Page 47 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

13. Research Monitoring, Feedback and Complaints (Research Misconduct)

In the interest of ensuring the safety, quality and the integrity of research and its data, PI is
accountable to comply with the requirements as stated in the guidelines during the conduct
of the research. Therefore, in order to ensure it is done in such manner especially in IIR,
institutional/facility director, HODs and CRC Unit (if available) is responsible to monitor the
research conducted at their respective sites. On the other hand, monitoring of ISR usually will
get the support from sponsor and/or CRO.
13.1. Independent Data Monitoring Committee (IDMC)

For IIR involving clinical trial, it is advisable to establish an independent data-monitoring
committee (IDMC) to evaluate the progress of the trial at particular interval (if necessary) in
order to ensure the safety of the subjects and scientific integrity of the trial is maintained during
the interim between trial initiation and trial completion. IDMC which comprises of independent
experts’ functions to analyse interim data of particular research to assure the ethical aspects,
safety and vulnerability of the study is not compromised, thus ensuring the subjects rights
is adequately protected throughout their participation [43-44]. IDMC may recommend to the
site(s) whether to continue, modify, or stop a trial, depending on the evaluation especially*:

a. When the study endpoint is such (e.g., mortality outcome) that it might be ethically vital
to terminate the trial early if the primary question(s) is/are definitely answered or when
there is a finding of futility.
b. When there are scientific reasons for a particular safety issue
c. The study is being performed on vulnerable populations.
d. The study is being performed in a population at a high risk of death or other serious
outcomes.
e. The study is large, involving multiple centres and requires complex interpretation of
data.
f. When the study is expected to be long, and compelling new information either external
or internal to the trial might require modifications in order to ensure the continued
scientific value of the trial.
*Adapted from: Guidance for Clinical Trial Sponsors, Establishment and Operation of Clinical Trial Data Monitoring
Committees, U.S. Department of Health and Human Services, Food and Drug Administration. (2006) [45].
IDMC is recommended to have written operating procedures and maintain written records as
per Malaysian GCP requirement. [10,43].

13.2. Feedback and Complaints

Any complaint of research misconduct by any investigator either during the conduct of
the research or dissemination of results is a serious allegation and should be thoroughly
investigated. All feedbacks and complaints pertaining to this matter should be managed in
a manner that provides protection to the interest and emphasises the safety of all individuals
and/or subjects involved while maintaining the integrity, credibility, quality of the research and
to some extent, privacy and sensitivity of the data and the personal information that have been
collected.

NIH Guidelines for Conducting Research in MOH, 2021 31