Page 23 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

circumstances, retractions most often do not appear in the media.
Therefore, it is important to avoid premature reports and publicity stunts.

The best safeguard against inaccurate reporting is for the researcher to
talk to media on condition that the reporter submit a full written, rather
than oral version, of what will be reported, so that it enables the
researcher to make necessary corrections, if needed, prior to publication.
Investigator’s publication plans should not threaten the privacy or
confidentiality of participants, for example publication of pedigrees in the
report on research in genetics can result in identification of study
participants. It is recommended that a clear consent for publication be
obtained besides the consent for participation in research or treatment and
such a consent should preferably be obtained on two different occasions
and not as a blanket one at the commencement of the study. Maintenance
of confidentiality while publishing data should be taken care of. In case
there is need for publication / presentation of photographs/ slides / videos
of participant (s), prior consent to do so should be obtained. Identification
features should be appropriately camouflaged. The same safeguard should
be observed for video coverage.

With regard to authorship, the International Committee of Medical
Journal Editors (ICJME) has laid down criteria based on credit and
accountability. Only those who make substantial contribution to the article
and take responsibility for the published matter can be co-authors.
Plagiarism or falsification of data and authorship are important ethical
issues in publications. The term ‘misconduct in research’ means
fabrication, falsification, plagiarism, selective omission of data and
claiming that some data are missing, ignoring outliers without declaring it,
not reporting data on side effects/ adverse reactions in a clinical trial,
publication of post-hoc analysis without declaring it, gift authorship, not
citing others’ work, not disclosing conflict of interest, redundant
publication, and failure to adequately review existing research. The
Commission on Research Integrity in US created by US Congress
addresses the scientific, ethical, social and legal issues involving scientific
misconduct in research. Consolidated standards of reporting trials
(CONSORT) guidelines have been prescribed for publishing results of
clinical research especially RCTs (Randomized Controlled Trials) and are
available at http://www.consort- statement.org. (ICMR-2006)

09. GUIDELINES ON RESEARCH ETHICS AS PER NATIONAL
HEALTH RESEARCH STRATEGIES:

➢ The National Research Ethics Committee (NREC) will set
standards, advice the Departments and the Ministry of Health &
Family Welfare on the management of research ethics for
Bangladesh and arbitrate on matters of Ethics.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 19