M6S2: Practising Ethics in Healthcare research

At the end of this session, you will be able to –

 Define the terms privacy and confidentiality in the context of healthcare research
 Explain the procedure for maintaining privacy and confidentiality throughout the process of
healthcare research
 Define informed consent in the context of healthcare research
 Illustrate the elements that are integral to informed consent document or procedure, and
 Summarise the procedure for obtaining ethical approvals for healthcare research

Privacy in research refers to protecting the research participant’s right to control access to their
participation in study with respect to extent, timing and circumstances
Confidentiality in research refers to right of the research participant that their personal and medical
information is kept private and confidential. Exception could be between research team and insurance
company.
The procedure for maintaining privacy and confidentiality are as follows – Anonymising the data;
Coding the data; Enter data using quality assurance measures; Store information securely except
access to legal requirements; and Periodic training of data operators and all research team members
Informed consent in the context of health care research is the process of informing the potential
participants about the proposed research in a systematic manner and empowers them to take an
informed decision to participate in research study.
The essential elements of informed consent are - Understanding study procedures, risks and benefits
of Research; Get all questions, doubts and concerns answered; and take a learned and informed
decision to participate or not to participate in Research

In an informed consent document, we will have - Name of the project or research; Research protocol
contents; Risks involved in participation of research; Benefits involved in participation of research;
Alternatives available for involvement in participation of research; Confidentiality of information for
involvement in research; Compensation to be paid for damages in involvement in research; Contact
person’s name, phone number and address to contact in case of emergency or occurrence of adverse
events; Clear statement that the research participant is participating in the research voluntarily and has
right to withdraw from research anytime; and Signature of research participant and witnesses who are
not part of the research study team.
The whole informed consent process is audio video recorded whenever consent is sought from
member of vulnerable population involved in new drug clinical trials
The principal investigator of proposed research applies to the ethics committee with the research
protocol for obtaining permission to carry out research.
The ethics committee members review the research protocol and address the ethical issues that arise in
proposed research and facilitates sound decision making that respects participants values concerns and
interests. And then approve or reject permission to conduct research.
The principal investigator has to periodically send reports to ethics committee during the conduction
of research regarding the progress, change in protocol, adverse events, conclusion and publication of
research findings
Even after approvals granted by ethics committee, they on their own can review or monitor the
progress of research, call for records or documents and for ethical violations, can even stop the
research.
At the end of this session, are you able to –

 Define the terms privacy and confidentiality in the context of healthcare research.
 Explain the procedure for maintaining privacy and confidentiality throughout the process of
healthcare research.
 Define informed consent in the context of healthcare research.
 Illustrate the elements that are integral to informed consent document or procedure, and
 Summarise the procedure for obtaining ethical approvals for healthcare research.