Houston, we have lift-off

To conduct research on humans you have to gain approval by an ethics committee or internal review board that reviews your project and says: We do not think you intend to harm people while researching them.  It’s a precaution to prevent situations of intentional harm in the name of scientific advancement.  Like the numerous tales of deliberate infection of prisoners or mental institution patients to test drug treatments.  Or the 1960s New Zealand incident, when the infamous Dr. Herb Green observed patients in pre-cancerous stages of cervical cancer, but neither told them nor treated them to see what would happen.  Well many of them died of cervical cancer, that’s what happened.

And my study is no different.  I intend to enroll human subjects, therefore my study must be subject to a review board who can rest assured that the risks do not outweigh the benefits, etc, etc.  My study application was reviewed by the University of Auckland Human Subjects Committee on April 27 and, well, was not approved.  This is annoying for me but conscientious for ethics committees.  They provided a laundry list of issues with my application, some completely bogus, but their main concerns were that they needed further assurance of my ability to conduct research with an indigenous population in a culturally sensitive context (ok fine), they wanted to see approval from a local Micronesia ethical committee (check), and they wanted further explanation of why I proposed to test for a disease that I did not intend to treat (fair enough).  Within 2 days I had addressed all their concerns, revised all the study documents accordingly, and submitted the study approval letter from the FSM Department of Health.  The Auckland ethics committee agreed to re-review my application in one month’s time.

So what do you do for 6 weeks in Pohnpei when you’re not enrolling participants? 
You go to meetings. 

I met the chiefs of the health department, I met the US ambassador, I gave a presentation to the physicians of the state hospital, I gave a presentation to the physicians of the Genesis hospital, I met with the laboratory coordinator, I met with the Environmental Protection Agency, I met with representatives of every other health-related Non-Governmental Organization, I met with the state hospital chief of staff, and I tried to give a forum lecture to the local college but its summer break.  (Imagine a movie montage here.)  This ethics purgatory was actually quite useful as I had a chance to build relationships with the physicians, laboratory, and support staff.

meeting of the health partners group at island foods

The Auckland ethics committee re-reviewed my application to conduct research involving human subjects on May 25 and I was given approval on Monday May 30.  Thundercats are go!  I spent Tuesday reformatting the study documents for printing and collating.  I was able to track down the directors of both hospitals and have them sign the Head of Hospital Consent Forms.  I also made a flyer for all the physicians reinforcing eligibility criteria.  I found Dr. Jim to coordinate translation of study documents into Pohnpeian.  Wednesday I went around to see each physician at the State Hospital and distribute my flyer.  I visited the Chief of Staff Dr. Hedson to let him know that I'd begin combing the hospital wards.  He sent out an official memo to all the hospital staff and posted the announcement on the Pohnpei Health Services website.  I met the outpatient nurse team, and they agreed to let me sit with them at the triage desk to screen any walk-in patients.  I also checked all the patient charts on the medical ward for fever and symptoms.  No participants.  Thursday I accompanied Dr. Almeda on morning rounds in the medical ward (MW) and went through every patient chart.  

state hospital on a rainy day

The MW is full: diabetes, COPD, and oral cancer.  These are the direct result of a diet high in fat, salt, and sugar; lifelong smoking; and chewing betel nut.  One boy has leukemia.  One man has nine lives.  I like the old style of the wards: one long room with rows of beds lined up on each side, separated by a curtain if it pleases you.  The other thing I like is how Pohnpeians bring their life to the hospital.  They don't like for family members to be alone, so there is always one or five family members sitting beside the patient bed, or napping, or preparing food.  They bring mats for sleeping and the entire contents of their kitchen.

So at this time, no participants have been enrolled but I’d say the study is moving along smoothly.  Well, at least my ethnography is underway.