Rosalyn Singleton MD MPH Alaska Native Tribal Health Consortium ;

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1 Rosalyn Singleton MD MPH Alaska Native Tribal Health Consortium ;

2 Why do research involving Alaska Native people? Lots of concerns Concerns about research Vulnerable at-risk population over-researched, feel like guinea pigs Potential for harm Reported alcoholism rates affected one region s application for grant funding Potential for genetic targeting bad genes?

3 Why research in Alaska Native people? To help eliminate health disparities In the 1970s Alaska Native people were found to have one of the highest reported rates of symptomatic hepatitis B in the U.S. Research into this disparity and hepatitis B vaccine led to an integrated hepatitis B immunization program Routine infant immunization and adult catch-up Hep B immunization has led to a decline in symptomatic Hep B infections from 250/100,000 to <0.5/100,000 Alaska Native people now have the lowest rate of Hep B infection of any racial group in the U.S.

4 Symptomatic Hepatitis B Incidence AK Native Persons Vaccine Demo Program begins in Yukon Kuskokwim Delta Statewide Program -newborn immunization

5 Incidence of Hepatitis A infections in Alaskans, Native and Non-Native, Rate per 100, Native Non-Native Year Singleton, McMahon, et al. Impact of vaccine program in Alaska VACCINE 2010;28:

6 Cases/100,000 Invasive Hib Disease, Children Aged <5 Years, Alaska, Native PRP-OMP PRP-OMP/HbOC DTwP-HbOC PRP-OMP Non-Native Year Singleton, et al. J Pediatr 2000; 137: and CDC, unpublished

7 However, research must adhere to the principles of the Belmont Report Justice Respect for Persons Beneficence Example from my experience: The Pneumo-13 Study

8 Rate per 100,000 Pneumococcal Disease, YK children <2 yrs, before Prevnar (PCV7) vaccine Invasive pneumococcal disease 10 times higher than non-native Alaskans. - Three-fourths caused by serotypes in PCV non-vaccine Vaccine type YK Children Other AK Native non-native Unpublished surveillance data AIP-CDC

9 Invasive Pneumococcal Disease Cases, YK Delta children <5 yrs, unk nonvaccine PCV A 19A 7F With routine PCV7 vaccine, pneumococcal disease rates initially declined dramatically. However, disease rates increased during due to non-vaccine serotypes But, Wyeth was finalizing studies for a 13 valent vaccine that covered ¾ of disease.

10 Rate per 100,000 Invasive Pneumococcal Disease Rates, Pre- and Post- PCV13, Children <5 years, Alaska % decrease in PCV13 disease 59 Pre Post (4/10-3/12) PCV13 Non-PCV13 PCV13 Non-PCV13 AK Native Non-Native

11 Justice Recruit participants fairly without discrimination, bias, or undue influence Distribute the benefits of research equitably Distribute the burdens of research fairly 11

12 Beneficence First, do no harm. Second, maximize possible benefits* and minimize possible harms. *Benefits to the participant associated with research participation as well as potential benefit to the community 13

13 Respect for Persons Individuals should be treated as autonomous agents. Individuals must not be coerced They must have adequate time to review and understand the informed consent and have all of their questions answered They must feel comfortable declining research Individuals with diminished autonomy are entitled to additional protections. 15

14 Respect for Community Tribal and village consultation takes time May need to meet with village councils Research includes local community members Expect face to face visits Travel to small villages Community members help set research priorities Discussion with tribal leaders may change proposal from placebo-controlled trial with greater chance to show effect, to a before and after trial which allows participants to benefit from the proposed intervention.

15 Example: 13-valent Pneumococcal Conjugate Study 1. We asked Wyeth to consider use of PCV-13 vaccine in YK children pre-licensure. 2. Wyeth agreed to sponsor a clinical trial in YK 3. The YKHC Board of Directors approved 4. We presented at the Tribal Gathering. Tribal elders voiced support. 5. The project was approved by Alaska Area IRB and ANTHC 6. Project Timeline: 1. Project Start: Jan Licensure: March 2010 (ended enrollment) 3. Last subject follow-up: Sept Study closure: Jan 27, 2011

16 What the Pneumo-13 Study involved We hired a YKHC study coordinator and 5 study nurses including 2 Alaska Natives We trained and certified ~50 health aides to recruit parents and administer study vaccine We shipped study vaccine under study regulations to YK and hand-carried vaccine to be stored in villages. Trained and certified nurses and health aides offered PCV-13 vaccine to eligible children Parents signed a voluntary informed consent. Children received PCV-13 vaccine on the same schedule as Prevnar 2, 4, 6, & 12 months. The project was voluntary. If parents declined PCV-13, their child received the licensed Prevnar vaccine.

17 Pneumo-13 study: Training and monitoring study staff and procedures YKHC village operations staff provided study training to study health aides Pfizer provided 2 day training on research procedures and protection of human studies to study personnel including health aides Pfizer study monitors visited Bethel monthly and reviewed all study documents and procedures An auditor came midway through the study and reviewed a sample of study documents and sites and procedures and vaccine storage

18 Pneumo-13 study : Study oversight The Principal Investigator (Ros) maintained daily contact with study personnel and had regular meetings with study health aides. PI traveled to Bethel ~ every 2 weeks to provide direct study oversight. PI teleconferenced with health aides and traveled to study villages to provide oversight PI reviewed all study documentation and all adverse event and answered questions from all study staff. PI met with other YKHC staff on a regular basis to answer questions and provide updates PI maintained approvals from Area and National IRBs, YKHC and individual study village tribal councils.

19 Pneumo-13 study: Protection of human subjects Adverse events monitored adverse events (including any hospitalizations or deaths for 6 months) were reported in all study participants A local study monitoring board met regularly and reviewed all adverse events reported in study participants The LSMB included YK community members and medical staff A Pfizer monitoring board reviewed all adverse events in study participants and reported to the FDA

20 Study-related Personnel Yukon Kuskokwim Health Corporation Jane Russell, Village Operations co-investigator Chris Desnoyers study coordinator Dr. Ellen Hodges co-investigator Dr. Jane McClure co-investigator Dr. Carolyn Lorenz co-investigator (moved) Christine Wiscombe research nurse (moved) Allison Samuelson research nurse Robin Gosney Data Manager Supervisor Kerry Cobbledick/Peggy Byrd research nurses Bessie Francis study data manager (new job) Dr. Joe Klejka, Medical Director Safety Monitoring Committee Numerous Health Aides and Providers Debbie Michael and Maxine Brink Safety Monitoring Comm Alaska Native Tribal Health Consortium Dr. Rosalyn Singleton, - Principal Investigator Arctic Investigations Program CDC Dr. Jay Wenger Safety Monitoring Committee Dana Bruden, statistician Safety Monitoring Committee Pfizer Vaccine Research and Development Dr. Daniel Scott Asst. VP, Pfizer Vaccine Clinical Research Dr. Allison Thompson Associate Director, Pfizer Vaccine Clinical Research David Reyes, and others 24

21 Why Have an Institutional Review Board To protect research participants To encourage health research To receive federal funds

22 Alaska is divided into regional tribal health organizations located in geographic regions that feed into 6 tribal health hubs

23 IHS IRB: The Two-Tier System National IHS IRB Area IHS IRBs: Aberdeen Alaska Albuquerque Bemidji Billings California Nashville Navajo Oklahoma Phoenix Portland Tucson Francine Romero, MPH, PhD

24 Criteria for Review of Research Risks to participants are minimized Selection is equitable Informed consent will be obtained Informed consent will be sought Risks are reasonable in relation to anticipated benefits

25 Research plan makes adequate provisions for monitoring safety Tribal Review of Research Additional safeguards for participants likely to be vulnerable to coercion or undue influence Adequate provisions to protect privacy and maintain confidentiality Waiver of consent obtained

26

27 IRB: Gate Keeper of the Belmont Principles Investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others who are independent of the research must share this responsibility. National Commission Report on Institutional Review Boards, 1978

28 Benefits of Ethical Research Review Review by participants can reduce risk and increase benefits Consent becomes a process not a signature Research can be more relevant to the participants Research is respectful of cultural guidelines Researchers can develop long term trust relationships Research can be enhanced and useful to the participants

29 Obligation to report research findings Report findings first to the study population (tribal health organization Report Pneumo-13 results at Tribal Gathering and at YKDRH Grand Rounds Obtain regional and Alaska Area tribal approval for any publication of results. PCV13 paper just printed in PIDJ

30 Research Involving Specimens March 2007 PRIM&R white paper The Stored Tissue Issue- Weir/Olick National Institutes of Medicine - report on Tissue Samples in the Laboratory The Indian Health Service Specimen Protocol The Alaska Area Specimen Banking Protocol 43

31 Summary Research involving Alaska Native people can help to further knowledge on ways to eliminate health inequities. Research must have community input and be approved by the community and regional tribal org. Research ideas should be shared and discussed early with community leaders and results must be shared Research should be conducted in concert with the tribal organization and, if possible, employ community members

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