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The Belmont Report:
             An Ethical Framework for
            Protecting Research Subjects
              Janet F. Zimmerman, MS, RN, Clinical Research Training Consultant, Newtown, PA




I       NTRODUCTION
        Twenty years ago, a select group of 11 American men and women were in the
        midst of a congressional assignment. The assignment was to “identify the basic
        ethical principles that should underlie the conduct of biomedical and behavioral
research involving human subjects and to develop guidelines which should be followed to
assure that such research is conducted in accordance with those principles.” 1 In 1979,
these principles were published in what is commonly known as The Belmont Report.
While never formally adopted, The Belmont Report has become the primary ethical framework for
protecting human research subjects in the United States.


    Most of us have some knowledge of     BACKGROUND                                  two international codes were adopted
the U.S. Food and Drug Administration         At its basic level, the U.S. Congress   for physicians and scientists conduct-
(FDA) statutes, which are published       is an agent of change, enacting laws as     ing research with human subjects.
in Title 21 of the Code of Federal Reg-   a response to events or problems            They were The Nuremberg Code in
ulations (CFR), or those of U.S. Public   requiring national uniformity. On July      1947 and the Declaration of Helsinki
Health Service (PHS) which are pub-       12, 1974, Congress passed the               in 1964, which has since been revised
lished in Title 45 CFR. However, we       National Research Act, primarily in         and updated. At the time, each of
may be less familiar with non-regula-     response to the USPHS-sponsored             these international standards delin-
tory guidelines, such as The Belmont      syphilis studies that were conducted        eated ethical principles for informed
Report, that have importance in           on indigent African-American males          consent and medical care of research
research involving human subjects.        in Tuskegee, Alabama from 1932 to           subjects, both of which were disre-
Our goal is to briefly explain some of    1972. When the story broke, the             garded in the syphilis studies. For
the historical events that led to The     tragic events of these studies were         whatever reasons, the United States
Belmont Report and to provide an          widely reported in the press. In fact,      government continued to sponsor
overview of the Belmont principles        the syphilis studies are still newswor-     research in humans that should have
and the underlying message of the         thy as exemplified by the made-for-         been guided by the Nuremberg and
report.                                   television movie, Miss Evers’ Boys,         Helsinki principles. While the United
                                          broadcast on HBO earlier this year.
                                              It is interesting to note that during
                                          the 40 years of the syphilis studies,


                                    the monitor               s             summer 1997
States was the primary sponsor of The      became the basis for future DHHS          THE BELMONT REPORT
Nuremberg Code, the United States          laws. In 1981, Congress enacted three         The objective of The Belmont
was not a signatory to the Declaration     DHHS statutes that demonstrated a         Report “is to provide an analytical
of Helsinki.                               remarkable collaborative effort within    framework that will guide the resolu-
    However, codes and principles are      DHHS. They are FDA regulation 21          tion of ethical problems arising from
not regulations, and therefore are not     CFR Part 50 and PHS regulation 45         research involving human subjects.” 2
enforceable by law. With the 1974          CFR Part 46, both titled Protection of    The framework of The Belmont Report
National Research Act, Congress            Human Subjects. The third 1981            is presented in three discussion
mandated the establishment of insti-       statute is FDA regulation 21 CFR Part     topics: boundaries between practice
tutional review boards (IRBs) to           56, titled Institutional Review Boards.   and research, basic ethical principles,
review all federally funded human                                                    and applications.
research. Until this time, hospital or
institutional review of research activi-                                             1. Boundaries Between Practice
ties for purposes of protecting human
subjects was voluntary, informal, and
                                                     “ Technically,                      and Research
                                                                                         Practice refers to interventions
without established criteria.                                                        that are intended to solely improve the
                                                   the United States
    The National Research Act also                                                   well being of the patient. They are
created the National Commission for                                                  accepted standards that have a reason-
the Protection of Human Subjects of                 does not have a                  able expectation of success. The goal
Biomedical and Behavioral Research.                                                  of practice is to provide a diagnosis,
The 11 members of the Commission,                                                    preventive treatment, or therapy that
                                                   national policy for
who represented science, law, ethics,                                                will enhance the patient’s wellness. In
and society, published several state-                                                most cases, practice standards are
ments or reports on various aspects of         protecting research                   supported by research findings.
research with human subjects. These                                                      Research refers to activities that
reports outlined recommendations to                                                  are designed to develop or contribute
                                                       subjects.”
the Secretary of the Department of                                                   to the general body of knowledge.
Health, Education, and Welfare                                                       General knowledge includes theories,
(DHEW), now known as the Depart-                                                     principles,       and      relationships.
ment of Health and Human Services              Since neither Congress or DHEW        Research activities test a hypothesis,
(DHHS).                                    (now DHHS) moved to formally adopt        are validated by statistical measures,
    One of the Commission’s statements     The Belmont Report in its entirety,       and allow conclusions to be drawn.
was The Belmont Report: Ethical Prin-      arguably, the United States does not          Research is written in a formal
ciples and Guidelines for the Protection   have a national policy for protecting     protocol that can be reviewed and
of Human Subjects of Research com-         research subjects. Yes, there are the     replicated by others. In research, ben-
monly referred to as The Belmont           aforementioned DHHS statutes, but         efits are not always known nor are
Report. The Commission recommended         these are mandates too restrictive and    they assured. Because harm may
to the DHEW Secretary that The Bel-        inflexible to be used as a dynamic        result during research, the protection
mont Report be adopted in its entirety,    foundation for evolving biomedical        of subjects is paramount.
representing DHEW policy. While The        ethics.                                       It is not uncommon to have practice
Belmont Report was never officially            Despite the lack of endorsement       and research occur simultaneously in
endorsed, many of the Commission’s         by either DHEW or Congress, The           clinical trials, particularly if the safety
recommendations in this statement          Belmont Report is indeed alive. It is     and efficacy of the investigational
                                           recognized by many, albeit quietly, as    treatment are being evaluated. During
                                           the United States’ contribution to the    the informed consent process,
                                           short list of international guidelines
                                           for protecting human subjects
                                           involved in research.


                                     the monitor              s             summer 1997
subjects must clearly know which            efforts to improve an individual’s well    activities: informed consent, assess-
study activities are standard practice      being. The principle of beneficence is     ment of risks and benefits, and selec-
and which are research.                     firmly embedded in the ethical tradi-      tion of research subjects.
                                            tion of medicine as defined by Hip-
2. Basic Ethical Principles                 pocrates: “As to diseases, make a          a. Informed Consent
    The Belmont Report identifies three     habit of two things — to help, or at           The first Belmont principle,
fundamental principles that underlie        least to do no harm.” However, in          respect for persons, requires that
all research involving human subjects:      order to help and avoid harm, we must      research subjects be given the oppor-
respect for persons, beneficence, and       first learn what is harmful.               tunity to decide what will or will not
justice.                                        For research that will benefit soci-   happen to them. This opportunity
                                            ety, subjects may be exposed to a risk     occurs during the informed consent
a. Respect for Persons                      of harm with no personal benefit. In       process, which contains three compo-
    Respect for persons includes two        research, an ethical dilemma occurs in     nents: information, comprehension,
ethical presumptions. The first is that     deciding when it is proper to pursue       and voluntariness.
persons should be treated as                certain benefits despite the risks             Information. When presenting
autonomous individuals, capable of          involved, and when the benefits            information, it is essential for subjects
making their own decisions.                 should be foregone because of known        to understand the research is neither
Autonomous individuals possess the          or potential risks to the subject.         necessary for their well being nor are
capacity for self-determination. We                                                    the effects of the research fully known
demonstrate our respect for persons         c. Justice                                 or understood. Understanding this,
when we encourage and accept an                 Justice is the third basic principle   subjects can decide if they wish to
individual’s opinions and choices. We       identified in The Belmont Report. Jus-     participate in the research for the pur-
show a lack of respect for persons          tice requires that each person is treat-   pose of contributing to general knowl-
when we withhold information and            ed fairly, equitably, and given what he    edge. If a direct benefit to subjects is
deny individuals the freedom to make        or she is due. There is an equal distri-   expected, they should clearly under-
an informed decision.                       bution of benefits as well as burdens.     stand the range of risks.
    The second presumption is that not      An injustice occurs when a benefit to          The minimum information required
every person is capable of self-deter-      which a person is entitled is denied       to be provided to subjects is found in
mination. The capacity for self-deter-      without good reason or when an exces-      21 CFR 50.25 for FDA reviewed
mination develops during a person’s         sive burden is imposed.                    research and 45 CFR 46.116 for all
life. Therefore, the very young have            In clinical research, we should        federally funded research. These sec-
diminished autonomy. Additionally,          always be mindful that certain classes     tions contain the 14 elements of
some individuals may lose the capacity      of persons, e.g., the indigent, ethnic     informed consent. While these regula-
for self-determination because of           groups, or the institutionalized may be    tions pertain to DHHS activities, they
physical illness, mental disabilities, or   selected because of their availability,    have become a framework for prepar-
situations that restrict personal free-     dependence, or because they are easy       ing and reviewing informed consents
dom, such as prisons and the military.      to manipulate rather than for reasons      in all types of research involving
Respect for persons who are immature,       related to the problem being studied.      human subjects.
incapacitated, or restricted requires       These classes are frequently referred          Comprehension. Another compo-
that we provide them protection as          to as “vulnerable populations” and         nent of informed consent is compre-
human subjects.                             require protection as human subjects.      hension. Comprehension is the
                                                                                       capacity to understand. The informa-
b. Beneficence                              3. Applications                            tion provided to a subject must be in a
   The second basic ethical principle           We can gain an understanding of        language and at a level that he or she
is beneficence. Beneficence is the          the Belmont principles by applying         can comprehend. Informed consent is
practice of doing good, making all          them to some of the steps in the           invalid if the consentor does not
                                            clinical research process. The Belmont
                                            Report singles out the following


                                      the monitor               s            summer 1997
understand the information upon                                 beneficence, is applied in the assess-      never officially adopted or endorsed,
which the consent was based. Investi-                           ment of risks and benefits. Risk refers     The Belmont Report has served as an
gators are responsible for determining                          to the possibility that harm may occur.     ethical framework for protecting
that a subject has comprehension of                             Benefit refers to something of positive     research subjects in the United States
the information.                                                value related to well being. Assess-        for nearly 20 years. Many of its
    Voluntariness. Voluntariness is                             ment of risks and benefits deals with       recommendations have been incorpo-
the third component of informed con-                            the probabilities and magnitudes of         rated into Title 21 CFR Parts 50 and
sent. The informed consent process                              possible harms and anticipated bene-        56, and Title 45 CFR Part 46.
must be free of coercion, undue influ-                          fits. In general, risks to the subject          To gain a full appreciation of The
ence, and unjustifiable pressures.                              should be outweighed by the sum of          Belmont Report, readers are encour-
Coercion is the threat or intention of                          anticipated benefits to the subject and     aged to obtain a copy of the statement
harm by one person to another in                                to society in the form of new knowl-        and to review it in its entirety. The
order to gain compliance. For exam-                             edge. It is commonly stated that risks      Belmont Report and the Declaration of
ple, the subject may be denied med-                             and benefits should be “balanced.”          Helsinki can be found in the March
ical care unless the subject enrolls in                         Unfortunately, there are few quantita-      1996 edition of the FDA’s Information
the study.                                                      tive measures available to provide this     Sheets for Institutional Review Boards
    Undue influence is an offer of an                           kind of objective assessment for            and Clinical Investigators. The Decla-
excessive or unwarranted reward in                              investigators or IRBs.                      ration of Helsinki may also be found in
order to gain compliance. An example                                                                        21 CFR 312.120(c)(4); Foreign clini-
of this might be the amount of money                            c. Selection of Subjects                    cal studies not conducted under an
offered to healthy subjects who parti-                              The third Belmont principle is jus-     IND.
cipate in Phase 1 trials, or making                             tice and this is applied during the
compensation contingent upon the                                selection of subjects. Justice in the       The author wishes to thank Carol
subject completing the study.                                   selection of subjects occurs at two         Saunders, RN, editor of Research
    Unjustifiable pressure occurs                               levels: individual justice and social       Nurse, for her thoughtful review of the
when a person in a position of author-                          justice. Individual justice requires the    manuscript.
ity urges a course of action for the                            investigator to consistently demon-
subject. This may occur with the                                strate fair procedures in selecting         References
investigator as well as with any mem-                           subjects. For example, investigators
                                                                                                            1
ber of the investigator’s team, when                            should not offer potentially beneficial         The National Commission for the Protec-
presenting the informed consent to the                          research to their favored patients              tion of Human Subjects of Biomedical and
                                                                                                                Behavioral Research: The Belmont Report:
subject. The dilemma is to recognize                            while offering riskier studies to less
                                                                                                                Ethical Principles and Guidelines for the
when objective discussion of the                                favored patients.                               Protection of Human Subjects of Research.
research study becomes unjustifiable                                Societal justice is based on a fair         DHEW Publication No. (OS) 78-0012,
pressure to participate.                                        and equitable selection of subjects             Washington, 1978, p. 2.
                                                                across economic, ethnic, and gender
                                                                                                            2
b. Assessment of Risks and Benefits                             classes. No class of subjects should            Ibid. p. 3.
   The second Belmont principle,                                bear the burdens of research particu-
                                                                larly if disabilities, restrictions, or a   Copyright ©1997 Janet F. Zimmerman, MS, RN
                                                                hostile social environment already
                 Janet F. Zimmerman, MS, RN                                                                                    Reprinted with
                                                President
                                                                burdens them.
                                                                                                                               permission from
              T
         IMPAC
                                        P.O. Box 1364                                                                          The Monitor, a quarterly
                                   Newtown, Pa 18940            SUMMARY
                                                  USA                                                                          publication of the
                                                                   The Belmont Report, which was
                                        (215) 579-7694                                                                         Association of Clinical
                                   Fax (215) 860-8942
                                                                published in 1979, was a direct
CONSULTING GROUP                                                                                                               Research Professionals.
                                                                response to the notorious syphilis
                         jzimmerman@impactcg.com
                            http://www.impactcg.com             studies that were conducted by the
 Innovative Methods for Providing Advanced Clinical Training    USPHS from 1932-1972. While it was


                                                          the monitor               s             summer 1997

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Belmont report

  • 1. The Belmont Report: An Ethical Framework for Protecting Research Subjects Janet F. Zimmerman, MS, RN, Clinical Research Training Consultant, Newtown, PA I NTRODUCTION Twenty years ago, a select group of 11 American men and women were in the midst of a congressional assignment. The assignment was to “identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.” 1 In 1979, these principles were published in what is commonly known as The Belmont Report. While never formally adopted, The Belmont Report has become the primary ethical framework for protecting human research subjects in the United States. Most of us have some knowledge of BACKGROUND two international codes were adopted the U.S. Food and Drug Administration At its basic level, the U.S. Congress for physicians and scientists conduct- (FDA) statutes, which are published is an agent of change, enacting laws as ing research with human subjects. in Title 21 of the Code of Federal Reg- a response to events or problems They were The Nuremberg Code in ulations (CFR), or those of U.S. Public requiring national uniformity. On July 1947 and the Declaration of Helsinki Health Service (PHS) which are pub- 12, 1974, Congress passed the in 1964, which has since been revised lished in Title 45 CFR. However, we National Research Act, primarily in and updated. At the time, each of may be less familiar with non-regula- response to the USPHS-sponsored these international standards delin- tory guidelines, such as The Belmont syphilis studies that were conducted eated ethical principles for informed Report, that have importance in on indigent African-American males consent and medical care of research research involving human subjects. in Tuskegee, Alabama from 1932 to subjects, both of which were disre- Our goal is to briefly explain some of 1972. When the story broke, the garded in the syphilis studies. For the historical events that led to The tragic events of these studies were whatever reasons, the United States Belmont Report and to provide an widely reported in the press. In fact, government continued to sponsor overview of the Belmont principles the syphilis studies are still newswor- research in humans that should have and the underlying message of the thy as exemplified by the made-for- been guided by the Nuremberg and report. television movie, Miss Evers’ Boys, Helsinki principles. While the United broadcast on HBO earlier this year. It is interesting to note that during the 40 years of the syphilis studies, the monitor s summer 1997
  • 2. States was the primary sponsor of The became the basis for future DHHS THE BELMONT REPORT Nuremberg Code, the United States laws. In 1981, Congress enacted three The objective of The Belmont was not a signatory to the Declaration DHHS statutes that demonstrated a Report “is to provide an analytical of Helsinki. remarkable collaborative effort within framework that will guide the resolu- However, codes and principles are DHHS. They are FDA regulation 21 tion of ethical problems arising from not regulations, and therefore are not CFR Part 50 and PHS regulation 45 research involving human subjects.” 2 enforceable by law. With the 1974 CFR Part 46, both titled Protection of The framework of The Belmont Report National Research Act, Congress Human Subjects. The third 1981 is presented in three discussion mandated the establishment of insti- statute is FDA regulation 21 CFR Part topics: boundaries between practice tutional review boards (IRBs) to 56, titled Institutional Review Boards. and research, basic ethical principles, review all federally funded human and applications. research. Until this time, hospital or institutional review of research activi- 1. Boundaries Between Practice ties for purposes of protecting human subjects was voluntary, informal, and “ Technically, and Research Practice refers to interventions without established criteria. that are intended to solely improve the the United States The National Research Act also well being of the patient. They are created the National Commission for accepted standards that have a reason- the Protection of Human Subjects of does not have a able expectation of success. The goal Biomedical and Behavioral Research. of practice is to provide a diagnosis, The 11 members of the Commission, preventive treatment, or therapy that national policy for who represented science, law, ethics, will enhance the patient’s wellness. In and society, published several state- most cases, practice standards are ments or reports on various aspects of protecting research supported by research findings. research with human subjects. These Research refers to activities that reports outlined recommendations to are designed to develop or contribute subjects.” the Secretary of the Department of to the general body of knowledge. Health, Education, and Welfare General knowledge includes theories, (DHEW), now known as the Depart- principles, and relationships. ment of Health and Human Services Since neither Congress or DHEW Research activities test a hypothesis, (DHHS). (now DHHS) moved to formally adopt are validated by statistical measures, One of the Commission’s statements The Belmont Report in its entirety, and allow conclusions to be drawn. was The Belmont Report: Ethical Prin- arguably, the United States does not Research is written in a formal ciples and Guidelines for the Protection have a national policy for protecting protocol that can be reviewed and of Human Subjects of Research com- research subjects. Yes, there are the replicated by others. In research, ben- monly referred to as The Belmont aforementioned DHHS statutes, but efits are not always known nor are Report. The Commission recommended these are mandates too restrictive and they assured. Because harm may to the DHEW Secretary that The Bel- inflexible to be used as a dynamic result during research, the protection mont Report be adopted in its entirety, foundation for evolving biomedical of subjects is paramount. representing DHEW policy. While The ethics. It is not uncommon to have practice Belmont Report was never officially Despite the lack of endorsement and research occur simultaneously in endorsed, many of the Commission’s by either DHEW or Congress, The clinical trials, particularly if the safety recommendations in this statement Belmont Report is indeed alive. It is and efficacy of the investigational recognized by many, albeit quietly, as treatment are being evaluated. During the United States’ contribution to the the informed consent process, short list of international guidelines for protecting human subjects involved in research. the monitor s summer 1997
  • 3. subjects must clearly know which efforts to improve an individual’s well activities: informed consent, assess- study activities are standard practice being. The principle of beneficence is ment of risks and benefits, and selec- and which are research. firmly embedded in the ethical tradi- tion of research subjects. tion of medicine as defined by Hip- 2. Basic Ethical Principles pocrates: “As to diseases, make a a. Informed Consent The Belmont Report identifies three habit of two things — to help, or at The first Belmont principle, fundamental principles that underlie least to do no harm.” However, in respect for persons, requires that all research involving human subjects: order to help and avoid harm, we must research subjects be given the oppor- respect for persons, beneficence, and first learn what is harmful. tunity to decide what will or will not justice. For research that will benefit soci- happen to them. This opportunity ety, subjects may be exposed to a risk occurs during the informed consent a. Respect for Persons of harm with no personal benefit. In process, which contains three compo- Respect for persons includes two research, an ethical dilemma occurs in nents: information, comprehension, ethical presumptions. The first is that deciding when it is proper to pursue and voluntariness. persons should be treated as certain benefits despite the risks Information. When presenting autonomous individuals, capable of involved, and when the benefits information, it is essential for subjects making their own decisions. should be foregone because of known to understand the research is neither Autonomous individuals possess the or potential risks to the subject. necessary for their well being nor are capacity for self-determination. We the effects of the research fully known demonstrate our respect for persons c. Justice or understood. Understanding this, when we encourage and accept an Justice is the third basic principle subjects can decide if they wish to individual’s opinions and choices. We identified in The Belmont Report. Jus- participate in the research for the pur- show a lack of respect for persons tice requires that each person is treat- pose of contributing to general knowl- when we withhold information and ed fairly, equitably, and given what he edge. If a direct benefit to subjects is deny individuals the freedom to make or she is due. There is an equal distri- expected, they should clearly under- an informed decision. bution of benefits as well as burdens. stand the range of risks. The second presumption is that not An injustice occurs when a benefit to The minimum information required every person is capable of self-deter- which a person is entitled is denied to be provided to subjects is found in mination. The capacity for self-deter- without good reason or when an exces- 21 CFR 50.25 for FDA reviewed mination develops during a person’s sive burden is imposed. research and 45 CFR 46.116 for all life. Therefore, the very young have In clinical research, we should federally funded research. These sec- diminished autonomy. Additionally, always be mindful that certain classes tions contain the 14 elements of some individuals may lose the capacity of persons, e.g., the indigent, ethnic informed consent. While these regula- for self-determination because of groups, or the institutionalized may be tions pertain to DHHS activities, they physical illness, mental disabilities, or selected because of their availability, have become a framework for prepar- situations that restrict personal free- dependence, or because they are easy ing and reviewing informed consents dom, such as prisons and the military. to manipulate rather than for reasons in all types of research involving Respect for persons who are immature, related to the problem being studied. human subjects. incapacitated, or restricted requires These classes are frequently referred Comprehension. Another compo- that we provide them protection as to as “vulnerable populations” and nent of informed consent is compre- human subjects. require protection as human subjects. hension. Comprehension is the capacity to understand. The informa- b. Beneficence 3. Applications tion provided to a subject must be in a The second basic ethical principle We can gain an understanding of language and at a level that he or she is beneficence. Beneficence is the the Belmont principles by applying can comprehend. Informed consent is practice of doing good, making all them to some of the steps in the invalid if the consentor does not clinical research process. The Belmont Report singles out the following the monitor s summer 1997
  • 4. understand the information upon beneficence, is applied in the assess- never officially adopted or endorsed, which the consent was based. Investi- ment of risks and benefits. Risk refers The Belmont Report has served as an gators are responsible for determining to the possibility that harm may occur. ethical framework for protecting that a subject has comprehension of Benefit refers to something of positive research subjects in the United States the information. value related to well being. Assess- for nearly 20 years. Many of its Voluntariness. Voluntariness is ment of risks and benefits deals with recommendations have been incorpo- the third component of informed con- the probabilities and magnitudes of rated into Title 21 CFR Parts 50 and sent. The informed consent process possible harms and anticipated bene- 56, and Title 45 CFR Part 46. must be free of coercion, undue influ- fits. In general, risks to the subject To gain a full appreciation of The ence, and unjustifiable pressures. should be outweighed by the sum of Belmont Report, readers are encour- Coercion is the threat or intention of anticipated benefits to the subject and aged to obtain a copy of the statement harm by one person to another in to society in the form of new knowl- and to review it in its entirety. The order to gain compliance. For exam- edge. It is commonly stated that risks Belmont Report and the Declaration of ple, the subject may be denied med- and benefits should be “balanced.” Helsinki can be found in the March ical care unless the subject enrolls in Unfortunately, there are few quantita- 1996 edition of the FDA’s Information the study. tive measures available to provide this Sheets for Institutional Review Boards Undue influence is an offer of an kind of objective assessment for and Clinical Investigators. The Decla- excessive or unwarranted reward in investigators or IRBs. ration of Helsinki may also be found in order to gain compliance. An example 21 CFR 312.120(c)(4); Foreign clini- of this might be the amount of money c. Selection of Subjects cal studies not conducted under an offered to healthy subjects who parti- The third Belmont principle is jus- IND. cipate in Phase 1 trials, or making tice and this is applied during the compensation contingent upon the selection of subjects. Justice in the The author wishes to thank Carol subject completing the study. selection of subjects occurs at two Saunders, RN, editor of Research Unjustifiable pressure occurs levels: individual justice and social Nurse, for her thoughtful review of the when a person in a position of author- justice. Individual justice requires the manuscript. ity urges a course of action for the investigator to consistently demon- subject. This may occur with the strate fair procedures in selecting References investigator as well as with any mem- subjects. For example, investigators 1 ber of the investigator’s team, when should not offer potentially beneficial The National Commission for the Protec- presenting the informed consent to the research to their favored patients tion of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: subject. The dilemma is to recognize while offering riskier studies to less Ethical Principles and Guidelines for the when objective discussion of the favored patients. Protection of Human Subjects of Research. research study becomes unjustifiable Societal justice is based on a fair DHEW Publication No. (OS) 78-0012, pressure to participate. and equitable selection of subjects Washington, 1978, p. 2. across economic, ethnic, and gender 2 b. Assessment of Risks and Benefits classes. No class of subjects should Ibid. p. 3. The second Belmont principle, bear the burdens of research particu- larly if disabilities, restrictions, or a Copyright ©1997 Janet F. Zimmerman, MS, RN hostile social environment already Janet F. Zimmerman, MS, RN Reprinted with President burdens them. permission from T IMPAC P.O. Box 1364 The Monitor, a quarterly Newtown, Pa 18940 SUMMARY USA publication of the The Belmont Report, which was (215) 579-7694 Association of Clinical Fax (215) 860-8942 published in 1979, was a direct CONSULTING GROUP Research Professionals. response to the notorious syphilis jzimmerman@impactcg.com http://www.impactcg.com studies that were conducted by the Innovative Methods for Providing Advanced Clinical Training USPHS from 1932-1972. While it was the monitor s summer 1997