Attitudes Of An Egyptian Population Living In Remote Area Towards Research

Participation And Storage Of Biological Specimens

Magdi G. Shehata1

Alaa Abou-Zeid2, Mohammed Shams3

Henry Silverman4

1 Department of Entomology, Faculty of Science, Ain Shams University, Cairo,Egypt2 Public Health Dept., Faculty of Medicine, Cairo University.

3 National Cancer Institute, Cairo University4 University of Maryland School of Medicine, Maryland, USA

Introduction

• Increasing importance of using biological stored and/or newly collected tissue samples for Genetic and Non-Genetic researches.

• Ethical issues involved with:– Participants’ preferences for participation– Consent issues– Collaborations and ownership

Why the potential opinions of human subjects are important to conduct

biomedical research?

To enhance:

• Process of informed consent

• Trust between researchers and human

subjects

Objectives

To determine the attitudes of an Egyptian population living in remote area towards:

• Willingness to participate in biomedical research• Willingness to provide biological samples for

future research• Preferences for consent for donating biological

samples.• Types of conditions placed on collected samples

Study Design: Setting Population of a remote

village in Rafah city (NE Sinai) near borders of Palestine.

Bedwins Local and sporadic workers

from other governorates Focus of university field

research on epidemiology and transmission of cutaneous leishmaniasis

Sample Selection: Sample Size: 250 residents Inclusion Criteria:

• Age group 18-70 yrs• Both males and females

Study Design: Respondents

Survey questionnaire was designed to cover the following domains:• Attitudes towards participation in medical research

• Attitudes regarding consent for unspecified future research on biological human stored samples.

• Preference for collaborating research in which human biological samples to be sent to foreign collaborating centers.

• Rights of local and collaborating scientists

Survey questionnaire was translated into plain and understandable Arabic format

Pre-testing of survey with subsequent revisions

Study Design: Survey Development

Data Collection: Randomly selected individuals from each sector

of the village (3 sectors)Data Collectors:

The principal investigator (PI) Assistants (trained on the questionnaire) Two nurses from the local health unit

Data Management: Data entry into MS excel file Statistical analysis (SPSS-version 13)

Study Design: Survey Administration

Response Rate: • 229 of 260 participants completed the survey

Gender:• Male/Female: (3/1)

Education:• Illiteracy: (35%)• Poor education (60%)

Employment:• 23% unemployed• 69% working • 8% landlord

RESULTS

Types of BMR considered most important

Attitudes Towards Biomedical Research (BMR)

TypeSelected

Most Important

%

Major Reason(s)

Sample collection

70To obtain information on diseases and to help others

Drug trials15To receive medication

Questionnaire15Easy to doFear of other types of BMR

Various responses included: no idea, research progress, avoid questioning, refused to participate, etc.

Reasons to volunteer for research

Attitudes Towards Biomedical Research (BMR)

Reason GivenResponse)%(

Help other patients63%

Get extra-attention/better treatment30%

Get better treatment/help others.25%

Chance to get better treatment18%

Get extra-attention12%

Attitudes Towards Biomedical Research Consent For Stored Biological Samples

Statement%Provide subjects with option to participate in future research involving biological samples

69%

Provide subjects with multiple options regarding types of future research (e.g., existing condition or other illnesses)

49%

re-contact the subject no need for re-contact: ( no restrictions)

57%

47%

Subjects should have the right to withdraw their samples27%

Subjects should be notified of results that may be relevant to their health

92%

Subjects should have the right to commercial gain52%

Attitudes Towards Biomedical Research Factors Important in Giving Permission for

Storage of Biological Samples

Factor%Type of disease to be studied88%

Type of sponsoring entity86%

Whether samples will be sent outside Egypt44%

Whether samples will be sent to Western Country40%

Whether samples will be sent to Arabian country47%

Whether samples will be used for genetic research51%

Attitudes Towards Biomedical Research (BMR) Transfer and Ownership of Samples

If samples are transferred, a portion must be left in the source country

94%

If samples are transferred, then the source country should have access to resulting material products

90%

If the researcher locates to another country, who should own the samples?

a. researcher b. source institution

c. government of source institution d. government of recipient institution

e. subject who donated the sample

14%

59%

16%

<1%

11%

High level of support by Egyptians for research Major reasons not to participate in research

Fear and lack of trust Lack of comprehension Social stigma

High level of support for storage of biological samples for future research

Summary A- Participation in BMR

SummaryB- Biological Samples

Desire for knowledge on the type of future research

Most would like to be re-contacted for future research

Most would like to retain the right to commercial gain

Ownership belongs to home country institution

Recommendations

1 .Enhance educational efforts regarding

meaning and value of research2 .Further studies to understand reasons for

a desire for re-contact

3 .Determine whether results are

generalizable to other sectors in Egypt

Acknowledgement

• MOHP-Local Health Authority in N Sinai• RTC-Ain Shams University• Health Research Ethics Training Initiative program

in Egypt (HRETIE). This project is funded by the NIH- Fogarty International foundation.

Thank You