irbs and the practice of research ethics

IRBs and the Practice of IRBs and the Practice of Research EthicsResearch Ethics

November 7, 2012November 7, 2012

ObjectivesObjectives

Abbreviated historical contextAbbreviated historical contextWhat is an IRB?What is an IRB?Review criteriaReview criteriaInformed ConsentInformed ConsentConfidentialityConfidentialityConflicts of InterestConflicts of InterestVulnerable PopulationsVulnerable PopulationsChallenges for faith-based careChallenges for faith-based care

The technological imperativeThe technological imperative

““When you see something that is When you see something that is technologically sweet, you go ahead and technologically sweet, you go ahead and do it and you argue about what to do do it and you argue about what to do about it only after you have had your about it only after you have had your technological success. That is the way it technological success. That is the way it was with the atomic bomb.”was with the atomic bomb.”

---J. Robert Oppenheimer ---J. Robert Oppenheimer

Concerns about Baby Fae’s Concerns about Baby Fae’s surgery (1984)surgery (1984)

Experimental rather than therapeutic Experimental rather than therapeutic nature of the transplant (alternatives were nature of the transplant (alternatives were available)available)Lack of prior peer review of the researchLack of prior peer review of the researchHospital’s refusal to release protocol or Hospital’s refusal to release protocol or consent formsconsent formsQuality and extent of information conveyed Quality and extent of information conveyed to parentsto parents

History and ContextHistory and Context

Nuremberg CodeNuremberg Code(1947) (1947)

Thalidomide in the US (1960-62)Thalidomide in the US (1960-62)

Declaration of Helsinki (1964)Declaration of Helsinki (1964)

Henry K. Beecher in Henry K. Beecher in NEJMNEJM (1966) (1966)

Tuskegee Syphilis Study (1932-73)Tuskegee Syphilis Study (1932-73)

National Research Act (1974)National Research Act (1974)

Belmont Report (1979)Belmont Report (1979)

The Common Rule (1991)The Common Rule (1991)

The Nuremberg Code (1947)The Nuremberg Code (1947)

Voluntary consent is “absolutely essential”Voluntary consent is “absolutely essential”

Primacy of individual good over societal Primacy of individual good over societal benefit (important results do not justify benefit (important results do not justify unethical studies)unethical studies)http://www.hhs.gov/ohrp/archive/nurcode.htmlhttp://www.hhs.gov/ohrp/archive/nurcode.html

Thalidomide in the USThalidomide in the US(1960-62)(1960-62)

1962: Dr. Frances Oldham Kelseyreceived 1962: Dr. Frances Oldham Kelseyreceived the medal for Distinguished Federal the medal for Distinguished Federal Civilian Service from President John F. Civilian Service from President John F. Kennedy. Kennedy.

The Declaration of Helsinki (1964)The Declaration of Helsinki (1964)

Animal welfare (12)Animal welfare (12)

Dependent relationship (23) – “the Dependent relationship (23) – “the therapeutic misconception”therapeutic misconception”

Permission and assent (24, 25, 26)Permission and assent (24, 25, 26)

Publication ethics (27)Publication ethics (27)

Controversy over placebo trials (footnote)Controversy over placebo trials (footnote)

““Ethics and Clinical Research”Ethics and Clinical Research”Henry K. Beecher, 1966Henry K. Beecher, 1966

Applied principles of Nuremberg and Helsinki to Applied principles of Nuremberg and Helsinki to US shores – problems “not uncommon” at top US shores – problems “not uncommon” at top institutionsinstitutions

Consent problemConsent problem

No No ethicalethical distinction between means and ends. distinction between means and ends.

Publication of unethically obtained data requires Publication of unethically obtained data requires at a minimum, stern editorial comments, and at a minimum, stern editorial comments, and perhaps should not be published at all.perhaps should not be published at all.

Dr. BeecherDr. Beecher

““An experiment is ethical or not at its An experiment is ethical or not at its inception; it does not become ethical inception; it does not become ethical postpost hochoc – ends do not justify means. There is – ends do not justify means. There is no ethical distinction between ends and no ethical distinction between ends and means.”means.”

Tuskegee Syphilis Study (1932-73)Tuskegee Syphilis Study (1932-73)

As of May,1980 50 surviving wives and 20 As of May,1980 50 surviving wives and 20 surviving children were receiving full medical surviving children were receiving full medical care for syphilis that was definitely the result of care for syphilis that was definitely the result of untreated syphilis in their husbands and fathers. untreated syphilis in their husbands and fathers. The estimated cost of care for family members The estimated cost of care for family members of men in the study was $139,000,000. (James of men in the study was $139,000,000. (James H. Jones, H. Jones, Bad Blood: The Tuskegee Syphilis Bad Blood: The Tuskegee Syphilis Experiment Experiment [New York: Free Press, 1981])[New York: Free Press, 1981])

National Research Act (1974)National Research Act (1974)

Established the National Commission for Established the National Commission for the Protection of Human Subjects of the Protection of Human Subjects of Biomedical and Behavioral ResearchBiomedical and Behavioral Research

Codified the role of IRBsCodified the role of IRBs

Commission’s charge:Commission’s charge:

Identify basic ethical principles that should Identify basic ethical principles that should underlie biomedical and behavioral underlie biomedical and behavioral research and develop guidelines for research and develop guidelines for carrying out that research on humans.carrying out that research on humans.

The Belmont Report (1979)The Belmont Report (1979)

Boundaries between research and Boundaries between research and practicepractice

Respect for personsRespect for persons: Nature & definition of : Nature & definition of informed consentinformed consent

Beneficence: Assessing risk-benefit in Beneficence: Assessing risk-benefit in human subject researchhuman subject research

Justice: Guidelines for subject selectionJustice: Guidelines for subject selection

Dr. Robert J. LevineDr. Robert J. LevineEthics and Regulation of Clinical Ethics and Regulation of Clinical

ResearchResearch (1986) (1986)““The behavior-prescribing statements The behavior-prescribing statements contained in the various codes and contained in the various codes and regulations on research involving human regulations on research involving human subjects may be regarded as variants of subjects may be regarded as variants of five general ethical norms. . . In addition, a five general ethical norms. . . In addition, a sixth general ethical norm has begun to sixth general ethical norm has begun to appear in some guidelines” (p. 19).appear in some guidelines” (p. 19).

The Question:The Question:

How do we implement/act upon the How do we implement/act upon the foundational ethical principles identified in foundational ethical principles identified in the the Belmont ReportBelmont Report? What norms should ? What norms should govern our behavior?govern our behavior?

Six Ethical Norms for Human Six Ethical Norms for Human Subject ResearchSubject Research

Good research designGood research design

Competent investigator (scientific training, Competent investigator (scientific training, clinical care, ethical competence)clinical care, ethical competence)

Favorable balance of harm and benefitFavorable balance of harm and benefit

Informed consentInformed consent

Equitable selection of subjectsEquitable selection of subjects

Compensation (research-related injuries)Compensation (research-related injuries)

The Common Rule (1991)The Common Rule (1991)

The laws of sixteen federal agencies The laws of sixteen federal agencies regulating HSR in the US were regulating HSR in the US were consolidated into one body of lawconsolidated into one body of law

Note: The FDA rules are contained in a Note: The FDA rules are contained in a separate code, although insofar as they separate code, although insofar as they pertain to IRBs they are quite similar to the pertain to IRBs they are quite similar to the Common Law (example: categories for Common Law (example: categories for pediatric research – see handout)pediatric research – see handout)

What is an IRB?What is an IRB?

““The Commission believes that the rights of The Commission believes that the rights of subjects should be protected by subjects should be protected by local local review committeesreview committees operating pursuant to operating pursuant to federal regulationsfederal regulations located in institutions located in institutions where research involving human subjects where research involving human subjects is conducted. Compared to the possible is conducted. Compared to the possible alternatives of a regional or national alternatives of a regional or national review process, local committees have the review process, local committees have the advantage of greater familiarity with the advantage of greater familiarity with the

actual conditions surrounding the conduct actual conditions surrounding the conduct of research. Such committees can work of research. Such committees can work closely with investigators to assure the closely with investigators to assure the rights and welfare of human subjects are rights and welfare of human subjects are protectedprotected and, at the same time, that the and, at the same time, that the application of policies is fair to the application of policies is fair to the investigators. They can contribute to the investigators. They can contribute to the education of the research community and education of the research community and the public regarding the ethical conduct of the public regarding the ethical conduct of

research. The committees can become research. The committees can become resource centers for information resource centers for information concerning ethical standards and federal concerning ethical standards and federal requirements and can communicate with requirements and can communicate with federal officials federal officials with other local with other local committees about matters of common committees about matters of common concernconcern.” .”

What is an IRB?What is an IRB?

Administrative body (local review pursuant Administrative body (local review pursuant to federal regulations)to federal regulations)

Specialized ethics committeeSpecialized ethics committee

Educational resource for the research Educational resource for the research community and the publiccommunity and the public

Points of contact with federal officials and Points of contact with federal officials and other local committeesother local committees

Role & Function of IRBsRole & Function of IRBs

Ensure that the IRB functions with as Ensure that the IRB functions with as much organizational independence as much organizational independence as possiblepossible– Independent from the research enterprise Independent from the research enterprise

(funding, collaborations with industry, etc.)(funding, collaborations with industry, etc.)– Mark Yessian (OIG): “IRBs are the only ones Mark Yessian (OIG): “IRBs are the only ones

in the research process that exist solely to in the research process that exist solely to protect human subjects.”protect human subjects.”

– Avoid actual and apparent/potential conflicts Avoid actual and apparent/potential conflicts of interest, not only as a matter of institutional of interest, not only as a matter of institutional integrity, but also in preservation of the public integrity, but also in preservation of the public trusttrust

Work collegially with other institutional Work collegially with other institutional offices that play an important role in offices that play an important role in human subject researchhuman subject research

Regulatory RequirementsRegulatory Requirements

Must have at least five membersMust have at least five members

Varying backgroundsVarying backgrounds

Diversity of gender and professionsDiversity of gender and professions

At least one non-scientific memberAt least one non-scientific member

At least one community memberAt least one community member

Avoid conflicts of interestAvoid conflicts of interest

Ad hoc members as need to review particular Ad hoc members as need to review particular protocolsprotocols

Review, Approve, MonitorReview, Approve, Monitor

Initial review (protocol, recruitment materials, Initial review (protocol, recruitment materials, and consent/HIPAA)and consent/HIPAA)Approval (Board has found project to be ethically Approval (Board has found project to be ethically and scientifically sound)and scientifically sound)Post-approval:Post-approval:– Amendments (risk and no risk)Amendments (risk and no risk)– DeviationsDeviations– Adverse events / unanticipated problemsAdverse events / unanticipated problems– Continuing review (at least annually)Continuing review (at least annually)

Levels of ReviewLevels of Review(categories of risk)(categories of risk)

Full Full (more than minimal risk)– must be reviewed (more than minimal risk)– must be reviewed by entire boardby entire boardExpeditedExpedited (no more than minimal risk) – may be (no more than minimal risk) – may be approved by chair or designee; may only be approved by chair or designee; may only be refused by entire boardrefused by entire boardExemptExempt (educational & truly anonymous (educational & truly anonymous research– IRB review not required (but IRB may research– IRB review not required (but IRB may choose to review)choose to review)

IRB ultimately determines level of risk.IRB ultimately determines level of risk.Retrospective review is forbidden by law.Retrospective review is forbidden by law.

RiskRisk

RiskRisk: The probability of harm or injury : The probability of harm or injury (physical, psychological, social, or (physical, psychological, social, or economic) occurring as a result of economic) occurring as a result of participation in a research study. Both the participation in a research study. Both the probability and magnitude of possible probability and magnitude of possible harm may vary from minimal to significant. harm may vary from minimal to significant. Federal regulations define only "minimal Federal regulations define only "minimal risk."risk."

Minimal Risk (OHRP)Minimal Risk (OHRP)

Minimal RiskMinimal Risk: A risk is minimal where the probability : A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during than those ordinarily encountered in daily life or during the performance of routine physical or psychological the performance of routine physical or psychological examinations or tests [Federal Policy §___.102(i)]. For examinations or tests [Federal Policy §___.102(i)]. For example, the risk of drawing a small amount of blood example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no from a healthy individual for research purposes is no greater than the risk of doing so as part of routine greater than the risk of doing so as part of routine physical examination.physical examination.

NoteNote

The definition of minimal risk for research The definition of minimal risk for research involving prisoners differs somewhat from involving prisoners differs somewhat from that given for noninstitutionalized adults. that given for noninstitutionalized adults. [[SeeSee 45 CFR 303(d) and Guidebook 45 CFR 303(d) and Guidebook Chapter 6, Section E, "Prisoners."]Chapter 6, Section E, "Prisoners."]

Risk includesRisk includes

PhysicalPhysical

PsychologicalPsychological

Social Social

EconomicEconomic

Risk Assessment and Risk Assessment and DisclosureDisclosure

Nature of risksNature of risks

Severity Severity

Frequency Frequency

Note: Specific review criteria are provided by Note: Specific review criteria are provided by law (FDA and DHHS) with exceptions law (FDA and DHHS) with exceptions and/or additional rules for particular and/or additional rules for particular categories of researchcategories of research

Informed ConsentInformed Consent

A process, not an eventA process, not an event

Elements:Elements:– Information (not “data”) – see handoutInformation (not “data”) – see handout– Decisional capacity (Decisional capacity ( legal competence) legal competence)– Voluntariness – no coercion, manipulation, Voluntariness – no coercion, manipulation,

undue influenceundue influence– Special considerations, e.g. vulnerable Special considerations, e.g. vulnerable

populations populations

Informed ConsentInformed Consent(required by law)(required by law)

Study involves researchStudy involves research

Purpose of researchPurpose of research

Duration of participationDuration of participation

Procedures to be followed Procedures to be followed

Which procedures are investigational or Which procedures are investigational or performed for research purposes onlyperformed for research purposes only

Foreseeable risks/discomfortsForeseeable risks/discomforts


Benefits to subjects (direct) or others Benefits to subjects (direct) or others (indirect) – payment for participation is (indirect) – payment for participation is notnot a benefita benefit

Alternatives, if anyAlternatives, if any

Extent to which confidentiality of records Extent to which confidentiality of records will be maintainedwill be maintained


For research involving more than minimal risk:For research involving more than minimal risk:– Is compensation availableIs compensation available– Are medical treatments available if injury occursAre medical treatments available if injury occurs– What are those treatments /OR/ where further What are those treatments /OR/ where further

information may be obtainedinformation may be obtained

Note: “Each IRB needs to articulate its own Note: “Each IRB needs to articulate its own financial reasonableness standards for financial reasonableness standards for research-related costs in order to evaluate research-related costs in order to evaluate whether subjects are adequately protected” (KM whether subjects are adequately protected” (KM Hunt in Amdur & Bankert).Hunt in Amdur & Bankert).


Contact info for questions about:Contact info for questions about:– Research procedures, side effects, etc.Research procedures, side effects, etc.– Rights as a research subjectRights as a research subject– Occurrence of research-related injuryOccurrence of research-related injury

Participation is Participation is voluntaryvoluntary therefore refusal therefore refusal to participate will involve no penalty or loss to participate will involve no penalty or loss of benefitsof benefitsRight to withdraw at any timeRight to withdraw at any time

Informed Consent (required by law Informed Consent (required by law “when appropriate”)“when appropriate”)

Disclosure of unforeseeable risks to Disclosure of unforeseeable risks to subject, embryo, or fetussubject, embryo, or fetus

Anticipated circumstances under which Anticipated circumstances under which subject may be withdrawn by investigator subject may be withdrawn by investigator without regard to consentwithout regard to consent

Additional costs that may result from Additional costs that may result from participation in researchparticipation in research

Informed Consent (required by law Informed Consent (required by law “when appropriate”)“when appropriate”)

Consequences of withdrawal and procedures for Consequences of withdrawal and procedures for “orderly termination”“orderly termination”

Approximate number of subjects in the studyApproximate number of subjects in the study

Significant new findings arising during the Significant new findings arising during the research which may relate to subject’s consent research which may relate to subject’s consent for continued participation will be providedfor continued participation will be provided

Note: This includes negative results and “gag Note: This includes negative results and “gag orders” Sponsors may want in contractsorders” Sponsors may want in contracts

Pediatric ConsentPediatric Consent

Only the research subject can consentOnly the research subject can consent

Therefore:Therefore:– Parents give permissionParents give permission– Children provide assent when appropriateChildren provide assent when appropriate

AssentAssent

Assent = “a child’s affirmative agreement Assent = “a child’s affirmative agreement to participate in research.”to participate in research.”

Note: passive resignation to submit Note: passive resignation to submit ≠ ≠ assentassent

Federal regs do not define “informed Federal regs do not define “informed assent” and do not specify an ageassent” and do not specify an age

Ethical GuidelinesEthical Guidelines

Just as we should conduct research on Just as we should conduct research on adults before children when possible, adults before children when possible, research should be conducted on children research should be conducted on children who can provide assent before those who who can provide assent before those who cannot (when possible)cannot (when possible)

Remember this distinction:Remember this distinction:

Protecting confidentiality ≠ anonymityProtecting confidentiality ≠ anonymity

If there is any LINK that identifies research If there is any LINK that identifies research subjects the research is not truly anonymous subjects the research is not truly anonymous (though it may qualify for expedited review).(though it may qualify for expedited review).

Generally it is difficult (though not impossible) to Generally it is difficult (though not impossible) to conduct medical research that is truly conduct medical research that is truly anonymous.anonymous.

You need a consent OR a HIPAA waiver.You need a consent OR a HIPAA waiver.

DefinitionDefinition

Any conflict between research or other Any conflict between research or other professional scientific judgments and professional scientific judgments and financial or personal interests where financial or personal interests where actingacting with disregard tot hat conflict by placing with disregard tot hat conflict by placing one’s personal or financial interests ahead one’s personal or financial interests ahead of professional interests compromises or of professional interests compromises or detrimentally influences professional detrimentally influences professional judgment in conducting or reporting judgment in conducting or reporting research.research.

ConflictsConflicts

RecognizeRecognize and avoid and avoidRecognize and Recognize and DiscloseDisclose (avoid the (avoid the appearanceappearance of a conflict) of a conflict)Recognize, Disclose, and Recognize, Disclose, and RemedyRemedy (end if (end if necessary)necessary)

Remember: each interest may in itself be Remember: each interest may in itself be legitimate, but the interests cannot co-exist legitimate, but the interests cannot co-exist without conflict.without conflict.

Conflicts of Interest and Conflicts of Interest and CommitmentCommitment

Financial or Service (consultant, peer Financial or Service (consultant, peer reviewer, etc.)reviewer, etc.)

Role (PI or entrepreneur?)Role (PI or entrepreneur?)

Time (multiple responsibilities)Time (multiple responsibilities)

Institutional (endowments, patents, etc.)Institutional (endowments, patents, etc.)

Vulnerable SubjectsVulnerable Subjects

OHRP lists these:OHRP lists these:

Embryos (in vitro vertilization)Embryos (in vitro vertilization)

FetusesFetuses

ChildrenChildren

WomenWomen

Cognitively impairedCognitively impaired

PrisonersPrisoners

Vulnerable SubjectsVulnerable Subjects

OHRP list continued:OHRP list continued:

Traumatized and comatoseTraumatized and comatose

Terminally illTerminally ill

Elderly and agedElderly and aged

MinoritiesMinorities

Students, employees and normal Students, employees and normal volunteersvolunteers

Subjects in international researchSubjects in international research

NOTE:NOTE:

It is not inherently unethical to conduct It is not inherently unethical to conduct research on vulnerable subjects.research on vulnerable subjects.The ethical requirement is to The ethical requirement is to protectprotect those those subjects from being coerced or exploited.subjects from being coerced or exploited.Therefore your research plan (IRB Therefore your research plan (IRB application) should explain what application) should explain what protections you will have in place. protections you will have in place. Women of CBP are considered vulnerable Women of CBP are considered vulnerable but should not be routinely excluded. but should not be routinely excluded.

Jay KatzJay Katz

The central issue in HSR = “the morality The central issue in HSR = “the morality with which the invitation to participation in with which the invitation to participation in research is extended so that the rights of research is extended so that the rights of subjects to be secure in their person and subjects to be secure in their person and body remain sacrosanct.”body remain sacrosanct.”

Dr. Myrick Dr. Myrick (“Extreme Measures” 1996)(“Extreme Measures” 1996)

““If you could cure cancer by killing ten If you could cure cancer by killing ten people, wouldn’t you have to do that?”people, wouldn’t you have to do that?”

It’s It’s goodgood research…is it research…is it ethicalethical??

Good research requires intellectually Good research requires intellectually sound data.sound data.Ethical research requires that the data Ethical research requires that the data were obtained by morally justified means, were obtained by morally justified means, and that the uses to which the research and that the uses to which the research are put can also be morally justified.are put can also be morally justified.Q: Is it really possible for research to be Q: Is it really possible for research to be good, but not ethical?good, but not ethical?

Paul Ramsey (1971)Paul Ramsey (1971)

“ “[I]n a scientific age, it is too easy to raise ethical [I]n a scientific age, it is too easy to raise ethical questions with a frivolous conscience and to no questions with a frivolous conscience and to no serious purpose. A man of frivolous conscience serious purpose. A man of frivolous conscience announces that there are ethical quandaries announces that there are ethical quandaries ahead that we must urgently consider before the ahead that we must urgently consider before the future catches up with us. By this he often future catches up with us. By this he often means that we need to devise a ‘new ethics’ that means that we need to devise a ‘new ethics’ that will provide the rationalization for doing in the will provide the rationalization for doing in the future what men are bound to do because of the future what men are bound to do because of the novel interventions and procedures that science novel interventions and procedures that science will soon make possible. . . Such a person is of will soon make possible. . . Such a person is of

serious conscience if and only if he is at the serious conscience if and only if he is at the same time prepared, in advance, to stop the trial same time prepared, in advance, to stop the trial or procedure in question in the event that the or procedure in question in the event that the “ethical finding” should turn out to be murder or “ethical finding” should turn out to be murder or deception or other serious wrong to actual or deception or other serious wrong to actual or (now) hypothetical human beings. A man of (now) hypothetical human beings. A man of serious conscience means to say in raising serious conscience means to say in raising urgent ethical questions that there may be some urgent ethical questions that there may be some things that men should never do that, now or in things that men should never do that, now or in the future, they could do.the future, they could do.

It would perhaps be better not to raise the It would perhaps be better not to raise the ethical issues of medical practice in an ethical issues of medical practice in an age when public policy and research age when public policy and research requirements threaten to be overriding requirements threaten to be overriding than not to raise them in earnest.”than not to raise them in earnest.”

Unique challengesUnique challenges

Do research goals fit our mission?Do research goals fit our mission?Do the research methods fit our mission Do the research methods fit our mission (albeit legally sound)?(albeit legally sound)?Watchdogs or lapdogs?Watchdogs or lapdogs?Example: obtaining fetuses from China Example: obtaining fetuses from China What do we understand science to be?What do we understand science to be?What is progress? (Simply moving ahead, What is progress? (Simply moving ahead, or moving in the direction that we have or moving in the direction that we have purposed to go?)purposed to go?)

C.S. LewisC.S. Lewis

““Supposing science ever became Supposing science ever became complete so that it knew every single thing complete so that it knew every single thing in the whole universe. Is it not plain that in the whole universe. Is it not plain that the questions ‘Why is there a universe?’ the questions ‘Why is there a universe?’ ‘Why does it go on as it does?’ ‘Has it any ‘Why does it go on as it does?’ ‘Has it any meaning?’ would remain just as they meaning?’ would remain just as they were?”were?”

National Academy of ScienceNational Academy of Science

““Students of science have shown that Students of science have shown that social and personal values social and personal values unrelated to unrelated to knowledge-based criteriaknowledge-based criteria--including --including philosophical, religious, cultural, political, philosophical, religious, cultural, political, and economic values--can shape scientific and economic values--can shape scientific judgment in fundamental ways. The judgment in fundamental ways. The obvious question is whether holding such obvious question is whether holding such values can harm a person’s science. In values can harm a person’s science. In many cases, the answer has to be yes.”many cases, the answer has to be yes.”

Two Aspects of ProgressTwo Aspects of Progress

Consideration of ends: Will attainment of Consideration of ends: Will attainment of the goals toward which science aims the goals toward which science aims maintain or enhance to moral quality of maintain or enhance to moral quality of human life (not merely our personal human life (not merely our personal enjoyment or length of life).enjoyment or length of life).

Consideration of means: At what speed Consideration of means: At what speed should the goals of science be pursued?should the goals of science be pursued?

C.S. LewisC.S. Lewis

Progress means not just changing, but Progress means not just changing, but changing for the better.changing for the better.

If you are on a wrong road, going faster or If you are on a wrong road, going faster or farther is not progress but its opposite.farther is not progress but its opposite.

The man who turns back first on the wrong The man who turns back first on the wrong road is road is the most progressive manthe most progressive man..

What is progress?What is progress?

A mandatory goal (as far and fast as we A mandatory goal (as far and fast as we can) or a value to be discerned?can) or a value to be discerned?

Paul Ramsey: “…a process of constantly Paul Ramsey: “…a process of constantly creating ordinary means out of creating ordinary means out of extraordinary ones, but also a process of extraordinary ones, but also a process of constantly creating more and more constantly creating more and more extraordinary means that need not be extraordinary means that need not be used and perhaps ought not to be used and perhaps ought not to be chosen.”chosen.”

For consideration . . . For consideration . . .

““Let us all remember that a slower progress in the Let us all remember that a slower progress in the conquest of disease would not threaten society, conquest of disease would not threaten society, grievous as it is to those who deplore that grievous as it is to those who deplore that particular disease be not yet conquered, but that particular disease be not yet conquered, but that society would indeed be threatened by the society would indeed be threatened by the erosion of those moral values whose loss, erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling scientific progress, would make its most dazzling triumphs not worth having.” triumphs not worth having.”

---Hans Jonas---Hans Jonas

irbs and the practice of research ethics

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