National Guidelines
To download a PDF version, click here
Acknowledgment……
Abbreviations
Minister preface
Preamble…
Milestones of preparing the guidelines……
Introduction……
Research involving human subjects includes…
What is ethics in research?
References……
Chapter 2: Principles of ethics for research involving Human Subjects……………
The major principles……
Other principles: …
References…
Chapter 3: Research Ethics Committees………
National Research Health Ethics Committee (NHREC)
Historical background…
Standard Operating Procedures of the National Health Research Ethic Committee (NHREC)
Authority under which NHREC will be constituted
Responsibilities of (NHREC)…
Membership of the (HREC) …
Term of the membership…
Meetings
Quorum
Independent consultants
Operational cost
Record keeping and Archiving
Updating NHREC members
State and Institutional Ethics Committees guidelines
References…
Chapter 4: Ethical clearance procedure……
How to get the ethical clearance?
Flowchart for getting ethical clearance………
Prepare
Elements of ethical review……………………
Application……………………………………
Review procedures……………………………
Expedited review………………………………
Decision making………………………………
Communicating the decision…………………
Follow up procedures…………………………
Chapter 5: Informed Consent……………
What is ‘Informed Consent’? …………………
Obtaining informed consent……………………
Process…………………………………………
Language………………………………………
Comprehension…………………………………
Documentation of consent………………………
Waiving of the consent requirement……………
Renewing consent………………………………
Cultural considerations…………………………
Use of biological materials from subjects in clinical trials
Use of medical records and biological specimens
Secondary use of research records or biological specimens
Obligations of sponsors and investigators………
Withholding information and deception………
Intimidation and undue influence………………
Equitable distribution of burdens and benefits in the selection of groups of subjects in research……………
Exception to the requirement for informed consent in studies of emergencies in which the researcher anticipates that many subjects will be unable to consent………………
Inducement to participate………………………
Incompetent persons……………………………
Withdrawal from a study………………………
Research involving vulnerable persons…………
Research involving vulnerable groups include…
Research involving children…………………
Women as research subjects…………………
Pregnant women as research participants……
References……………………………………
Annexes…………………………………
Form A: NATIONAL APPLICATION FORM FOR ETHICAL APPROVAL OF A RESEARCH PROJECT
Form B: Ethical Considerations
NOTE: See below in attachemnts for a printable PDF version