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120514P - REVIEW OF THE RESEARCH APPLICATION FORM

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Presentation at the Workshop on Research Ethics held at Jazan University 14-15th  May 2012 by Professor Omar Hasan Kasule Sr. MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman Institutional Review Board and Department of Bioethics King Fahad Medical City Riyadh EM: omarkasule@yahoo.com


1.0 IDENTIFYING INFORMATION
  • Title of the research project
  • Information on each of the principal investigators: name, address, professional title, qualifications, name and address of employer, experience in clinical research, and recent research projects involved in
  • Information on the person completing the application form: name. Qualifications, address, professional status
  • Name, address, and telephone of person to be contacted about the project in urgent and non-urgent matters
  • Sponsor of the research: name, contact person, address, level of support, conditions attached to the sponsorship, equipment and staff provided by the sponsor, payments to research subjects, restrictions if any on the publication of research results.

2.0 DESCRIPTION OF RESEARCH
  • Type of research subjects (healthy volunteers, inpatients, outpatients),
  • Scale of the research (single center, national multi-center, international multicenter),
  • Sponsor (commercial or academic institution),
  • Commercial research (drug development, testing devices of equipment),
  • Academic and non-commercial research (therapeutic study, non-therapeutic study, laboratory research, epidemiological research)

3.0 PROTOCOL AND DATES
  • Study protocol: existing protocol, new protocol submitted with application
  • Dates: starting date, closing date, duration

4.0 METHODOLOGY OF RESEARCH
  • Methodology of the research: background, justification, research subjects, research design, data collection, data analysis, power of the study
  • Research subjects: proposed cases, proposed controls, method of selection including inclusion and exclusion criteria, age range, gender distribution, number anticipated

5.0 ETHICO-LEGAL ISSUES
  • Informed consent: patient/volunteer information sheet, use of a standard consent form, who will seek consent? method of approaching potential research subjects, time given to respondents to make up their mind about participation,
  • Potential benefits
  • Potential hazards and discomforts
  • Methods of assuring confidentiality
  • Insurance
  • Signed declaration