Special Consideration in Public Health Practice & Research Delia Wolf, MD, JD, MSCI Associate Dean, Regulatory Affairs and Regulatory Compliance Lecturer, Health Policy and Management Harvard School of Public Health KAU-Public Health Ethics Course May 7, 2015

Ethical Frameworks  Harm principle – it is applicable when predictable harm is likely to occur for individuals with infectious diseases, who are untreated may pose harm to communities  Least Restrictive Means – education and facilitation are preferred to interdiction and incarceration  Reciprocity – if restrictive measures are invoked, assistance and protections must be provided to those who are restricted/detained  Discourse ethics –representation of those to be restricted 2

3 Vaccination Programs Mandatory/compulsory vs. voluntary Exemption typology Medical – compromised immune system, allergies, etc Religious – “meddling in the work of God,” some vaccines stem from aborted fetal cell strains Philosophical – government interfering in the private lives of individuals and their families; how healthcare resources are spent, i.e. vaccination vs. improved nutrition and sanitation Personal (particularly on behalf of children) – perceived risks and health concerns

4 Vaccination Programs (cont.) Points to consider Other reasons for individuals’ objecting to vaccination (e.g., the cost of the vaccine, transportation to the clinic, time off work, potential illness) Providing assistance and compensation for sick days resulting from immunization Providing education Vaccine-by-vaccine, population-by-population bases Avoid imposing compulsory vaccination programs on an entire society

5 Genetic Research-Associated Risks psychological risks social risks family discord stigmatization employment discrimination insurance discrimination breach of confidentiality limitations of genetic testing

6 Important Considerations Research using prospectively collected samples Research using existing samples Tissue repository/bank for future genetic research Secondary use of existing samples Recruitment of family members Inclusion of children Disclosure of research results to subjects

7 Using Prospectively Collected Samples Unless the samples are collected anonymously, research involving the prospective collection of coded or identified samples requires subject consent The investigators has the obligation to maintain confidentiality to the extent permitted by local law

8 In addition to the required elements, a consent form should include: What information will result from the research What the implications and limitations are Unexpected findings may result What follow-up information subjects will receive How samples are to be disposed How to withdraw from the study List of regulatory agencies/parties that may review study results Steps that will be taken to ensure subjects confidentiality Using Prospectively Collected Samples

9 If a study asks to storage of samples for future research, subjects need to be informed: Where and how long their samples will be stored; Once the sample is provided, if samples are stored in the anonymous fashion, remove one’s samples from further testing is not possible; and They have the option of being re-contacted to consider use of their samples in future studies. Using Prospectively Collected Samples

10 Using Existing Samples When retrospective research is to be conducted using anonymous or anonymized samples, consent from subjects is not necessary For research using samples that are identifiable, consent must be obtained. In certain cases, where the informed consent process that was in place when the samples were taken does not meet current consent standards for genetic studies, the investigator may seek a waiver of written informed consent and authorization

11 Tissue Repository/Bank All tissue repositories, whether they focus on specific types of diseases, or they serve as a resource for research on any diseases, require IRB review and approval if the repository retains any identifiers. The investigator is required to provide the following information to the IRB: How will samples be obtained How the repository will handle the samples How confidentiality will be protected; and How tissue samples will be made available to other researchers

12 Tissue Repository/Bank (cont.) Investigators must seek informed consent from individuals who are asked to provide sample(s) to a tissue repository. The consent document must include: A description of the repository and how it is operated A description of what type(s) of research the tissue will be used for A list of conditions under which samples and data will be released to recipient-investigators Procedures for protecting the privacy of subjects and maintaining the confidentiality of data.

13 Tissue Repository/Bank (cont.) For recipient-investigator, if one requests unidentifiable or coded samples from the repository and the code is kept by the repository, then that investigator does not need to have an approval from IRB If the investigator requests samples with identifiers, then the recipient investigator must submit the proposed research protocol to the IRB, and the IRB will determine whether obtaining consent from the tissue donor is required, or whether the requirement of informed consent can be waived

14 Recruitment of Family Members Investigator may not directly contact any family members from a list provided by a proband. Instead, investigator must ask probands to initiate contact with family members about research studies To help the probands communicate effectively, investigator should prepare an information sheet that is similar to a recruitment letter. Family members could then contact researchers directly if they are interested in participating in the study.

15 Recruitment of Family Members Deciding whether family members are subjects: What is collected for research? Subjects?What is required? Tissue or blood sample from family members YesInformed consent Review of family members’ medical records YesInformed consent Data obtained from identifiable proband YesUsually waiver of informed consent Data from de-identified proband NoNo consent necessary

Inclusion of Children While the requirements to include children as subjects in genetic studies, in which these children display the phenotype under the study, are similar to these in other studies in which children may be asked to participate, special issues should be considered when children are enrolled not as the direct subjects of investigation, but to provide information necessary to analysis of the family

Inclusion of Children (cont.) Following issues should be addressed in the protocol: Is there a possibility that information would be discovered as a consequence of the study that may impact the health or future family planning of the child? If the child does not display the phenotype under study, what is the likelihood that he/she will eventually develop this phenotype? If there is a reasonable possibility that the phenotype will eventually appear, follow-up genetic counseling and psychological counseling should be made readily available. If the child does not display the phenotype, and is believed to be unaffected, provide justification as to why it is necessary to include the child in this family study. Is there any potential benefit to the family unit by having the child participate? If so, specify. What types of tissue samples would be collected for the study. What efforts will be made to obtain the child’s assent to participate in the study?

Disclosure of Research Results In general, should not disclose genetic research results to a research subject. Disclosure may be approved by the IRB if all of the following conditions are met: The research results are scientifically valid and are performed by a certified laboratory Research results have significant implications for the subject’s or the public’s health A course of action to ameliorate or treat the subject’s or the public’s health concerns is readily available