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January 9, 2013 Ethical Considerations in Substance Abuse and Addiction Research Sandra L. Alfano, Pharm.D. Chair, HIC II and IV Research Scientist, General.

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Presentation on theme: "January 9, 2013 Ethical Considerations in Substance Abuse and Addiction Research Sandra L. Alfano, Pharm.D. Chair, HIC II and IV Research Scientist, General."— Presentation transcript:

1 January 9, 2013 Ethical Considerations in Substance Abuse and Addiction Research Sandra L. Alfano, Pharm.D. Chair, HIC II and IV Research Scientist, General Internal Medicine Sandra L. Alfano, Pharm.D. Chair, HIC II and IV Research Scientist, General Internal Medicine

2 January 9, 2013 Objectives Understand the ethical foundations of human subjects research Explore the conflicts and tension between and among the principles and roles of researchers Review special considerations in doing research with human subjects with substance abuse or addiction disorders Delineate additional safeguards that may be necessary when involving vulnerable populations in research Understand the ethical foundations of human subjects research Explore the conflicts and tension between and among the principles and roles of researchers Review special considerations in doing research with human subjects with substance abuse or addiction disorders Delineate additional safeguards that may be necessary when involving vulnerable populations in research

3 January 9, 2013 Ethical Foundations of Human Subjects Research Nuremberg Code (1949) –Nazi war crimes –Code stresses voluntary informed consent –Idea of ‘do no harm’ Nuremberg Code (1949) –Nazi war crimes –Code stresses voluntary informed consent –Idea of ‘do no harm’

4 January 9, 2013 Ethical Foundations of Human Subjects Research Declaration of Helsinki (1964, last updated 2008) –World Medical Association’s best known policy statement –Distinction between therapeutic and non- therapeutic research –Best care standard raises problems with placebo controls; 2002 clarification allows some placebo use Declaration of Helsinki (1964, last updated 2008) –World Medical Association’s best known policy statement –Distinction between therapeutic and non- therapeutic research –Best care standard raises problems with placebo controls; 2002 clarification allows some placebo use

5 Helsinki, placebos The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: –The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or –Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: –The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or –Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option January 9, 2013

6 Ethical Foundations of Human Subjects Research Outrage over Tuskegee Syphilis Trial National Research Act enacted in 1974 Established National Commission for Protection of Human Subjects of Biomedical and Behavioral Research Issued Belmont Report (1979) Established the IRB system for regulating research Outrage over Tuskegee Syphilis Trial National Research Act enacted in 1974 Established National Commission for Protection of Human Subjects of Biomedical and Behavioral Research Issued Belmont Report (1979) Established the IRB system for regulating research

7 January 9, 2013 INSTITUTIONAL REVIEW BOARD Responsible for protecting the rights and welfare of human subjects participating in research studies Ensure research is conducted in accordance with accepted ethical standards Responsible for protecting the rights and welfare of human subjects participating in research studies Ensure research is conducted in accordance with accepted ethical standards

8 January 9, 2013 Role of the IRBs Each biomedical IRB meets weekly Reviews and approves every research protocol involving human subjects, along with consent forms and all materials shared with subjects Approval must be in place before the research can begin, and each protocol must be re-approved at least once a year Changes to protocols must be approved prior to implementation Each biomedical IRB meets weekly Reviews and approves every research protocol involving human subjects, along with consent forms and all materials shared with subjects Approval must be in place before the research can begin, and each protocol must be re-approved at least once a year Changes to protocols must be approved prior to implementation

9 January 9, 2013 Belmont Report Ethical Principles Respect for Persons Beneficence Justice Contains the ethical principles upon which the U.S. Federal regulations for protection of human subjects are based Respect for Persons Beneficence Justice Contains the ethical principles upon which the U.S. Federal regulations for protection of human subjects are based

10 January 9, 2013 Belmont Report Ethical Principles Provide an analytical framework that will guide resolution of ethical problems Acknowledges tensions between principles, need for trade offs Provide an analytical framework that will guide resolution of ethical problems Acknowledges tensions between principles, need for trade offs

11 January 9, 2013 First Ethical Principle: Respect for Persons Individuals should be treated as an autonomous agents; avoid paternalism; let subject make decision about what will or will not happen However, not every human being is capable of self-determination. Therefore, those with diminished autonomy should be protected Voluntary participation Individuals should be treated as an autonomous agents; avoid paternalism; let subject make decision about what will or will not happen However, not every human being is capable of self-determination. Therefore, those with diminished autonomy should be protected Voluntary participation

12 January 9, 2013 Respect for Persons Demonstrated through informed consent Capacity Information, comprehension, voluntariness Demonstrated through informed consent Capacity Information, comprehension, voluntariness

13 January 9, 2013 Four Elements of Consent Informing –Convey information –Not a legal document, avoid legalese Assessing comprehension Assessing autonomy Consenting –Agreeing to be a subject Informing –Convey information –Not a legal document, avoid legalese Assessing comprehension Assessing autonomy Consenting –Agreeing to be a subject

14 January 9, 2013 Consent issues Informed consent is not only a document. It is a process: a dialogue between the researcher and the subject. Information exchange needs to take place before, during, and sometimes after the study. Information, comprehension, and voluntariness. Intended to facilitate understanding. Informed consent is not only a document. It is a process: a dialogue between the researcher and the subject. Information exchange needs to take place before, during, and sometimes after the study. Information, comprehension, and voluntariness. Intended to facilitate understanding.

15 January 9, 2013 Consent Issues: Information Purpose of the research Research procedures/expectations explained Known (and unknown) risks explained with possible consequences Economic considerations (impact on individual) Benefits stated reasonably in relation to phase of protocol Alternatives noted to inform decision Procedures to protect privacy and ensure confidentiality Purpose of the research Research procedures/expectations explained Known (and unknown) risks explained with possible consequences Economic considerations (impact on individual) Benefits stated reasonably in relation to phase of protocol Alternatives noted to inform decision Procedures to protect privacy and ensure confidentiality

16 January 9, 2013 Consent Issues: Comprehension The manner and context in which information is conveyed are as important as the information itself Organized presentation of the material Providing private, appropriate space, and sufficient time to ask questions and to consider participation Investigator getting consent must assure comprehension The manner and context in which information is conveyed are as important as the information itself Organized presentation of the material Providing private, appropriate space, and sufficient time to ask questions and to consider participation Investigator getting consent must assure comprehension

17 January 9, 2013 Consent Issues: Voluntariness Begin with an invitation to participate Free of coercion (overt threat of harm) Free of undue influence (offer or promise of excessive or improper reward) Participant is free to decline or to withdraw at any time without repercussions Begin with an invitation to participate Free of coercion (overt threat of harm) Free of undue influence (offer or promise of excessive or improper reward) Participant is free to decline or to withdraw at any time without repercussions

18 January 9, 2013 Consent issues Be sure that the informed consent process is not misleading Benefit is not overstated Risk/Benefit ratio is carefully considered Be sure that the informed consent process is not misleading Benefit is not overstated Risk/Benefit ratio is carefully considered

19 January 9, 2013 Process of consent Ensure autonomy: begin with an invitation to participate, ensure there is no coercion or undue influence (remove impediments) Allow ample time for considered response, take home and sharing Consider breaking up the material into multiple sessions Pay attention to verbal and non-verbal cues Verify understanding, comprehension Use of witnesses or consent monitors Consider use of quiz Ensure autonomy: begin with an invitation to participate, ensure there is no coercion or undue influence (remove impediments) Allow ample time for considered response, take home and sharing Consider breaking up the material into multiple sessions Pay attention to verbal and non-verbal cues Verify understanding, comprehension Use of witnesses or consent monitors Consider use of quiz

20 January 9, 2013 Process of consent Process of consent should be described in the protocol, including time, place, and who will do it Involves discussion as an educational interchange (not handing person the form to read) Avoid jargon, medical acronyms Use the reasonable person standard for amount of information to be shared Solicit consent in advance, not day of surgery Process of consent should be described in the protocol, including time, place, and who will do it Involves discussion as an educational interchange (not handing person the form to read) Avoid jargon, medical acronyms Use the reasonable person standard for amount of information to be shared Solicit consent in advance, not day of surgery

21 Background “Confluence of several considerations, including perceived gaps in the federal system for the protection of human subjects; historical and contemporary cases in which the protection of human subjects appears to be inadequate; and the need to ensure that research designed to develop better treatments for mental disorders can proceed with full public confidence in its ethical framework. The continuing vitality of the research enterprise ultimately depends on the public’s trust that appropriate ethical constraints are in place and will be followed.” “Confluence of several considerations, including perceived gaps in the federal system for the protection of human subjects; historical and contemporary cases in which the protection of human subjects appears to be inadequate; and the need to ensure that research designed to develop better treatments for mental disorders can proceed with full public confidence in its ethical framework. The continuing vitality of the research enterprise ultimately depends on the public’s trust that appropriate ethical constraints are in place and will be followed.” January 9, 2013

22 Background Regulatory citation: ‘When some or all of the subjects are likely to be vulnerable to coercion or undue influence, including those with cognitive limitations, the IRB must be sure that additional safeguards have been included in the study to protect the rights and welfare of these subjects {45 CFR (b)} Regulatory citation: ‘When some or all of the subjects are likely to be vulnerable to coercion or undue influence, including those with cognitive limitations, the IRB must be sure that additional safeguards have been included in the study to protect the rights and welfare of these subjects {45 CFR (b)} January 9, 2013

23 Definitions Adults with decisional impairment: ‘Limited decision making capacity covers a broad spectrum. A healthy person in shock may be temporarily decisionally impaired. Another may have been severely mentally retarded since birth, while yet a third who has schizophrenia may have fluctuating capacity. Researchers should be sensitive to the differing levels of capacity and use assessment methods tailored to the specific situation. Further, researchers should carefully consider the timing of assessment to avoid periods of heightened vulnerability when individuals may not be able to provide valid informed consent.’ Adults with decisional impairment: ‘Limited decision making capacity covers a broad spectrum. A healthy person in shock may be temporarily decisionally impaired. Another may have been severely mentally retarded since birth, while yet a third who has schizophrenia may have fluctuating capacity. Researchers should be sensitive to the differing levels of capacity and use assessment methods tailored to the specific situation. Further, researchers should carefully consider the timing of assessment to avoid periods of heightened vulnerability when individuals may not be able to provide valid informed consent.’ January 9, 2013

24 Assessment of Capacity Society has not decided what degree of impairment counts as a lack of capacity Case by case basis Protocol-specified method Quizzes, consent monitor, formal assessment via Mc-CAT, etc Society has not decided what degree of impairment counts as a lack of capacity Case by case basis Protocol-specified method Quizzes, consent monitor, formal assessment via Mc-CAT, etc January 9, 2013

25 Transitional capacity Fluctuating: consider delaying consent process, or re-consenting Progressive: consider using advance directives while capacity is retained Fluctuating: consider delaying consent process, or re-consenting Progressive: consider using advance directives while capacity is retained January 9, 2013

26 Second Ethical Principle: Beneficence Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well- being (an obligation) Two general rules –Do not knowingly cause harm –Maximize possible benefits/minimize possible harms Are the risks presented justified? Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well- being (an obligation) Two general rules –Do not knowingly cause harm –Maximize possible benefits/minimize possible harms Are the risks presented justified?

27 January 9, 2013 Beneficence Not exactly the Hippocratic Oath Even avoiding harm requires learning what is harmful Researchers and their IRBs must decide with imperfect knowledge when it is justifiable to seek certain benefits despite the risks involved, versus when the potential benefits are so small that the risks outweigh the benefits Not exactly the Hippocratic Oath Even avoiding harm requires learning what is harmful Researchers and their IRBs must decide with imperfect knowledge when it is justifiable to seek certain benefits despite the risks involved, versus when the potential benefits are so small that the risks outweigh the benefits

28 January 9, 2013 Beneficence Initial analysis as part of approval of the proposed protocol: sound scientific design, and favorable risk:benefit assessment Ongoing monitoring of risks and benefits throughout the study (via data and safety monitoring plan) Initial analysis as part of approval of the proposed protocol: sound scientific design, and favorable risk:benefit assessment Ongoing monitoring of risks and benefits throughout the study (via data and safety monitoring plan)

29 January 9, 2013 Research Risks Research by its very nature involves risk Subjects may be exposed to risk and may be harmed Obligation to minimize probability of harm, maximize potential benefits and never knowingly cause (permanent) injury IRBs must ensure risks are reasonable in relation to benefits expected; an acceptable risk:benefit relationship must exist for a protocol to be approved Research by its very nature involves risk Subjects may be exposed to risk and may be harmed Obligation to minimize probability of harm, maximize potential benefits and never knowingly cause (permanent) injury IRBs must ensure risks are reasonable in relation to benefits expected; an acceptable risk:benefit relationship must exist for a protocol to be approved

30 January 9, 2013 Research Risks Investigators must identify risks and objectively estimate magnitude and likelihood Both the risks and the benefits should be presented to prospective subjects in the consent form Vulnerable subjects deserve special protections; may be reasonable to place limits on the level of risk to which these subjects may be exposed Investigators must identify risks and objectively estimate magnitude and likelihood Both the risks and the benefits should be presented to prospective subjects in the consent form Vulnerable subjects deserve special protections; may be reasonable to place limits on the level of risk to which these subjects may be exposed

31 January 9, 2013 Research Design Need reasonable precautions when designing a study Good design, data and safety monitoring, and selection of least susceptible subjects Identify opportunities for risk exposure Need reasonable precautions when designing a study Good design, data and safety monitoring, and selection of least susceptible subjects Identify opportunities for risk exposure

32 January 9, 2013 Risks in Consent form What to disclose? At least what a “reasonable volunteer” would find important to decision making Reasonable Man Theory: the reasonable person is a hypothetical, rational, reasonably intelligent individual who is intended to represent a sort of ‘average’ citizen How would a reasonable person act under the circumstances? What to disclose? At least what a “reasonable volunteer” would find important to decision making Reasonable Man Theory: the reasonable person is a hypothetical, rational, reasonably intelligent individual who is intended to represent a sort of ‘average’ citizen How would a reasonable person act under the circumstances?

33 January 9, 2013 Minimizing Risks Highly competent research team Well designed study Procedures that have the least likelihood of harm Adequate monitoring Adverse events quickly identified, managed and reported Privacy and confidentiality protected Highly competent research team Well designed study Procedures that have the least likelihood of harm Adequate monitoring Adverse events quickly identified, managed and reported Privacy and confidentiality protected

34 January 9, 2013 Risk:Benefit Assessment Probability and magnitude of possible harms Versus Anticipated benefits Imperfect knowledge Probability and magnitude of possible harms Versus Anticipated benefits Imperfect knowledge

35 January 9, 2013 Therapeutic Misconception prone to misunderstand the risks and potential benefits associated with participation and to have unreasonable expectations about potential individual benefits May lead to discounting of risks and overestimating personal benefits Especially problematic when treating physician is researcher as well prone to misunderstand the risks and potential benefits associated with participation and to have unreasonable expectations about potential individual benefits May lead to discounting of risks and overestimating personal benefits Especially problematic when treating physician is researcher as well

36 Risk:Benefit Assessment Approach In the absence of a regulatory framework, many people will adopt a model that incorporates aspects of an existing regulatory framework, such as Subpart D, Children January 9, 2013

37 Third Ethical Principle: Justice The Belmont Report tells us, “An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly…” Ethical Obligation: fair sharing of burdens and benefits Requirement: Equitable selection of research subjects; fairness in inclusion and exclusion criteria The Belmont Report tells us, “An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly…” Ethical Obligation: fair sharing of burdens and benefits Requirement: Equitable selection of research subjects; fairness in inclusion and exclusion criteria

38 January 9, 2013 Justice Fair distribution of the burdens and the benefits of research Must be borne by some but not all members of a society ‘Representative’: should not select for convenience/ease Good research design Fair distribution of the burdens and the benefits of research Must be borne by some but not all members of a society ‘Representative’: should not select for convenience/ease Good research design

39 January 9, 2013 Justice Does the research involve individuals who are unlikely to benefit from the results of the research? Who is likely to benefit? What connection do they have to the research subjects? Does the research involve individuals who are unlikely to benefit from the results of the research? Who is likely to benefit? What connection do they have to the research subjects?

40 January 9, 2013 Inclusion/Exclusion Criteria Attributes necessary to accomplish purpose of the research Well defined criteria increase the likelihood of producing reliable and reproducible results, decrease likelihood of harm, and guard against exploitation of vulnerable populations Attributes necessary to accomplish purpose of the research Well defined criteria increase the likelihood of producing reliable and reproducible results, decrease likelihood of harm, and guard against exploitation of vulnerable populations

41 January 9, 2013 Conflicts between Principles One does not ‘trump’ the others Weighing and prioritizing conflicting ethical norms is a difficult task Discussion, debate, struggle One does not ‘trump’ the others Weighing and prioritizing conflicting ethical norms is a difficult task Discussion, debate, struggle

42 January 9, 2013 IRB Approval considerations –Risk:Benefit ratio reasonable? – Selection of subjects equitable? – Appropriate informed consent? – Data collected adequately monitored? – Adequate provisions to protect privacy and maintain confidentiality of data/information? – Risks are minimized? – Additional safeguards for those who need it (children, prisoners, etc.)? –Risk:Benefit ratio reasonable? – Selection of subjects equitable? – Appropriate informed consent? – Data collected adequately monitored? – Adequate provisions to protect privacy and maintain confidentiality of data/information? – Risks are minimized? – Additional safeguards for those who need it (children, prisoners, etc.)?

43 January 9, 2013 How are the principles applied? Careful review of the protocol –Inclusion/Exclusion Criteria –DSMP and Stopping Rules –Risks/Benefits –Consent Process –In Case of Injury Section Careful review of the protocol –Inclusion/Exclusion Criteria –DSMP and Stopping Rules –Risks/Benefits –Consent Process –In Case of Injury Section

44 January 9, 2013 How are the principles applied? Careful review of the consent form –Purpose –Research Procedures –Risks –Anticipated Benefits –Alternative Treatments –Voluntariness –Confidentiality Careful review of the consent form –Purpose –Research Procedures –Risks –Anticipated Benefits –Alternative Treatments –Voluntariness –Confidentiality

45 January 9, 2013 Recruitment Advertisements Internet Registries Targeted letters Phone calls All considered beginning of consent process IRB must review and approve methodology and content Advertisements Internet Registries Targeted letters Phone calls All considered beginning of consent process IRB must review and approve methodology and content

46 January 9, 2013 Economic Considerations and ICOI Inform participants about costs of participation, and payments to made (if any) Costs of research should be clearly differentiated from costs of standard care Tell them what will happen in case of injury (who will pay) Inform participants about costs of participation, and payments to made (if any) Costs of research should be clearly differentiated from costs of standard care Tell them what will happen in case of injury (who will pay)

47 January 9, 2013 Additional protections For those who need them Vulnerability of a given population or person sometimes changes For those who need them Vulnerability of a given population or person sometimes changes

48 January 9, 2013 Vulnerability A condition, either permanent or temporary Substantial inability to protect one’s own interests Interferes with autonomy or decision- making capacity Personal circumstances may make them subject to intimidation or exploitation A condition, either permanent or temporary Substantial inability to protect one’s own interests Interferes with autonomy or decision- making capacity Personal circumstances may make them subject to intimidation or exploitation

49 January 9, 2013 Special considerations in human subjects research: Vulnerable subjects “…vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons…” “…additional safeguards have been included in the study to protect the rights and welfare of these subjects.” Subparts B, C, D “…vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons…” “…additional safeguards have been included in the study to protect the rights and welfare of these subjects.” Subparts B, C, D

50 January 9, 2013 Examples of Potentially Vulnerable Populations Clinic population Prisoners Critically ill Students who need money Homeless who need money Third world countries who need care Clinic population Prisoners Critically ill Students who need money Homeless who need money Third world countries who need care

51 January 9, 2013 Additional Safeguards IRB may place limits on level of risk to which subjects may be exposed IRB may require consent monitor, subject advocate, use of quizzes to assess comprehension, require a DSMB, introduce a delay in consenting process Substituted judgment? Paternalism?: ‘Father (doctor, researcher, IRB) knows best’ IRB may place limits on level of risk to which subjects may be exposed IRB may require consent monitor, subject advocate, use of quizzes to assess comprehension, require a DSMB, introduce a delay in consenting process Substituted judgment? Paternalism?: ‘Father (doctor, researcher, IRB) knows best’

52 January 9, 2013 Special considerations in human subjects research: Vulnerable subjects Proposed Risk:Benefit assessment approach Categories of approval tied to risk and benefit of the protocol no more than minimal risk greater than minimal risk, but potential for direct benefit to the subject Greater than minimal risk without potential for direct benefit: set parameters for level of risk and necessary societal benefit Not otherwise approvable : set parameters for alternate review mechanism Proposed Risk:Benefit assessment approach Categories of approval tied to risk and benefit of the protocol no more than minimal risk greater than minimal risk, but potential for direct benefit to the subject Greater than minimal risk without potential for direct benefit: set parameters for level of risk and necessary societal benefit Not otherwise approvable : set parameters for alternate review mechanism

53 January 9, 2013 Special considerations in human subjects research: Vulnerable subjects Decisionally impaired Example: patient with Alzheimer’s Assess capacity to consent Certain populations may be predisposed to impairment (e.g. brain mets, new devastating diagnosis, etc) Precautions in place to add protections, such as surrogate consent, consent monitor, independent evaluator Precautions required are tied to risk level of protocol Decisionally impaired Example: patient with Alzheimer’s Assess capacity to consent Certain populations may be predisposed to impairment (e.g. brain mets, new devastating diagnosis, etc) Precautions in place to add protections, such as surrogate consent, consent monitor, independent evaluator Precautions required are tied to risk level of protocol

54 January 9, 2013 Other potentially vulnerable subjects Non-English speaking Principle of Justice: do not overly burden one group, nor exclude a group from potential benefit Translation issues Issue of ongoing communication (consent process) Non-English speaking Principle of Justice: do not overly burden one group, nor exclude a group from potential benefit Translation issues Issue of ongoing communication (consent process)

55 Researcher Investment Justification for inclusion of vulnerable subjects must be rigorous and defensible Cannot target vulnerable population if you can achieve the research objective through enrollment of others (Relevant principle of distributive justice) Justification for inclusion of vulnerable subjects must be rigorous and defensible Cannot target vulnerable population if you can achieve the research objective through enrollment of others (Relevant principle of distributive justice) January 9, 2013

56 Researcher Investment Points to Consider: additional safeguards –Consent monitors –Subject advocates –Family education/consultation –Consent process waiting period –Use of a DSMB Points to Consider: additional safeguards –Consent monitors –Subject advocates –Family education/consultation –Consent process waiting period –Use of a DSMB January 9, 2013

57 Trust in researchers “No matter how many regulations are put in place or guidelines are written, and no matter how intense the scrutiny by IRBs or other authorities, there can be no substitute for the ongoing commitment by researchers and the institutions in which they work to ethically appropriate behavior throughout the research process.” “No matter how many regulations are put in place or guidelines are written, and no matter how intense the scrutiny by IRBs or other authorities, there can be no substitute for the ongoing commitment by researchers and the institutions in which they work to ethically appropriate behavior throughout the research process.” January 9, 2013

58 Conclusions Belmont principles are the ethical underpinnings of our work Application of the principles to the protocol development and review process Tension/struggles Belmont principles are the ethical underpinnings of our work Application of the principles to the protocol development and review process Tension/struggles

59 January 9, 2013 Conclusions Justice requires balancing the burdens and benefits of research among a representative sampling of society Vulnerability can be situational, necessitating implementation of additional safeguards to minimize potential for undue influence Limits on risks associated with certain vulnerable populations set by federal regulations Justice requires balancing the burdens and benefits of research among a representative sampling of society Vulnerability can be situational, necessitating implementation of additional safeguards to minimize potential for undue influence Limits on risks associated with certain vulnerable populations set by federal regulations


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