APPROVAL OF THE 2ND EDITION OF THE NATIONAL ETHICAL GUIDELINES FOR HEALTH AND HEALTH RESEARCH 2017”. REYES AND THE MEMBERS OF THE AD HOC COMMISSION FOR THEIR EFFORTS TO REVIEW THE NATIONAL ETHICAL GUIDELINES”.
MESSAGE
Congratulations to the Philippine Health Research Ethics Board (PHREB) as it releases the recent revision of the National Ethics Guidelines. As one of the implementing institutions of the Philippine National Health Research System (PNHRS), UP Manila supports national initiatives and programs in the research ethics review of the Philippine Health Research Ethics Board (PHREB).
HOW TO USE NEGHHR 2017
The provision “All clinical studies must be adequately justified by reference to the priority health needs of the country” in the Clinical Research Guidelines can be cited as (NEGHHR 2017, Clinical Research, Guideline 1). The technical terms defined in the Glossary (pages 246 to 262) should be understood and used in the context of the specific provisions in NEGHHR 2017.
INTRODUCTION
The Ad Hoc Committee for Updating the National Ethics Guidelines for Health Research has reconvened to consider all of the above developments and issues in determining relevant material in the review of the Research Ethics Guidelines. It should also be said that the work on the revision of the National Ethical Guidelines was made possible and feasible through the dedication and commitment of Mr.
LIST OF ACRONYMS
NAST National Academy of Science and Technology NCBP National Committee on Biosafety of the Philippines. PALAS Philippine Association for Laboratory Animal Science PCHRD Philippine Council for Health Research and Development PHREB Philippine Health Research Ethics Board.
G ENERAL
GUIDELINES
ELEMENTS OF RESEARCH ETHICS
For all research involving human subjects, the researcher must obtain voluntary informed consent from the prospective research participant. If there are significant changes in the circumstances or procedures of the research; or
ENSURING QUALITY RESEARCH
Philippine Health Research Ethics Board
Provide advice and make recommendations to the PNHRS Governing Board and other appropriate entities (including the Food and Drugs Administration [FDA]) regarding programs, policies and regulations related to ethical issues in human health research;. Initiate and contribute to discourse and discussions of ethical issues in human health research; and.
Regional Ethics Monitoring Boards
Develop guidelines for setting up and managing RECs and standardization of research ethics review; Monitor and evaluate the performance of institutional RECs in accordance with procedures set out in a previous agreement.
Research Ethics Committees
The officers and members of the NEK will be officially appointed by the administrative head of the institution. All documentation and communications from the REC will be dated, filed and archived according to the committee's written procedures (WHO, 2011).
OTHER CONSIDERATIONS
S PECIAL
ETHICAL GUIDELINES FOR CLINICAL RESEARCH
Careful consideration should be given to the different phases of clinical trials as they raise different ethical issues (ICH-GCP E8, 1997). The informed consent document should clearly describe which parts are standard care and which parts are part of the study. Safety procedures when inserting a medical device into the study participant must be followed.
ETHICAL GUIDELINES FOR HERBAL RESEARCH
There must be evidence of a long history of use of the herbal plant or remedy to be tested. An exhaustive literature search on the therapeutic or diagnostic value of the herbal plants must serve as background, or justification for the research proposal. Blinding in herbal research can be challenging due to the difficulty of preparing control galenics/concoctions that are indistinguishable from the herbal preparation being tested.
ETHICAL GUIDELINES FOR RESEARCH IN
COMPLEMENTARY AND ALTERNATIVE MEDICINE
Other methods used in alternative medical systems, such as in medical traditions developed in the West (eg naturopathy and homeopathy), and in Eastern traditional medicine (eg Ayurveda, unani and traditional Chinese medicine). There must be sufficient documentation of the use of the therapy in the community in at least one generation. The REC will include an expert or practitioner in the specific traditional medicine modality considered in the research protocol.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING ASSISTED REPRODUCTIVE TECHNOLOGY
The possibility of multiple embryos should be discussed with the partners; with decisions made in the light of institutional practice and religious considerations. Researchers must indicate in the protocol to be submitted to the REC, any financial interest they have in the research. If any staff member or trainee expresses a conscientious objection to research conducted by an ART clinic or research institution, he or she should be allowed to withdraw from involvement in the research to which he or she objects.
ETHICAL GUIDELINES FOR RESEARCH ON COSMETICS
Inclusion and exclusion criteria will take into account different skin conditions, allergic reactions, participant's occupation and past experiences with cosmetics. A participant who withdraws from the research for reasons related to the study, such as unacceptable side effects of the test product (as defined in the protocol), or who withdraws for health reasons, will be compensated for lost wages for uncompleted visits and subject to appropriate medical care in accordance with procedures approved by the REC. In the event of an unexpected/adverse skin reaction, the investigator should assess the severity of the reaction, complete the required safety report (eg SAE, SUSAR) and initiate appropriate therapy immediately.
ETHICAL GUIDELINES FOR ENVIRONMENTAL HEALTH RESEARCH
A major issue in environmental health research is the existence of potential COI that would call into question research results and recommendations. The study design should not include the withholding of effective environmental health interventions from research participants. Environmental health research involving children must consider their unique sensitivity to certain toxins that is different from adults.
ETHICAL GUIDELINES FOR EPIDEMIOLOGIC RESEARCH
Informed consent must be obtained from parents or, in their absence, a guardian or a legally authorized representative (LAR), for the collection of data from children. This legal requirement must be included in the information to be disclosed when informed consent is requested. Potential or actual financial conflicts of interest must also be disclosed when informed consent is obtained from research participants.
ETHICAL GUIDELINES FOR RESEARCH USING ONLINE AND DIGITAL TOOLS
Researchers and RECs must ensure that research on the Internet involves only minimal risk or includes mechanisms that address more than minimal risk. Additional safeguards to maintain privacy and confidentiality of information must be used (eg, pseudonyms, altered citations to prevent immediate retrieval by search engines, encryption, separation of data files into identifiers and responses). The investigation team must include a member familiar with technical issues related to Internet security, including additional security measures.
ETHICAL GUIDELINES FOR HEALTH - RELATED SOCIAL RESEARCH
The researcher must conduct a proper consultation with community leaders and stakeholders before starting the research. The researcher must consider the customary or culturally valued practices of decision-making in the community while noting permissible waivers or modifications to the informed consent process. Researchers must take appropriate measures to prepare research participants or the community to leave the study.
ETHICAL GUIDELINES FOR RESEARCH IN MENTAL HEALTH
Informed consent is an ongoing process, and the mental health researcher must base his or her assessment of the potential subject's decision-making capacity on the tools or instruments in place. The inclusion of LARs in informed consent should be properly documented as required by law, such as Family Code of the Philippines (EO 209). The rationale must be weighed against the risk of harm to current and future members of the community.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING INDIGENOUS PEOPLES
The competence of researchers to conduct the research will be assessed as part of the ethical review process. A non-technical summary of the research findings, written in their language, should be provided to the community at the end of the research. If necessary, the REC will invite an expert to assist in the review of the study.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING MINORS OR CHILDREN
Any other relevant documents such as, but not limited to, the child's school records, dental records or travel documents;. In case of doubt about the child's age, after all measures for its determination have been exhausted, the age is decided in the best interest of the child. However, an examination of a child's competence, motu proprio or at the request of a party, will be made when there is substantial doubt about the child's ability to understand the nature and consequences of giving consent.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING OLDER PERSONS
LS3: the research participant is aware of the emotional consequences of his or her positive or negative choice; LS5: The study participant has the ability to understand the meaning of the information and the treatment situation. The researcher should ensure that research participants (with special reference to those who are institutionalized, housebound, or those who have communication and mobility difficulties) are informed of the results of the research.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING MILITARY PERSONNEL
ETHICAL GUIDELINES FOR RESEARCH INVOLVING PEOPLE WITH DISABILITIES
Respect for autonomy means that PWDs participating in research have the right to make their own decisions about participating in the research process. The researcher should consult with PWDs or their representative groups regarding the research topic, research questions and research design. The researcher must ensure that research participants and disability groups are involved in the dissemination of research findings.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING PEOPLE LIVING WITH HIV AND AIDS
Particular attention will be paid to the potentially sensitive nature of the information to be extracted from research participants and, if applicable, the need to undergo an HIV test. It is not acceptable for the control group of affected individuals to undergo placebo treatment or to withdraw from the current treatment regimen before the start of the study. Special effort will be made to make the useful findings of the research project accessible and available to participants under reasonable circumstances.
ETHICAL GUIDELINES FOR RESEARCH INVOLVING POPULATIONS IN DISASTER SITUATIONS
The research proposal should explain how its objectives relate to community interest priorities. Further, there will be close coordination with the local government in conducting the research. Direct benefits to participants and the community will be a primary consideration in conducting the research.
ETHICAL GUIDELINES FOR RESEARCH ON EMERGING TECHNOLOGIES: NANOTECHNOLOGY, NANOMEDICINE,
Preclinical and all phases of clinical trial data are provided prior to the full use of emerging technologies to treat research participants. Nanotechnology research is conducted with the least possible risk to humans and public welfare. Approval of a similar biologic is based on demonstrating efficacy and safety comparable to the innovative reference product in the relevant study population.
ETHICAL GUIDELINES FOR GENETICS AND GENOMIC RESEARCH
Forensic medicine, in which case the use of samples must be in accordance with national laws and human rights; Disposal of stored biological specimens should be in accordance with standards for handling biohazardous and infectious materials. Documents related to the transportation, transfer, use and disposal of all stored biological samples must be properly archived in accordance with national and international guidelines.
ETHICAL GUIDELINES FOR STEM CELL RESEARCH
Research participants and participating researchers will be informed of the origin of the stem cells in the study to give them the option of not participating in the study if the stem cells were obtained in a way that they feel is unethical. Documentation of the original origin of stem cells must be readily available to researchers and potential recipients of experimental stem cell-based therapies. The protocol also includes biomarkers, surrogate markers and other indicators of the viability and functionality of the infused stem cells in the recipient's target tissue.
ETHICAL GUIDELINES FOR RESEARCH USING HUMAN DATA AND SAMPLES FROM BIOBANKS, REGISTRIES, AND
The Participant will be informed during the consent process if the HBRD custodian is required by law to make available material or human biological data to third parties such as insurers, employers, law enforcement agencies or other civil law agencies, for non-research purposes. . A Material Transfer Agreement (MTA) will be entered into between institutions involved in a collaborative project that will use human samples or stored data. Researchers will only have access to materials or human biological data that are coded or anonymized, and they will be required not to attempt to re-identify participants.
ETHICAL GUIDELINES FOR INTERNATIONAL COLLABORATIVE RESEARCH
Filipino researchers will be deeply involved in setting the research agenda, especially in Type 2 agreements. Basic agreements between collaborators will be entered into at the outset of the collaboration that will outline how profits and recognition will be enjoyed and shared. Sustainability of good results will be part of the strategic plan from the first day of cooperation.
ETHICAL GUIDELINES FOR AUTHORSHIP AND PUBLICATION
Authors must obtain the informed consent of research participants as a condition for publishing photographs or identifiable information. The first author is the one who did most of the work, the last author is the most senior in the group. The student will be listed as the primary author of a publication that derives substantially from the student's dissertation or thesis.
A PPENDICES
APPENDIX A: EXCERPTS FROM THE PHILIPPINE NATIONAL HEALTH RESEARCH SYSTEM ACT (RA 10532)
The PHREB, created under DOST Special Order No. 2006, will ensure compliance with the universal principles for the protection of human participants in research.
APPENDIX B: EXCERPTS FROM THE IMPLEMENTING
RULES AND REGULATIONS OF THE PNHRS ACT (RA 10532)
