Revised Implementing Rules and Regulation of Executive Order No.51


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SECTION 9. Research, Ethics Committee, Purpose. -The DOH shall ensure that research conducted for public policy purposes, relating to infant and young child feeding should, at all times, be free from any commercial influence/bias; accordingly, the health worker or researcher involved in such must disclose any actual or potential conflict of interest with the company/person funding the research. In any event, such research and its findings shall be subjected to independent peer review. Towards accomplishing these ends;

a. Assistance for research and clinical trials given by manufacturers and distributors are allowed only upon approval by an ethics committee led by DOH. The same committee shall monitor said researches.

b. The researches shall be conducted in accordance with an approved protocol. Any changes in the protocol after it has been approved will be subject to a new review and approval by the Ethics Committee.

c. Assistance for research maybe allowed subject to the following conditions:

c.1. Researches involving well or ill infants and children as subjects shall be limited to physiological factors and therapeutic studies;

c.2. These studies should in no case be harmful to the subject; and

c.3. Should be limited to those with potential benefits for the particular subject.

d. Recipients of research awards shall not allow themselves, their organizations or their subjects, to be used directly or indirectly for any promotional activity related to products within the scope of the Code. These may be by way of display of posters and streamers patronizing the Company, their products, and/or as lecturers/speakers or testimonials in the promotion of the products that undermine breastfeeding.

e. Assistance for support of laboratory costs, reagents and other materials shall be allowed only upon approval and review by the Ethics Committee regarding their use based on a submitted protocol.

SECTION 10. Public Disclosure. – For transparency purposes, a disclosure and/or disclaimer of the sponsoring company should be done by the company itself, health worker, researcher involved through verbal declaration during the public presentation of the research and in print upon publication.