Informed Consent Discussion as part of the Ethical Consideration in Research

Informed Consent

1. Orientation on the Ethics Review Process y

By: Jose Glenn C. Capanas
(for USC REC)

2. Informed Consent

* a decision
by a competent potential
participant
to be involved in research

after receiving and understanding
relevant information

without having been subjected to
coercion, undue influence, or

inducement

3. ch

Informed Consent

+ by informing + prospective + to avoid deception, undue

+ by answering questions participants’ consent influence or intimidation

+ by ensuring understanding + consent of legally + to convey the information in a
of the procedure authorized language and manner that suit

+ by obtaining agreement representative (LAR) the individual capacity and

level of understanding
+ to ensure adequate

understanding of the

information

4. ICF - 2 parts

Part 1
Part 2

5. Part 1

* Intro

+ Purpose

* Type of Research
Intervention

+ Participant
Selection

+ Voluntary
Participation

+ Procedures

+ Duration

* Risks

Part 1

Benefits
Reimbursements
Confidentiality
Sharing the
Results

Right to Refuse or
Withdraw

Who to Contact
Ethics Review

Part 2

+ Name of partici

+ Signature o
participant

+ Statement of the
researcher

6. « Intro
o who you are; institution; invitation to

participate
o reasons for considering the individual
o voluntary

+ Purpose
o explain the research question in lay
terms
o use of simple words, terms

« Type of Research Intervention
o is it FG? survey? questionnaire?
interview?

+ Participant selection
o why the participant is chosen
o may or may not participate

7. + Procedures
o state the procedures sequentially and clearly
(presentation of ICF, answering the survey,
collection of data, processing of data, storage
of data, disposal of data

o expected duration; include number al

duration of visits and total time involved

+ Risks
o describe any foreseeable risks, pain,
discomfort or inconvenience, include
possible discrimination
o how risks will be minimized or
mitigated

+ Benefits
o direct benefits to participants
benefits to community or society

8. + Reimbursements
whether money or material goods will be
provided (if yes, kind and amount)
anticipated expenses to the participant, if
any
compensation and/or medical treatment
in case of injury

+ Confidentiality

o maintaining data (who will maintain)

o access of data (who will have access)
© storing data (where data will be stored)
o

disposal of data (when and how data
will be disposed of)

+ Right to Refuse or Withdraw

© may or may not participate; right to
withdraw

o foreseeable circumstances and reasons
under which participation may be
terminated 0
whether or not refusal or discontinuance at
any time will involve penalty or loss of 0
benefits

9. Part 1 + Who to Contact

© contact particulars
o who to contact in case of research-
related injury

Ethics Review
o include grievances and complaints

+ Others
o use of word "researcher", not Pl
o use of appropriate language

10. 0

* written in the first person

Part 2 * vulnerabilities

o illiteracy
© minority
Pa) = 12-14 y.o. - ICF (by parents)
ey and AF (by minor)

= 15-17 y.o. - ICF (minor will
sign on the ICF signed by
parents)

11. Thank You!

Sources
+ 2017 National Ethical

Guidelines
+ USC REC Forms

Email
[email protected]

Phone
[phone] local 204