The Belmont report: Ethical principles and guidelines for
the protection of human subjects of research. Office of
Protection from Research Risks (OPRR). NIH-PHS-HHS. Washington
DC: US, 1988.
8. Society for Adolescent Medicine. Guidelines
for adolescent health research. J Adolesc Health 1995;17:264-9.
9. Susser, M. Editorial: Authors and
authorship-reform or abolition? Am J Public Health 1997;
87:1091-2.
10. International Committee of Medical
Journal Editors. Uniform requirements for manuscripts submitted
to biomedical journals. JAMA 1997;227:927-34.
11. Integrity and misconduct in research:
Report of the Commission on Research Integrity to the Secretary
of Health and Human Services, the House Committee on Commerce,
and the Senate Committee on Labor and Human Resources, 1995.
United States Department of Health and Human Services.
12.
Association of American Medical Colleges. Developing a code
of ethics in research: A guide for scientific societies.
Washington, DC: 1998.
Prepared by
Audrey Smith Rogers, Ph.D., M.P.H. (Chair)
National Institute of Child Health and Human Development
Bethesda, Maryland
Sara B. Kinsman, M.D.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
John S. Santelli, M.D., M.P.H.
Centers for Disease and Prevention
Atlanta, Georgia
Tomas
Jose Silber, M.D., FSAM
Children's National Medical Center
Washington, D.C.
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