Page 14 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

publication). It will need consideration whether participants data will still
be useful if they decide to withdraw. If this is the case, they will need to
consent for its use, they can therefore be given the option to withdraw and
also have their data withdrawn, or to withdraw but state that they will
allow their data to be used. If a focus group is being carried out, it will not
be possible to withdraw one person’s data following the intervention
without removing the data for all the participants, because what one
person says will affect the responses from others. It must be made clear on
the participant information sheet that it will not be possible to withdraw
data in this case. It is also necessary to make it as easy as possible for
people to withdraw, bearing in mind that they might not feel comfortable
telling the investigator directly that they no longer wish to participate.
Options, such as posting a slip, will need to be included.

One should also guard against unrealistic assurances to participants about
data being anonymous. It is essential that every effort is made to remove
all identifying information relating to participants prior to dissemination.
Information that could identify people is not limited to their names. It is
sometimes possible with case studies that people may be identified. This
needs to be made explicit in the participant information sheet. The words
anonymous and confidential are often confused. These must be refereed to
correctly on the participant information sheet.

It must be ensured that the documentation is inclusive. For example if the
research involves people who cannot speak or write English, the
documentation needs to be translated (a professional translator needs to be
employed unless the investigator is fluent in Bengali). Consideration for
people with special needs, for example, dyslexia, will need to be included
and the provision for alternative formats of documentation should be
made.

If research is related to other people, for example asking questions about
family member’s participants, consent or permission from them should also
be taken, as applicable. The assumption should not be made that because
participants are revealing information about family members (as opposed
to others outside their family) that this will be all right. Even if research is
carried out that does not ask participants about other people.
Consideration should be given beforehand whether others are likely to be
discussed. If so, it should be considered whether consent should be taken
from them.

3.2. Confidentiality

Confidentiality refers to management of information that a subject
(individual) has disclosed expecting that the information will not be
divulged.* It is the duty of the investigator to maintain appropriate
confidentiality of research data. The investigator should handle the data in

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 10