Inside the Research Process & Protocol

Inside the Research Process & Protocol

Inside the Research Process Process The research process includes: The idea, need, priority, question, interest, opportunity Obtaining support Conducting project activities Interpreting results Disseminating results Designing the research protocol Obtaining approvals

Research Process Obtaining funding Conducting project activities Designing the research protocol Interpreting results Disseminating results Obtaining approvals

Obtaining Funding • Meet with communities • Federal Request For Proposals (RFPs) or Request For Applications (RFAs) • Comprehensive federal grant information can be found online at US Dept. of Health & Human Services website: www.grants.gov • Indian Health Service • Centers for Disease Control and Prevention • Administration for Native Americans • National Institutes of Health • State Funding • Private Foundations • Special announcements or allocations

Obtaining Funding • Requirements or eligibility • Timeframe from announcement to submission • Pre-determined focus of announcement • Experienced grant writer • Lead project person or project personnel • Duration of the announcement • Amount of money available • Number of projects to be funded

Obtaining Approvals • Approvals from PARTICIPATING SITES • Regional Approval • Regional approval should be sought prior applying for funding. • AATCHB Resolution • Tribal Approval • If the project will target a specific community, approval should be sought as the project develops. • Once the project receives funding and project activities are to begin, official tribal approvals, such as a tribal resolution, should be sought from each participating site. • Program Director, Tribal Health Director, Health Board or Committee, Tribal Council • IHS Approval • Service Unit Director • Clinical Director

Obtaining Approvals • Approvals from IRBs IRB approval is required once a project receives funding • Indian Health Service if research involves IHS facilities, personnel, data, or resources • Aberdeen Area • National IHS IRB • University, if affiliated

Designing the Research Protocol • Identifying a research question • Developing a hypothesis • Developing activities to test the hypothesis, developing a study design • Identifying potential tribal sites based on study design • Identifying and convening people to carry out the project • Establishing a timeline for how and when project activities need to occur • Establishing a budget to pay for personnel and project activities

Conducting Project Activities • Once approval and/or funding are received, the project is ready to begin • Advisory group from the Tribe • If necessary, the hiring of personnel • Reviewing research protocol for timeline and budget and adjust as necessary • Conducting objectives and activities as described in the proposal: recruitment, data collection, etc. • Providing regular project status updates to Tribal Council and Health Board • Providing regular project and financial status updates to funding agency

Interpreting Results • As the project progresses, the data accumulated will be analyzed • Databases will be established and statistical software programs used to analyze the information

Dissemination Results • Results can be shared: • With the participating site’s tribal health committee, tribal council • With participants in a community open forum, in an article in the tribal newsletter, etc. • Regionally, with tribal organizations, such as Chairmen’s Health Board • In a publication, in a scientific journal for public use • At a national conference for public use • Reports can be either oral or written or both

Follow-up (Next) Steps • Based on results, the project should specify additional follow-up or next steps that will be pursued.

Research Process Obtaining funding Conducting project activities Designing the research protocol Interpreting results Disseminating results RESEARCH PROTOCOL Obtaining approvals

Parts of a Research Protocol • Introduction • Background & Significance • Sampling Methodology • Recruitment Process • Consent Process • Project Activities & Data Collection Method • Data Storage • Data Analysis & Interpretation • Dissemination of Results • Documentation of Approvals

Introduction • A brief overview of the project (abstract) • Who, what, where, when, how, why • Who is involved • What the project proposes to achieve • Where the project will take place • Timeframe of the project • How the objectives will be accomplished • The importance of the project

Background & Significance • Provides the context of the project • Underlines the burden of disease, need, priority, interest (use Epi Center data) • Should provide as much information specific to American Indians as available • Should explain any relevant work that has been completed in this area, including findings or initiatives • Provides the need or significance of the project • Explains the importance of the proposed work • Explains how this approach may be new or different Attachments: Journal articles of relevance

Sampling Methodology • Explains who and how many will be involved in the study • Explains how this sample was identified as being representative of the study population (sampling scheme) • Provides the demographics of the study population

Recruitment Process • Explains how tribal sites will be recruited • Tribal approvals • Explains how participants will be identified and recruited to the study, for example: • Through public advertisements • Using clinic patient lists • Using a convenience sample Attachments: soliciting advertisements, recruitment letter, telephone script

Consent Process • Informed consent is not only the consent form, it is a process. There are required procedures and elements of the consent process and form. • Explains how participants will be approached and asked to participate. There may be translation and literacy level challenges. • Explains what will be told to the participants about the research, activities, and participant involvement. • Explains how investigators will remain in communication with the participants throughout the life of the project. Attachments: informed consent form, child assent form, parental permission form

Project Activities& Data Collection Method • Explains in detail what will be involved to successfully carry out the study; who, what, when, where, how of all activities to be conducted as a part of the study • Explains what data are going to collected, e.g., name, tribe, age, height, tobacco use • Explains how data will be collected: • Surveys • Focus Groups • Screenings • Extracting from existing databases such as RPMS • Intervention-based activities • Clinical trials Attachments: data abstraction forms, questionnaires, intake forms

Data Storage • Explains the way data are going to be… • Identified, e.g., numbered, coded • Stored, e.g., software, locked, password protected • Accessed, e.g., staff members only • Explains how long the information is going to kept, where, by whom • Explains data ownership; to whom does the data belong?

Data Analysis & Interpretation • Explains… • How the data will be computed • What tests will be done • What software program will be used • How small numbers will be handled • What other information the results will be or might be compared to

Disseminating Results • Explains how and to whom the data results will be disseminated: • Individual participants • Participating sites • National conferences • Publications • Explains who will be involved in reviewing and approving dissemination

Documentation of Approvalsand Support • University IRB approvals • Indian Health Service IRB approvals • AATCHB resolution • Letters of support from tribal personnel

Marianna Kennedy, MSW, MPA, MPH Executive Director/NARCH Principal Investigator Rita Kie, MA Tribal Research Liaison Albuquerque Area Indian Health Board, Inc. 5015 Prospect Avenue NE Albuquerque, NM 87110 Tel: (505) 764-0036 or 1-800-658-6717 Email: mkennedy@aaihb.org Website: www.aaihb.org

For More Information Francine Romero (Jemez Pueblo) PhD, MPH Director, Northern Plains Tribal Epidemiology Center Aberdeen Area Tribal Chairmen’s Health Board 1770 Rand Road Rapid City, SD 57702 Tel: 605-721-1922 x104 or 1-800-745-3466 x104 Email: epiromero@aatchb.org Website: www.aatchb.org/epi/

Inside the Research Process & Protocol