Fundamental to mental health research is the use of mental health status or behavioral scales. These are clinical or behavioral scales that have been developed, validated, established, and licensed in Western countries. There is a perceived lack of validated translations, both conceptually and culturally, for Filipino participants. Mental health organizations are thus urged to translate and validate internationally-sourced clinical/behavioral scales such that they are conceptually and culturally applicable for Filipinos and, thereby, be able to contribute to global mental health knowledge and policies.
Methodology
1. The researcher shall develop ways and means, other than blinding, to promote objectivity of data collection. One way is for the observer or assessor to be uninformed (assessor-blind) about the intervention.
Another is for the control and experimental groups to be geographically separate so that there is no contamination of data observations.
Selection of participants
2. All persons, regardless of mental health status and place of care, who will potentially benefit from the knowledge generated in the proposed mental health research, shall be considered as possible participants.
3. Exclusion of certain groups of individuals because of their lack of capacity (e.g., poor insight) to provide a valid informed consent is not fair especially if the study can generate benefits to the individual or group. This incapacity is addressed by a proxy consent (LARs), while continuing to exert effort to obtain the individual’s informed consent when the individual's insight improves.
Informed consent
4. Researchers need to determine the best way by which consent will be obtained, and continuing participation will be ensured from a person who has difficulty with written or oral communication, cognition, and emotion.
5. Informed consent is a continuing process and the mental health researcher must base his or her assessment of the decisional-capacity of the potential subject on established tools or instruments.
6. Proxy consent based on best interest shall be obtained from LARs whenever there is doubt. The involvement of LARs in the informed consent must be properly documented as required by law, such as, The Family Code of the Philippines (EO 209).
7. In cases where the decisional capacity is not a permanent disability, the researcher shall endeavor to obtain the informed consent during moments of rationality.
8. Researchers must take care to clarify the purpose of the study in order to address participants' desires for therapeutic outcome, social contact, or practical help.
Confidentiality
9. Confidentiality is the responsibility of the person with whom this private information was given. However, when the right to safety of another individual is infringed, the policy of right to privacy may be breached.
This happens, for example, when the plan to harm another individual is unearthed during an interview, or in the data interpretation and analysis. The researcher shall exercise due diligence in determining whether such findings justifies breaching of the privacy of the participants.
Special guidelines in clinical trials
10. In clinical trials, the protocol shall include a rescue strategy or rescue medication, including a close monitoring strategy (that may include hospitalization) in order to look after the safety of the subject patient during a wash-out period, where there is a risk of exacerbation of symptoms and heightened risk of adverse events. This requires that the clinical trial site has the capability to manage serious adverse events.
11. Investigators involved in clinical drug trials for management of
depression shall include the risk of suicide among the enrolled patients in the orientation and training of the research staff, and in the arrangements regarding patient care. For example, the investigator shall weigh his or her options for outpatient or inpatient observations and the need for round-the-clock monitoring and observation.
12. Clinical trials of drugs for mental illness where standard care includes psychotherapy shall be designed, such that a psychotherapy regimen is clearly described and is included in the protocol for both the control and the experimental. Non-inclusion of the psychotherapy regimen must be justified, and clear clinical metrics be put in place to monitor early signs of deterioration.
13. The investigator and the REC shall clarify the nature and extent of care for clinical trial participants at the end of the trial period. Arrangements for continuing care shall reflect fairness, as an important ethical principle in research.
14. Pharmacogenetic studies that usually ride on clinical drug trials shall have a separate informed consent process and a separate form for signature of the patient or the LAR.
15. Studies on genetic causation of and susceptibility to mental illness shall be carefully conceptualized, and the limits in the interpretation of data seriously considered and analyzed. Genetic counseling must be in place before embarking on these endeavors.
Community-based research
16. Research conducted in specific communities that have implications on the general mental health of the constituents and their possible stigmatization must be avoided, unless there is a strong justification for it. The justification must be weighed against the risk of harm for the present and future members of the community.
Research where illegal activities may be encountered
17. As much as possible, unless the objectives of the study significantly address problems related to illegal activities, such studies shall be avoided by researchers. However, if the benefits to society are commensurate with the risks, proper and adequate consultation with the law and police authorities shall be done prior to its implementation to protect both the researcher and the participant.