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 IRB’s 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 of interest is in a non scientific area

Schedule Y- Appendix VIII For review of each protocol the quorum of Ethics Committee should be at least 5 members with the lay person from the community.

ICMR Guidelines 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 subject’s 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

Lay persons

EC members

Variable Number (%)

Age •<45 •45-60 •>60

8 (40)

8 (40)

4 (20)

Sex •Female •Male

13 (65)

7 (35)

Education •Medical Postgraduate •Doctorate •Postgraduates

6 (30)

6 (30)

8 (40)

Experience in IHEC •<2 years •2-5 years •>5years

6 (30) 4 (20) 10 (50)

Table 1: Demographic details of the study

participants

20 participants ( 16 EC

members, 4 lay persons)

Table 2 :Specific role of lay persons Role Responses(N) Role in EC

Harm to participants

5 EC members 4 Lay person 1

Risk/benefit analysis

4 EC members 3 Lay person 1

Consent form 5 EC members 3 Lay person 2

Socio cultural aspects

1 Lay person 1

Harm to investigators

1 EC member 1

Community good 3 EC member 1 Lay person 2

Pharmaceutical company

1 Lay person 1

Don’t 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”

• Don’t 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