Docstoc

PARENTAL AUTHORITY FOR CHILDREN A Kaiser Permanente Video Conference

Document Sample
PARENTAL AUTHORITY FOR CHILDREN A Kaiser Permanente Video Conference Powered By Docstoc
					HISTORY OF INFORMED CONSENT
  – Human subjects research has a checkered past
  – Nazi experiments 1935-1945
  – “Extensive, willfully harmful experimentation”
  – Nuremberg war trials for participants
  – USA government testing in World War II to
    develop vaccines, malaria drugs, long acting
    penicillin on non-consenting orphaned
    children, retarded and mentally ill persons,
    prisoners and conscientious objectors
EXPOSE IN NEW ENGLAND JOURNAL
OF MEDICINE, 1966
   – Jewish Home for the Aged residents
     injected with live cancer cells
   – Willowbrook children’s home residents
     given hepatitis virus
   – Tuskagee syphilis study 1972; African
     American men with untreated syphilis
   – Tea room trade 1967: Observation of sexual
     activity
CODES IN RESPONSE TO ETHICAL
VIOLATIONS
   – Nuremberg code 1949
   – Geneva convention
   – Belmont report 1979
   – NIH Title 45 1981-1991
   – International ethical guidelines from the
     Council for International Organizations of
     Medical Sciences in Collaboration with the
     World Health Organization 1993
   – Helsinki code 1964, 1997, 2001
INFORMED CONSENT

 Ranges   from nod of head
 Spoken to written
 From general to specific
 To ultra specific
 Treatment treated more lightly than
  research, but equally important
    REQUIREMENTS
 Patient must receive explanation of risks, consequences,
  benefits, and alternatives
 Must be written and spoken in a language that the patient
  understands
 Patient must give consent without coercion or
  persuasion
 Be competent / have legal right to competence
 Should not have received narcotics x amount time prior
 Advance directive or will may not be witnessed by
  anyone having financial interests
 Witnesses need to be 18 years of age
 For treatment issues, it is also appropriate to discuss
  when the decision will be revisited
BASIC ELEMENTS OF RESEARCH CONSENT
    –   Study involves research purpose
    –   Procedure risks and benefits to subject and others
    –   Appropriate alternatives
    –   Confidentiality of records, discs, tapes, papers
    –   Compensation and medical treatment
    –   Whom to contact
    –   Voluntary
    –   Refusal = no loss of benefits
    –   Expected duration; Withdraw at any time
    –   IRB approval and approval of agency
    –   Consents may need to be anonymous or verbal, “By
        participating in this, I grant consent..”
ADDITIONAL ISSUES
 Costs  to subject
 Approximate number of subjects
 Government or program approval
 Consequences of withdrawal
 Future risks, to person, pregnancy,
  fetus, embryo
 When can the researcher terminate
 How new findings may affect study
WHAT IS AN IRB?
 Helsinki declaration of 41st world medical
  assembly
 Committee membership must include
  scientists, non scientists, institutional,
  and non institutional members
 Must be at least five members, must be of
  ethnic diversity to reflect surrounding
  community, all five may not be of same
  gender or profession
 The IRB must keep written records and
  respond to submitted proposals in writing
INSTITUTIONAL REVIEW BOARD
SPECIFIC FUNCTIONS:
  Approve , disapprove, or modify research
   proposals
  Conduct continuing review of research
   involving human subjects
  Observe adequacy of the consent process
  Suspend or terminate approval of
   research which violates ethical principles
   or that is associated with any potential or
   unexpected serious harm to participants
WAIVERS TO THE FULL IRB
Studies of Minimal Risk
 Hair, nails, plaque, excreta, secretions
 18 or older, non pregnant, good health
 Not more than 450 ml of blood in 8 weeks
 Recorded speech
 Exercise by healthy individual
 Records, charts, specimens
 Studies of perceptions
 Non stressful
STUDIES ON PREGNANT WOMEN
 Must be preceded by animal studies
 Preceded by studies on non-
  pregnant persons
 Must meet the health needs of fetus
  or mother
 Must not be related to termination of
  pregnancy
 Cannot be given money to terminate
FETAL STUDIES
 Must be of minimal risk
 Fetus must need health care
 Mother and father must be fully competent
  and fully informed
 Other regulations for fetal tissue, placenta
  material
 Often dependent on political process, i.e.,
  Bush and Reagan versus Clinton
OTHER SPECIAL RESEARCH
POPULATIONS
 Prisoners (non coercion)
 Non competent persons (permission of
  guardian)
 Animals (special regulations regarding
  pain and sacrificing)
 Children have special regulations, but
  rather than forbid research with children
  as was done after Nuremberg trials, now
  this is being encourages to test
  appropriate drug dosages, etc.
ANIMAL REGULATIONS
 Extremely strict
 Enormous amount of work done to secure
  rights of animals
 Extremely well treated, well cared for in
  laboratories
 May not be allowed to suffer from pain
 Must die with dignity
    1993 NIH REGULATIONS
 Stress inclusion of women and minorities in
  research
 Include peer panel review, I.e., breast cancer
  survivors involved in project selection
 Human genome project began and has full
  ethical component
 Financial conflicts of interest now revealed
 International research has new inclusion of
  autonomy which has been difficult to obtain in
  societies who do not value this concept
 International AIDS studies have been a source
  of conflict; now new regulations
PATIENT SELF DETERMINATION ACT,
1990
   Patient may delineate wishes now for the future
   Patient has the right to make choices
   Patient has the right to refuse treatment
   Patient has the right to execute an advance directive
   Patient has the right to select a surrogate decision
   maker
RESEARCH ON NEWBORNS
 Right to freedom from pain, loud noises,
  and visual intrusions
 Right to be comforted by parents
 Much discussion about how to obtain
  informed consent for researched
  treatment during birth emergencies
 Many have critiqued that elements of NICU
  care are not research based
CONSENT FOR CHILDREN
RESEARCH/TREATMENT
 Parent or guardian consent
 Both parents
 Risk justified by benefit
 Generalizable knowledge
 Serious health problem for children
 Sound ethical thinking behind any study
  necessitating children as subjects
 Panel of experts
 Assent and permission
 Parent present during the procedure
CONCRETE OPERATIONALISM
 Thought  to need to be at least 12 to
  show moral development and
  operationalize
 Most countries state 16 years of age
 Recently important in trial and
  incarceration issues
YOUNG CHILDREN
 Must have information explained at a
  developmentally appropriate level about why
  they are a candidate for study or treatment
 Must be told what is the nature of the
  treatment/experiment and how will it feel in
  terms familiar to them
 Should feel free of coercion by parents or
  health care professionals
 Should be willing to do it
 When too young to legally give research or
  treatment consent, have most recently been
  asked to give assent
ASSENT
 CHILD ASSENT: “I understand that I do not
  have to be part of this research even if my
  parents give permission for me to do it. I
  also know that I can stop being part of this
  research even if my parents want me to stay
  in it.”
 PARENTS: “I understand that assent of my
  child will be solicited. I understand that my
  child is free to refuse to participate in this
  research and to withdraw from this research
  even if I have given permission or wish
  him/her to continue.”
VULNERABLE CHILDREN
 One or no parents
 Parents mentally retarded or disturbed
 Foster care or institutional placement
 Children with AIDS or dying children
 Cognitive disorders or attention deficit
 Physical or sensory impairment
 Genetic disorders
 Ethnicity differing from the researcher
  (although now push to include multiple
  cultures in a study)
NEW PEDIATRIC PROBLEM
 Research and treatment has traditionally been
  done for the good of the minor patient
 Parents may consent to such research or
  treatment
 New phenomena of transplants from minors to
  sibling
 Consent for the good of “other” -- Is this ethical?
  Legal?
 Are “designer babies” ethical?
ADOLESCENTS
 Adolescents are a distinct group with emerging
  cognitive abilities
 Although NIH requires racial, ethnic, and gender
  inclusion, age has not been addressed
 Yet research in this age group is very important,
  as health indicators for adolescents are declining
ADOLESCENTS
 National movement to understand adolescents better
 Specifically how puberty affects drug distribution and
  metabolism
 More about Human Papilloma Virus and cervical cancer
 Social deficits and pregnancy; Social deficits and HIV
 Resiliency- How to increase this trait
ADOLESCENTS
Have the right to consent to care without parental
  involvement regarding
 Reproductive issues; contraception, abortion
 Drug and alcohol treatment
ADOLESCENTS
 May be considered an emancipated minor:
 By marriage
 Judicial decree
 Consent of parent
 Failure of parents to meet responsibilities
 Self supporting and living separately
 Differs from state to state
 Refers to medical treatment but not other
  rights, i.e., voting, alcohol, cigarettes
     NEW ADOLESCENT ISSUES
 Most adolescent research takes place in schools
 U.S. Department of Education requires parental consent for
  unemancipated minors
 However, minors are not necessarily children under the law
 Areas adolescents are considered mature minors:
     contraceptive services
     pregnancy
     sexually transmitted infections
     substance abuse
     mental health services
RISK TO ADOLESCENT
 If low risk, may be able to simply notify parents
  that study is taking place and assume passive
  parental consent unless they send a written
  objection
 If high risk, parents should give actual consent
     This is a debated issue in the laws about abortion
     with strong feelings on all sides
STUDIES OF CONSENT
 Usually 93-100% passively agree to study and
  did mean it
 Usually only 30-60% will send active consent
  due to being busy
 There is a bias in which parents do send back
  notes to home which is a threat to the validity of
  the study
COST FOR ACTIVE PARENTAL
CONSENT
 Extensive follow up is expensive
 Additional calls, letters, prizes, contests,
  incentives for child, parents, and school staff can
  cost up to $25 per student
 If school is involved, may be lower cost
LEGAL STANDARDS OF
COMPETENCY
 Evidence of choice
 Reasonable outcomes
 Rational reasons
 Understanding
    If problems with adolescent consent, related to
    emotional factors such as anxiety, not chronilogical
    age or cognitive development
PASSIVE CONSENT
 If school agrees, passive consent is most likely
  acceptable if the “probability and magnitude of
  harm or discomfort anticipated in the research
  are not greater in and of themselves than those
  encountered in daily life or during the
  performance of routine physical or psychological
  examinations or tests.”
CONFIDENTIALITY
 Adolescent gives informed consent
 Investigator protects privacy
 Certificate of confidentiality may need to be
  obtained
 Storage assures confidentiality
 Investigator encourages teen to discuss
  research with parent or adult
 Protocol must be established if study identifies
  that teen needs assistance
CERTIFICATES OF CONFIDENTIALITY

   Issued by the National Institutes of Health (NIH)
 Protect investigators and institutions from being compelled to
  release information that could be used to identify research
  study participants
 Allow the investigator and others who have access to
  research records to refuse to disclose identifying information
  in any
        –   civil
        –   criminal
        –   administrative
        –   legislative, or other proceeding, whether at the federal, state, or local level
Statutory Authority

   Section 301(d) of the Public Health Service Act (42
    U.S.C. 241(d))

   Secretary DHHS may authorize persons engaged in:
        –   biomedical
        –   behavioral
        –   clinical
        –   other research
        –   to protect the privacy of individuals who are the subjects of that
            research.


   Authority has been delegated to the NIH.
Identifying Information

 Broadly defined


 Not just name, address, social security number,
  etc.

 Includes any item or combination of items that
  could lead directly or indirectly to the
  identification of a research participant.
Eligibility
 For IRB-approved research collecting identifying
  information
 If disclosure could have adverse consequences
  for subjects or damage:
       – financial standing
       – employability
       – insurability, or reputation
   NIH or PHS funding not required
Examples of research with potential
adverse consequences for subjects
 Collecting genetic information
 Collecting information on psychological well-being of
  subjects
 Collecting information on sexual attitudes, preferences
  or practices
 Collecting data on substance abuse or other illegal risk
  behaviors
 Studies where participants may be involved in litigation
  related to exposures under study (e.g., breast implants,
  environmental or occupational exposures)
Other issues

 Issued for single, well-defined research projects
 Certificates granted to Institutions based on PI’s
  application
 Sometimes issued for cooperative multi-site
  projects
      – Must have a coordinating center or “lead” institution
      – Lead institution can apply on behalf of all institutions
        associated with the multi-site project.
      – Lead institution must ensure that all participating
        institutions conform to the application assurances
PROJECTS NOT ELIGIBLE FOR A
CERTIFICATE

 Not research
 Not collecting personally identifiable information
 Not reviewed and approved by the IRB as
  required by these guidelines
 Collecting information, that if disclosed, would
  not significantly harm or damage the subject
     REQUIREMENTS

 Must tell subjects that Certificate is in effect in Informed
  Consent form
 Must provide fair and clear explanation of Certificate’s
  protection, including
      – limitations and exceptions
 Must document IRB approval and IRB qualifications
 Must provide a copy of the informed consent forms
  approved by the IRB
 PI and Institutional Official must sign application
ASSURANCES
 Agree to protect against compelled disclosure
  and to support and defend the authority of the
  Certificate against legal challenges
 Agree to comply with Federal regulations that
  protect human subjects
 Agree to not represent Certificate as
  endorsement of project by DHHS or NIH or use
  to coerce participation
 Agree to inform subjects about Certificate, its
  protections and limitations
    BOUNDARIES OF PROTECTION

 Protects data collected between date of issuance and
  date of expiration
 Protects those data in perpetuity
 Does not protect against voluntary disclosure:
      – child abuse
      – threat of harm to self or others
      – reportable communicable diseases
      – subject’s own disclosure
 Must disclose information about subjects for DHHS audit
  or program evaluation or if required by the Federal Food,
  Drug, and Cosmetic Act
AN IMPORTANT CAVEAT
 Certificates of Confidentiality do not obviate the
  need for data security
 Data security is essential to the protection of
  research participants’ privacy
 Researchers should safeguard research data
  and findings.
 Unauthorized individuals must not access the
  research data or learn the identity of research
  participants
FOR ADDITIONAL INFORMATION

 Go to the Certificates of Confidentiality Kiosk at
  http://grants1.nih.gov/grants/policy/coc/index.htm
 Kiosk includes:
      – background information and Instructions
      – application information for extramural investigators
      – application information of intramural investigators
      – FAQs
      – contact list
      – reportable communicable diseases policy
PARENTAL AUTHORITY
 Familyprivacy safeguards parental
 autonomy in child raising, while at
 the same time attempting to
 safeguard each child’s entitlement to
 parents who care and feel
 responsible and who are held
 accountable for meeting child’s
 needs
PARENTAL AUTHORITY
In the United States, parents
 are granted wide discretion
 but generally have not been
 granted the right to
 disadvantage a child’s health
 and safety
DECISION MAKING FOR CHILDREN
 Generally allows parents to make decisions
 Best interest of child are examined
 Family context also taken into account
 In rare occasions, family and care providers at
  odds on treatment decisions
 May be parents insisting on futile care
 May be providers insisting on unproven
  treatment
SURROGATE DECISION MAKING
 Generally assumed that parent has best interest
  of child at heart
 Health care providers may disagree
 Often stated “Parent too stressed to make logical
  decision”
THREE CONDITIONS MAY OVERRIDE
PARENTAL AUTONOMY IN THE USA

1.   The medical profession is in
     agreement about the treatment
2.   The expected outcome of the
     treatment is what society agrees to
     be right for any child (a chance for
     a normal life or a life worth living)
3.   The expected outcome of denial of
     treatment would mean death for the
     child
 OVERRIDING PARENTAL CONSENT
 In emergency medicine, care has been provided if
  parent not available
 In emergency or non emergent medicine, if
  parents are available but disagree, court order
  must be obtained
 Guardian ad litem may be appointed
 Both sides have the right to be heard
 Patient has the right to transfer care
 In historical instances, families have had no
  opportunity for due process, whereas health
  facility has been heard. Consent has been
  granted to physicians by court on behalf of
  child’s best interests
 Many cases of court order have occurred in
  people of color or new immigrants
AMERICAN ACADEMY OF
PEDIATRICS
 Informed Consent, Parental Permission, and
  Assent in Pediatric Practice (RE9510)
 Religious Objections to Medical care (RE9707)
SONOMA STATE UNIVERSITY
INTERESTS
 Class projects do not have to go through IRB
 However, if the intent is to publish, must go
  through IRB
 Need to give them time to respond and ask
  questions
 Form available on line

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:0
posted:8/29/2012
language:English
pages:54