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					Evaluating Minimal Risk: Time to
   Adopt a Uniform Standard

            Celia B. Fisher, Ph.D.
        Marie Ward Doty Professor of Psychology
          Director Center for Ethics Education
                  Fordham University




              November 16, 2006
  Annual HRPP Conference, Washington DC
The Significance of the Minimal Risk
            Classification

• “Minimal Risk” is a regulatory “sorting” or
  “gateway” mechanism that permits IRBs to
  waive certain human subject protection
  requirements and approve certain types of
  research with vulnerable populations.



                                                2
“Minimal Risk” Classification Permits IRBs to:

   Expedite review of research (Protocol is reviewed by IRB
    Chair or subset of IRB members assigned by chair instead
    of by the full IRB) (46.110)

   Waive some or all informed consent requirements
    (46.116(d)

   Waive signed consent form (46.117c)

   Waive explanation of available compensation 46.116(a)6

   Waive explanation of available treatment 46.116(a)(6)
                                                             3
“Minimal Risk” Classification Permits IRBs to:
   Approve research involving pregnant women and fetus
    that hold out no prospect of benefit (Subpart B)
   Approve research involving prisoners that study the
    possible causes, effects, and processes of incarceration,
    of criminal behavior, prisons as institutional structures or
    prisoners as incarcerated persons (Subpart C)
   Approve research involving children that does not hold out
    the prospect of direct benefit (Subpart D, 46.404)
   Critical baseline for approval of higher risk “non-beneficial”
    research involving children §§ 46.406 & 407

                                                                   4
         Subpart A Definition

§ 46.102(i)
Minimal risk means that the probability and
magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than
those ordinarily encountered in daily life or during
the performance of routine physical or
psychological examinations or tests.

Applies to Subparts A, B and D
                                                  5
        The Definitional Problem
        Who’s Life is it Anyway?

General Population?    Subject Population?
• Absolute Standard    • Relative Standard
• Objective Standard   • Subjective Standard
• Uniform Standard     • Variable Standard




                                               6
           History: Uniform Definition
1977 National Commission: Research Involving Children
“healthy children”

1977 NPRM proposing subpart D (19784 3FR31786)
“healthy children”

1978 HHS Research Involving Prisoners Subpart C (43 FR 53655)
“healthy person”

1978 Notice of Proposed Rulemaking for Subpart D (43 FR31786)
“healthy children”

1979 NPRM HEW 44 FR 47688 for Subpart A
“healthy individuals”


                                                                7
1981 Shift to “Variable” Definition

              1981 Preamble 45 CFR 46
            Protection of Human Subjects
“In light of the public comments…HHS has reworded the
   final regulation to reflect its intention that the risks of
   harm ordinarily encountered in daily life means those
   risks encountered in the daily lives of the subjects
   of the research

Subpart D
“The terms „research‟ and „minimal risk‟ are removed
   from this subpart [subpart D] since they appear in
   subpart A §46.102” (NPRM 48 FR 9814)                      8
     Subpart A Definition 1981
§ 46.102(i) Minimal risk means that the probability and
magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those
ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests.
Note. The final rule language does not include specific
reference to either a uniform (healthy) or relative (subject of
research) standard.


                                                             9
    Response of FDA & OHRP
• 1981 FDA 21CFR 56 Preamble
• “healthy individual”

• 2005 OHRP communication to SACHRP
  Chair
• “healthy person” standard

                                      10
     Absolute vs. Relative
    Objective vs. Subjective:
         False Dichotomies

Minimal Risk judgments for SBER can not
be absolute (fixed level) or objective
(independent of individual judgment)




                                          11
       Who‟s Life is it Anyway?

 There is no absolute definition of “general
   population.”
 “Subject populations” are diverse in experience
   and susceptibility to harm
 Harms encountered in daily life or routine
   examinations as well as individuals’ reactions to
   these activities are influenced by differences
   between and within the general population and
   subject populations (e.g. age, gender, ethnicity,
   health, social status).
                                                       12
 Probability & Magnitude of Harm
Minimal risk means that the probability and
 magnitude of harm or discomfort
 anticipated in the research are not greater
 in and of themselves than those ordinarily
 encountered in daily life or during the
 performance of routine physical or
 psychological examinations or tests.

                                           13
          Objective Metric Fallacy

• There is no objective metric to determine
  whether the actual probability of
  experimentally induced harm is equivalent to
  the daily life or routine examination harm to
  which it is compared (even if the daily life or
  routine examination probabilities could be
  accurately estimated).

                                                    14
     Magnitude & Probability of Harm

        Magnitude                    Probability

● The worst harm that         ● If the harm is serious,
  could occur in a study        then the probability of
  should not be very            any given subject
  serious—even if many          experiencing it should be
  subjects experience it,       quite low (NHRPAC 2003)

● Just because a serious
  harm can be imagined        ● A high probability harm
  does not mean that a          can be minimal risk
  project must be treated       provided that the
  as more than minimal risk     magnitude of the harm is
  (NRC, 2003)                   very low (NSF, 2002)
                                                           15
    Lack of Objective or Absolute Metric
    for Magnitude & Probability of Harm
•    When is a procedure with a moderate probability of
     producing a low or moderate level of harm minimal risk?
•    When is a procedure with a low probability of producing a
     serious harm minimal risk? The magnitude and
     probability of experimentally induced psychological (and
     in many instances social)
•    Harms are influenced by differences between and within
     subject populations (e.g. age, gender, ethnicity, health,
     social status). There can thus be no absolute standard
     for all populations.

                                                                 16
 Minimal Risk Definition: Absence of
       Risk-Benefit Balance
• IRB determination that research is no more than
  minimal risk is independent of evaluation of
  potential benefit.
• There is no mention of benefit in the definition.
• A study without prospect of direct benefit can be
  expedited and informed consent waived, simply on
  the basis of an assessment of the probability and
  magnitude of harm.

                                                      17
 Life-Research Risk Fallacy for Research
     without Prospect of Direct Benefit

• Harms of Research     • Harms of Daily Life or
  present no prospect     Routine Medical or
  of direct benefit       Psychological
                          Examinations often
                          present the prospect
                          of direct benefit



                                               18
       Life-Research Risk Fallacy
• People drive cars to get to work or school, shop for food
  or visit friends knowing risks of a car accident are
  serious.
•   Parents permit their children to play competitive sports
    with a probability of physical harm because of they
    believe it builds character and socialize children.
•   People attend scary movies because of emotional
    gratification
•   Individuals take stressful tests because they want to get
    into an academic program, obtain employment, or it
    might identify a disorder.

                                                           19
       UNIFORM VS VARIABLE
            STANDARD
• Since minimal risk judgments can not be
  absolute or objective the debate should rest
  on ethical justifications for applying uniform
  vs. variable standard for determining whether
  research is minimal risk .




                                               20
              Minimal Risk Standard
                                           UNIFORM STANDARD
AMBIGUOUS STANDARD
                                           “The probability and magnitude of physical or
Subpart A §46.102(i)                          psychological harm that is normally
                                              encountered in the daily lives or in the
“Minimal risk means that the probability      routine medical, dental, or psychological
   and magnitude of harm or discomfort         examination of healthy persons”
   anticipated in the research are not     Subpart C, National Commission(1977) and
   greater in and of themselves than          SACHRP Subpart D recommendations
   those ordinarily encountered in daily      (normal, average, healthy children living in

   life or during the performance of           safe environments
   routine physical or psychological       VARIABLE STANDARD
   examinations or tests.”                 “Minimal risk means that the probability and
                                               magnitude of harm is not greater than that
Subpart A and by default Subparts B            encountered in the daily lives of the
   and D.                                      subjects of the research.”
                                           46cfr45 Preamble


                                                                                            21
          Distributive Justice
• All persons should have equal access to the
 benefits and burdens of research

• The benefits and burdens of research should
 be fairly distributed across all research
 populations.


                                                22
           Procedural Justice
• The decision-making criteria for determining
  whether the magnitude and probability of
  research harm is minimal risk should be
  uniformly applied for all research populations.




                                                23
Distributive Justice: Research Burdens

When research presents no probability of
direct benefit….

Should persons who are exposed to greater risk
in their daily lives or routine health procedures
be exposed to greater research harms and less
human subjects protections

                                               24
      The Fallacy of “Is to Ought”

• Are populations exposed to greater risks of
 daily life and routine examinations less
 susceptible to physical, psychological, or
 social risks of research that mimic their
 experience?




                                                25
           The Fallacy of “Is to Ought”
• Individuals who live in crime filled environments will be less
  frightened by a confederate entering a classroom with a gun
  to test memory.

• Individuals with learning disabilities feel less frustrated by
  research analogs to academic failure

• Shy individuals deceived that they made a social faux pas
  are less embarrassed that individuals who are not shy.

• Ethnic minorities are less sensitive to racial slurs because
  they are more likely to experience them in daily life?

                                                                   26
           Compound Risk
• It might be argued that individuals who are
  exposed to higher levels of risk in their daily
  lives would be more vulnerable to equivalent
  research risks.




                                                    27
             Compound Risk
• People who experience greater than average
  distress in their daily lives, will be asked to
  experience greater stress in research
  without the protections of a full-board
  review and perhaps fully informed
  consent.



                                                28
   Justice Arguments When Research
   Offers no Prospect of Direct Benefit
Uniform Standard
Individuals should not be deprived of IRB protections or
   subjected to greater research risk simply because their
   daily lives or routine examinations are filled with
   greater risk than healthy persons or those living in safe
   and free environments.

Variable Standard
Persons whose daily lives or routine examinations are
   filled with greater risk may receive less IRB protections
   and be exposed to greater risks so as not to be
   deprived the knowledge benefits of research.
                                                               29
     Knowledge Benefit Fallacy
Uniform criteria for minimal risk does not
 preclude research participants from
 participation in research without the prospect
 of direct benefit.




                                              30
    Permissible Greater than Minimal Risk
  Research with No Prospect for Direct Benefit
• Subpart A 46.111 (a) Risks to subjects are minimized; (b) Risks to
  subjects are reasonable in relation to anticipated benefits
• Subpart B §46.207 Research not otherwise approvable which
  presents an opportunity to understand, prevent, or alleviate a
  serious problem affecting the health or welfare of pregnant women,
  fetuses, or neonates.
• Subpart C §46.306 (a)2 (iii) Research on conditions particularly affecting
  prisoners as a class (for example, vaccine trials and other research on
  hepatitis …and on social and psychological problems such as
  alcoholism, drug addiction, and sexual assaults)
• Subpart D §46.406 Research involving greater than minimal risk and
  no prospect of direct benefit to individual subjects, but likely to
  yield generalizable knowledge about the subject's disorder or
  condition.
                                                                           31
       Informed Consent Fallacy
• Populations experienced with harm may have a
  better reference for judging increased risk during
  informed consent.
• Informed consent is not a panacea for variable
  distribution of research harms.

• IRBs must first decide that is ethically appropriate to
  subject any member of the population to a particular
  magnitude and probability of harm. An IRB does not
  follow the principle of “consumer beware”

                                                        32
   Argument for Uniform Standard
• The experience of harm is not relative
• On what basis is it fair to deprive individuals of less IRB protections?
  Expedited, waiver of informed consent, some types of non-therapeutic
  research to which better off individuals will not be subjected.
• Not just that more vulnerable populations are made more vulnerable by
  research
• Buyer beware
• There is no absolute criteria nor objective metric for determining minimal
  risk. While some might argue that this speaks to a relative, in fact it is the
  opposite. It says that given the uncertainty a relative standard increases
  the probability that more vulnerable persons will be subjected to greater
  harms and less IRB protections in research with no prospect for direct
  benefit.
• Given the uncertainties and compounding of harms, IRBs should use as
  their standard the “safest activities of daily life” Grimes.

                                                                              33
The Minimal Risk Problem for SBR
 Documented degree of IRB variability in risk
  assessment for all protocols for both medical and
  non-medical procedures (Wendler & Shah,

 Variability in assigning similar research protocols to
  expedited ro full review (SBER report)

 Perceived over-estimation of risk for SBER


                                                       34
      Overestimation of Risk
• Just because a risk can be imagined does not
  mean that it is probable.
• Lack of available examples of SBR minimal risk
  procedures/protocols.

“Determination concerning the probability of physical
  harms are often easier to make than those involving
  the probability of non-physical harms (NBAC, 2001,
  72)
                                                    35
Minimal Risk Routine Medical Procedures
                     NHRPAC, IOM. SACHRP

 Venipuncture/fingerstick/       Vision test
    heelstick                    Hearing test
 Urine collection via bag        Neurological exam
 Chest X-ray                     Tests of fine or gross motor
 Bone density test                  skills
 Wrist X-ray for bone age        Medical and social history
 Collection of saliva
 Collection of small sample of      including age appropriate
    hair                            questions about sexual
 Oral glucose tolerance test        activity, drug use, anxiety,
 Non-invasive physiological         depression
    monitoring                   Personal or Family history
 Modest changes in diet or       Educational interventions for
    schedule                        health promoting habits for
                                    child, parents, family

                                                                   36
 Index Routine Psychological Tests (SACHRP, 2005)

• Child and adolescent intelligence tests
• Infant mental and motor scales
• Educational tests
• Reading and math ability tests
• Neurological or motor disorder screening
• Social development assessments
• Family and peer relationship assessment
• Emotional regulation scales
• Feelings of sadness or hopelessness scales        37
      Referents for Risks of Daily Life
• Competitive sports
• Educational tests
• Employment tests
• National surveys
• Video games
• Computer work
• Social interactions (e.g., peers, family)
(Fisher, Fried, Panicker, 2005)
                                              38
   SBER Risk and Confidentiality
• Much of the risk in social and behavioral science
  research is related to inadvertent or unintended
  disclosure.
• An adequate data protection plan can and should
  reduce the risk of such occurrences.
• The OHRP has clarified that the Common Rule
  allows institutions and IRBs the flexibility to review
  and approve appropriately designed confidentiality
  protections.

                                                           39
            Confidentiality Fallacy
SBER research does not pose confidentiality risks greater than
  those encountered in routine medical or psychological
  examinations.
• Routine medical and mental health examinations have the
  same if not more confidentiality risks (which is why we have
  HIPAA and confidentiality ethics codes for the health
  professions).
• Routine health examinations ask questions about sexual
  behaviors, drug use behaviors, medical conditions, family
  relationships, history of sexual or physical abuse all of which
  if revealed have a probability of social, economic, or legal
  harms.

                                                                 40
 Expedited Review & Confidentiality
Applicability
(C) The expedited review procedure may not be
used where identification of the subjects and/or
their responses would reasonably place them at
risk of criminal or civil liability or be damaging to
the subjects financial standing, employability,
insurability, reputation, or be stigmatizing, unless
reasonable and appropriate protections will be
implemented so that risks related to invasion of
privacy and breach of confidentiality are no
greater than minimal.
                                                   41
     SBER Minimal Risk Fallacy
There is a confusion on the part of the SBER
  community over restrictions on expedited review
  and waiver of informed consent imposed by:

• The uniform standard
• Inconsistent IRB judgments, overestimations of
  SBER harms and failure to restrict risk estimations
  to evidenced based risks.


                                                        42
Guidelines for Determining Minimal Risk

 (IOM 2004, NHRPAC, 2002; SACHRP SRIC 2005, Fisher, Fried &
       Panicker, 2005; Fisher, Kornetsky & Prentice, 2006)




                                                              43
Guidelines for Minimal Risk
     Determinations




                              44
          1. Uniform Standard
1. IRBs should apply a uniform standard
   (general population*) when assessing
   whether the probability and magnitude of
   research harms are no greater than minimal
   risk.

* Healthy persons living in safe environments
   (age-indexed for studies involving children)
                                                  45
            2. Equivalent Risk
Research risks should be equivalent not
 identical to risks of daily life and routine
 examinations based upon:
   Duration
   Frequency
   Cumulative Effect
   Reversibility

                                                46
        3. Evidence Based Risk
            Determinations
• Evaluation of risk equivalence should
  draw on scientific or clinical evidence
  and avoid conjecture.




                                            47
 4. Determination of Minimal Risk should
   include Human Subjects Protections

IRBs should evaluate research risk within the
  context of the human subjects protections
  described in the protocol (e.g. risk minimizing
  procedures, subject exclusion criteria,
  confidentiality protections, type of
  compensation)

                                                48
   SBER Risk Minimizing Procedures
Economic, Legal            Physical & Psychological
● Anonymous data           ● Appropriate
                             inclusion/exclusion criteria
● Coded Date with secure
  master list              ● Appropriate compensation
                             (non-coercive)
● Transcribed tapes
● Certificate of           Psychological
  Confidentiality
                           ● Debriefing/or withholding
Dignitary                    information
● Informed consent         ● Counseling
● Parental or Guardian     ● Referrals
  permission

                                                            49
        5. The Uniform Standard
           Sets a Risk Ceiling
• The uniform standard sets the upper not
  lower limits of risk to which subjects can be
  exposed in research classified as minimal
  risk.
• Risks that are judged to be minimal for the
  general population may be greater than
  minimal for special populations.

                                              50
      Example 1: College Drinking Prevention
         Request for Expedited Review
• Purpose. Implementation & evaluation of a training program for
  Resident Assistants aimed at reducing alcohol consumption in
  college freshmen campus dorms.
• Participants. College students 18 years or older living in the
  campus dorms.
• Data collection. Survey questions on alcohol related behaviors
  and attitudes and
  Information from student records on alcohol violations in the dorm
  and GPA.
• Human subjects protections.
  Confidentiality. Student ID #s (no names) separated from surveys
  immediately following data is entry, Certificate of Confidentiality &
  appropriate data storage.
  Informed consent, voluntary participation, reasonable
  compensation                                                            51
            Minimal Risk Decision Criteria
Uniform Standard: Questions about about alcohol use are routine in
     medical and psychological assessments of young adults.
Equivalence: The magnitude and probability of harm resulting from a
    confidentiality violation in the research is equivalent to that
    resulting from a confidentiality violation by a practitioner.
Evidence-based: There is no evidence that asking college students
     questions about drinking increases drinking behavior.
Human Subjects Protections. The confidentiality protections meet
   regulatory standards and are equivalent to confidentiality
   protections provided for alcohol related information obtained in
   routine medical or psychological assessments.
Special Population Risks: The survey questions address frequency
    and quantity of alcohol consumption and do not include mental
    health related items (e.g. questions about suicide or indices of
    substance abuse [i.e. blackouts]). Students with substance abuse
    problems are not at greater risk.
                                                                      52
  Spousal Abuse: Request for Signed Consent Waiver
• Purpose. Factors contributing to recurrence of spousal abuse when
  men incarcerated for domestic violence return home.
• Participants. Wives of husbands on parole following incarceration for
  domestic abuse.
• Data collection. Interview questions about husbands‟ past and
  current abusive threats and behaviors toward spouse or children;
  family involvement with alcohol, drugs, and illegal activities.
• Human subjects protections.
  Recruitment. Wives privately told about study during regular home
  visit from social worker.
  Confidentiality. Interviews conducted in home when husband is
  absent, code names used, Certificate of Confidentiality, adequate
  record protections. Investigator argues consent signature would
  create confidentiality risk.
  Informed consent, voluntary participation, reasonable compensation
                                                                      53
              Minimal Risk Decision Criteria
Uniform Standard: Questions about about domestic violence and child abuse
     are not part of daily life or routine in medical and psychological
     assessments in the general adult population.

Equivalence: The magnitude and probability of harm resulting from a
     confidentiality violation in the research is greater than harms resulting
     from a confidentiality violation in daily life or by a practitioner for
     information shared by the general population.

Evidence-based: There is evidence that the risk of spousal abuse increases
     when abusive husbands learn their wives have informed others about
     the abuse.

Human Subjects Protections. Storage of data and the Certificate of
    Confidentiality are appropriate. However, there is a risk that the husband
    will learn directly or indirectly about the wives‟ discussions with the
    social worker or agreement to the interviews. There is a possibility of
    mandatory child abuse reporting.

Special Population Risks: Victims of domestic abuse living with abusive
     spouses are at greater risk of physical harm than the general population.
                                                                                 54
     IRB-Investigator Partnership
 IRBs and investigators are jointly committed to protecting
  subjects’ rights and welfare.
 IRBs should advise investigators to include in protocols a
  rationale for the minimal risk classification accompanied by
  sufficient information about subject characteristics, exclusion
  criteria, the research design, and human subjects
  protections to permit IRBs to make evidence based risk
  determinations.
 When investigators provide comprehensive evidence based
  rationales for minimal risk classification, IRB risk
  determinations should be grounded in available evidence. If
  there are unsupported concerns additional information
  should be sought.
                                                                55

				
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