How to obtain consent during research

1. Issues related to
Consent in
research
Dr Manori Gamage
University of Sri
Jayewardenepura
Sri Lanka

2. Issues related to consenting process
1. Who is going to take it ?
2. Where is it going to happen ?
3. Who is going to give it ?
4. Need re consenting or not ?
5. Is it valid consent

3. Types of consent
Informed consent- An adult subject capable of
giving permission to participate in research
study.

4. Parental permission- when children or
minor involved in reseach parents must
give parental permission (less than 18
years)
Assent- willingness to participate in
research by a person who is too young to
give informed consent but old enough to
understand the purpose of research (12
–up to 18 years

5. Proxy consent- consent given by LAR when the
subject is not competent to give consent.
Verbal consent- ?

6. Informed consent?
Voluntary agreement to participate in
research
It is not a form but it is a process.
Essential before enrolling for
diagnostic, therapeutic, interventional,
social, and behavioral research.

7. Why it is important
It is the process which respects
AUTONOMY of the subject.

8. Steps involved
 “Sufficient” information given
-What would an average participant need to
know
- What would this particular subject needs to
know
 Sufficient time given
To decide on voluntary participation

9. What are essential elements needed on an information
sheet?
1. Purpose of the research
2. Procedure involved in research
3. Possible risks associated
4. Possible benefits associated
5. Length of time expected to participate
6. Person to contact for queries, in an event of research
related injury or an emergency.
7. Alternative to participation
8. Statement indicating participation is voluntary and
subjects right to withdraw

10. In addition to the , above depending on certain
projects some other elements needed to be
added.
1. Incentives/payments if applicable
2. Additional cost if subject has to bare
3. Probability of random assignment

11. Assent- Minor’s affirmative agreement to
participate in research. (12-18 years)
Elements of an assent sheet
Same as for informed consent all the relevant
information should be given but in a more
simpler and more understandable language.

12. Proxy Consent –A person may consent on
behalf of another who lacks decision making
capacity , to participate in research is referred as
a “proxy” or “surrogate”
Given by a LAR
Who can be the legally authorized
representative (LAR)
Depends on the country or area of the country .
In Sri Lanka ?????

13. Ex : In USA
Parent /parents of a subject who is a minor
The legal guardian
The spouse
An adult child of the prospective subject……etc

14. Thank You