10 Years in Guatemala with Indigenous People: Lessons I’ve Still to Learn Michael J Kowolik

LAKE ATITLAN

Guatemala – basic statistics (2002 census) Population – 12.7M (102M:100F) 51% - <15yrs 5.3% - >60yrs 41% indigenous

Some other information….. 36 yrs of “civil war” ended in 1996……with a legacy….mistrust Indigenous women are pregnant most of the time…that’s changing Fear of intrusion….Japanese tourists….research workers?

Motives: Pure or Corrupted? “…The risk is that when research takes a utilitarian turn, its speculative dimension, which is the inner dynamic of man’s intellectual journey, will be diminished or stifled” Pope John Paul II, 2002 Pope John Paul II, 2002

Purity of motive….? “..for as long as human beings have embarked on the activity called science, their inquiries have had the twin functions of helping us to do as well as to know..” (Russell)

Universal Declaration on Bioethics and Human Rights u Recognizing that unethical scientific and technological conduct has had particular impact on indigenous and local communities u Stressing the need to reinforce international cooperation in the field of bioethics, taking into account in particular the special needs of developing countries, indigenous communities and vulnerable populations, UNESCO, June, 2005 UNESCO, June, 2005 Critique in: Developing World Bioethics, Vol 5, Sept. 2005

IRB Issues Many, but essence is that we shouldn’t take advantage of people or situation “..should be as rigorous in host country as in US” Shapiro & Meslin, N. Eng. J. Med., 2001

Legal + Ethical Context  Europe + U.S. Highly legalistic approach IRB IRB Developing Countries Trust and Authority Trust and Authority

 persons in underdeveloped communities will not ordinarily be involved in research that could be carried out reasonably well in developed communities;  the research is responsive to the health needs and the priorities of the community in which it is to be carried out;  every effort will be made to secure the ethical imperative that the consent of individual subjects be informed; and  the proposals for the research have been reviewed and approved by an ethical review committee that has among its members of consultants persons who are thoroughly familiar with the customs and traditions of the community. Guideline 8: Research involving subjects in underdeveloped communities Before undertaking research involving subjects in underdeveloped communities, whether in developed or developing countries, the investigator must ensure that:

Towards Truly Informed Consent “Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants’ understanding” Flory & Emanuel, JAMA, 2004 Flory & Emanuel, JAMA, 2004

Lake Atitlan and surrounding villages and towns (Tax, 1968) N

Some of the Main Issues Informed Consent How weak are the links in the chain? Does it have to be written? Shouldn’t we test the understanding? Subject/Community Compensation? How much and how?

Some of Main Issues Post-Study Investigator Responsibility Must be recognized But, how far should this extend? What is reasonable?

So, what’s changing? Much, or not much? Yes! I’m worrying more! IRB’s are happy, so why not me? ……….because there’s at least one very weak link in the chain of consent… Highlights a need to re-think IRB constitution at the local level

There will always be something else to learn: Blood draws & “replacement” Problems with blood pressure measurements Subject recruitment! Publication of their photos

So, how do we succeed?  Communication – Before  Communication – During  Communication – After……a lot…..also because it might (should) be another “Before”