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HISTORY OF INFORMED CONSENT –Human subjects research has a checkered past –Nazi experiments 1935-1945 –“Extensive, willfully harmful experimentation” –Nuremberg.

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Presentation on theme: "HISTORY OF INFORMED CONSENT –Human subjects research has a checkered past –Nazi experiments 1935-1945 –“Extensive, willfully harmful experimentation” –Nuremberg."— Presentation transcript:

1 HISTORY OF INFORMED CONSENT –Human subjects research has a checkered past –Nazi experiments –“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

2 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

3 CODES IN RESPONSE TO ETHICAL VIOLATIONS –Nuremberg code 1949 –Geneva convention –Belmont report 1979 –NIH Title –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

4 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

5 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

6 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..”

7 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

8 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

9 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

10 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

11 STUDIES ON PREGNANT WOMEN  M ust 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

12 FETAL STUDIES  M ust 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

13 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.

14 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

15 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

16 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

17 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

18 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

19 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

20 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

21 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.”

22 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)

23 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?

24 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

25 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

26 ADOLESCENTS Have the right to consent to care without parental involvement regarding  Reproductive issues; contraception, abortion  Drug and alcohol treatment

27 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

28 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

29 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

30 STUDIES OF CONSENT  Usually % 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

31 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

32 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

33 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.”

34 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

35 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

36 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.

37 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.

38 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

39 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)

40 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

41 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

42 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

43 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

44 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

45 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

46 FOR ADDITIONAL INFORMATION  Go to the Certificates of Confidentiality Kiosk at  Kiosk includes: –background information and Instructions –application information for extramural investigators –application information of intramural investigators –FAQs –contact list –reportable communicable diseases policy

47 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

48 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

49 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

50 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”

51 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

52 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

53 AMERICAN ACADEMY OF PEDIATRICS  Informed Consent, Parental Permission, and Assent in Pediatric Practice (RE9510)  Religious Objections to Medical care (RE9707)

54 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


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