Part Two: Ethical Considerations
1. What is an estimate of total time involved for participants in the study?
2. Who will carry out the research procedures?
3. What other research studies is the principal investigator currently involved with?
4. Where will the research procedures take place?
5. Does the project Involve collection or use of human tissue?
6. If yes: will this material be used in further studies?
8. Is it intended to inform the participant’s doctor of individual results of the investigations, and their participation, if the participant consents?
9. If no, outline the reasons
10. Does the researcher, the host department, the host institution, have any financial interest in the outcome of this research? If “yes”, please give details.
1- Minimization of Harm
11. How do the research procedures differ from standard treatment procedures?
12. What are the benefits to research participants taking part?
13. What are the physical or psychological risks, or side effects to articipants or third parties? Describe what action will be taken to minimize any such risks or side effects.
14. What facilities/procedures and personnel are there for dealing with emergencies?
15. What arrangements will be made for monitoring and detecting adverse outcomes?
16. Is the trial being reviewed by a data safety monitoring board (DSMB)?
17. If yes, who will fund of the DSMB?
18. What are the criteria for terminating the study?
19. Will any potential toxins, mutagens or teratogens be used?
20. If yes, specify and outline the justification for their use
21. Will any radiation or radioactive substances be used?
22. Has the National Committee for atomic energy completed risk assessment?
23. If yes, please enclose a copy of the risk assessment, and the contact name and phone number
24. If no, please explain why
25. Will any drugs be administered for the purposes of this study?
26. If yes:
a. is approval of the concerned authorities required?
b. trade name of drug
c. Chemical name of drug
d. Pharmacological class:
e. Pharmacological class, e.g., long half life, receptor selectivity.
f. Recommended dose range
g. Form of administration in the study
h. Known or possible interactions with non-trial drugs the participants may be taking
i. Side effects and adverse reactions
27. Does the study involve the use of healthcare resources?
28. If yes, please specify:
29. What effect will this use of resources have on waiting list times for patients ie. for diagnostic tests or for standard treatments?
2- Privacy and Confidentiality
30. How will participants be recruited? (e.g. advertisements, notices)
31. Where will potential participants be approached? (e.g. outpatient clinic) If appropriate describe by type (eg students)
32. Who will make the initial approach to potential participants?
33. How will data including audio and video tapes be handled and stored to safeguard confidentiality (both during and after completion of the research project)?
34. What will be done with the raw data when the study is finished?
35. How long will the data from the study be kept and who will be responsible for its safe keeping?
36. Who will have access to the raw data and/or clinical records during, or after, the study?
37. Describe any arrangements to make results available to participants, including whether they will be offered their audio tapes or videos.