Clinical Research Regulation For Vietnam | ClinRegs

Overview

As per the
ECReg, the ClinDrugTrialGCP, and PharmLaw-VNM, Vietnam requires
institutional and national level ethics committee (EC) approval for clinical
trials. According to VNM-12, an EC that is registered as a Council of Ethics
in Biomedical Research at the Grass Root Level (CEBRGL) with the Ministry of Health
(MOH)’s
Administration of Science, Technology and Training
(ASTT)
provides institutional level EC approval. NECBR2018 and PharmLaw-VNM state that
national level EC approval is conducted by the MOH’s National Ethics
Committee in Biomedical Research (NECBR).

According
to the ECReg and VNM-12, if the
study is not a clinical trial, applicants are only required to obtain ethics
approval from a CEBRGL.

Ethics
Committee Composition

The ECReg details general EC
requirements applicable to both the CEBRGLs and the NECBR, as well as
specific requirements for each type of EC.

Per the ECReg, EC membership
should include the following:

• Members
  with a professional degree in the health sector related to the common
  research areas assessed by the EC, including at least one (1) person
  independent from the organization that establishes the EC

• Clinical
  doctors

• Members
  with legal expertise or knowledge of ethical principles in biomedical
  research, with a university degree or higher

• Members
  with no expertise in the health sector

• Members
  under 40 years of age, members from 40 years old to under 50 years old,
  and members aged 50 or older

• Male
  and female members (neither gender may be less than 20% of the total
  membership)

In
addition, EC members must have the necessary experience, knowledge, skills,
and ability to perform his/her duties in order to validate the science and
protect the interests of research participants. Members with expertise in the
health sector must have at least five (5) years of experience working in the
field of research assessed by the EC. All members must also have time to
participate in and perform the duties of the EC, and keep confidential any
information related to the research, opinions discussed during the meeting,
commercial secrets of individuals and organizations participating in the
study, and personal information about the research participant. Members must
also receive training and certification from the MOH or MOH-accredited
organizations in Good Clinical Practice (GCP) and the EC’s standard operating
procedures (SOPs).

Council
of Ethics in Biomedical Research at the Grass Root Level

As
explained in the ECReg and CEBRGLReg, institutional
ECs, known as CEBRGLs, should consist of at least five (5) members. The ECReg states that a
CEBRGL consists of one (1) chair, one (1) to two (2) vice-chairs, a standing
division, and specialized subcommittees (if necessary).

CEBRGLReg further indicates
that CEBRGLs may have at most 11 members. All members must be honest,
objective, and have biomedical research ethics knowledge and expertise. The
chair and vice-chair should be prestigious scientists.

The ECReg requires that the
chair and vice-chairs have at least 15 years of experience working in the
field of research evaluated by the EC, a good reputation, and the capacity to
independently manage and run the EC. The chair and vice-chairs must also be
fair and impartial, and not be pressured by the research institution,
investigators, and other agencies, organizations, and individuals. An
individual cannot be appointed as the chair of the EC for more than two (2)
consecutive terms.

According
to the ECReg, a CEBRGL should
have no more than two (2) professional secretaries and no more than two (2)
administrative secretaries. Professional and administrative secretaries must
be honest, objective, and university-educated. Furthermore, professional
secretaries must have knowledge about scientific and technological
management, scientific research, and ethics in biomedical research, while
administrative secretaries must have administrative, clerical, and archival
skills.

According
to CEBRGLReg, a secretariat
based in the host institution’s Science Research Management Office should
assist the CEBRGL with application processing and other administrative tasks.

See the ECReg and CEBRGLReg for additional
CEBRGL membership criteria.

National
Ethics Committee in Biomedical Research

The ECReg requires the NECBR
to have at least nine (9) official members, including one (1) chair, three
(3) vice-chairs, and other official members, including professional and
administrative secretaries. The NECBR also includes data monitoring and other
subcommittees as needed. The ASTT and the MOH act as standing members of the
office of the NECBR.

As per NECBR2018, for the 2018-2023
term, the NECBR is comprised of an MOH Standing Office, a Standing Committee,
five (5) specialized subcommittees (Pharmaceuticals, Traditional Medicines,
Vaccines and Medical Biologicals, Medical Equipment, and New Technology), a
professional secretary team, an administrative secretary team, and an
advisory team. The NECBR is headed by a chair, a standing vice-chair, and two
(2) other vice-chairs. Each subcommittee consists of five (5) to seven (7)
members.

The ECReg requires that the
chair and vice-chairs have at least 15 years of experience working in the
field of research evaluated by the EC, a good reputation, and the capacity to
independently manage and run the EC. The chair and vice-chairs must also be
fair and impartial, and not be pressured by the research institution,
investigators, and other agencies, organizations, and individuals. An
individual cannot be appointed as the chair of the EC for more than two (2)
consecutive terms.

According
to the ECReg, the NECBR should
have no more than three (3) professional secretaries, and two (2)
administrative secretaries at most. However, NECBR2018 indicates that for
the 2018-2023 term, there are four (4) professional secretaries.

The ECReg states that
professional and administrative secretaries must be honest, objective, and
university-educated. Professional secretaries must have knowledge about
scientific and technological management, scientific research, and ethics in
biomedical research, while administrative secretaries must have
administrative, clerical, and archival skills.

See the ECReg for additional
NECBR membership criteria and NECBR2018 for the list of
2018-2023 NECBR term members.

Terms
of Reference, Review Procedures, and Meeting Schedule

According
to the ECReg, both CEBRGLs and
the NECBR have five (5) year terms. However, CEBRGLReg indicates that
CEBRGLs have three (3) to five (5) year terms, as specified in the EC’s
establishment decision.

The ECReg also stipulates
that the EC must be established or reorganized at the end of the term. The EC
for the next consecutive term must include at least 25% new members.

As stated
in the ECReg, EC activities are
non-profit. The EC must fully apply the ethical principles prescribed in the ECReg and relevant legal
documents, and comply with ethical guidelines of international organizations.
The ethical guidelines used by the EC should be clearly stated and
disseminated to investigators.

In
addition, ECs function on the principles of collectivity, democracy, and
independence when evaluating research proposals and making decisions. If
necessary, ECs may invite an independent consultant to provide a professional
opinion to the EC. ECs should also facilitate the coordination of and/or
reference the appraisal results of other domestic or foreign ECs.

According
to the ECReg, the EC’s decision
for a research proposal should be based on the consensus of the EC members
and must be recorded in the EC’s meeting minutes. In case it is difficult to
reach a consensus, the EC’s chair has the right to decide to immediately
commence voting, or request that the principal investigator supplement the
research dossier for the EC to consider and vote on during the next EC
meeting. Research is approved only when there are less than two (2)
disapproval votes out of the total number of valid votes.

In
addition, ECs must conduct periodic assessments of ongoing studies within a
time period that is consistent with the level of risk for study participants,
but at least once a year on or before the date the EC approved the research
protocol. The conclusion of the periodic assessment results should state that
the EC’s previous decisions are still valid, or have been changed, suspended,
or revoked.

The ECReg requires that EC
members be trained prior to appointment and provided with updated and
supplementary training in the ethical and scientific aspects of biomedical
research. The head of the organization that establishes the EC is responsible
for assigning a unit to manage scientific research activities to develop and
deploy training plans for EC members. The updated and supplementary training
must be conducted at least once every two (2) years. For more information on
training requirements for EC members, see the ECReg.

As set
forth in CEBRGLReg, the CEBRGLs
should operate within written SOPs to conduct their reviews. The chair
oversees the meetings, makes conclusions, and reports this information to the
institutional head. Voting members must have no conflict of interest with the
research. The CEBRGL members must review research documentation and prepare
comments for the secretary prior to the meeting. Most CEBRGLs do not meet
regularly but instead meet upon request for review and on the availability of
the majority of its members. The CEBRGLs should also refer to the NECBR’s
SOPs to develop their own SOPs. See CEBRGLReg for detailed
CEBRGL review procedures.