Institutional Review Board

The Institutional Review Board was organized by the Tropical Disease Foundation in February 1987 to serve as a combined technical and ethical review board to evaluate the proposals for research of the TDF and oversee their implementation. The Tropical Disease Foundation transferred its laboratories and office at the Makati Medical Center at that time through a Memorandum of Agreement signed by the late Dr. Constantino P. Manahan, then Director of the MMC and Dr. Raul G. Fores, then Assistant Medical Director and Executive Vice President as signatories of the MMC and Dr. Thelma E. Tupasi, and Dr. Roberta C. Romero, President and Vice President, respectively, signing on behalf of the Tropical Disease Research Foundation, as it was then known.

In 2002, the TDF submitted a proposal for the International Clinical, Operational, and Health Research for Tuberculosis in response to a Request for Application (RFA) from the National Institutes of Health (NIH), US Department of Health and Human Services (DHHS), USA. In compliance with requirements by NIH:

  • The Tropical Disease Foundation submitted an application for Federalwide Assurance to the Division of Assurances and Quality Improvement, Office for Human Research Protection, US Department of Health and Human Services (DHHS). The application was signed by Dr. Edmundo Villacorta both in his capacity as Member of the TDF Board of Trustees, and as Vice President for Professional Services, Makati Medical Center. The application was approved under the name of Tropical Disease Foundation Institutional Review Board #1 with identification No. IORG No. 00002157.

  • The Tropical Disease Foundation, the registered parent organization of the IRB 00002157, was accredited by the USDHHS for human subject protection with a Federalwide Assurance Number FWA 00002837 on February 13, 2002 up to March 2005, and renewed until November 13, 2020.

  • The TDF applied and was granted a DUN and Bradstreet Number (DUNS): No. 71-890-8684 .

 

The members who have served in the IRB through the years are as follows:

 

CHAIRMAN

  • Dr. Florentino Solon, 2009-February 2013
  • Dr. Roberta C. Romero, 2006-2009
  • Dr. Claver P. Ramos, 2002 – 2005
  • Dr. Thelma E. Tupasi, 2000 – 2001
  • Dr. Romeo H. Gustilo, 1987-1999

CO-CHAIRMAN

  • Dr. Marita VT. Reyes, 2009 to present
  • Dr. Florentino Solon, 2006-2009
  • Ms. Miriam Davis, 2002-2005
  • Dr. Claver P. Ramos, 1987-1999
  • Dr. Roberta C. Romero, 1987-1999

In September 2005, the President of the MMC and the Director of the MMC re-organized the MMC IRB. It was deemed that the TDF IRB should continue apart from the MMC IRB.

MANDATE

The IRB is an independent committee organized by the Board of Trustees of the Tropical Disease Foundation (TDF). The IRB is mandated to conduct ethical and technical reviews of research proposals in order to protect the rights and welfare of human subjects involved in clinical investigations. It is an assurance to the public and the medical profession that the safety and well-being of these human subjects is upheld at all times.

COMPOSITION

The IRB should consist of at least 5 members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposal. It is recommended that the membership should include

  • One member whose primary area of interest is non-scientific/non-medical
  • One member who is independent of the institution or the trial site
  • One member who represents the behavioral sciences
  • A representative of the religious community
  • A representative of either female or male for gender balance, and if possible representatives from the older and younger generation
  • A public health practitioner
  • A member with experience in biomedical research
  • A list of IRB members and their qualifications should be maintained.

The tenure of office of the Chairperson as well as the members is three (3) years subject to re appointment.

RESPONSIBILITIES

  1. To review, discuss and deliberate on submitted research proposals and decide whether these are approved or disapproved or need modifications.
  2. To monitor serious adverse events and recommend appropriate actions.
  3. To suspend or terminate approval of the research as it sees fit.
  4. To evaluate the final outcome of the research
  5. Others: to maintain confidentiality, to declare any conflicts of interests and to participate in continuing medical and biomedical activities.

ORGANIZATIONAL CHART OF THE TDF INSTITUTIONAL REVIEW BOARD

Roberta Romero, MD - CHAIR

Marita V. Reyes, MD - CO-CHAIR

Nellie Mangubat - Human Subjects Administrator

MEMBERS

  • Thelma Tupasi, MD – Public Health
  • Fr Rene Lagaya SDB – Moral Theology
  • Ruben Encarnacion – Behavioral Science
  • Michelle Co – Youth Representative
  • Catherine Maceda – Lay Representative