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ETHICS REVIEW
COMMITTEE (ERC)
Ensuring Research Integrity in Uncertain Times
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WHAT IS A RESEARCH
ETHICS REVIEW?

▪ A research ethics review is a process that is

undertaken to ensure the ethical and responsible
conduct of a research project.
▪ Most higher education institutions and non-profit
organizations around the world have their own
identified bodies to conduct a research ethics
review.
▪ Mandatory
➢DOST A.O.001Series2007
➢CHED(CMO)34Series2007
➢Joint DOST,DOH,CHED, UPM
Memorandum Order 001series2012
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PROPOSED
ORGANIZATIONAL
CHART
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MEMBERS OF
ERC

- is composed of
appointed faculty
members and non-
affiliated members who
possess the expertise
and skills to assess the
ethical issues in a
research proposal.
 WHY IS THERE A
NEEDzFOR
ETHICS REVIEW?

▪ All research projects require some form of ethics

review to ensure that research conducted
complies with existing ethical standards and
requirements.

▪ Ethics reviews help assure the safety and

respect of those involved and those who might
be affected by the research’s activities.

▪ Ethics review committees provide mechanisms

that help address issues and respond to
unfavorable events related to safety occurring in
approved studies

▪ Some grant agencies or donors require

institutional ethical clearance before releasing
funds to a research proponent.

▪ National and international scholarly journals

require institutional ethical clearance before
accepting a research paper for publication
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PURPOSE OF ETHICS REVIEW:

Protect
Protect human participant and
community

Determine acceptability/worth of research,

Determine
useful, credible

Improve Improve research

Promote academic
excellence and guard against
fraud and misconduct
 NAVIGATING THE
ETHICS REVIEW
z PROCESS
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Submit required documents:

INITIAL
ØResearcher
• Application/registration form, accomplished
checklists, proposal, informed consent/ assent

REVIEW
documents
• Study tools (questionnaires, letters etc.)
• CV of investigators

PROCESS
• Results of technical/ethical review from other ERC
• Funding, sponsors, institutional affiliations

ØSecretariat
• Accepts, checks completeness, records,
• Indicates time frame for completing review process.
ØERC Chair/representative determines:
• Kind of review
• Assign Reviewers
 z Exempted

• does not undergo full or expedited review

• Not involving human participants nor identifiable
human tissue, biological samples and data

KINDS
• decision by ERC

Expedited

OF • no more than minimum risk and burden to non-

vulnerable participants

REVIEW
• non-sensitive/confidential nature
• one/two primary reviewer/s and Chair who decide
approval (and informs proponent and ERC) or
need for full review

FullReview

• Protocols that entail more than minimal risks to

participants
• Involve vulnerability issues
• Discussed and approved at ERC meeting
 1.Social value
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2.Scientific soundness

3.Ethical soundness
Criteria for • Informed Consent/assent –voluntary
Approval • Vulnerability issues
• Risks, benefits, safety
• Privacy & Confidentiality
• Justice

4. Qualified Researcher

5. Adequacy of facilities

6. Transparency

7. Consideration of all stakeholders

 - Approved
z - Modifications (Minor or Major)
Decisions: • with explanation of required modifications
- Disapproved

INITIAL
• objections and reasons

Written, signed, dated

REVIEW
Communication feedback within 4 weeks of
receipt of documents:
to proponent:

PROCESS
•Decision with explanation

Procedure as in SOP
Appeal for
•Reviewed by previously
reconsideration: assigned reviewers.

Required from researcher if decision is

major/minor modifications
Resubmission: •Ensures that the researcher
addressed the required modifications
before approval of the protocol.
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1.Amendments of 2.Progress/interim
protocol or ICF reports

POST APPROVAL
REPORTS/SUBMISSIONS 3.Protocol
4.SAEs,SUSARs
deviations/violations

Researcher has responsibility for

reports within time frame 5.Early termination 6.Participants
report Queries and
Complaint

7.Application for 8.End of Study

Continuing review /Final report
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ADVICE TO
RESEARCHERS
View as educational and
collegial rather than
adversarial and burdensome

Approval gives credibility to

your study

Listen, read, learn and follow

suggestions

Develop humility,
perseverance, integrity and
courage
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THANK YOU FOR

LISTENING!