Role of Lay Persons in Reviewing

Informed Consent
Sudha Ramalingam MD
Alternate Member Secretary ,IHEC
Associate Professor
Department of Community Medicine and
PSG Center for Molecular Medicine and Therapeutics
PSGIMS&R
Coimbatore
 Objectives

Who is a lay person?

Role of Lay persons in Ethics Committees
Challenges faced by them
Our findings
 Lay person

Laity means "common people (Greek: laik'l, )

A layperson or layman is a person who is not

an expert in a given field of knowledge.
 Lay Person In IRBs
Guideline Specification

45 CFR 46.106(c) and 21 CFR 56.106(c)
Each IRB shall include at least one
member whose primary concerns are
in scientific areas and at least one
member whose primary concerns are
in non scientific areas

ICH GCP E6 At least one member whose primary area

Schedule Y- Appendix VIII
ICMR Guidelines
of interest is in a non scientific area
For review of each protocol the quorum
of Ethics Committee should be at least 5
members with the lay person from the
community.
One lay person from the community
 Why Lay person in Human Ethics
Committees?

Less influenced by the financial and non

financial conflicts of interests

Represent the interests of the

community/participant at large
 Informed Consent
The voluntary consent of the human subject is absolutely
essential.
Nuremberg code (1947)
In any research on human beings, each potential subject must
be adequately informed of the aims, methods, anticipated
benefits and potential hazards of the study and the
discomfort it may entail
Declaration of Helsinki (1996)
A process by which a subject voluntarily confirms his
or her willingness to participate in a particular trial,
after having been informed of all aspects of the trial
that are relevant to the subjects decision to
participate. Informed consent is documented by
means of a written, signed and dated informed
consent form
1.28, ICH E6 Guideline for GCP
 Role of Lay persons
Reviewing informed consent process to ensure
participant protection

Reviewing protocols helping to ensure that

language and other aspects of a study make
sense to the layperson

Evaluating benefits and risks to research

participants
 Informed consent elements (ICMR)

Nature and purpose of study stating it as research

Duration of participation with number of participants

Procedures to be followed

Investigations, if any, to be performed

Foreseeable risks and discomforts adequately described and whether project

involves more than minimal risk

Benefits to participant, community or medical profession as may be applicable

Policy on compensation

Availability of medical treatment for such injuries or risk management

Alternative treatments if available

 Steps taken for ensuring confidentiality

No loss of benefits on withdrawal

Benefit sharing in the event of commercialization

Voluntary participation

If test for genetics and HIV is to be done, counselling for consent for testing must
be given as per national guidelines

Storage period of biological sample and related data with choice offered to
participant regarding future use of sample, refusal for storage and receipt of its
results

Contact details of PI or local PI/Co-PI in multicentric studies for asking more

information related to the research or in case of injury

Contact details of Chairman of the IEC for appeal against violation of rights
 Our Study
Table 1: Demographic details of the study
participants
Variable Number (%)
Age
Lay persons
<45 8 (40)
EC members 45-60 8 (40)
>60
4 (20)
Sex
Female 13 (65)
Male 7 (35)
20 participants ( 16 EC
members, 4 lay persons) Education
Medical Postgraduate 6 (30)
Doctorate 6 (30)
Postgraduates
8 (40)
Experience in IHEC
<2 years 6 (30)
2-5 years 4 (20)
>5years 10 (50)
Table 2 :Specific role of lay persons
Role Responses(N) Role in EC
Harm to 5 EC members 4
participants Lay person 1
Risk/benefit 4 EC members 3
analysis Lay person 1
Consent form 5 EC members 3
Lay person 2
Socio cultural 1 Lay person 1
aspects
Harm to 1 EC member 1
investigators
Community good 3 EC member 1
Lay person 2
Pharmaceutical 1 Lay person 1
company
Dont know 3 EC member 2
Lay person 1
 Other findings
Lay person can be of any gender
1 EC member and 1 lay person felt there is no need
for a lay person in the EC
All lay members educated and employed (highest
degree MBA, Occupation- CEO of an industry)
Need for separate curriculum and training for lay
persons
Lay person need not be affiliated to the Institution
Educational Qualifications ( Mostly graduates)
 Lay persons -Challenges
Too much technical terms cannot
understand many times
Dont know what I am doing in the meeting.
Most of the time observing the others talk
Medical terms not understandable. But the
other members teach me . So I am confident
now
I am an outsider so unbiased opinion .. But
feel out of place
 Conclusions
Lay persons play a crucial role in reviewing
study protocols in IHEC
Their primary role is in reviewing informed
consent
No guidelines with respect to qualification,
gender, affiliation
Need for separate curriculum to train them