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Resources & Tools - PPT Presentation

Resources amp Tools for IRBs Deana Around Him DrPH ScM AIHEC NARCH IRB Professional Development Session Agenda Collaborative Research Center for American Indian Health CRCAIH Resources Office of Human Research Protections OHRP Resources ID: 764689

tribal research review irb research tribal irb review www org crcaih https health data ohrp american rrb ncai amp

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Resources & Tools for IRBs Deana Around Him DrPH, ScMAIHEC NARCHIRB Professional Development Session

Agenda Collaborative Research Center for American Indian Health (CRCAIH) ResourcesOffice of Human Research Protections (OHRP) Resources Public Responsibility In Medicine & Research (PRIM&R) ResourcesNational Congress of American Indians (NCAI) ResourcesResearch Ethics Training for Health in Indigenous Communities ( rETHICS) CurriculumTribal RRB/IRB Websites

Collaborative Research Center for American Indian Health (CRCAIH) Goal: Address Social Determinants of Health through Transdisciplinary Collaboration

Tribes Partnering with CRCAIH CRCAIH Tribal partners shown in red.

Building Research Infrastructure Tribal College Tribal Health Administration Tribal Health Clinic Tribal Education Dept. Tribal 501(c)3 5

Where to start? 6

Tribal Partners’ Oversight Structures External IRB/RRB Tribal College IRB/RRB Tribal IRB/RRB Human Services IRB Tribal Nations Research Group (TNRG), a non-profit 501c3 organization for Turtle Mountain Band of Chippewa Indians (TMBCI) Cankdeska Cikana Community College Institutional Research Review Board [CCCC-IRB] of the Spirit Lake Nation Oglala Sioux Tribe Research Review Board [OSTRRB] Sisseton Wahpeton Oyate Local Research Review Board [LRRB] Rose bud Sioux Tribe Fond du Lac Human Services Division Institutional Review Board

Tribal IRB Toolkit

Tribal IRB ToolkitWho Can Use It?Teams, organizations, tribal or Indigenous communities that want to develop an IRB/RRB Existing Tribal IRBs/RRBs Entities that review research in addition to other responsibilities, such as a tribal council, tribal college, or tribal historic and preservation office

Section B: Starting a Tribal IRBObtaining Tribal ApprovalNaming Your Tribal IRBDeveloping Policies and Procedures Selection and Recruitment of IRB MembersOrientation and Training for IRB Members

Cataloging Tribally-based Research:Preliminary StepsWhat research is currently being done?Who is conducting research? What tribally-based entities are reviewing research or granting approval for research to occur?What existing tribal law is there relevant to research or the review of research?

Section C: IRB Administration ToolsSubmission Process Flow ChartsInvestigator Submission Forms Pre-Review ToolsLetter Templates

Section D: Research Review ChecklistsDesigned to be used by IRB members, or individuals performing the ethical review of researchIncorporate both federal guidelines for the review of human subjects’ research as well as guidelines to ensure community protections for tribal nations.

Tools Specific to Tribal Context: Reviewer Checklist Item

Tools Specific to Tribal Context: Publication Review

What about Research Data? 16

Research Data Management ToolkitData:acquisitionstorage protectionPractical tools and guidance for tribal organizations interested in collecting and storing research data.  

Research Data Management Toolkit

Other CRCAIH ResourcesWhat is an FWA? How is it relevant to Tribal Research?https://crcaih.org/assets/9_11_14_What_is_an_FWA_Relevance_to_Tribal_Research_FINAL.pdf OHRP Pre-Summit Educational Workshop (2017)Includes review of Common Rule Revisionshttps://crcaih.org/summit/501-summit-workshops

For more information contact:Collaborative Research Center for American Indian Health Phone: 605-312-6232www.crcaih.org info@crcaih.org

OHRP ResourcesIRB Quality Assurance Self-Assessment ToolStructure for tracking/evaluating processes https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-program-fundamentals/ohrp-self-assessment-tool/index.html Decision ChartsTools you may want to use or adapthttps://www.hhs.gov/ohrp/regulations-and-policy/decision-charts/index.html

PRIM&R ResourcesAt Your Doorstep Training https://www.primr.org/Subpage.aspx?id=1544 Focus on the Revised Common Rule https://www.primr.org/commonrule/ Webinars:Preserving a role for Tribal Review of Research in the Context of Single IRB Policies https://www.primr.org/webinars/sept2016/ Data Sharing in Research with American Indians and Alaska Natives https://www.primr.org/webinars/oct262017/

NCAI ResourcesResearch that Benefits Native People: A Guide for Tribal Leaders http://www.ncai.org/policy-research-center/research-data/NCAIModule1.pdf Walk Softly & Listen Carefully: Building Research Relationships with Tribal Communities http://www.ncai.org/attachments/PolicyPaper_SpMCHTcjxRRjMEjDnPmesENPzjHTwhOlOWxlWOIWdSrykJuQggG_NCAI-WalkSoftly.pdf Tips for Researchers: Strengthening Research that Benefits Native Youth http://www.ncai.org/policy-research-center/research-data/prc-publications/TipsforResearchers-NativeYouth.pdf

rETHICS CurriculumAvailable at: https://www.washington.edu/news/2018/02/22/new-curriculum-prioritizes-tribal-sovereignty-cultural-respect-in-scientific-research-of-american-indian-alaska-native-communities/

Tribal IRB/RRB WebsitesChickasaw Nation IRBhttps://dpcpsi.nih.gov/sites/default/files/5.Chickasaw_IRB_Slides.pdf Sisseton Wahpeton Oyate Research Office http://www.swo-nsn.gov/?page_id=663 Tribal Nations Research Grouphttp://www.tnrg.org/research-protection.html Southwest Tribal IRBhttp://www.mynarch.net/SW_Tribal_IRB.aspx

Thank You! ( wa -do) Questions? deana.aroundhim@gmail.com