**Updated 9/23/05**

RESEARCH ETHICS AND INSTITUTIONAL REVIEW BOARD (IRB) RESOURCES FOR TRIBES AND RESEARCHERS
Resource for Tribes: How to Review Research to Benefit Tribal Communities including How to Build and Sustain a Tribal IRB
Resource for Researcher: How to Conduct Research in AI/AN communities

The following resources were developed as a part of the Individual and Community Research Protections Trainings recently conducted by the Northern Plains Tribal Epidemiology Center (NPTEC). NPTEC would like to thank the dedicated members of our Advisory Committee who helped plan and implement the trainings and develop the resources. For a list of our Advisory Committee Members, please visit the bottom of the page.

For Tribes: How to Review Research to Benefit Tribal Communities, May 2-3, 2005, Rapid City, SD
This training provided tools for tribes to review and assess research in the context of their local community. Participants gained the skills to ensure that the research conducted in their communities address the values specific to their tribe and people. The emphasis of this training was to help participants identify criteria that are rooted in local realities, values, and aesthetics, and establish a process by which to review research according to these criteria to minimize harms and maximize benefits for individuals and the community. Click here for the full agenda

For Researchers: How to Conduct Research in American Indian and Alaska Native (AI/AN) Communities, June 16-17, 2005, Fort Yates, ND
This training provided tools to help researchers better conduct effective and culturally competent research in American Indian and Alaska Native (AI/AN) communities. The Institutional Review Boards (IRB) and federal guidelines address protections for the individual; this training addressed research benefits and harms to both individuals and their communities. The process of community consultation, an element of community-based participatory research, was discussed as a method to increase: effectiveness of the research; acceptability of the research to AI/AN communities; research protections to communities and individuals; and benefits to communities and individuals. Click here for the full agenda

For Tribes: How to Build and Sustain a Tribal IRB , July 11-13,2005, Rapid City, SD
This training provided tools to help tribes and tribal colleges establish and administer an IRB. Topics covered include: role of IRBs, review of the federal regulations under which IRBs operate; IRB structure including membership and meetings; IRB administration including receiving, reviewing, and tracking protocols; and obtaining a Federalwide Assurance and registering an IRB. Participants became familiar with the nuts and bolts of IRBs. Click here for the full agenda

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For questions or comments regarding these resources and trainings, please contact Sayaka Kanade at epikanade@aatchb.org or call 605-721-1922 x115.
Northern Plains Tribal Epidemiology Center, Aberdeen Area Tribal Chairmen's Health Board. Homepage: www.aatchb.org/epi
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RESOURCE FOR TRIBES:
HOW TO REVIEW RESEARCH TO BENEFIT TRIBAL COMMUNITIES including HOW TO BUILD AND SUSTAIN A TRIBAL IRB

Information from the the two trainings have been combined
Foundations in Research Ethics
History of Research Ethics (PowerPoint); Presentation by William Freeman, MD, MPH, CIP, Northwest Indian College This presentation reviews the timeline of events that shaped research ethics and the key documents that guide current practices. Example of past and present research are used to describe individual harms versus community harms.
Guiding Principles of the Belmont Report (PowerPoint); Presentation by Ernest Prentice, PhD, University of Nebraska Medical Center This presentation reviews the evetns eading to the development of the Belmont Report, the guiding principles of human research protections. The principles and application of the Belmont Report are reviewed.
Definitions of Research (PowerPoint); Presentation by Shirley Hicks, Office for Human Research Protections This presentation identifies the elements that consistute research as defined by federal regulations, researchers, and communities.
Ethical Code: Belmont Report (Available through OHRP www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm) The Belmont report established the three principles-respect for persons, beneficience, and justice-that are crucial to the understanding of ethical issues in research. They are used as the framework for the protection of human subjects for both biomedical and behavioral research in the U.S.
Ethical Code: Nuremberg Code (Available through OHRP www.hhs.gov/ohrp/references/nurcode.htm) The Nuremberg Code is a set of principles for human experimentation established as a result of the Nuremberg trials at the end of World War II. Specifically, they were in response to the inhumane Nazi human experimentation carried out during the war by individuals such as Dr. Josef Mengele. It remains a landmark document on medical ethics and one of the most lasting products of the "Doctors Trial."
Ethical Code: Declaration of Helsinki (Available through World Medical Association www.wma.net/e/policy/b3.htm) A code of ethics for clincial research adopted by the World Medical Association in 1964 and widely adopted by medical associations in various countries. The Declaration addresses ethical issues fro physicians conducting biomedical research involving humans. Recommnedations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.
Federal Regulation: 45 CFR 46 Protection of Human Subjects (Available through OHRP www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects. Most recently updated in June 1991, these regulations govern human subjects research conducted by all federal agencies. This body of regulations governs the conduct of human subjects research today.
Tools to Review Research Protocols
Research Types and Potential Harms (PowerPoint); Presentation by Francine Romero, PhD, MPH, Northern Plains Tribal Epidemiology Center and Terry Powell, Alaska Area IRB Potential harms and benefits may vary depending on whether the research is a survey, screening, clincial trial, intervention, quality assuracne, or other type of project. This presentation explores the potential harms and benefits for the different types of research.
Inside the Research Process and Protocol (PowerPoint); Presentation by Francine Romero, PhD, MPH, Northern Plains Tribal Epidemiology Center and Marianna Kennedy, MSW, MPA, MPH, Albuquerque Area Indian Health Board The current research process is described, including designing of the research plna or protocol, obtaining tribal approval, collecting data, conducting data analysis, and publication of resuls. This presentation also reviews the various components that make up a research plan or protocol.
Research Review Checklist: Tribal Research Assessment Checklist (Word) This checklist was developed for tribes to review research protocols acoording to tribal commmunity values. The elements included in this checklist do not constitute all of the federal requirements for human subjects protections.
Research Review Checklist: IRB Review Checklist for Exempt Research (Word) This checklist may be used by tribes and tribal college IRBs to assess whether a protocol is "exempt" from IRB review. The elements included in this checklist are in accordance with the federal regulations. IRBs may want to consider modifying and adding elements to suit tribal and tribal college needs.
Research Review Checklist: IRB Review Checklist (Word) This IRB checklist may be used by tribes and tribal college IRBs to review protocols. The elements included in this checklist are in accordance with the federal regulations. IRBs may want to consider modifying and adding elements to suit tribal and tribal college needs.
Articles referenced in the IRB Review Checklist
"Participatory research maximises community and lay involvement" Volume 319; Page 774
"Qualitative research in health care: Assessing quality in qualitative research" Volume 320; Page 50
Available through the BMJ (British Medical Journal) website (free access) www.bmj.com/
The IRB Checklist references these articles in 8A on minimizing harms and maximizing benefits to tribe and community through participatory research and in 9B on ensuring that the research has scientific methods essential for good qualitative research.
Sample Protocols and Consent Forms: Model Protocol- Northwest Tribal BRFSS Project; Available from NPTEC Guidelines for Researchers pages 18-23 (PDF) This research protocol is presented as a model protocol in regards to the project activties presented in the narrative.
Sample Protocols and Consent Forms: Sample Protocol (PDF) The following is provided as an example of a protocol that IRBs should expect to receive and review. This is not meant to serve as a model protocol, rather to illustrate the level of detail required in a protocol, including all of the attachments, for IRB review.
Sample Protocols and Consent Forms: Model Consent Forms- From IHS; Available from NPTEC Guidelines for Researchers pages 24-55 (PDF) These consent forms are provided by IHS as guidance for consent forms.
Tools to Build a Tribal or TCU IRB
IRBs: Contributors and Resolvers of Problems (PowerPoint); Presentation by Bernard Schwetz, DVM, PhD, Office for Human Research Protections IRBs are the single most important element in our efforts to protect human subjects research. Federal regulations and applicable state and local laws, regulations, and policies provide a comprehensive articultation of society's expectations for the responsible use of human subjects in research. Implementation of these regulations and guidelines, however, rests largely in the hands of IRBs in the US. This presentation demonstrates ways in which IRB have been contributors and reolvers of problems.
Planning Your Tribal or Tribal College IRB (PowerPoint); Presentation by Francine Romero, PhD, MPH, Northern Plains Tribal Epidemiology Center This session is meant to help in brainstorming ideas for tribal and tribal college IRBs. There are many ways to establish an IRB and advantages and disadvantages for various methods.
Guidance on Starting an IRB (Word) This document is meant to assist in planning and starting an IRB.
IRB Policies and Procedures:
OHRP Guidance on Written IRB Procedures; Available through OHRP www.hhs.gov/ohrp/humansubjects/guidance/irbgd702.htm
Sample Tribal "IRB" Policies and Procedures (Word)
The OHRP guidance outlines the required elements of written IRB procedures under federal regulations. The sample tribal "IRB" policies document is provided as a starting point for writing tribal or tribal college IRB policies and procedures. As noted in the document, it does not contain all of the elements required by federal regulation.
Procedure and Cue Sheet to Chair TCU/Tribal IRB Meetings (Word) This document is meant to assist IRB Chairs in facilitating an IRB meeting.
OHRP Decision Charts; Available through OHRP www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm These charts are provided by OHRP as graphic aids to determine whether an activity is considered research involving human subjects that must be reviewed by an IRB under federal regulation. Tribal and TCU IRBs may want to modify this flowchart to provide additional protections to tribal members and communities.
Annual Renewal Application and Status Report (Word) This template form is meant for investigators to complete for annual renewals and submit to tribal or TCU IRBs for review. Forms such as this may be helpful in facilitating IRB reviews and should be modified to suit tribal and tribal college needs.
Database of the IRB (PDF; screen shots) This database may be a useful tool for TCU and tribal IRBs in tracking and documetning IRB activites and other important information. Following are screen shots from DIRB to demonstrate its capacity and the inforamtion that can be stored. This database uses Microsoft Access.
Sample IRB Documents: Memo for IRB Packet, Meeting Agenda, Primary Reviewer Assignment Memo, Primary Reviewer Summary, IRB Meeting Minutes, Sample IRB Letters (Word) Included in this document are: (1) Memo for IRB packet- a template for a cover memo for the IRB meeting packet; (2) Meeting Agenda- a template for a meeting agenda; (3) Primary Reviewer Assignment Memo- a template for a memo used to assign a protocol to a Primary Reviewer; (4) Primary Reviewer Summary- an example of a summary written by the Primary Reviewer prior to an IRB meeting; (5) IRB Meeting Minutes- an example of IRB meeting minutes; (6) Sample IRB Letters- examples of letters written to the Principal Investigator for approval, approval with contingencies, deferral, disapproval.
Additional Tools and Templates
Overview of the IHS IRBs and Review Process; Available from NPTEC Guidelines for Researchers pages 70-71; 56-57 (PDF) These documents serve as an introduction to the purpose and process of the IHS IRB.
Model Tribal Research Code; Available through IHS www.ihs.gov/MedicalPrograms/Research/pdf_files/mdl-code.pdf The Model Tribal Research Code was developed by the American Indian Law Center, Inc.
On Data and Specimen Use: Model Data Sharing Agreement (PDF) Researchers and tribes can establish policies for data sharing. This document is provided as a model.
On Data and Specimen Use: IHS Guidelines for Implementing and Complying with IHS Policy on Specimens (PDF) These guidelines on research involving specimens may be used as a template for tribal policies on specimen use.
Useful References from the Web (PDF) There are many useful resources available through the web. The following is only a short list of references.
References and Interesting Reading
Story of Jesse Gelsinger; Available through CIRCARE www.circare.org/jintent.pdf A thoughtful memoir describing why Jesse Gelsinger volunteered to participate in the research at the Insitute for Gene Therapy that ultimately took his life.
On Community Harms: Genetic Research- Possible Harms and Benefits; Available from NPTEC Guidelines for Researchers pages 72-79 (PDF) This article describes the potential individual, family, and community harms and benefits of genetic research.
Example of Community Harms: Havasupai "Indian Givers"; Available from Phoenix New Times www.phoenixnewtimes.com/issues/2004-05-27/feature.html An article on an ongoing lawsuit between the Havasupai Tribe and Arizona State University.
Example of Community Harms: Nuu-chah-nulth "Bad Blood"; Please contact me for a copy of these articles Three articles written by David Wiwchar of the Ha-Shilth-Sa on the research conducted in the Nuu-chah-nulth community.
Example of Community Consultation: People Awakening Project
People Awakening Project (PowerPoint); Presented by Gerald Mohatt, EdD, University of Alaska at Fairbanks, and Samuel Demientieff, People Awakening Project
"Tied together like a woven hat": Protective pathways to Alaska Native sobriety; Available through Harm Reduction Journal www.harmreductionjournal.com/content/1/1/10
The presentation from the research team of the People Awakening Project: Discovering Alaska Native Pathways to sobriety on how they were able to develop a community based participaty research project that involved community members in all phases of the research process from beginning to present. The presentation discusses ways in whcih the research was modified to address community concerns. The article is also on their approach.



RESOURCE FOR RESEARCHERS:
HOW TO CONDUCT RESEARCH IN AI/AN COMMUNITIES
Training Presentations
Canadian experiences carrying out Genetic research with aboriginal communities (PowerPoint); Presentation by Laura Arbour, MD, University of British Columbia This presentation Provides examples of culturally competent research involving aboriginal communities in Canada.
History of Research in AI/AN communities (PowerPoint); Presentation by William Freeman, MD, MPH, CIP, Northwest Indian College The historical cultural of research in AI/AN communities must be examined to understand where we are today in relation to research ethics. Human subjects protections in conventional terms of individuals have not always prevented harms to entire communtiies. This presentation explores the concepts of individual and community research protections through the timeline of research events in AI/AN communities and other 'vulnerable' groups.
Definitions of Research (PowerPoint); Presentation by Elyse Summers, JD, Office for Human Research Protections This presentation identifies elements that constitute research as defined by federal regulations, researchers, and community.
Types of Community Harms (PowerPoint); Presentation by Connie Garcia, Albuquerque Area Indian Health Board This presentation defines some of the more common forms of community harms and how they may be identified.
The Validity of Informed Consent is Dependent Upon the Process, Not the Document (PowerPoint); Presentation by Ernest Prentice, PhD, University of Nebraska Medical Center This presentation begins with an overview of the history of Informed Consent, and then it focuses on the process of consent using a brief case sutdy approach.
Community Consultation
Community Consultation Process (PowerPoint); Presentation by William Freeman, MD, MPH, CIP, Northwest Indian College.
Example: Spirit of EAGLES-North Central NARCH (PowerPoint); Presentation by Rick Strickland, MA, University of Wisconsin Comprehensive Cancer Center.
Example: Northwest Tribal BRFSS PRoject (PowerPoint); Presentation by Francine Romero, PhD, MPH, Northern Plains Tribal Epidemiology Center.
These presentations provide an overview of community consultation as a method to engage communities as partners in research. Two examples of effective community consultation and particpatory research are also provided.
Models and Templates
Model Protocol- Northwest Tribal BRFSS Project; Available from NPTEC Guidelines for Researchers pages 18-23 (PDF) This research protocol is presented as a model protocol.
Model Consent Forms- From IHS; Available from NPTEC Guidelines for Researchers pages 24-55 (PDF) These consent forms are provided by IHS as guidance for consent forms.
Model Documents: Tribal Resolution, IHS Service Unit Approval, IHS IRB Submission cover letter (Word) Tribal Resolution and Service Unit Approval- When requesting tribal resolutions and service unit approvals, investigators should provide drafts to tribes and service unit directors. These documents are provded as models.
IHS IRB Submission Cover Letter- Many IHS IRBs do not have their own required formats and accept grant applications and submissions to other IRBs. The cover letter to the IHS IRB should describe the overall project and address some of the specific requirements of the IHS IRBs, including the status of tribal approvals. The cover letter is provided as a model.
Model Data Sharing Agreement (PDF) Researchers and tribes can establish policies for data sharing. This document is provided as a model.
Resources on Tribal and IHS Reviews
Sample review Criteria used by tribes: Model Tribal Research Code; Available through IHS www.ihs.gov/MedicalPrograms/Research/pdf_files/mdl-code.pdf The Model Tribal Research Code was developed by the American Indian Law Center, Inc.
Sample review Criteria used by tribes: Research Review Checklist: Tribal Research Assessment Checklist (Word) This checklist was developed for tribes to review research protocols acoording to tribal commmunity values.
Indian Health Service IRBs: Overview of the IHS IRBs and Review Process; Available from NPTEC Guidelines for Researchers pages 70-71; 56-57 (PDF) These documents serve as an introduction to the purpose and process of the IHS IRB.
Indian Health Service IRBs: IHS IRB Review Checklist; Available from NPTEC Guidelines for Researchers pages 58-67 (PDF) This Checklist is currently used by IHS IRBs to assess research protocols according to federal regulations and IHS IRB standards.
Indian Health Service IRBs: IHS Guidelines for Implementing and Complying with IHS Policy on Specimens (PDF) This Checklist is currently used by IHS IRBs to assess research protocols according to federal regulations and IHS IRB standards.
References
DHHS on Community Harms and Community Consultation Response of the DHHS to NBAC's Report on Research Involving Human Biological Materials: Ethical Issues and Policy Guidelines (PDF) This document is excepts from DHHS relevant to group harms and community consultation. The full report is available online at www.aspe.hhs.gov/sp/hbm/index.htm
DHHS on Community Harms and Community Consultation- Building Community Partnerships in Research: Recommendations and Strategies; Available at www.minority.unc.edu:9014/reports/cdc1998/CDC1998rptTitPg.htm This document was developed by DHHS and provides a framework through which Federal health agencies can establish an ethical basis for community-based research, enhance scientific and public credibility, and provide mechanisms to help build public trust in health research.
On Community Harms Genetic Research- Possible Harms and Benefits; Available from NPTEC Guidelines for Researchers pages 72-79 (PDF) This article describes the potential individual, family, and community harms and benefits of genetic research.
Example of Community Harms: Havasupai "Indian Givers"; Available from Phoenix New Times www.phoenixnewtimes.com/issues/2004-05-27/feature.html An article on an ongoing lawsuit between the Havasupai Tribe and Arizona State University.
Example of Community Harms: Nuu-chah-nulth "Bad Blood"; Please contact me for a copy of these articles Three articles written by David Wiwchar of the Ha-Shilth-Sa on the research conducted in the Nuu-chah-nulth community.
Example of Community Consultation: People Awakening Project
"Tied together like a woven hat": Protective pathways to Alaska Native sobriety; Available through Harm Reduction Journal www.harmreductionjournal.com/content/1/1/10
This article is on the approach of the People Awakening Project: Discovering Alaska Native Pathways to sobriety.


Advisory Committee Members

Dewey Ertz, MD
Co-Chair, Institutional Review Board
Aberdeen Area Indian Health Service

William L. Freeman, MD, MPH, CIP
Director of Tribal Community Health Programs
Human Research Protection Administrator
Northwest Indian College

Marianna Kennedy, MSW, MPA, MPH
Executive Director
Albuquerque Area Indian Health Board

Terry J M Powell
Administrator, Institutional Review Board
Alaska Area Indian Health Service

Ernie Prentice, PhD
Chair, Institutional Review Board
University of Nebraska Medical Center

Francine Romero, PhD, MPH
Director, Northern Plains Tribal Epidemiology Center
Aberdeen Area Tribal Chairmenís Health Board

Rick Strickland, MA
Director, North Central Spirit of EAGLES: AI/AN Leadership Initiative on Cancer
University of Wisconsin Comprehensive Cancer Center

Timothy L. Taylor, PhD, MPH
Director, Division of Planning, Evaluation & Research
Indian Health Service
Office of Public Health and Science

Copyright © 2004, Northern Plains Tribal Epidemiology Center