prototype SWTIRB

(display: "MenuCode") <h3>Introduction</h3> This module is designed to give you an opportunity to work through a mock protocol review. There is a lot of text to read just like the protocols IRB members review. You will be asked a series of questions related to the IHS IRB checklist used by SWTIRB. If you cannot complete the full module now you can use the table of contents at the begining to pick up where you left off at a later time. Imagine you have received the following protocol for review. Please keep in mind this is for training purposes only - this is not to be used as a best case example but is intended to help you work through issues that arise during protocol review. [[Continue->Description of the Research]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Research Methods</h3> **Tribal Approval** Before implementing the study, the two tribal communities and the urban Native American school advisory board will have passed resolutions approving the "Adapting A114You! For Native American Youth in the Southwest" **Recruiting the Sample** Concern for improving the health and well-being of youth in tribal communities contributed to the decision to select an EBP that targeted youth. Also, the increasing rates of substance abuse, tobacco use, and aggressive behavior among Native American youth influenced the decision to target youth. The EBP A114You! curriculum includes interactive activities such as games, discussion, and role playing that appeal to all youth. The core elements and venue of the Center for Disease Control and Prevention (CDC) Evidence-Based Practice (EBP), A114You!, which was implemented in Philadelphia and Denver for Latino youth ages 13-18 years, are appropriate and adaptable for Southwestern Native American youth. The themes of ethnic pride and caring for oneself and one's family are readily adaptable to Native values related to the importance of Native pride and the centrality of the family. The materials and activities will be modified to be culturally and linguistically appropriate for Native American values and to increase knowledge, attitudes, and behaviors that reduce risky behaviors. The sessions that can be delivered in community centers and schools will be suited to the collaborating tribal communities and the urban Native American school. **Adaptation Sites** Two tribal communities and one school for Native American students, Los Altos Native American Academy, in Santa Fe, New Mexico, have expressed an interest in participating in the high risk behavior prevention intervention. The three sites represent diverse tribal backgrounds, geographic locations, and urban and rural settings. Before initiating the intervention, Tribal Council approval will be obtained for the tribal communities and school board approval will be obtained for Los Altos Academy. **Adaptation Participants** Youth who have completed the pilot test of the A114You! curriculum will be asked to volunteer to participate in focus groups. The selection of community collaborators for the Community Advisory Panel (CAP) meetings, who will provide guidance for identifying culturally relevant themes and messages in the adaptation of the EBP, will be based on recommendations from key professionals in the two tribal communities and at the urban Native American school. Among the collaborators will be school counselors, health educators, behavioral health personnel, community health representatives, parents, and elders. Youth who participate in the adapted A114You! intervention will vary according to site. In one tribal community, youth who participate in an after school program will be recruited for the intervention. At the other tribal community, students will be recruited from health classes. At Los Altos Academy, students will be recruited from personal wellness classes. After completing the implementation of the adapted A114You! curriculum, students who have completed the curriculum will be asked to volunteer to be interviewed. Focus group and interview participants will be asked to sign a consent form that describes the purpose of the high risk behavior prevention intervention, informs them that their participation will involve minimal risk and is voluntary, assures them of confidentiality and that no names will be used, and provides a name and number to contact if they have any questions. Only those persons who sign a consent form will participate in the study. All adolescents under the age of 18 must also have consent forms signed by a parent. Participants in focus groups, classes, and interviews will receive an incentive in the form of a gift card. Do you think this protocol has sound research methods? [[Yes]] [[No]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Research Methods - Characteristics of sound research metohds</h3> For *quantitative* research e.g. (display: "sidearrow") Validated measures (display: "sidearrow") Adequate sample size (display: "sidearrow") Pretest (display: "sidearrow") Controls For *qualitative* research e.g. (display: "sidearrow")Respondent validation (display: "sidearrow") Negative cases (display: "sidearrow")Triangulation (display: "sidearrow")Good methods to collect and analyze data (display: "sidearrow")Fair dealing (display: "sidearrow")Reflexivity Other considerations include: The research is understood as written Study population is clearly defined (who is included versus excluded) Rationale and risks/benefits distribution addressed Context and Tribal/community involvement discussed Necessary elements of informed consent * A clear statement that the study is research * All the research purposes clearly stated * How and whyprospective volunteers are selected * Expected duration of the volunteer's involvement * Procedures or treatments to be done * Reasonably expected benefits to folunteer and others * Especially for experiments, a statement that the treatment or procedure "may involve risks that are currently unforseable" * Contact for who will answer questions about the research itself * Indicates how confidentiatlity and/or anonymity are maintained [[Next->Cultural concerns]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Research Methods - Characteristics of sound research</h3> For **quantitative** research e.g. (display: "sidearrow")Validated measures (display: "sidearrow")Adequate sample size (display: "sidearrow")Pretest (display: "sidearrow")Controls For **qualitative** research e.g. (display: "sidearrow")Respondent validation (display: "sidearrow")Negative cases (display: "sidearrow")Triangulation (display: "sidearrow")Good methods to collect and analyze data (display: "sidearrow")Fair dealing (display: "sidearrow")Reflexivity Other considerations include: * The research is understood as written * Study population is clearly defined (who is included versus excluded) * Rationale and risks/benefits distribution addressed * Context and Tribal/community involvement discussed Necessary elements of informed consent * A clear statement that the study is research * All the research purposes clearly stated * How and whyprospective volunteers are selected * Expected duration of the volunteer's involvement * Procedures or treatments to be done * Reasonably expected benefits to folunteer and others * Especially for experiments, a statement that the treatment or procedure "may involve risks that are currently unforseable" * Contact for who will answer questions about the research itself * Indicates how confidentiatlity and/or anonymity are maintained Do you want to continue with review of this protocol or... [[No, defer final review, request more information from primary investigator]] [[yes, continue ->Information on the Consent Process]] <hr> [[Home->Table of contents]]

(display: "MenuCode") Common questions asked of all protocols: Does the research involve special concerns? Should the research be exempt from IRB review? Does the research qualify for expedited review? [[Continue->Research Methods]] to answer these and other questions. <hr> Refer to checklist topics: [[special concerns]] [[exempt]] [[expedited review]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Data Collection</h3> A mixed-methods approach will combine both qualitative and quantitative data. The Community Readiness questionnaire will ask questions that provide both qualitative and quantitative data. The pre and post questionnaires administered to students who take the intervention classes will generate quantitative data. The Community Advisory Panel (CAP) meetings, focus groups, and interviews will provide qualitative data. Interviews will be conducted by a research project staff member at a location that is convenient for the participant. Interviews will last approximately one hour. Interviews will be tape recorded with the participant's permission. If the participant does not wish to be tape recorded, notes will be taken during the interview. Audio tapes will be transcribed and written notes will be typed up. Transcribed interviews and typed notes from interviews will be identified only by a number and will be stored in a locked file cabinet. Strict standards of confidentiality will apply to all data. All transcripts and data sets will be stored on secure, password-protected computers accessibly only by the research project staff. Three months after analysis tapes will be destroyed. Field coordinators will contact CAP members and students to obtain verbal consent to participate and to schedule and/or confirm classes, meetings, focus groups, and interviews. Participants will be provided with an explanation of the study purpose, content, and estimated time commitment. *Community Readiness Model:* Among the 22 questions in the Community Readiness questionnaire, 18 are open ended questions that will generate qualitative data. Four questions that ask respondents to select a number using a scale from 1-10 will generate quantitative data. The results of this questionnaire will assist in planning and executing the intervention in each community. *Focus groups with youth:* After completion of the pilot test of the A114You! curriculum, 30 volunteers from the classes (10 per focus group) will be asked to participate in a focus group that will ask about impressions of the class and suggestions for adapting the curriculum to their tribal community or school. *Community Advisory Panel (CAP) meetings with adults:* Community tribal leaders and the principal of Los Altos Academy will be asked to recommend individuals to participate in these meetings that will address concerns about youth and sexual health and will give input about culturally relevant themes and messages. CAP meetings will take place twice a year. *Pre and post questionnaires for youth:* The 75 students (25 at each site) who participate in the intervention will complete a questionnaire that will be administered at the beginning of the first session and at the end of the third and last session. The questionnaire asks about high risk behavior knowledge, attitudes, and behavior. *Interviews with youth:* After completing the A114You! intervention, students will be asked to volunteer to participate in an in depth interview about knowledge, behavior change, and the cultural relevance of the curriculum. A sample of 18 students (6 from each site) will be interviewed using an interview guide with open ended questions. Does any portion of this data collection process raise concerns for you? [[Yes, I need more information -> Project Evaluation and Reporting]] [[No concerns->representative protocol]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Project Evaluation and Reporting</h3> You may want some additional information related to project evaluation and reporting before you can make an informed decision. Process evaluation will document the implementation of study activities. * Field coordinators will document the dates and times of the high risk behavior intervention classes, focus groups and interviews. * Field coordinators will collect attendance sheets for classes and compile the number of students attending each class. * Focus groups with youth will assess the initial implementation of the A114You! curriculum. * Meetings with adults will gather recommendations for creating a culturally relevant curriculum. Outcome evaluation measures will assess the effectiveness of study activities. * The pre and post questionnaires will document changes in knowledge, attitudes, and behavior among students who have participated in the high risk behavior intervention. * The interviews with students who participated in the high risk behavior intervention will assess how and why the intervention was effective and culturally appropriate. * The Community Advisory Panel (CAP) meetings will provide a community perspective on how and why the intervention was effective and culturally appropriate. **Dissemination, Notification, and Reporting** Monthly tribal health committee meetings and quarterly SAMHSA advisory council meetings ensure opportunities to disseminate the results of the adapted Southwest Tribal high risk behavior prevention intervention curriculum. Dissemination to the participating tribal communities and community school for Native American students will receive top priority. A community report will be prepared for IHS Albuquerque Area tribes that highlight the benefits to Native American students from participating in a culturally sensitive and culturally appropriate high risk behavior intervention. Other opportunities for reporting and training include IHS clinics, tribal health departments, regional Indian Health Boards, and Tribal Epidemiology Centers. **Project Staff** Staff members for this project include Alfreda Jones, PI and Mary King, Program Manager **Data analysis and Interpretation** Data analysis and interpretation will incorporate both qualitative and quantitative analysis techniques. The answers to open ended questions in the Community Readiness questionnaire and the contents of the focus groups and interviews will be entered in NVIVO, a qualitative data analysis program, in preparation for coding and content analysis to identify common themes and patterns. Research project staff members and field coordinators will identify prevalent themes, patterns, and trends that emerge from the coded interviews. Preliminary findings will be shared with CAP members. The questions that have been answered with a number or Likert scale will be analyzed using descriptive statistics. The responses to the student questionnaires will be analyzed using an appropriate quantitative analysis to compare the pre and post responses. Are these methods appropriate and approvable by the SWTIRB? [[Yes, they are]] [[No, they aren't]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Project Evaluation and Reporting</h3> Next you'll want to determine if the protocol meets requirements for maintaining confidentiality. **Human Subjects' Protection Training** Staff members have completed CITI training for human subjects' protection. **Procedures to Maintain Confidentiality and Anonymity** All signed consent forms will be stored in a locked file cabinet. Interviews will be identified only by a number. A list that links names to interviews numbers will be stored separately. Both lists and interviews will be stored in a locked file cabinet. Data analysis will aggregate interviews to consider major themes, patterns, and trends in order to avoid identifying specific tribal communities and individuals. Does the protocol meet requirements for confidentiality and anonymity? [[Yes, continue ->Budget]] [[No ->confidentiality concerns]] Review confidentiality and anonymity [[here->necessary elements of informed consent]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Project Evaluation and Reporting</h3> Do you want to continue with review of this protocol or... [[No, defer final review, request more information from primary investigator]] [[yes continue ->Budget]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Letter Example - Request more information</h3> Dear Principal Investigator (PI) NAME, DEGREE The Southwest Tribal Institutional Review Board has considered the All4You! protocol submission. The SWTIRB has deferred a final decision on this study, pending the Board's review of the clarifications/modifications listed below. These requested clarifications/modifications will be reviewed by the Board at a fully convened meeting. Please make the necessary revisions to all appropriate documents, or provide written justification for not doing so. In addition, please provide a cover letter with a point by point response to all requested items. Modifications Requested: (list here) If you have any questions, please contact the SWTIRB. Please include your project title and project title in all correspondence with the IRB. [[Finish]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Procedure for Adverse Events</h3> Upon reflection, do you feel good about this protocol overall? [[Yes, I do]] [[No, I do not]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Procedure for Adverse Events</h3> Do you want to continue with review of this protocol or... [[No, defer final review, request more information from primary investigator]] [[Yes, continue ->Yes, it does]] <hr> [[Home->Table of contents]]

(display: "MenuCode") Please explain why you support this protocol in 3-5 sentences. <textarea rows="4" cols= "150"> </textarea> Does this protocol pass review? * [[Yes, approve with conditions]] * [[No, defer final review, request more information from primary investigator]] * [[Recommend protocol approval without further changes]] <hr> [[Home->Table of contents]]

(display: "MenuCode") Please explain the concerns you have related to this porotocol in 3-5 sentences. <textarea rows="4" cols= "150"> </textarea> Does protocol pass review? * [[No, defer final review, request more information from primary investigator]] * [[Yes, approve with conditions]] * [[Recommend protocol approval without further changes]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Letter Example - With conditions</h3> Dear Principal Investigator (PI): Your IRB application for All4You! has been approved with conditions: This actions means that your study has been approved but contains an Additional Condition(s) which is an unmet requirement that may prevent all or some of your research from being conducted until the condition is fulfilled. [[Finish]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Letter Example - Without changes</h3> Dear Principal Investigator (PI): The above-referenced project was reviewed and approved by one of this institution's Institutional Review Boards in accordance with the requirements of the Code of Federal Regulations on the Protection of Human Subjects (45 CFR 46 and 21 CFR 50 and 56), including its relevant Subparts. This approval, based on the degree of risk, is for 365 days from the date of IRB review and approval unless otherwise stated in this letter. The regulations require that continuing review be conducted on or before the 1-year anniversary date of the IRB approval, even though the research activity may not begin until some time after the IRB has given approval. Date of IRB review and approval: 01/20/2018 [[Finish]] <hr> [[Home->Table of contents]]

Welcome to the the protocol review module. Think of a time you were involved in a research study either as an investigator or participant. How would you explain the study to a family member in 3-5 sentences? <textarea rows="4" cols= "150"> </textarea> [[Continue->Introduction]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h3>Introduction to checklist</h3> This module will introduce you to the checklist used by PR to access protocols. You do not need to memorize the questions or conditions but just need to be awear of the types of questions asked about research proposals. (css: "font-size: 150%;")[The Indian Health Service checklist encompasses the 6 basic steps of IRB Review:] **1. Understand the research as written** a. Science & methods: type of research, scientific merit, risks & benefits b. Study population: definition, inclusion-exclusion, rationale, risks/benefits distribution c. Influencing factors & contexts: confidentiality & security, coercions on research team (e.g. type of compensation), conflicts of interest, Tribal/community involvement d. Consent process: capacity to consent feasibility, compensation/coercion, waivers **2. Obtain additional information:** resolve contradictions, needed information not present **3. Minimize potential harms:** biological, medical, psychological, social, and cultural harms to individual, family, Society and community **4. Maximize potential benefits:** to individual, family, community and society (knowledge) **5. Ensure justice:** Is the intended population appropriate? Does it receive maximum benefits? **6. Ensure that the consent process fully informs & freely consents potential participants ** [[Next->General]] <hr> [[Home->Table of contents]]

(display: "MenuCode2")<h1>Checklist</h1> <h3>General</h3> If a question is not open ended the optional answers are YES, N/A, or NO General questions on the checklist 1. Does the research involve [[special concerns]]? 2. Should the research be [[exempt]] from IRB review? 3. Does the research qualify for [[expedited review]]? [[Next->special concerns]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>General - Special Concerns</h3> <div class="boxed">Special consideration for projects involving vulnerable populations or special classes of subjects. Vulnerable or special populations include children, pregnant women, fetuses, prisoners, and people with mental impairment. Special classes of subjects include genetic research; radiation; the collection of sensitive information that could affect insurability,compensation or litigation; screening for diseases with potential for loss of insurance or other services, stigmatization, or self-stigmatization. Research is also considered to have special concerns if it involves possible coercion, on potential participant or researcher to entice consent. Research that may mislead volunteers about thier health status, the reserachers, or the research purpose are considered to contain major deception and have special concerns. Research that incompletely discloses a reserch purpose to avoid biasing the results is also considered to have special concerns and has minor deception. </div> [[Next->expedited review]] or return to the [[protocol review ->Continue]] module. <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>General - Exempt</h3> Research is exemptible when the methods consist of at least one of the following methods but does not include other methods (if the research uses a method that is not one of the 5 outlined below, the research is not exemptible from IRB review). <div class="boxed">1. The research must only use existing data, documents, records, or specimines that were properly obtained. AND one of the follwoing: The information is recorded by the investigator so that subjects cannot be identified in the research data directly or statstically, and no one can trace back from the research data to identify a participant -or- The sources are publicly available. 2. Research or demonstration service/care programs (e.g. health care delivery). AND all of the following: The research/demonstration is directly conducted or approved by the head of a US Government department or agency (e.g. Director of the IHS). -and- The research concerns only issues under usual administrative control (e.g. regulations, eligibility, services, or delivery systems. -and- The research/evaluation methods are also exempt from IRB review. 3. For research not involving [[vulnerable peopulations ->special concerns]] and is only an observation of public behavior (including participatory observation), interviews, surveys, or educational tests. AND one of the following: The participants cannot be identified, directly or statistically. -or- The responses/observations could not harm participants if made public. -or- Federal statute(s) completely protect all participants' confidentiality. -or- All respondents are elected, appointed, or candidates for public officials. 4. It takes place in educational settings to research or evaluate normal educational practices. 5. For research not involving vulnerable populations and is for food research to evaluate quality, taste, or consumer acceptance. AND one of the following: The food has no additives. -or- The food is certified safe by the USDA, FDA, or EPA. If all research methods meet at least one of these conditions it may be considered exempt and not require review if the additional 4 exemptable criteria are also met. [[Exemptable Criteria]] </div> [[Next->expedited review]] or return to the [[protocol review ->Continue]] module. <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>General - Expedited Review</h3> Expedited review is done by one IRB member and the Chair. It can be done only if all the research is one or more of the following and meets "exempt" categories. <div class="boxed"> >The IRB review is for either of the following: ''A. Emergency use of an Investigational New Drug (IND) therapy for non-research care to a patient'' -or- ''B. Minor changes in previously approved research within the approval period'' -or- ''C. Annual Continuing Review'', and the research meets one of the following: <blockquote>either had received expedited review initially and has had no adverse events </blockquote> <blockquote>or was found by full IRB to be not greater than minimal risk and has had no adverse events</blockquote> <blockquote>or finished enrollment and completed all interventions and has only long-term follow up</blockquote> <blockquote>or has not yet enrolled any person, and has found no new risks for the research</blockquote> <blockquote>or is doing only data analysis</blockquote> -or- ''D. New research that is not more than minimal risk'', with all methods one or more of the following: <blockquote>existing data, documents records, specimens orginally for nonresearch purposes</blockquote> <blockquote>non-exempt research on individual/group behavior or characteristics by surveys, interviews, focus groups, oral histories, program evaluations, human factors evaluation, or studies of quality assurance methods</blockquote> <blockquote>collect data of adult/child by noninvasive clinical procedure (e.g. weight, hearing)</blockquote> <blockquote>collect data by non-radiation devices (e.g. MRI, EKG, EEG, ultrasound, doppler)</blockquote> <blockquote>moderate testing of/by exercise, muscle strength, flexibility, or body composition</blockquote> <blockquote>collect data from voice, video, digital, or image recordings made for research</blockquote> </div> [[Next->Context]] or return to the [[protocol review ->Continue]] module. <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>General - Exemptable Criteria</h3> For the IRB to consider research Exempt and not review it, the research must also meet all 4 criteria listed below. 1. It is in fact less than minimal risk to individuals, families, and communities. AND 2. If potentially exempt because participants cannot be identified, the research indeed protects anonymity. AND 3. If volunteers give information about others, inadvertent disclosure presents no more than minimal risk to those others. AND 4. If done in an IHS facility, the information sheet has the IHS disclaimer. [[next ->expedited review]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Description of the Research</h3> Sample Protocol *(for training purposes only)* **Protocol Title:** Adapting the All4You! curruiculum to prevent high risk behavior among youth in the Southwest **Background:** Nationally, the rise in reported high risk behavior among Native Americans and Alaska Natives (AI/AN), although small in absolute numbers, has larger implications for close knit tribal communities. Multiple factors place Native Americans at risk for car crashes, poor nutrition, teen pregnancy, mental health issues, sexually transmitted diseases (STDs), diabetes, distrust of the health care system, poverty, violence, and substance abuse. The high rates of chlamydia and syphilis among Native Americans act as a major risk factor for multiple complications in a vulnerable population. Alcohol use stands out as a risk factor, and those who claimed more episodes of using alcohol before or during sex, reported significantly more events of unprotected sexual intercourse. **High Risk Behavior Prevention Intervention Programs for Native American Youth: ** The literature on high risk behavior prevention education designed for Native American youth consistently stresses the importance of incorporating culturally sensitive and culturally appropriate activities and information. In a series of focus groups, Native American out-of-treatment drug users recommended that high risk behavior prevention programming involve Native people as sources of information and use local and tribally relevant messages. Also, alcohol prevention education needs to be linked to high risk behavior education. Because of the uniqueness of Native American cultural groups, the culturally specific elements may vary widely. A Cherokee Youth substance abuse intervention utilized the Talking Circle as the structural format to share knowledge. The Navajo youth intervention incorporated Native American stories and elements from a Beauty Way curriculum for substance abuse prevention, A Canadian First Nations educational program was taught by peer facilitators who provided information in a culturally sensitive manner. The Youth Services Program at the Native American Health Center in Oakland, California serves American Indians and Alaska Natives from numerous tribes. Based on a traditional value system, the substance abuse prevention program included youth empowerment, leadership training, traditional activities, and wellness and life skills education. The adaptation of A114You! for Southwest Native American youth will contribute to existing high risk behavior prevention education with a Center for Disease Control and Prevention (CDC) Evidence-Based Practice (EBP). **Purpose and Aims:** The primary goal of this research project is to develop a culturally relevant high risk behavior prevention intervention for Native American youth. Community readiness for a high risk behavior intervention will be assessed using the Community Readiness Model. The intervention will be an adaptation of a CDC EBP that incorporates the knowledge and expertise of community members. Using a community-based participatory research approach, the project staff will conduct focus groups with youth and convene an advisory panel in each community. In the two tribal communities, the Community Advisory Panel (CAP) will involve school, clinic, and behavioral health personnel, community health representatives, parents, and elders. In the urban school for Native American youth, the CAP will involve school personnel, parents, and elders. These collaborators will determine the specific changes to the intervention for each site. The adapted curriculum will be implemented, analyzed,and disseminated to tribal communities. Take a few minutes to think about some questions you may have about this protocol? [[Continue]] <hr> [[Home->Table of contents]]

(display: "AAIHBLOGO") (css:"font-size:150%;") [Welcome, this training module contains two sections that can be reviewed individually or together.] The first is an overview of the Indian Health Service (IHS) IRB checklist. The second is a mock protocol review designed to test your knowledge of the checklist. You may return to this menu by clicking on the [[Home->Table of contents]] link at anytime. Don't use your browser back button, it will take you out of the training module. <hr> **Checklist** If you have not used the IHS IRB checklist before it is recommended that you start [[here->checklist starter]] If you want to reference a specific section of the checklist select one of the following [[General]] [[Context]] [[Risks, Benefits, and Justice]] [[Informed Consent]] [[Additional IRB decisions]] <hr> **Mock Protocol Review** If you have not completed the mock protocol review it is recommended that you start [[here->Starter]] If you want to reference a specific section select one of the following. [[Introduction]] [[Description of the Research]] [[Research Methods]] [[Information on the Consent Process]] [[Data Collection]] [[ Project Evaluation and Reporting]] [[Procedures to Maintain Confidentiality and Anonymity->Yes, they are]] [[Budget]] [[Procedure for Adverse Events]] [[Letter Templates to PI]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context</h3> Questions related to the research context. Are [[anonymity, security, confidentiality, and privacy]] maintained? If research with [[children and greater than minimal risk]], does it meet regulations? Does the research meet requirements and recommendations for [[trials]]? Are all appropriate [[documents from other IRB(s)]]) included? Will the research [[comply with best practices and government policies]]? [[Next->anonymity, security, confidentiality, and privacy]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context - Anonymity and Privacy</h3> **Are anonymity, security, confidentiality, and privacy maintained?** If 'anonymous,' are all data in fact anonymous, e.g., no birthdates, person's initials, etc.? Are all computer & non-computer data held in a secure manner? If 'confidential,' are confidentiality measures adequate? If sensitive identifiable data, is there a Certificate of Confidentiality? Do the procedures protect against the risks sufficiently? [[Next->children and greater than minimal risk]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context - Children</h3> **If the research involves children less than 18 and is greater than minimal risk, does it meet the regulations?** **A.** Does the research present the prospect of direct benefit to child? If yes IHS IRB may approve if no, go to B **B.** Is it both a minor increase over minimal risk, and will it give vitally important knowledge about child's disorder? If yes IHS IRB approval; both parents must permit. If no, go to C **C.** Does it present opportunity to understand, alleviate, or prevent a serious problem affecting children? If A and B are 'no' but C is 'yes' send protocol to [[Office for Human Research Protections|https://www.hhs.gov/ohrp/]] for review. If A, B, and C are 'no,' it is not approvable. [[Next->trials]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context - Trials</h3> **Does research meet requirements and recommendations for trials?** A monitoring committee for safety ([[Phase II]]) or for data & safety ([[Phase III->Phase II]]), especially for double-masked ([['blind'->Phase II]]) trials? If a controlled trial, will all eligible volunteers be offered the proven effective treatment? [[Next->documents from other IRB(s)]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context - Other IRB Documents</h3> **Are all appropriate documents from other IRB(s) included?** Is an entity with an IRB (e.g. state, university, CDC, NIH) involved? -If yes, does the research have both: <blockquote>Form 596^^*^^ or letter with Multi Purpose Agreement #, effective date, and conditions?</blockquote> AND <blockquote>Is the approval still valid, i.e., effective date is not less than 1 year old?</blockquote> ^^*^^Certification of IRB approval - HHS form 596 appendix 7 certifies: An institution with an approved assurance has 60 days after submission of the application to complete IRB review of the project. [[Next ->comply with best practices and government policies]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Context - Best Practices</h3> **Will the research comply with best practices & government policies?** Does it minimize harms and maximize benefits to the tribe(s) by Participatory Research? Whether or not Participatory Research, does the research plan to: (display: "sidearrow")work with communities to identify & minimize harms AND (display: "sidearrow")report timely results to the tribe(s), and to IHS AND (display: "sidearrow")have the tribe(s), and IHS if relevant, review all publications? [[Next->Risks, Benefits, and Justice]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Risks, Benefits, and Justice</h3> **Analysis of risks, benefits, and justice** Does [[scientific merit outweigh risk]]? For individuals, communities, and families, are [[risks minimized]], [[benefits maximized]], and [[justice ensured]]? [[Next->scientific merit outweigh risk]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Risks, Benefits, and Justice - Scientific Merit</h3> **Does scientific merit outweigh risk?** Is the research more than minimal risk? Phase I, II, or III trials of Investigational New Drugs or Investigational Device Exemptions are 'indeterminate risk,' i.e., more than minimal risk. Due to workload, this IRB usually only assesses risks, benefits, and science methods in more than minimal risk research. **Please note the SW Tribal IRB does not review this type of research** If more than minimal risk, do its scientific methods and merit outweigh its risks? Does the research have the scientific methods that are essential for good quantitative and qualitative research? <blockquote>For **quantitative** research * Validated measures * Adequate sample size * Pretest * Controls </blockquote> <blockquote>For **qualitative** research * Respondent validation * Negative cases * Triangulation * Good methods to collect and analyze data * Fair dealing * Reflexivity </blockquote> If the research does not have these characteristics what should be changed? [[Next->risks minimized]] <hr> Return the to protocol review module [[here->Yes]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Risks, Benefits, and Justice - Risks Minimized</h3> **If more than minimal risk research, are potential harms minimized to individuals, families, and communities?** (e.g., provide follow-up counseling to families and individuals) If not what should be changed? [[Next->benefits maximized]] <hr> Return the to protocol review module [[here->Yes]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Risks, Benefits, and Justice - Benefits Maximized</h3> **If more than minimal risk research, are potential benefits maximized to individuals, families, and communities?** (e.g. newsletters to participants with the status of the research and meaning to individuals, families, and community of the results) If not, what should be changed? [[Next->justice ensured]] <hr> Return the to protocol review module [[here->Yes]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Risks, Benefits, and Justice - Justice Ensured</h3> **Is justice ensured to individuals, families, and communities?** The study population should be suitable for research In Randomized Controlled Trials (RCT), the treatment proven effective should be offered to individuals, families, and communities in the RCT Randomized controlled trial: (RCT) A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all. Someone who takes part in a randomized controlled trial (RCT) is called a participant or subject. RCTs seek to measure and compare the outcomes after the participants receive the interventions. Because the outcomes are measured, RCTs are quantitative studies. If the protocol does not meet these criteria what should be changed? [[Next ->Informed Consent]] <hr> Return the to protocol review module [[here->Yes]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Informed Consent</h3> Should the IRB [[waive all, or some elements of]], informed consent? Should the IRB [[waive requirements to document]] informed consent? Are procedures adequate to [[negotiate and administer full consent]]? Are all [[necessary elements of informed consent]] included? [[Next->waive all, or some elements of]] <hr> Return to the protocol review [[here->Information on the Consent Process]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Informed Consent - Waive Informed Consent</h3> **Should the IRB waive the requirement to obtain informed consent, or some required elements of informed consent?** **A.** project can qualify for waiver of requirements to give all essential elements of informed consent, if it meets both conditions A) and B), below. Both that <blockquote>**A.** The research could not practicably/feasibly be done without the waiver. **AND** **B.** The research is either 1) or 2), below: *1. A research or demonstration project* both that (a) is directed or approved by state, local, or tribal governments and that (b) concerns only administrative/regulatory issues in service programs -or- *2. A type of research meeting ALL of the following:* (a) involves no more than minimal risk AND (b) will give volunteers pertinent information at the end if appropriate AND (c) the waiver will not adversely affect volunteers' rights or welfare (e.g., an activity for which consent is usually not obtained, or research that involves deception of the volunteer and thus cannot seek fully informed consent initially)</blockquote> **Please note this is currently receiving changes under implementation of the new Common Rule; which will become effective next year January 2019. Current logic may be subject to change. New items are being added as well.** If the research qualifies for waiver of informed consent, should the IRB still require the research to obtain full informed consent? [[Next->waive requirements to document]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Informed Consent - Full Consent</h3> **Are procedures adequate to negotiate and administer full consent?** May researcher compensation (e.g., capitation payments) or other factors influence them to try too strongly to enroll participants? May the method or amount of participant compensation or other factors unduly influence or coerce them to 'consent'? Does the project adequately describe all the processes of consent: <blockquote> inform prospective volunteers (e.g., skilled negotiating, unhurried time, setting facilitates information transfer) AND offer time for prospective volunteers to discuss with family AND assess prospective volunteers' comprehension AND document the consent process </blockquote> Does the research have all relevant consent documents, including: * consent form * assent form * parental permission * telephone script * recruitment advertisement * introduction/approach letter Give an information copy of the consent document to all volunteers? For children age 0-17, a form and process of parental or legal guardian permission? For minors old enough, a process of their assent? [[Next->necessary elements of informed consent]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Informed Consent - Included</h3> **Are all necessary elements of informed consent included?** <div class="boxed">A clear statement that the study is "research" * the word research should be early in the document and not hidden All the research purposes (e.g., research objectives) clearly stated * check the document's list of purposes against the protocol's list How and why prospective volunteers are selected Expected duration of the volunteer's involvement * necessary if the duration is long, or is not obvious Procedure(s) or treatment(s) to be done Reasonably expected benefits to volunteer and others explained and does not overpromise Reasonably foreseeable discomfort and risks, including all in protocol * check the documents list against the protocol's list Especially for experiments, a statement that the treatment(s) or procedure(s) *"may involve risks that are currently unforeseeable"* * applicable most often in clinical trials of drugs or procedures When procedures are treatments that are experimental--say *"experimental"* The alternatives to the research's diagnostic method or treatment * Applicable primarily to research of diagnosis or treatment. A boilerplate *"the alternative not to take part"* is seldom sufficient; rather, what are the real alternatives (e.g., routine car). Procedure for the orderly termination of a volunteer's participation Plans to inform volunteers of significant research findings during or after the study relevant to their continued participation or treatment If more than minimal risk should include the following language: *"In case of injury or severe adverse affect..."* Who will answer questions about the research itself? How are confidentiality or anonymity are maintained? Who will answer other concerns, complaints, or grievances? Financial factors are included (extra costs of, or compensation for, participation) Any other elements a reasonable person would want to know as determined by the SWTIRB If a Certificate of Confidentiality, an appropriate description (e.g., *"We have a Certificate of Confidentiality from IHS"*) Non-coercion disclaimer (e.g., taking part is voluntary)</div> [[Next->Additional IRB decisions]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Additional IRB Decisions</h3> Should the IRB seek reports of compliance from other than the PI? Should it review the research sooner than annually, or monitor the process? Is the research more than minimal risk? [[Next->checklist reflection]] <hr> [[Home->Table of contents]]

(display: "MenuCode2") <h1>Checklist</h1> <h3>Informed Consent - Waive Need to Document</h3> **Should the IRB waive requirements to document informed consent?** A project can qualify for waiver of written documentation that informed consent was obtained, if it meets either condition **A** or condition **B**, below: either that **A.** the existence of signed informed consent forms itself would place the volunteer at major risk (e.g., potential loss of confidentiality or anonymity of people interviewed about extremely sensitive behavior -or- **B.** the research both 1. presents only minimal risk AND 2. involves no procedures which normally require written consent If the research qualifies for waiver of documenting informed consent, should the project still require the research to: either 1. document fully informed consent -or- 2. offer each volunteer a written fact sheet? [[Next->negotiate and administer full consent]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Informed Consent</h3> You may want more information to make this decision. Here is a copy of the consent form: *Consent Form A* New Mexico Department of Indigenous Health Evidence-Based Intervention for Tribal Communities **CONSENT FOR YOUTH TO PARTICIPATE IN RESEARCH ADAPTING & EVALUATING ALL4YOU! FOR NATIVE AMERICAN YOUTH IN THE SOUTHWEST (PILOT INTERVENTION)** **PURPOSE AND BACKGROUND** The primary goal of this research project is to develop a culturally relevant high risk behavior prevention intervention for Native American youth. Community readiness for a high risk behavior prevention intervention will be assessed using the Community Readiness Model. The intervention will be an adaptation of a Center for Disease Control and Prevention (CDC) Evidence-Based Practice (EBP) that incorporates the knowledge and expertise of community members. Using a community-based participatory research approach, the project staff will conduct focus groups with youth and convene a Community Advisory Panel (CAP) in each community. In the two tribal communities, the CAP will involve school, clinic, and behavioral health personnel, community health representatives, parents, and elders. In the urban school for Native American youth, the CAP will involve school personnel, parents, and elders. These collaborators will determine the specific changes to the intervention for each site. The adapted curriculum will be implemented, analyzed, and disseminated to tribal communities. **PROCEDURES** If you volunteer to participate, the following may happen: 1. You may be one of several individuals selected to answer questions to assess the community's readiness, knowledge, attitudes, and resources for high-risk behavior intervention. 2. You may be one in a group of Native American youth to participate in the original A114You! Intervention and you will be asked to complete a pre and post questionnaire related to the information presented in the sessions. 3. You may also participate in a focus group to gather input on the effectiveness of the curriculum and how it can be changed to make it more culturally meaningful. **RISKS AND DISCOMFORT** There are no known risks involved in participating in this project. You will not be asked to provide any personal identification information on questionnaires or interviews. Should you become uncomfortable asking a question, that question can be skipped or you may choose to not complete the questionnaire or the interview. Does this meet approval for informed consent? [[Yes, it does move on to data collection methods->Data Collection]] [[No, it doesn't meet approval]] You can review informed consent [[here->Informed Consent]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Informed Consent</h3> A copy of the consent form may help you make this decision. Here is a copy of the consent form: *Consent Form A* New Mexico Department of Indigenous Health Evidence-Based Intervention for Tribal Communities **CONSENT FOR YOUTH TO PARTICIPATE IN RESEARCH ADAPTING & EVALUATING ALL4YOU! FOR NATIVE AMERICAN YOUTH IN THE SOUTHWEST (PILOT INTERVENTION** **PURPOSE AND BACKGROUND** The primary goal of this research project is to develop a culturally relevant high risk behavior prevention intervention for Native American youth. Community readiness for a high risk behavior prevention intervention will be assessed using the Community Readiness Model. The intervention will be an adaptation of a Center for Disease Control and Prevention (CDC) Evidence-Based Intervention (EBI) that incorporates the knowledge and expertise of community members. Using a community-based participatory research approach, the project staff will conduct focus groups with youth and convene a Community Advisory Panel (CAP) in each community. In the two tribal communities, the CAP will involve school, clinic, and behavioral health personnel, community health representatives, parents, and elders. In the urban school for Native American youth, the CAP will involve school personnel, parents, and elders. These collaborators will determine the specific changes to the intervention for each site. The adapted curriculum will be implemented, analyzed, and disseminated to tribal communities. **PROCEDURES** If you volunteer to participate, the following may happen: 1. You may be one of several individuals selected to answer questions to assess the community's readiness, knowledge, attitudes, and resources for high-risk behavior intervention. 2. You may be one in a group of Native American youth to participate in the original A114You! Intervention and you will be asked to complete a pre and post questionnaire related to the information presented in the sessions. 3. You may also participate in a focus group to gather input on the effectiveness of the curriculum and how it can be changed to make it more culturally meaningful. **RISKS AND DISCOMFORT** There are no known risks involved in participating in this project. You will not be asked to provide any personal identification information on questionnaires or interviews. Should you become uncomfortable asking a question, that question can be skipped or you may choose to not complete the questionnaire or the interview. Does this meet approval for informed consent? [[Yes->Data Collection]] [[No->No, it doesn't meet approval]] You can review informed consent [[here->Informed Consent]] if necessary. <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Letter Templates to Principle Investigators</h3> Common approval related letters that come from protocol review include [[Approved with no changes->Recommend protocol approval without further changes]] [[Approved with conditions (recommended changes)->Yes, approve with conditions]] [[Approval deferred, request more information->No, defer final review, request more information from primary investigator]] <hr> [[Home->Table of contents]]

(set: $name to (prompt: "Please enter your full name and today's date (MM/DD/YYYY) for reporting purposes", "")) (display: "AAIHBLOGO") Southwest Tribal Institutional Review Board <hr> <center>(css:"font-size:150%")[***CERTIFICATE OF TRAINING is hereby presented to***]</center> (css:"font-size:150%")[$name] In recognition of completing the SWTIRB New Member Orientation & Training. [[Home->Table of contents]] *Please print or save a copy for your records and send one to swtribal@aaihb.org On a Windows computer Ctrl+P, print or save as PDF On a Mac Fn+P, print or save as PDF

(display: "AAIHBLOGO") (css:"font-size:150%") [Congratulations!] You have completed the IHS IRB checklist review For questions related to the checklist material please contact swtribalirb@aaihb.org or any of the following staff members: **Southwest Tribal IRB Coordinator** Rachell Tenorio, MSW, PhD rtenorio@aaihb.org **Southwest Tribal IRB Staff** Geanna Capitan, BS gcapitan@aaihb.org **Southwest Tribal IRB Staff** Delrae Peterson dpeterson@aaihb.org <img src="http://www.aaihb.org/images/logo.png"/> Return to [[Home->Table of contents]] or begin the [[protocol review->Starter]] module

(display: "AAIHBLOGO") Think of a time when you created a checklist or to do list for someone else or used one yourself. Was it a useful tool? Why or why not? <textarea rows="4" cols= "150"> </textarea> [[Continue->Introduction to checklist]] <hr> [[Home->Table of contents]]

(display: "AAIHBLOGO") As you can see there is a lot to think about when reviewing a research protocol. What do you think the purpose of the IHS IRB checklist is? <textarea rows="4" cols= "150"> </textarea> [[Next->Final checklist]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Information on the Consent Process</h3> **Consent Process** Participants will be asked to sign consent form that describes the purpose of the "Adapting and Evaluating A114You! For Native American Youth in the Southwest" study, informs them that their participation will involve minimal risk and is voluntary, assures them of confidentiality and that no names will be used, and provides a name and number to contact if they have any questions. Only those persons who sign a consent form will participate in the study. There are three different consent forms that investigators will use. Consent Form A is for students who will participate in the original A114You! curriculum, complete a questionnaire related to information presented in the sessions, and participate in focus groups to gather input on the effectiveness of the curriculum and how it can be changed to make it more culturally meaningful. Parent/guardian signature will be required on this consent form. Consent Form B is for students who will participate in the adapted curriculum and will be asked to complete a questionnaire related to information presented in the sessions. Students may also be one of a group of Native American youth to be interviewed after completing all three sessions to help researchers determine the effectiveness of the adapted intervention. Parent/guardian signatures will be required on this consent form. Consent Form C is for adults who are selected to answer questions to assess the community's readiness, knowledge, attitudes, and resources for an high risk behavior intervention and/or members of the Community Advisory Panel to be interviewed about the adaptation of the A114You! curriculum. Informed consent questions to consider: Are procedures adequate to negotiate and administer full consent? May the method or amount of participant compensation or other factors unduly influence or coerce them to 'consent'? Does the project adequately describe all the processes of consent inculding documentation of the consent process? Are all necessary elements of informed consent included? [[Yes, informed consent]] [[No, informed consent]] <hr> Review [[Informed Consent]] checklist criteria here if necessary. <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Budget</h3> Year 1 $308,183 - Personnel and Fringe $4,938 - Supplies $45,559 - Travel $201,096 - Other Expenses <hr> $559,777 - Total Direct $140,223 - Indirect at 45.5% <hr> $700,000 - Total Project Costs **Timeline** Adapting and Evaluating the All4You! for Native American Youth in the Southwest 2011 * Principal investigator curriculim training * Project director curriculum training * Project specialist curriculum training * IRB Approval * CRM assessment * Hire field Corrodinator 2012 * Piolt testing for all three sites * Focus group for youth at all three sites * Intervention and stie 1 2013 * Intervention at sites 2 and 3 * Evaluation at site 1 and 2 2014 * Evaluation at sites 2 and 3 * Reporting for all 3 sites * Dissemination for all 3 sites **Funding Source Disclosure** The "Adapting and Evaluating A114You! For Native American Youth in the Southwest" project will be supported by the Indian Health Service and Substance Abuse and Mental Health Services Administration (SAMHSA) -Evidence-Based Intervention Research Project grant award. [[Next->Procedure for Adverse Events]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Procedure for Adverse Events</h3> Risks to participants are limited to the small risk of disclosure of personal information in an interview, and any personal information disclosed will be protected by anonymity and confidentiality. The likely benefits to the individual participants are minimal although the overall impact for the tribal community will be significant. If any unexpected consequences adversely affect the participant, an interview will be halted and the interviewer will be prepared to seek help. In the case that an adverse event occurs, the principal investigator will promptly contact the Southwest Tribal IRB and any other IRBs the PI reports to. Given everything you have read about this study do you feel that it minimizes potential harms and maximizes potential benefits? [[Yes, it does]] [[No, it doesn't]] Review [[Risks, Benefits, and Justice]] in the checklist if necessary. <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Informed Consent</h3> Do you want to continue with the protocol review... [[Yes, continue ->Data Collection]] [[No, defer final review, request more information from primary investigator]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Project Evaluation and Reporting</h3> Do you want to continue with the protocol review... [[yes, continue->Budget]] [[No, defer final review, request more information from primary investigator]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Research Methods - Cultural Concerns</h3> Take a moment to assess whether the protocol has taken relevant cultural factors of the tribes into account. Based on what you have read, are there any relevant cultural perspectives missing from the protcol? To the best of your knowledge are any aspects of the protocol considered taboo or inappropriate for this stakeholder? Describe any concerns you may have here or continue. <textarea rows="4" cols= "150"> </textarea> [[Continue->Information on the Consent Process]] <hr> [[Home->Table of contents]]

(display: "MenuCode") <h3>Data Collection - Representative protocol</h3> SWTIRB strives to ensure protocol is representative of the unique interests of relevant tribal community stakeholders. Based on what you know, is this protocol inclusive and supported by relevant tribes/stakeholders? Take a moment to evaluate the level of committment to/involvement with researchers and the tribal communities and then continue. [[Continue -> Project Evaluation and Reporting]] <hr> [[Home->Table of contents]]

<div id="menu">(display: "AAIHBLOGO") **Checklist Table of Contents** ➤  [[General]] ➤  [[Context]] ➤  [[Risks, Benefits, and Justice]] ➤  [[Informed Consent]] ➤  [[Additional IRB decisions]] **Protocol Review Table of Contents** ➤  [[Introduction]] ➤  [[Description of the Research]] ➤  [[Research Methods]] ➤  [[Information on the Consent Process]] ➤  [[Data Collection]] ➤  [[ Project Evaluation and Reporting]] ➤  [[Procedures to Maintain Confidentiality and Anonymity->Yes, they are]] ➤  [[Budget]] ➤  [[Procedure for Adverse Events]] ➤  [[Letter Templates to PI]] </div>

<div id="menu">(display: "AAIHBLOGO") **Protocol Review Table of Contents** ➤  [[Introduction]] ➤  [[Description of the Research]] ➤  [[Research Methods]] ➤  [[Information on the Consent Process]] ➤  [[Data Collection]] ➤  [[ Project Evaluation and Reporting]] ➤  [[Procedures to Maintain Confidentiality and Anonymity->Yes, they are]] ➤  [[Budget]] ➤  [[Procedure for Adverse Events]] ➤  [[Letter Templates to PI]] **Checklist Table of Contents** ➤  [[General]] ➤  [[Context]] ➤  [[Risks, Benefits, and Justice]] ➤  [[Informed Consent]] ➤  [[Additional IRB decisions]] </div>

Phase III clinical trials. Phase III clinical trials test a new treatment that has worked well for patients in a phase II clinical trial. Doctors compare the clinical trial treatment with the standard treatment. Standard treatment means the best treatment known. "Blind" trial is an experiment or clinical trial in which the researchers but not the subjects know which subjects are receiving the active medication or treatment and which are not: a technique for eliminating subjective bias, as the placebo effect, from the test results. The SW Tribal IRB does not review this type of research (Investigational New Drugs/Investigational Device Exemptions). [[back->trials]]