influence study results. For example, marketing of vaccines in developing countries may be based on the prevalence of a disease established in an epidemiologic study or public health programs, and may be influenced by ideologically driven epidemiology data.
Requirement for ethical review
1. Epidemiologic studies that aim to contribute to generalizable knowledge shall undergo ethics review prior to start of the study.
Exemption from review is a decision made by an REC. (See The Research Ethics Review Process, page 36)
2. The ethical review of an epidemiologic study shall consist of the same elements of review for other studies, namely: social value, scientific soundness, fair selection of participants, favorable balance of risks and benefits, validity of the informed consent process, protection of privacy and confidentiality, respect for participants and protection of vulnerable populations, and appropriateness of the qualifications of the researcher.
3. Collection of data by questionable means, such as deception, shall not be condoned.
Scientific validity
4. The nature of the data and biological samples to be collected, the method of collection, the population from whom the data shall be collected, the method of data analysis shall all be as dictated by the objectives of the study and basic statistical principles.
5. Explicit and detailed research protocols shall fully account for the requirements for scientific validity.
6. Human participant protection, through adherence to ethical principles, precedes that of science and society.
Informed consent
7. Researchers, in principle, shall obtain written informed consent from all research participants prior to conducting any epidemiological study.
Researchers shall stipulate in their research proposals: a) how a study is explained to the research participants involved, b) how informed consent will be obtained from the participants, c) and any other relevant issues concerning informed consent.
8. In cases where written informed consent is impracticable, alternative methods of obtaining consent (e.g., verbal consent) shall be employed as discussed in Guidelines for Health-Related Social Research (page 108).
9. Informed consent shall be obtained from parents or in their absence, a legal guardian or legally authorized representative (LAR), for collection of data among children. The informed consent process shall ensure that there is no basis to think that the participant would have dissented.
10. For individuals who are temporarily or permanently incapable of giving a valid consent (as determined by an appropriate assessment method) for themselves, the LAR can sign the ICF, provided that the research does not involve more than minimal risks to the participants.
11. Researchers may request for waiver of the informed consent process if the process is impractical and the research procedures entail not more than minimal risk, for example:
11.1. Collection of information in the public domain. However, it should be noted that communities differ in their definition of what type of information about individuals is regarded as public.
11.2. Review of medical records, if anonymity can be maintained and if information sought is considered non-sensitive (Data Privacy Act of 2012). This means if a data set is successfully anonymized—and therefore, it no longer permits the identification of the individual whom the data set pertains to—
it is taken out of the scope of the Data Privacy Act, and the
latter's provisions will no longer be made to apply to the processing (e.g., review) of such data set (e.g., anonymized medical records).
11.3. Exemption from the use of the standard form for informed consent (e.g., non-disclosure of all the study objectives) may be permissible if full disclosure of the study hypothesis could bias the investigation. (For other criteria for exemption from the use of standard informed consent form, see Guidelines on Health- Related Social Research, page 108)
12. When feasible, debriefing of research participants shall be included in a study that waived full disclosure. This may be done towards the end of the study so the results may be disseminated to those involved.
13. In general, if the information is obtained by means of a questionnaire, and adequate information has been given to the research participant, there is no need for a written informed consent (waiver of informed consent documentation), since answering the questionnaire implies consent.
14. Appropriate consent for storing biological material for research must be obtained from the research participants. If the samples are to be used for research are not covered by the original consent, an REC shall decide whether renewed consent is needed or if the analyses may be done on anonymized samples. Details regarding the collection and storage of biological material are covered in the document on Ethical Guidelines for Genetic and Genomic Research (page 157).
Risks and benefits
15. The protocol shall clearly describe identified risks and ensure that these are minimized by, for example, proper timing of interviews and appropriate design of questionnaires.
16. Since individual participants are not always benefited by epidemiologic studies, benefits to the community and society should be carefully weighed against possible harms to individuals.
Privacy and confidentiality
17. Working with personal data is a privilege that calls for a high degree of data protection, especially in situations where data are used without personal consent.
18. Researchers shall properly manage and protect the personal data of all research participants in compliance with the Data Privacy Act of 2012 and its 2016 IRR. A working standard for data protection that secures as little risk of disclosure as possible shall be developed.
19. Data regarding income, personal habits, preferences, personal opinions, political and religious inclinations, among others, may be considered sensitive and will require consent prior to collection.
20. Researchers shall avoid identifying individuals or groups when release of information about them can expose them to possible harm or social stigma, unless required by law. This legal requirement shall be included in the information to be disclosed when soliciting informed consent.
21. Whereas, the general population can benefit from information required for timely control or prevention, in no case, however, shall protection of privacy and respect for confidentiality be waived. Removal of identifiers or keeping to the minimum data that could identify groups shall be done to avoid labeling or stigmatizing them. In cases where populations at risk have to be notified, researchers have to ensure that risks of harm outweigh the benefits.
Sharing of study results with participants
22. Important findings from the research shall be made available to all the participants in a suitable form.
Compensation for participants
23. Compensation commensurate to the time given and effort exerted for participation is encouraged, while taking care not to use this as undue inducement.
Management of conflict of interest
24. Researchers shall disclose all potential and actual COI including involvement in an ideological advocacy related to the research, all forms of financial interests, and sources of funding when applying for ethical clearance, obtaining informed consent from participants, and when publishing or disseminating research results.
25. Potential or actual financial conflicts of interest shall also be disclosed when obtaining informed consent from research participants.
26. Researchers shall avoid entering into contractual agreements that prevent them from publishing results in a timely manner.