ETHICAL GUIDELINES FOR GENETICS AND GENOMIC
information. Confidentiality, privacy, and security are important considerations in the ethics of a genetic study, given the hereditary nature of genetic traits.
These guidelines are intended to assist research institutions, scientists, pharmaceutical companies, health researchers, and RECs in the ethical pursuit of genetic studies so that the expected benefits in the improvement of health and healthcare can be attained with minimal harm.
Collection of samples from humans
1. Human biological samples shall be collected, processed, used, and stored only for the following purposes:
1.1. Therapeutic and non-therapeutic genetic research (i.e., epidemiological, prognostic, population-based genetic studies, anthropological or archeological studies);
1.2. Forensic medicine, in which case, use of samples shall be in accordance with domestic laws and consistent with laws on human rights;
1.3. Development of drugs, biomedical devices, molecular diagnostics, and medical technologies; and
1.4. Other reasons of public interest.
Informed consent
2. Prior, voluntary, informed, and expressed consent, shall be obtained for the collection of biological samples, human genetic and proteomic data, and for their subsequent processing, use, and storage; without inducement relating to the offer of financial or personal gain.
3. Research participants shall be provided with proper and full, but comprehensible information that explains the basics of genetics, the research in its various steps, and the potential benefits and risks to the participants.
4. Potential research participants shall be adequately informed about what will happen to any genetic material or information obtained as part of the study including where (local or foreign institutions) they will be stored and kept.
5. The informed consent shall include statements on the disclosure and sharing of the results and findings of the study, that is, to whom the information be revealed, among others.
6. Research participants shall be recruited as individuals in their own right, rather than as a family group, and shall consent as individuals.
7. In cases where identities of groups or communities can be linked with genetic traits under study, permission or endorsement may be obtained from an elected or recognized leader who will be responsible for giving the permission for the participation of the group in the study.
8. If genetic markers are yet to be determined at some future date, this information shall also be included in the consent form.
9. Informed consent shall not be required for those protocols for genetic research that use anonymous samples or samples that have no identifiers. Any sample that can be linked to an individual through an identifier, or through any person or institution that has the capability to link the sample with its source, is not to be considered anonymous.
10. All second and third party uses of biological samples shall be restricted to anonymized or anonymous samples, as above. Such use shall require ethical approval. Limited, non-identifying, demographic information may be retained on the sample.
11. Stored biological samples collected for purposes, other than those stated above, may be used to produce human genetic or proteomic data with the prior, free, informed, and expressed consent of the person concerned.
12. In case informed consent is withdrawn, the samples and data shall be
irreversibly unlinked from their source through the destruction of all identifiers. Non-anonymized human biological materials shall also be destroyed.
Genetic studies among indigenous peoples
13. Genetic studies involving indigenous groups shall be guided by international and national laws and regulations on respect for human rights and privacy, and protection from exploitation. (See Guidelines on Research among Indigenous Peoples, page 124)
Requirement for genetic counseling
14. Genetic counseling shall be provided before and after the test when there may be a need to disclose the findings of the genetic testing.
Privacy, confidentiality, and security
15. Researchers must ensure the confidentiality of stored genetic information or research results relating to identified or potentially identifiable participants in accordance with the national (Data Privacy Act of 2012) and international laws on human rights. Researchers shall also ensure that safeguards are in place to avoid accidental disclosure of sensitive personal information.
16. In general, no individual results shall be disclosed to research participants; neither shall result of genetic research go into the individual's medical record. Nevertheless, the potential for disclosure shall be declared in the initial process of seeking consent.
17. In case the disclosure of genetic information becomes impossible to avoid, such information shall be dealt with sensitively and with proper counseling.
18. Researchers shall ensure that the results of genetic testing and genetic counseling records are protected from access by third parties.
19. Identifying genetic information shall not be released to others, including
family members, without the written consent of the individual to whom the information relates, or to a person or institution which may legally provide consent for that person.
20. The research participant’s right to privacy (researcher’s duty for confidentiality) continues after the participant’s death, so that confidential information may be revealed after death only with proper legal authority. The only exception is the right to disclose information to a family member, if there is a clear and urgent need to provide information to avoid a serious health risk.
Storage and handling of biological specimen
21. The researcher shall ensure that handling and preservation of biological samples shall be in accordance with standard scientific procedures and local laws and policies, for example, Guidelines on the Use, Retention, and Storage of Residual Dried Blood Spots from Newborn Screening (DOH AO 2012-017).
22. Disposal of stored biological specimens shall be done in accordance with standards for handling biohazardous and infectious materials.
23. Documents pertaining to the transport, transfer, use, and disposal of all stored biological samples shall be properly archived in accordance with national and international guidelines. Transfer of custody of biological samples to foreign institutions shall be covered by a Material Transfer Agreement (MTA) that shall be concluded at institutional levels. The terms of the MTA must include compliance with applicable Philippine laws.
24. Retention time for stored biological samples shall be determined by the respective institutions, in accordance with the applicable provisions of the Data Privacy Act of 2012 (RA 10173), and must be declared in the informed consent form signed by the participant or subject.
25. All specimens in a tissue bank must be accompanied by a copy of the consent agreement signed by the donor.
26. No specimen shall be removed from a tissue bank for research purposes without an approved research protocol.
27. A researcher must not transfer genetic material or related information to another research group, unless:
27.1. The researcher and the other research groups are collaborating on research which has been approved by their respective RECs;
27.2. The genetic material and information are provided in a form that ensures participants cannot be identified.
International collaborative genetic research
28. An approved MTA or Limited Use Agreement (LUA) shall accompany genetic research of collaborative nature. The terms of reference of these documents must comply with applicable Philippine laws.