1. Attitudes Of An Egyptian Population Living In Remote Area Towards Research Participation And Storage Of Biological Specimens Magdi G. Shehata 1 Alaa Abou-Zeid 2, Mohammed Shams 3 Henry Silverman 4 1 Department of Entomology, Faculty of Science, Ain Shams University, Cairo,Egypt 2 Public Health Dept., Faculty of Medicine, Cairo University. 3 National Cancer Institute, Cairo University 4 University of Maryland School of Medicine, Maryland, USA

2. 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

3. 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

4. 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

5. 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

6. Sample Selection:  Sample Size: 250 residents  Inclusion Criteria: Age group 18-70 yrs Both males and females Study Design: Respondents

8.  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

9. 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

10.  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

11. Types of BMR considered most important Attitudes Towards Biomedical Research (BMR) Major Reason(s)Most Important % Type Selected To obtain information on diseases and to help others 70Sample collection To receive medication15Drug trials Easy to do Fear of other types of BMR 15Questionnaire Various responses included: no idea, research progress, avoid questioning, refused to participate, etc.

12. Reasons to volunteer for research Attitudes Towards Biomedical Research (BMR) Response (%)Reason Given 63%Help other patients 30%Get extra-attention/better treatment 25%Get better treatment/help others. 18%Chance to get better treatment 12%Get extra-attention

13. Attitudes Towards Biomedical Research Consent For Stored Biological Samples %Statement 69%Provide subjects with option to participate in future research involving biological samples 49%Provide subjects with multiple options regarding types of future research (e.g., existing condition or other illnesses) 57% 47% re-contact the subject no need for re-contact: ( no restrictions) 27%Subjects should have the right to withdraw their samples 92%Subjects should be notified of results that may be relevant to their health 52%Subjects should have the right to commercial gain

14. Attitudes Towards Biomedical Research Factors Important in Giving Permission for Storage of Biological Samples %Factor 88%Type of disease to be studied 86%Type of sponsoring entity 44%Whether samples will be sent outside Egypt 40%Whether samples will be sent to Western Country 47%Whether samples will be sent to Arabian country 51%Whether samples will be used for genetic research

15. Attitudes Towards Biomedical Research (BMR) Transfer and Ownership of Samples 94%If samples are transferred, a portion must be left in the source country 90%If samples are transferred, then the source country should have access to resulting material products 14% 59% 16% <1% 11% 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

16.  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

17. Summary B- 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

18. Recommendations 1. Enhance educational efforts regarding meaning and value of research 2. Further studies to understand reasons for a desire for re-contact 3. Determine whether results are generalizable to other sectors in Egypt

19. 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.

20. Thank You