ROLE OF THE

ETHICS REVIEW
COMMITTEE
Abraham Daniel C. Cruz, MD, MSc, FPSECP
Vice Chair, FEU – NRMF Institutional Ethics Review Committee
Department of Pharmacology
Far Eastern University – Nicanor Reyes Medical Foundation
Objectives
• By the end of this talk, the attendees should be able to:
• Define the responsibilities of the ERC
• List the composition, functions and operations of the ERC
• Describe the procedures of the ERC regarding the review of
research protocols
• Enumerate the relevant records that the ERC retains in the
conduct of its function
CLINICAL RESEARCH
A study undertaken involving a particular person or group of people with the purpose of
increasing knowledge and determining how well treatment or diagnostic test works in a
particular patient population. PATIENT-ORIENTED RESEARCH involves a particular person
or group of people or uses materials from humans. This research can include: studies of
mechanisms of human disease; studies of therapies or interventions for disease; clinical
trials; and studies to develop new technology related to disease. EPIDEMIOLOGICAL AND
BEHAVIORAL STUDIES examine the distribution of disease, the factors that affect health,
and how people make health-related decisions. OUTCOMES AND HEALTH SERVICES
RESEARCH seeks to identify the most effective and most efficient interventions, treatments,
and services.
National Ethical Guidelines for Health Research (2011)
CLINICAL TRIAL
A planned scientific research or study among human volunteers to
determine the effects of treatment or diagnostic test on their safety, efficacy, and
its effect on quality of life. It is also a systematic study on pharmaceutical
products in human subjects (including patients and other volunteers) in order to
discover or verify the effects of and/or identify any adverse reactions to
investigational products, and/or to study the absorption, distribution,
metabolism, and excretion of the products with the object of ascertaining their
efficacy and safety (WHO, Guidelines for Good Clinical Practice for Trials of Pharmaceutical Products).
National Ethical Guidelines for Health Research (2011)
CLINICAL TRIAL
It is also defined as investigative work to evaluate new
drugs, medical devices, biologics, or other interventions to
patients in strictly scientifically controlled settings. Clinical
trials may be designed to assess the safety and efficacy of an
experimental therapy, to assess whether the new intervention
is better than standard therapy, or to compare the efficacy of
two standard or marketed interventions.
National Ethical Guidelines for Health Research (2011)
CLINICAL TRIAL

a systematic study on pharmaceutical products in human

subjects (including research participants and other volunteers)
in order to discover or verify the effects of and/or identify any
adverse reactions to investigational products, and/or to study
the absorption, distribution, metabolism, and excretion of the
products with the object of ascertaining their efficacy and
safety (WHO).
National Ethical Guidelines for Health and Health-Related Research (2017)
ETHICS REVIEW COMMITTEE
Also called research ethics committee (REC), institutional ethics
review board (IERB), independent ethics committee, (IEC) or
institutional review board (IRB); a committee constituted to review the
ethical aspects of a research proposal and its possible
implementation.
This is an independent body whose responsibility is to ensure the
protection of the rights, safety and well-being of human participants
involved in a trial and to provide public assurance of that protection.
National Ethical Guidelines for Health Research (2011)
Institutional Research Ethics Committees
Philippine institutions that engage in biomedical and behavioral
research shall establish an institutional REC, which shall provide
independent, competent, and timely ethical review of proposed
studies. The main purpose of the REC is to help safeguard the
dignity, rights, safety, and well-being of all actual or potential research
participants. To this end, it is important that in its composition,
procedures, and decision-making, the REC shall be independent of
political, institutional, professional, and market influences.
National Ethical Guidelines for Health and Health-Related Research (2017)
Institutional Research Ethics Committees
The REC should consider both the scientific and ethical aspects of
the proposed research even when the REC is distinct from the
technical review committee.

National Ethical Guidelines for Health and Health-Related Research (2017)

ETHICS REVIEW
The evaluation of a research protocol by an ethics review
committee to promote the safety and protection of the dignity of
human participants. This is a systematic process by which this
independent committee evaluates a study protocol to determine if it
follows ethical and scientific standards for carrying out biomedical
research on human participants. It checks if the protocol complies
with the guidelines to ensure that the dignity, rights, safety and well-
being of research participants are promoted.

National Ethical Guidelines for Health and Health-Related Research (2017)

Basic Ethical Principles
• Respect for persons
• Beneficence
• ”do no harm”
• “maximize benefits”
• “minimize possible harms”
• Justice
Guidelines on Ethics Review
• Review should be done on a regional, national, institutional and local level
institutional and local level
• The Ethics Committee should be independent, multi-disciplinary, multi-
sectorial, and pluralistic: scientific expertise, age and gender, lay
representative
• Mechanisms must be established to ensure cooperation, clear and efficient
communication
• IERC is established according to regulations of the country and with
community values and principles
GUIDELINES
• INTERNATIONAL
• Guideline for Good Clinical Practice – ICH Harmonized Tripartite Guideline (1996)
• CIOMS-WHO International Ethical Guidelines for Biomedical Research Involving
Human Subjects (2002)
• CIOMS Guidelines for Epidemiological Studies (2009)
• Declaration of Helsinki, World Medical Association (2013)
• NATIONAL
• National Ethical Guidelines for Health and Health-Related Research (2017)
• PHREB Requirements for Registration and Accreditation Research Ethics Review
Committees (2014)
• INSTITUTIONAL
• FEU – NRMF Institutional Ethics Review Committee (IERC) Standard Operating
Procedures (SOP) (2017)
National Governance in Research Ethics Review
• 2003 – MOU between DOST and DOH
• 2007 – MOU completed when CHED and UPM were drawn in as
implementing agencies
• 2013 - PNHRS was legislated through the PNHRS Act of 2013 (RA 10532)
• enacted 23 July 2012
• signed by President Benigno Simeon Aquino on 7 May 2013
• led to the creation of PHREB as the national policy making body in health research
ethics
DOES YOUR STUDY REQUIRE ETHICS REVIEW?
• After institutional/departmental technical review, protocols generally
undergo review by the:
• Ethics Review Committee – involve human participants, specimen, or
information
• Institutional Animal Care and Use Committee – animal studies or
specimens
• Biosafety Committee – with biosafety issues or pose hazards to the
environment (including those involving animals and plants)
EXEMPTED FROM ETHICS REVIEW
• Rely exclusively on publicly available information legally accessible to the
public and appropriately protected by law through data guardians (e.g.
registries of death, court judgements, public archives, data from NSO) and/or
publicly accessible with no reasonable expectation of privacy (e.g. identifiable
information in the media, public exhibitions, literary events)
• Observation of people in public places where:
• There is no intervention by the researcher
• There is no reasonable expectation of privacy
• Dissemination of research results does not allow identification of participants
• Rely exclusively on secondary use of anonymous information or anonymous
biological materials (so long as data linkage or dissemination of results does
not generate identifiable information)
EXEMPTED FROM ETHICS REVIEW
• Quality assurance and quality improvement studies, program evaluation
activities, performance reviews or testing within the educational environment
when used exclusively for assessment, management or improvement
purposes
• if data are later proposed for research purposes  secondary use of information 
may require ethics review
• Legally mandated public health surveillance
• Research for a critical biography not involving living participants based
exclusively on published or publicly available material
EXEMPTED FROM ETHICS REVIEW
• Occasions when individuals other than the researcher provide
information, but are not themselves the focus of the research 
data collection and consultation to frame or develop the research;
discussion with stakeholders and consultants; data collection for
internal or external organizational reports
• Student assignments that pose minimal risk
• Activities that teach about the design, conduct and process of
research  might involve “practice” data collection
 YOUR RESEARCH REQUIRES
ETHICS REVIEW IF IT INVOLVES:
• living human participants
• human biological materials, as well as human embryos, fetuses, fetal tissue,
reproductive materials and stem cells
• observation of people in public places IF there is any kind of intervention by
the researcher (interviews, access to private papers), IF the individuals have
reasonable expectation of privacy, IF dissemination of results could allow
identification of participants
• secondary use of data (use of data collected for purposes other than this
research) - health records, computer listings, banked tissue – IF data linkage
of recording or dissemination of results could generate identifiable information
WHAT TYPE OF RESEARCH
CAN YOU DO?
ERC ACCREDITATION
• 3 - can review all types of researches including clinical drug trials
(Phases 1 to 4)
• part of the Ethics Review Research Committees of the Philippine FDA
• 2 - can review most health researches: highly sensitive social-
behavioral researches, clinical trial protocols not intended for FDA
registration - conducted by doctors (including residents and fellows)
to test safety and efficacy of clinical interventions and products
• 1 - can only review low risk researches involving human participants
but not clinical trials
 Far Eastern University – Nicanor Reyes Medical Foundation
Institutional Ethics Review Committee
(FEU-NRMF IERC)

LEVEL 3 – Philippine Health Research Ethics Board (PHREB) Accredited

Recognized by SIDCER (Strategic Initiative for Developing Capacity in Ethical

Review) – FERCAP (Forum for Ethical Review Committees in Asia and the
Western Pacific)
RESPONSIBILITIES
(ICH GCP 3.1.1 – 3.1.9)
RESPONSIBILITIES
• Safeguard rights, safety, and well-being of all, including vulnerable,
trial subjects
• Obtain necessary documents from the investigator, review a clinical
trial within a reasonable time, document its views in writing (trial,
documents, date, and review decision  approved, with
modifications, disapproved, suspension/termination)
• Consider qualifications of investigator
• Conduct continuing review of an ongoing trial at least once a year
• Request more information to be supplied by the investigator in the
informed consent form to the trial participant, if deemed necessary
RESPONSIBILITIES
• Ensure that relevant ethical considerations are addressed in:
• non-therapeutic trials carried out with the consent of the subjects legally
acceptable representative (LAR)
• situations where prior consent of the subject or the LAR is not possible
(emergencies)
• Review amount and method of payment to subject (coercion or
undue influence); payments should be prorated
• Must be indicated in the written informed consent form and any other
written information
COMPOSITION, FUNCTIONS and
OPERATIONS
ICH – GCP 3.2.1 – 3.2.6
COMPOSITION
• Reasonable number, with qualifications and experience to review
and evaluate science, medical aspects, and ethics of a proposed
trial; consider age and gender
• Should include
• At least 5 members
• At least one non-scientific member
May be the same person
• At least one non-institutional member
• Only members independent of the investigator and sponsor (no
conflict of interest) should vote/provide opinion on a trial-related
matter
ERC Resources (NEGHHR 2017)
In addition to the REC members, the institution shall support
the REC with adequate resources including staff, adequate
and equipped office and facilities, and financial resources to
enable it to carry out its responsibilities.
External or Independent Consultants (NEGHHR
2017)
• provide specific expertise regarding ethical, scientific,
psychological or social aspects of research for review; NOT
considered REC members (no voting privilege)
• In deliberations involving special participant groups or
concerns (e.g., HIV, AIDS, the physically challenged) -
include participation of advocates
• qualified individuals with the needed expertise and training;
appointed by the institutional authority
Training and Continuing Education of REC
Members (NEGHHR 2017)
• Initial - required of new members; if no basic ethics training
available, REC Chair shall ensure proper orientation (basic ethical
principles, international and national ethical guidelines, and REC
SOP)

• Members shall be encouraged and given support to attend regular

continuing educational activities on research ethics (advanced
training on ethical issues and concerns); REC shall include similar
activities at least once a year
TRAINING AND CONTINUING EDUCATION
OF ETHICS COMMITTEE MEMBERS
• Initial training – basic health research ethics and GCP (every
3 years)

• Continuing training – SOP writing, continuing review (at least

once a year)
FUNCTIONS AND OPERATIONS
• perform its functions according to written SOPs, maintain
written records of activities and meetings, and comply with
GCP and applicable regulatory requirements
• Make decisions at announced meetings, with a quorum, as
stated in the SOP
• More than half of the members shall constitute a quorum
• As much as possible, decisions shall be made by consensus
FUNCTIONS AND OPERATIONS
• Only those present in the review and discussion should vote
and provide opinion/advise
• Investigator may provide information during meetings but not
vote or deliberate
• May invite nonmembers with expertise in special areas for
assistance
• Advocates for special participant groups (HIV, AIDS, PWDs, etc.)
FUNCTIONS AND OPERATIONS
• Report to institutional authorities any matter that affects the
conduct and ethics of research

• Submit an annual report to PHREB

REC Functions (NEGHHR 2017)
The REC shall act in the full interest of potential research
participants and affected communities, taking into account the
interests, needs of the researchers, and having due regard for
the requirements of relevant regulatory agencies and
applicable laws (WHO, 2000 and 2011).
REC Functions (NEGHHR 2017)
In the Philippines, the regulatory agencies include the
PNHRS-PHREB, DOHFDA, CHED, the National Committee
on Biosafety of the Philippines (NCBP), National Commission
on Indigenous Peoples (NCIP), and others. The REC should
be updated with regards to Philippine laws and policies of
regulatory agencies about possible areas or groups for
research.
Specific Functions (NEGHHR 2017)
1. Review the scientific merit and ethical acceptability of the
research involving human participants;
2. Undertake the same review process for foreign research protocols
even if they have been ethically cleared by a foreign institution
3. Ensure that the proposed research is responsive to the priorities
and health needs of the country
4. Issue the ethical approval required for implementation
5. Promote research integrity by identifying and resolving conflicts of
interest
Specific Functions (NEGHHR 2017)
6. Establish appropriate mechanisms in all stages of the research to:
a. Ensure the safety, protect the rights, and promote the welfare and well-
being of research participants;
b. Provide counsel to research participants, including proponents and
researcher;
c. Ensure prompt reporting of changes in the protocol and unanticipated
problems
d. Ensure the proper documentation of and adherence to the confidentiality
rule and policy on informed consent; and
e. Monitor the progress of ongoing research until its completion.
Specific Functions (NEGHHR 2017)
7. Report to the institutional or national authorities any matter that
affects the conduct and ethics of research which in its view may
affect the rights and safety of research participants;
8. Keep a systematic and organized record of all proposals
reviewed, including actions taken and other pertinent information;
9. Submit an annual report to the PHREB (within the first quarter of
the year ending on March 31)
Contents of Annual Report
1. The composition of the REC, including a short CV (name,
educational attainment, most recent ethics training/seminars
attended), and term of office;
2. Members of the REC secretariat, office and email addresses, and
contact numbers;
3. Number of meetings (regular and special; date and venue)
4. Number of research reviewed by the REC during the year,
classified by the types of research, REC decision or action
(approval, minor or major modifications, disapproval), and other
information required by PHREB.
PROCEDURES
(ICH GCP 3.3.1 – 3.3.9)
PROCEDURES
• establish, document in writing, and follow its procedures on:
• ERC composition and the authority under which it is established
• Scheduling, notifying members, and conduct of meetings
• Initial and continuing reviews
• Frequency of continuing review
• Providing expedited reviews
• Specifying that
• No subject should be admitted to a trial before ERC approval
• No protocol deviations or changes should be initiated without prior ERC approval
(except when necessary to eliminate immediate hazards or when changes involve
logistical or administrative aspects)
PROCEDURES
• establish, document in writing, and follow its procedures on:
• Specifying that investigator should promptly report
• Deviations from, or changes of the protocol
• Changes increasing the risk to subjects or affecting conduct of trial
• All adverse drug reactions that are serious and unexpected
• Information that may adversely affect subject safety or conduct of trial
• Notifying the investigator/institution regarding
• Trial-related decisions and opinions
• Reasons for its decisions/opinions
• Procedures for appeal
WHAT DO WE REVIEW IN YOUR STUDY PROTOCOL?

SCIENTIFIC DESIGN CONDUCT OF THE STUDY ETHICAL CONSIDERATIONS

Objectives Specimen handling Conflict of interest
Literature review Investigator qualifications Privacy and confidentiality
Research design Suitability of site Informed consent process
Operational Definition of Variables Duration of study Vulnerability
Sampling design Recruitment
Sample size Assent
Statistical analysis plan Risks
Data analysis plan Benefits
Inclusion criteria Incentives or compensation
Exclusion criteria Collaborative study terms of
Withdrawal criteria reference

Recommendations: Approval, Minor Modifications, Major Modifications, Disapproval

WHAT DO WE REVIEW IN YOUR INFORMED CONSENT FORM?
Statement that the study involves research Expected benefits to the community or to society, or contributions to scientific Possible direct or secondary use of participant’s medical records and biological
knowledge specimens taken in the course of clinical care or in the course of this study
Statement describing the purpose of the study Description of post-study access to the study product or intervention that have Plans to destroy collected biological specimen at the end of the study; if not,
been proven safe and effective details about storage (duration, type of storage facility, location, access
information) and possible future use; affirming participant’s right to refuse future
use, refuse storage, or have the materials destroyed
Study-related treatments and probability for random assignment Alternative procedures or treatment available to participant Plans to develop commercial products from biological specimens and whether
the participant will receive monetary or other benefit from such development
Study procedures including all invasive procedures Compensation or insurance or treatment entitlements of the participant in case of Statement that the participant or participant’s legally acceptable representative
study-related injury will be informed in a timely manner if information becomes available that may be
relevant to willingness of the participant to continue to participation
Responsibilities of the participant Anticipated payment, if any, to the participant in the course of the study; whether Statement describing access of participant to the result of the study
money or other forms of material goods, and if so, the kind and amount
Expected duration of participation in the study Compensation (or no plans of compensation) for the participant or the Statement describing extent of participant’s right to access his/her records (or
participant’s family or dependents in case of disability or death resulting from lack thereof vis à vis pending request for approval of non or partial disclosure)
study-related injuries
Approximate number of participants in the study Anticipated expenses, if any, to the participant in the course of the study Foreseeable circumstances and reasons under which participation in the study
may be terminated
Study aspects that are experimental Statement that participation is voluntary, and that participant may withdraw Sponsor, institutional affiliation of the investigators, and nature and sources of
anytime without penalty or loss of benefit to which the participant is entitled funds
Foreseeable risks to participant/embryo/ fetus/nursing infant; including pain, Statement that the study monitor(s), auditor(s), the Ethics Review Committee, Statement whether the investigator is serving only as an investigator or as both
discomfort, or inconvenience associated with participation including risks to and regulatory authorities will be granted direct access to participant’s medical investigator and the participant’s healthcare provider
spouse or partner; records for purposes ONLY of verification of clinical trial procedures and data
Risks from allowable use of placebo (as applicable) Statement that the records identifying the participant will be kept confidential and Person(s) to contact in the study team for further information regarding the study
will not be made publicly available, to the extent permitted by law; and that the and whom to contact in the event of study-related injury
identity of the participant will remain confidential in the event the study results are
published; including limitations to the investigator’s ability to guarantee
confidentiality
Reasonably expected benefits; or absence of direct benefit to participants, as Description of policy regarding the use of genetic tests and familial genetic Statement that the Ethics Review Committee has approved the study, and may
applicable information, and the precautions in place to prevent disclosure of results to be reached for information regarding rights of study participants, including
immediate family relative or to others without consent of the participant grievances and complaints.
WHO Informed Consent Form Templates

http://www.who.int/rpc/research_ethics/informed_consent/en/
WAIVER OF INFORMED CONSENT
• Public Benefit or Service Programs Research. The research or demonstration
project is to be conducted by or subject to the approval of state or local
government officials and is designed to study, evaluate or otherwise examine:
• Public benefit or service programs,
• Procedures for obtaining benefits or services under those programs,
• Possible changes in or alternatives to those programs or procedures, or
• Possible changes in methods or levels of payment for benefits or services under those
programs, and
• The research could not practicably be carried out without the waiver or alteration.
WAIVER OF INFORMED CONSENT
• Waiver for Minimal Risk Studies
• The research involves no more than minimal risk to subjects, and
• The waiver or alteration will not adversely affect the rights and welfare of the
subjects, and
• The research could not practicably be carried out without the waiver or alteration, and
• Whenever appropriate, the subjects will be provided with additional pertinent
information after participation
• Unless all four conditions are met, informed consent shall be deemed feasible.
WAIVER OF INFORMED CONSENT
• Emergency Situations. Treatment of individual subjects/patients with an
investigational test article (i.e. investigational drug, biologic product or medical
device) in an emergency situation is allowed by local regulatory authorities.
Obtaining of informed consent shall be deemed feasible unless, before the use of
the test article, both the investigator and a physician who is not otherwise
participating in the clinical investigation certify in writing all of the following:
• The subject is confronted by a life-threatening situation,
• Informed consent cannot be obtained from the subject because of an inability to communicate
with or obtain legally effective consent from the subject,
• Time is not sufficient to obtain consent from the subject's legal representative, and
• There is no available alternative method of approved or generally recognized therapy that
provides equal or greater likelihood of saving the life of the subject.
 Retroactive approval for studies
initiated before review and approval
is never granted.
POST-APPROVAL REVIEW
• Study Protocol Amendment
• Continuing Review
• Final Report
• Non-Compliance: Deviation/Violation
• Early Study Termination
• Queries and Complaints
• Serious Adverse Event reports (SAEs) and Suspected Unexpected Serious
Adverse Reactions (SUSARs)
• Site Visit
RECORDS
(ICH GCP 3.4)
IF IT IS NOT WRITTEN,
IT DID NOT HAPPEN.
RECORDS
• Relevant records
• written procedures
• membership lists
• lists of occupations/affiliations of members
• submitted documents
• minutes of meetings
• correspondence
• Retain for a period of at least 3 years after completion of the trial and make
them available upon request from the regulatory authority (ies)
• Provide investigators, sponsors or regulatory authorities with its written
procedures and membership lists
Review Fees (NEGHHR 2017)
Review fees are intended to support the operations of the REC,
training activities, and continuing education of its members. Charging
review fees for other purposes puts the REC in a COI situation, from
which it may not be easy to extricate itself.
Three Important Obligations Placed on the
Research Ethics Committee
1. Research participants; rights must be protected by ensuring that:
a. individuals receive sufficient information which can be easily understood
b. appropriate strategies are in place to protect participants from potential
adverse consequences of the research

2. Society - provides the resources for research; will be affected by

the results

3. Researcher - research proposal should be treated with respect

and consideration
 THE ETHICS REVIEW
COMMITTEE PROTECTS:
RESEARCH SUBJECTS
SCIENCE
INVESTIGATOR
THANK YOU!!!
 FEU-NRMF IERC Review
Process
FEU-NRMF IERC SOP 2 (Initial Review) and 3 (Post-Approval Review)
version 3 (2017)
INITIAL REVIEW
Initial Review
• All protocols must have already undergone technical review by their
respective committees
• Principal Investigator (PI) is responsible for submitting a complete
set of documents to the FEU-NRMF IERC. These include:
• Review Checklist
• Registration and Application Form
• Study Protocol Assessment Form
• Informed Consent Assessment Form
• Other protocol-related documents
Initial Review
• Secretariat manages study protocol submissions
• Chair:
• decides whether the study protocol is for full board review or for
expedited review, or is exempted (see criteria below in following
slide)
• assigns Primary Reviewers based on expertise and experience.
• assigns Independent Consultant as needed
Initial Review – Criteria for Expedited Review
• The research poses no more than minimal risk.
• The study does not involve vulnerable populations.
• The study does not involve the collection of stigmatizing
information.
• The study uses anonymized or archived samples.
Initial Review – Criteria for Full Board Review
• Clinical trials about investigational new drugs, biologics or
device in various phases (Phase 1, 2, 3)
• Phase 4 Intervention research involving drugs, biologics or
device
• Protocols including questionnaires and social interventions
that are confidential in nature.
• Protocols involving vulnerable subjects.
• Protocols that involve collection of identifiable biological
specimens for research
Initial Review – EXEMPTED (unless required by
an external body or utilize vulnerable participants)
Researches that involve:
• animal subjects or specimens (review c/o IACUC)
• biosafety issues or pose hazards to the environment (review
c/o Biosafety Committee)
• information freely available in the public domain
• anonymized records and data sets that exist in public
domain, where appropriate permissions have already been
obtained and is not possible to identify individuals from the
information provided
Initial Review – Exempted (unless required by an
external body or utilize vulnerable participants)
Researches that involve:
• public behavior that are purely observational (non-invasive
and non-interactive), unless the recorded observations
identify individuals (names, photographs)
• use of non-sensitive, completely anonymous educational
tests, survey and interview procedures when the participants
are not defined as “vulnerable” and participation will not
induce undue psychological stress or anxiety
Initial Review – Exempted (unless required by an
external body or utilize vulnerable participants)
Researches that involve:
• use of educational tests, survey, and interview procedures
on human participants in the public arena
• Taste and food quality evaluation and consumer acceptance
studies, if the food consumed is:
• Wholesome without additives, or
• Contains a food ingredient, agricultural, chemical or
environmental contaminant, for a purpose and a level declared
safe
Initial Review
• The decision on exempted protocols is finalized at the level
of the Chair
• For protocols requiring Full Board Review, the decision may
be any of the following:
• Approved
• Minor Modification (PI must make revisions and resubmit
protocol; protocol undergoes Expedited Review)
• Major Modification (PI must make revisions and resubmit
protocol; protocol undergoes Full Board Review)
• Disapproved (PI may submit a new protocol)
Criteria for Major or Minor Modification
• Major Modification – there are substantive changes to the
informed consent document; or inadequacy of scientific
basis for the study and scientific design and therapy
changes
• Minor modification - do not involve significant changes to:
• scientific design and therapy (minor scientific changes; eg.
changes in targeted sample size, accrual objectives, minor
changes to inclusion/exclusion criteria)
• content of informed consent document (typographical errors,
formatting)
Initial Review
• Expedited Review
• decisions are the same
• However, for protocol needing Minor or Major Modifcation,
subsequent submissions will undergo Expedited Review.

• The decisions are made known to the PI by the IERC in a

timely manner.
Initial Review Process Flow
Initial Review – Protocol Submission
Secretariat receives and manages study protocol submissions (2 days)
↓
Chair classifies submission as expedited review, full board review, or exempted
↓
Expedited or Full Board Review Exempted
Chair assigns Primary Reviewers and Chair return protocol submissions to
Independent Consultants and returns protocol Secretariat (2 days)
submissions to Secretariat (2 days) ↓
↓
Secretariat Send study protocol package to primary Secretariat Notify the PI of exemption with
reviewers, IERC members, and Independent NOTIFICATION OF EXEMPTION FROM ETHICS
Consultants for review (STUDY PROTOCOL REVIEW (2 days)
ASSESSMENT FORM, INFORMED CONSENT
ASSESSMENT FORM, TRANSMITTAL LETTER (2
days)
Initial Review – Full Board Review
Primary Reviewers and Members review the protocol and return accomplished STUDY PROTOCOL
ASSESSMENT FORM, INFORMED CONSENT ASSESSMENT FORM to the Secretariat
(10 – 12 days)
↓
Secretariat Includes the protocol in the agenda of the next full board meeting
↓
Primary Reviewers present review findings during full board meeting
↓
Members deliberates on full board action on the protocol
↓
If approved: IERC sends notification of decision to PI
If minor modification: IERC sends notification with recommendations to PI; process resubmission by
expedited review
If major modification: IERC sends notification with recommendations to PI; process resubmission by full
board review
If disapproved: IERC sends notification of decision to PI with justification
(7 days)
Initial Review – Expedited Review
Primary Reviewers review the protocol and return accomplished STUDY PROTOCOL
ASSESSMENT FORM and INFORMED CONSENT ASSESSMENT FORM to the Secretariat
(7 days)
↓

If approved: IERC sends notification to PI

If major or minor modification: IERC sends notification with recommendations to PI then
process resubmission by expedited review
If disapproved: IERC sends to full board review and process accordingly
(3 days)
POST-APPROVAL REVIEW
Post-Approval Review
• Post approval submissions by the Principal Investigators
• May be processed by either “expedited” or full board review
• These submissions are the following:
• requests for amendments
• continuing review
• final reports
• non-compliance (deviation or violation) reports
• early study termination
• queries from stakeholders
• serious adverse event reports (SAEs) and suspected unexpected serious adverse
reactions (SUSARs)
• site visit reports
Post-Approval Review
• PI must comply with post-approval review requirements
(listed in the approval letter)

• Secretariat is receives and processes submission

• Chair decides whether the submission requires Full Board or

Expedited Review based on several criteria (see next slides)
Post-Approval Review
EXPEDITED REVIEW
Proposed continuing reviews, protocol amendments and end of study
reports that have minor modifications and no significant risk to study
participants, such as:
 Administrative revisions, such as correction of typing errors
 Addition or deletion of non-procedural items, such as the addition of study
personnel names, laboratories, etc.
 Research activity includes only minor changes from previously approved
protocol.
 Minor protocol amendments that do not change the risk/benefit assessment.
 Progress/final reports that do not deviate from approval given by the IERC
 Offsite SAEs.
Post-Approval Review
FULL BOARD REVIEW
 Major revisions of the protocol and informed consent after initial review.
 Amendments that involve major changes from previously approved protocol
or consent form
 Major amendments that change the risk/benefit ratio
 Major protocol violations
 Progress /Final reports that deviate from original approval given by the FEU-
NRMF IERC
 Onsite SAEs or SUSARs that may require protocol amendment or reconsent
of participants
Post Approval Review
• Original Primary Reviewers reviewing these post-approval
submissions
• Decision may be any of the following:
• Uphold original approval with no further action
• Request further information
• Recommend further action
• The decisions are made known to the PI by the IERC in a timely
manner.
Post-Approval Review Process Flow
Secretariat receives and manages documents submission (2 days)
↓
Chair classifies submissions as full board review, expedited review, or exempted (2 days)
↓
Secretariat forwards submissions to Primary Reviewers and Members
↓
Reviewers review submissions and return the same to the Secretariat
(10 – 12 days for full board review; 7 days for expedited review)
↓

Chair and Members deliberate full board study protocols in committee meeting
↓
Secretariat communicates results to PI/Participant
(7 days after full board meeting for full board review; 3 days after review of Primary Reviewers)
SERIOUS ADVERSE EVENTS
REVIEW
SAE Review
• SAE and SUSAR reports are submitted by investigators and sponsors to
comply with ICH GCP.
• SAE - Serious Adverse Event; serious adverse drug reaction (ADR); any
untoward medical occurrence that at any dose:
• results in death,
• is life threatening,
• requires hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability or incapacity, or
• results in a congenital anomaly or birth defect,
• any other adverse event that, based upon appropriate medical judgment, may
jeopardize the subject’s health and may require medical or surgical intervention to
prevent one of the other outcomes listed in this definition.
SAE Review
• SUSAR - Suspected Unexpected Serious Adverse
Reaction
• serious event; nature and severity is not consistent with
the applicable product information
• Investigator’s Brochure (or its equivalent) for unapproved
investigational product
• Package insert or summary of product characteristics for a
licensed product
SAE Review
• FEU NRMF IERC can suspend or terminate approval of research at
its site when the safety of participants is no longer assured; FEU
NRMF IERC must:
• provide the reasons for its action
• pomptly report such decision to the investigator, the sponsor, the institution
and relevant regulatory authorities.
• FEU-NRMF IERC Vice Chair - head of the SAE Subcommittee
• The SAE Subcommittee
• Vice Chair
• Primary Reviewers of the study protocol with SAE/SUSAR submission
SAE Review
• All onsite SAEs and SUSARs undergo Expedited Review
(unless the SAE subcommittee recommends that the issue
be deliberated on in a full board meeting) in order to hasten
the decision-making, especially when the safety of study
participants are involved

• All offsite SAEs and SUSARs are collated and reported to

the board quarterly
SAE Review
• Secretariat receives all the necessary documents and
forwards them to the SAE Subcommittee
• SAE Subcommittee reviews the report and the Vice Chair
makes any of the following recommendations the Chair:
• Uphold original approval with no further action
• Request further information
• Recommend further action
• The decision is then finalized at the level of the Chair, after
which the PI is informed of the decision in a timely manner.
SAE Review Process Flow
 Investigators and/or Sponsor Report SAE and SUSAR
↓
Secretariat receives SAE and SUSAR reports
↓
(Onsite SAEs) (Offsite SAEs)
Secretariat Informs Chair and forward reports to the Vice Chair and Secretariat Informs Chair and Vice
Primary Reviewers Chair; Encodes and collates data in
(2 days) database
↓
↓
Vice Chair and Primary Reviewers review SAE and SUSAR reports  
and make a recommendation to the Chair  
(2 days) ↓
↓
 Chair refers to full board as Chair finalizes action  
needed ↓ ↓
↓
Chair and Vice Chair summarize   Chair and Vice Chair summarize and
and report to full board   report to full board quarterly
↓ ↓ ↓
 
Chair and Members deliberate on    
board action ↓ ↓
↓  
Secretariat informs Investigator, sponsor & other officials about IERC decision
 
Onsite: Full board - 7 days after full board meeting; Expedited: 3 days
Offsite: as needed
SJREB
• Single Joint Research Ethics Board
• A PHREB-accredited REC who facilitates the conduct of ethics
review of researches involving multiple sites particularly those that
identify DOH hospitals and private institutions who subscribed to the
joint process as participating sites.
SJREB
• SJREB conducts joint review of study protocols to be implemented in at least
three (3) sites in the Philippines.
• All DOH funded research studies shall be reviewed by SJREB.
• Sponsors and researchers who choose to do their studies in 3 or more
sites may submit their protocols to SJREB.
• At least one site is a Level 3 PHREB-accredited hospital with letter of
intent
• It accepts multi-site protocols that are funded by DOH, PCHRD, DOST,
PHIC, PHREB, CHED and other local organizations, including industry
organizations and other foreign entities.
• SJREB also accepts and reviews multicenter researches that are
community-based.
THANK YOU!!!