Page 13 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

❖ See that the consent is voluntary. The decision of a subject or group
or community not biased by improper influences.

❖ Ensure that the participant of group or community is given the
detailed truthful information necessary to make a considered
judgment about whether to participate.

❖ Renew informed consent in case of any methodological change in
the research.

Consent is an important area and one that the reviewer and the committee
will focus when reviewing the application. Consent must be informed and
freely given. There must be no coercion. Participants must have the
capacity to consent and the right to withdraw without penalty and
providing an explanation. It must be ensured that all relevant information
is included and it must be explained clearly what the participants will be
asked to do on the participant information sheet. Participants should be
told why they have been selected to take part and how many people
have been approached.

As part of the information given to the participants, it must be stated that
the research study has been approved by the ethical committee of the
BMRC. Participants must be informed of any risks. There will always be
some, is not acceptable to say there are no risks. Participants must also be
informed of their legal rights, the storage and destruction of data and right
to withdraw from participation in research at any time, without giving a
reason. Participants must also be provided with contact details for further
information, which should include a postal address and a telephone
number where a person will be available at certain time to answer
questions. Taking consent must be viewed as a process, not just the person
reading the information sheet and signing a consent form. There is
evidence that people understand much less than what they are thought to
understand. The participant information sheet should therefore be checked
for readability.

The committee will also want to be assured that the participants are being
adequate time to decide whether they wish to take part and have the
opportunity to discuss the research with family and friends. If direct
quotes from participants is going to be used for dissemination, or recording
using audio or video equipment, this must be stated on both the
participant information sheet and as one of the statements on the consent
form. If personally identifiable information is going to be used for
dissemination for example photographs, participants must be given the
opportunity to be contacted on each occasion that these will be used, in
addition to taking their consent.

It is good practice to notify all participants regarding the last approximate
date it will be possible to withdraw their data (for example, prior to

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 9