history of informed consent –human subjects research has a checkered past –nazi experiments...
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HISTORY OF INFORMED CONSENTHISTORY 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
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 VIOLATIONSCODES 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 CONSENTINFORMED CONSENT
Ranges from nod of headSpoken to written From general to specific To ultra specificTreatment treated more lightly than
research, but equally important
REQUIREMENTSREQUIREMENTS
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 CONSENTBASIC 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 ISSUESADDITIONAL ISSUESCosts to subjectApproximate number of subjectsGovernment or program approvalConsequences of withdrawalFuture risks, to person, pregnancy,
fetus, embryoWhen can the researcher terminateHow new findings may affect study
WHAT IS AN IRB?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: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 IRBStudies of Minimal RiskWAIVERS TO THE FULL IRBStudies 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 WOMENSTUDIES ON PREGNANT WOMEN Must be preceded by animal studiesPreceded by studies on non-
pregnant personsMust meet the health needs of fetus
or motherMust not be related to termination of
pregnancyCannot be given money to terminate
FETAL STUDIESFETAL 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 POPULATIONSOTHER 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 REGULATIONSANIMAL 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 REGULATIONS1993 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 SELF DETERMINATION ACT, 1990
Patient may delineate wishes now for the futurePatient has the right to make choicesPatient has the right to refuse treatmentPatient has the right to execute an advance directivePatient has the right to select a surrogate decision maker
RESEARCH ON NEWBORNSRESEARCH 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/TREATMENTCONSENT 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 OPERATIONALISMCONCRETE OPERATIONALISM
Thought to need to be at least 12 to show moral development and operationalize
Most countries state 16 years of ageRecently important in trial and
incarceration issues
YOUNG CHILDRENYOUNG 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
ASSENTASSENT 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 CHILDRENVULNERABLE 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 PROBLEMNEW 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?
ADOLESCENTSADOLESCENTS
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
ADOLESCENTSADOLESCENTS 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
ADOLESCENTSADOLESCENTS
Have the right to consent to care without parental involvement regarding
Reproductive issues; contraception, abortion Drug and alcohol treatment
ADOLESCENTSADOLESCENTS
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 ISSUESNEW 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 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 CONSENTSTUDIES 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 CONSENTCOST 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 COMPETENCYLEGAL 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 CONSENTPASSIVE 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.”
CONFIDENTIALITYCONFIDENTIALITY 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 CONFIDENTIALITYCERTIFICATES 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 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 InformationIdentifying 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 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
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 issuesOther 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 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
REQUIREMENTSREQUIREMENTS
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 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 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 CAVEATAN 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
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 PARENTAL AUTHORITY
Family privacy 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 AUTHORITYPARENTAL 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 CHILDRENDECISION 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 MAKINGSURROGATE 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 USATHREE 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 CONSENTOVERRIDING 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 PEDIATRICSAMERICAN ACADEMY OF PEDIATRICS
Informed Consent, Parental Permission, and Assent in Pediatric Practice (RE9510)
Religious Objections to Medical care (RE9707)
SONOMA STATE UNIVERSITY INTERESTSSONOMA 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