Ethical issues in HIV vaccine trial: Moderator's comment.

[Guest guest]

Dear Forum subscribers,

The government of India and Therion Biologics are partnering with

IAVI to develop and test preventive AIDS vaccines for India. This clinical trial

raises several questions about the ethics of clinical trials in India.

The following is a list of questions which could be of use for analysing the

ethical implications of the proposed clicinal trial.

Questionnaire to analyse the ethical issues of vaccine research in

India

1. What is the exact title of the project?

2. Who are the responsible investigators in India and globally. Name

and address of all the key staff and their affiliation ( and in

other countries)

3. Address and location of the project

4. Sponsors of the project and the total budget of the project

5. A copy of the project proposal (Purpose, methods and procedures)

6.What are the specific risks of the project (as identified by the

researchers? What method they have used to identify the risk)

7. Steps to be taken to reduce the risk?

8. What are the direct benefits to the participants (list all the

benefits)

9. What are the toxicological/ pharmacological data available on the

drugs to be used in this project?

10. Is this a priority area of research (for eg research on locally

appropriate treatment options?)

11. What is the inclusion and exclusion criteria for this project

and its justifications

12. How the participants of this study will be recruited?

13. Are these criteria sensitive to (i) gender; (ii) age; (iii)

vulnerable group considerations?

14. Details of the pacebo arm of the study

15. Does the design include appropriate criteria for project

discontinuation, by the investigator or sponsor, of (a) individual

participants; and ( the project as a whole?

16. Are the project staff sufficiently qualified (on basis of

education, experience, reputation) to carry out this project ? (CVs

of the key investigators)

17. Details of the process of " community consensus-building " prior

to initiating the project, i.e. consultation/discussion of impact of

project and its relevance to (a) potential beneficiaries, (

participants' communities?

18. To what degree possible, are (a) potential participants; (

beneficiaries; © other community members; (d) local clinicians,

researchers, involved in: (i) the design; (ii) evaluation; (iii)

analysis; (iv) publication and/or dissemination of the proposal, (v)

implementation results?

19. Specific plan for the implementation of the result of the

project in India

20. How does this project contribute to local capacity building,

e.g. local researchers, local clinicians?

21. Are the communities from which participants are drawn likely to

benefit from the project ?

22. Will the product (if any), if successful, be reasonably

available to participants and the communities from which they are

drawn?

23. What specific steps are taken to ensure that the potential

products would be available to the community at the earliest?

24. Have adequate arrangements been made to ensure that the results

findings of the project are made available to (a) participants; (

relevant communities, within a reasonable time frame?

25. Who all will be the authors of the result of this study

26. Who will hold the patents of the potential product of this study?

27. Details of reviews carried out by any other relevant national or

institutional ethical review committee(s)?

28. Details of procedures to ensure that the project is

appropriately monitored as it progresses

29. Does the recruitment process include adequate protections for

the privacy and psychosocial needs of potential participants?

30. Is voluntary, non-coercive recruitment/participation ensured by

informing participants that hey may refuse to participate

31. Does the participation ensures that the participant may

withdraw from the project at any time without penalty or adverse

consequences?

32. Has voluntariness of consent been adequately ensured for

vulnerable/ hierarchical groups/individuals?

33. A copy of the informed consent form

34. Does the informed consent form/information sheet provide

sufficient information regarding: (i) purpose of the project (ii)

procedures to be carried out; (iii) risks (including possible

discrimination); (iv) discomforts; (v) inconveniences, including the

time required for participation; (vi) benefits to participants and

others; (vii) alternatives to participation; (viii) additional

costs, if any, to participants and whether those costs will be

reimbursed?

35. Is the informed consent form/information sheet written or

presented (a) in lay language; ( at an appropriate level of

simplicity to ensure that participants can understand, and ©

specify contact person/s to discuss and explain details of the study?

36. Details of the procedures of acquiring informed consent?

37. Does research protocol and consent form/information sheet (a)

describe steps taken to protect confidentiality; and ( ensure that

participants are informed of the extent to which confidentiality can

be maintained and possible protective steps to be taken, if breached?

38. Are inducements provided for participation?

39. Do the inducements constitute an undue inducement or influence

for participation?

40. Are there adequate provisions to deal with adverse consequences

(medical, psychological, social) arising from the project, including

compensation for injury/loss?

41. Details of the proposed compensation for injury or loss

42. Is it likely that the participants could be infected with HIV

during the project lifecycle?

43. What percentage of participants are likely to be infected?

44. Do they belong to any particular groups?

45. What specific steps will be taken to reduce/eliminate such

chances?

46. What are the potential adverse incidents anticipated in this

project?

47. Are participants (and if appropriate, their families) given

adequate support (medical/psycho-social, e.g. provision of or

referral to counselling) during and after the conduct of project?

(Spell out the details of these support)

48. What steps will be taken to register these adverse events and

who will have access to this registry?

49. Details of the ethics review committee (s) reviewing the project

proposals (List of members of the ERC)

50. Recommendations and suggestions of the ethic review committee (S)

51. Conflict of interest of the investigators

52. Conflict of interest of the ERC members

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Dr. Joe .

Moderator

eFORUM

E-mail: AIDS Treatment

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