Wa Doc Policy on Prisoner Medical Research Approval 2006 Attachment
Download original document:
This text is machine-read, and may contain errors. Check the original document to verify accuracy.
WASHINGTON STATE DEPARTMENT OF CORRECTIONS APPLICATION TO SEEK APPROVAL OF A RESEARCH PROJECT Harold W. Clarke, Secretary Rev. (12/06) DOC 260.050 Attachment 1 TABLE OF CONTENTS PAGE General Application Format Requirements...................................................................... 1 Level 1 – Research Project – Flow Chart ........................................................................ 2 Level II – Research Project – Flow Chart ........................................................................ 3 Form Instructions............................................................................................................. 4 Form A – Project Application Summary......................................................................... 11 Form B – Administrative Information Summary ............................................................. 12 Form C – Biographical Information................................................................................ 13 Form D – Approval Human Subject Review .................................................................. 14 Form E – Project Budget ............................................................................................... 15 Form E1 – Cooperative Project Contributions ............................................................... 16 Requested from Department of Corrections Form E2 – Cooperative Project Contributions Requested from..................................... 17 Department of Corrections Administrators/Superintendent/Supervisor Form F – Project Description......................................................................................... 18 Form G – Description of Risks and Safeguards for Subjects in this Research Project.. 19 Form H – Informed Consent Documents ....................................................................... 21 Attachment H1 – Sample of Consent Format ................................................................ 22 Form I – Waiver of Informed Consent ........................................................................... 24 Form J – Review of ongoing Research Projects(s) and Project Completion ................. 25 Rev. (12/06) i. DOC 260.050 Attachment 1 STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS RESEARCH APPLICATION FORMS GENERAL APPLICATION FORMAT REQUIREMENTS The Department of Corrections welcomes research proposals and we thank you for your interest. When your application for research is received, we will process this application in a timely manner. 1. Please notify the Department of Corrections Research Review Committee of your intent to submit a proposal prior to completing this application. You may contact us by phone at (360) 725-8690, by email at firstname.lastname@example.org, or by mail at: Anmarie Aylward, Chair Research Review Committee P.O. Box 41127 Olympia, WA 98504-1127 2. The application forms are not form-field protected or set up as text boxes. Type your answers and information into each form and the forms will expand to accommodate the amount of text entered. Forms are formatted for use with Microsoft Word; formatting may change if edited in other word processing applications. 3. Submittal and formatting of your application: Use 12-point font. If foreign language materials are to be used, send them after receiving approval for your study. Provide adequate detail, especially on all forms. Consent forms should be written at no more than an eighth grade reading level. Submit only the completed forms and attachments; instruction pages do not need to be returned with the application. Submit one original application, with signatures, and 6 copies of your research proposal. 4. Please read through the entire packet before filling out the forms and carefully follow the instructions for all the forms in this application kit. Submission of an incomplete application is a common cause for delay in the review of proposals. If you have questions about the information requested in this application, please contact Barbara Manning at (360) 725-8690 or at email@example.com the Research Review Committee Chair. Rev. (12/06) 1 DOC 260.050 Attachment 1 LEVEL I — RESEARCH PROJECT There are two types of research projects – Level I and Level II. The Level I type of research is generally limited to the study and analysis of policies, procedures, and statistical materials. This does not include the study or review of specific identifiable individuals and/or individuals' records. Here are the steps you will take as you complete this application and the process used by the Research Review Committee to evaluate your proposal. Request Application Packet from Department of Corrections Complete Forms: A, B, C, D, E, F, I, J Submit Application Packet to Department of Corrections’ Research Review Chair Obtain Approval Request Additional Information Denied Recommend Approval Recommend Approval Denied Letter of Approval / Denial from Secretary of Department of Corrections. There is no appeal of the Secretary's decision. Conduct Research Research Review Committee Establishes Time Frames for Project Updates to be Submitted to the Committee Project Updates as Approved SUBMIT your original application with 6 copies of your research project proposal and all reports to: Anmarie Aylward, Chair Research Review Committee Department of Corrections P.O. Box 41127 Olympia, WA 98504-1127 Rev. (12/06) Submit Final Report to Chair of Research 2 DOC 260.050 Attachment 1 LEVEL II — RESEARCH PROJECT Level II is research typically sponsored or associated with some other organization. It may or may not involve direct contact with identifiable individuals and/or individual's records. Request Packet from Department of Corrections Complete Forms: A, B, C, D, E, F, G, H, I, J Submit Packet to Department of Corrections’ Research Review Chair Request Additional Information Obtain Approval Denied Recommend Approval Recommend Approval Denied Letter of Approval / Denial from Secretary of Department of Corrections. There is no appeal of the Secretary’s decision Acquire ALL Consent Forms of Human Subjects Where Applicable Research Review Committee Establishes Time Frames for Project Updates to be Submitted to the Committee Conduct Research Project Updates, as Approved SUBMIT Original application with 6 copies of your research project proposal and all reports to: Anmarie Aylward, Chair Research Review Committee Department of Corrections P.O. Box 41127 Olympia, WA 98504-1127 Rev. (12/06) Submit Final Report to Research Review Committee Chair 3 DOC 260.050 Attachment 1 INSTRUCTIONS FORM A: PROJECT APPLICATION SUMMARY Briefly describe the Objectives, Methods and Procedures, and Significance of this Project on Form A. Do not complete this form by referencing pages in other attached material. Please do not use continuation pages; Form A is intended to be a brief, one-page summary. FORM B: ADMINISTRATIVE INFORMATION SUMMARY Principal Investigator/Researcher Fill in the information requested in this section for the person who will conduct the proposed research. Form B must be signed and dated by the Principal Investigator/Researcher. FORM C: BIOGRAPHICAL INFORMATION Provide biographical information for project staff directly involved with your study on Form C. Copies of resumes or curricula vitae will be accepted in lieu of Form C. Please do not exceed five pages per person. FORM D: HUMAN SUBJECT REVIEW This section documents that the responsible officials at the researcher’s professional organization are aware of the proposal, and have assumed responsibility for the appropriate level of review of the proposed research. 1. Complete Section 1 - If you are a Researcher who is affiliated with an organization that has an Institutional Review Board (IRB), you need to obtain the signature of the appropriate Institutional Review Board (IRB) official or administrator. 2. Complete Section 2 - If you are a Researcher who is affiliated with an organization not having an Institutional Review Board (IRB), you should obtain the signature of the organizational official authorized to approve the research proposal. 2. Complete Section 3 AND either Section 1 or 2 - If you are a Researcher who is proposing to conduct research for graduate credit, you should obtain the signature of your academic advisor or the chair of your supervisory committee, in addition to obtaining the signature on either Section 1 or 2. Rev. (12/06) 4 DOC 260.050 Attachment 1 FORM E: PROJECT BUDGET Proposals supported by formal budgets (grants, contracts, state funds) Summarize the major budget categories for the proposed research on Form E. If this is a multi-state or agency study, include only the amount of the budget allocated to the Department of Corrections' study site described in this proposal. Indicate whether budget amounts are for one year or for the total study period. Proposals not supported by formal budgets Provide enough information on Form E to explain how the proposed research will be funded or otherwise supported. Significant Financial Interest: If any member of the research team has a significant financial interest in the research, or in its products, or in the study sponsor, please explain the nature of this financial interest and describe the monetary value of the financial interest. FORMS E1 and E2: COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED FROM THE DEPARTMENT OF CORRECTIONS This two-part form demonstrates that the researcher(s) have discussed project plans with staff in the applicable state agency or agencies and have obtained preliminary agreements from them to provide the resources needed for the proposed research to be conducted. INSTRUCTION FOR RESEARCHERS: If the project requires resource contributions from Department of Corrections, you must discuss your plans with the administrator(s) of the immediate Department of Corrections unit(s). On the basis of your plans and your discussions with Department of Corrections, complete and sign Form E1 and send a copy of Forms E1 and E2, along with a copy of the proposal, to each person from whom resource contributions are requested. WHO RESEARCHERS SHOULD CONTACT: If the research requires access to case records maintained in a local Department of Corrections facility/site, or if the research involves other activities conducted in a local office, you should contact the Department of Corrections Superintendent/Supervisor. If the research requires access to computerized data maintained by Department of Corrections, you should contact the Department of Corrections Budget Resource Management Section at (360) 725-8270. If the research involves interviews or interventions with persons in Department of Corrections institutions or facilities, and/or access to offender or staff records maintained in the institution, you should contact the Superintendent of the institution. IF THE PROPOSED RESEARCH REQUIRES ACCESS TO DEPARTMENT OF CORRECTIONS FACILITIES FOR SUBJECT RECRUITMENT PURPOSES, STATE AGENCY STAFF MUST BE INVOLVED IN MAKING INITIAL CONTACT WITH POTENTIAL SUBJECTS. Agency assistance in recruiting research subjects must be negotiated with appropriate administrators and documented on Form E1. Rev. (12/06) 5 DOC 260.050 Attachment 1 FORM F: PROJECT DESCRIPTION The expected level of detail in the project description depends upon the nature and purpose of the proposed activity. Minimal risk projects involving only access to existing records or administration of anonymous surveys require the least level of detail. Projects involving direct interventions or contacts with human subjects must provide more detailed information. Clearly label and attach data collection instruments, flow charts, and other supporting documentation relevant to the proposed research. The Project Description should provide all the following information that is relevant to the proposed research: Conceptual Introduction 1) Provide a clear conceptual rationale for conducting the proposed research. 2) Specify the research questions and the reasons for asking them. 3) Clearly state the project purposes, objectives, and hypotheses, and relate them to findings by others. 4) For program evaluations, describe the program in sufficient detail to provide a context for the evaluation design. 5) Include a summary of the pertinent literature, with citations, if relevant. Project Methods Sampling and Subject Selection 6) Describe the sampling rationale and procedures. 7) Specify the proposed sample size, the age range of subjects, the subject inclusion and exclusion criteria, and the power of the planned statistical tests. 8) Identify the population from which subjects will be drawn, the source of subjects, and the location where study procedures will be carried out. 9) Indicate whether subjects will be recruited from non-English speaking populations, and if so, identify which non-English speaking groups will be included. 10) Indicate whether subjects will be compensated for study participation, and if so, how much. 11) Specify how subjects will be identified, contacted, and recruited in Form F. Study Design 12) Describe the design of the proposed research. Study designs may vary from simple descriptive survey research with no comparison groups to quasi-experimental or experimental designs. 13) Specify the independent, dependent and extraneous variables, and discuss possible threats to internal and/or external validity (e.g., effects of uncontrolled factors) that are implicit in the proposed design. 14) Indicate if the design requires deception or withholding complete information about study purposes, and if so, provide justification. Rev. (12/06) 6 DOC 260.050 Attachment 1 Measurement and Data Production 15) Describe how study variables will be defined and operationalized, and how the data will be obtained. 16) Identify and attach a copy of the research instruments, (e.g., questionnaires, structured interviews, observational methods, psychological tests, medical tests, etc.) you plan to use to collect the data. 17) Provide evidence for the reliability and validity of the research instruments. Attach copies of data collection instruments to the application. Data Analysis 18) Specify any planned statistical tests or comparisons, and describe the relationship between the expected outcome of such tests and the project’s purposes and/or hypotheses. Project Logistics 19) Describe the timetable and specific working arrangements for conducting the research. Significance of Proposed Project Professional Proposals 20) Provide a realistic estimate of the relevance of expected study results, both in terms of applied and basic knowledge. The implications of the research for programs administered by the relevant state agencies are of particular interest. Student Proposals 21) Student research projects, up to and including Master’s thesis research, are considered professional learning experiences and are reviewed as student proposals. Students and their academic advisors are strongly urged to tailor their proposals carefully to what the student may realistically hope to accomplish in light of likely limitations in time, funds, and experience. FORM G: DESCRIPTION OF RISKS AND SAFEGUARDS FOR SUBJECTS IN THIS RESEARCH PROJECT NOTE: If the research involves only use of records, indicate “Not Applicable” for #2, Subject Recruitment. All other sections must be completed for record research. 1. Risks to Subjects: All possible physical, psychological, social, and economic risks to the rights and welfare of the subjects who are asked to participate in the research (including threats to the right of privacy and freedom from undue harassment). Describe the provisions made to minimize the risks of harm and to protect subjects’ rights and welfare. Rev. (12/06) 7 DOC 260.050 Attachment 1 2. Subject Recruitment: Describe the methods you will use to identify, contact, and recruit potential subjects, and to obtain their informed consent, with special emphasis on the appropriateness of these methods to the class of subjects being recruited (e.g., children, hospitalized mentally ill). If the proposed research requires access to Department of Corrections facilities, for subject recruitment purposes, the agency must be involved in making initial contact with potential subjects. 3. Targeted Population: Explain why the research must be conducted with offender population rather than with a less vulnerable population. 4. Confidentiality: Describe the methods proposed to ensure the confidentiality of identified research data and documents. Please specify the point in time when all identifiers and codes linked to identifiers will be permanently removed from all study records, thus rendering all study records unidentifiable. By signing Form G, the Investigator/Researcher agrees to on-site inspection of agreedupon safeguards so the Department can be sure the information is used only for research or statistical purposes and is not re-disclosed without prior permission. Disclosure of Identified Record Information Research or statistical proposals requesting direct access to offender or employee records or requiring that the Department provide identified information extracted from such records will only be approved if all of the following conditions are satisfied: 1. Disclosure of the identified information is compatible with state and federal laws and regulations. 2. The information requested in an identifiable form for the use of a statistical or research activity will not be used to contact, in any way, any person identified in that information. 3. The requested information or activity does not place an unacceptable burden on ongoing departmental operations. 4. A mutually acceptable Confidentiality Contract with the outside Investigator/Researcher is provided. FORM H: INFORMED CONSENT CONSENT DOCUMENTS and ATTACHMENT H1 Attach the consent and assent forms in exactly the format that they would be used in the proposed research. Also, attach copies of contact letters, recruitment scripts, telephone scripts, and posters or advertisements that will be used for study recruitment. If you will direct participants to a website, please provide the web address and copies of all web materials. Please identify all types of consent documents proposed for this study on Form H. The consent documents should be written in clear, short, declarative sentences, using lay language that prospective subjects can readily understand. Avoid the use of technical terms, and define such terms if their use cannot be avoided. Font size should be at least 12 point and margins at least one inch. All consent documents must be printed one-sided. Rev. (12/06) 8 DOC 260.050 Attachment 1 Use the Flesch-Kincaid test in Word (or other comparable measure) to assess the readability of the consent documents, and report the results on Form H. Please submit copies of all proposed consent documents with your application. If subjects will be recruited from populations in which English is not the primary spoken language, please describe on Form H the provisions that are planned for communicating with potential subjects in their native language and for translating consent documents. NOTE: Do not submit translations until all consent documents have been approved by the Research Review Committee. Attachment H1: A sample consent form in Attachment H1. Please follow the format in this sample when writing consent forms for your research. The sample consent form specifies the information, which typically should be included in each section of the form. Please ensure that your consent form includes all information necessary to obtain informed consent for study participation. FORM I: WAIVER OF INFORMED CONSENT Complete this form ONLY IF you are requesting Unidentified Record Information (information stripped of identifiers) for your project. DISCLOSURE OF DEPARTMENT RECORD INFORMATION FOR RESEARCH AND STATISTICAL PURPOSES The Secretary of Department of Corrections may approve proposals by outside Investigator/Researchers requiring the release of information from individual offender and employee records without the consent of the persons to whom the records pertain under the following disclosure conditions: Disclosure of Unidentified Record Information (Information stripped of identifiers) Many statistical and research activities do not require information in a format that identifies specific offenders or employees. Therefore, whenever possible, the Department will release record information for statistical or research purposes only in a form that cannot be associated with particular individuals. FORM J: REVIEW OF ONGOING RESEARCH PROJECT(S) AND PROJECT COMPLETION Once your research project is approved by the Department’s Secretary, you will receive an approval letter listing dates that periodic status reports are due. THE DEPARTMENT’S PUBLICATION RIGHTS A. The Investigator/Researcher or project director shall furnish four (4) copies of your final publication to the Department. Rev. (12/06) 9 DOC 260.050 Attachment 1 B. Manuscripts by students to be submitted for publication in a professional journal or a non-professional publication must be reviewed and approved by the Department prior to their submission to the publication source. C. Unless otherwise mutually agreed to, the outside professional Investigator/Researcher or project director may not copyright the results of the project without the written consent of the Department. Rev. (12/06) 10 DOC 260.050 Attachment 1 FORM A STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS PROJECT APPLICATION SUMMARY Project Title: Principal Investigator/Researcher: Organizational Affiliation: Objectives: Methods and Procedures: Significance of this Project: Rev. (12/06) 11 DOC 260.050 Attachment 1 FORM B STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS ADMINISTRATIVE INFORMATION SUMMARY TITLE OF PROPOSAL: PRINCIPAL INVESTIGATOR/RESEARCHER: Performance Site: Name: TITLE/POSITION: MAILING ADDRESS: PROPOSED PROJECT DATES: FROM: TO FUNDING SOURCE: DAY TIME TELEPHONE: AFFILIATED WITH DEPARTMENT OF CORRECTIONS? Yes _______ Rev. (12/06) 12 No ________ DOC 260.050 Attachment 1 FORM C STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS BIOGRAPHICAL INFORMATION Use one sheet for each of the personnel involved in the proposed project; number sheets consecutively. NAME: TITLE: Affiliated with Department of Corrections? Yes ____ No ____ NAME AND ADDRESS OF EMPLOYING AGENCY OR ORGANIZATION EDUCATIONAL BACKGROUND (Degree(s) and institutions) PROFESSIONAL BACKGROUND (positions and appointments) SCIENTIFIC BACKGROUND (description of research activities and interests) Bibliography: list not more than five publications relevant to the proposed project showing you as author or co-author. If less than two publications have been produced, list graduate theses, papers read at conferences, or project reports. Rev. (12/06) 13 DOC 260.050 Attachment 1 FORM D STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS APPROVAL HUMAN SUBJECT REVIEW To be completed by sponsoring agency or organization. (University, Professional Organization, Public Agency, Commercial Research Firm, etc.) SECTION 1: Approval by Institutions or Organization with an Accredited Human Subject Review Board(s) NAME: TITLE/POSITION: MAILING ADDRESS: I have reviewed the proposed methodology and feasibility of the research project and recommend approval. Signature Date SECTION 2: Approval by Institutions or Organization without an Accredited Human Subject Review Board NAME: TITLE/POSITION: MAILING ADDRESS: I have reviewed the proposed methodology and feasibility of the research project and recommend approval. Signature Date SECTION 3: Approval by academic advisor or Chair of Advisory Committee of Research for graduate credit. NAME: TITLE/POSITION: MAILING ADDRESS: Signature Rev. (12/06) Date 14 DOC 260.050 Attachment 1 FORM E STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS PROJECT BUDGET Use as many continuation pages as needed. Please number pages consecutively. Formal Budget – Provide Summary: No Formal Budget - Explain how the proposed research will be supported: Significant Financial Interest: Does any member of the research team have a significant financial interest in the research, or in its products, YES NO or in its sponsor? If Yes, please explain the nature of this financial interest and describe the monetary value of the financial interest: Rev. (12/06) 15 DOC 260.050 Attachment 1 FORM E1 STATE OF WASHINGTON COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED FROM DEPARTMENT OF CORRECTION Project Title: TO BE COMPLETED BY THE PRINCIPAL INVESTIGATOR/RESEARCHER: On the basis of your plans and your discussions with Department of Corrections administrators, please complete and sign Form E1 and send a copy of Forms E1 and E2, along with a copy of the proposal, to each administrator or data coordinator from whom resource contributions are requested. Department of Corrections Contributions Requested: YES NO 1. Department of Corrections Clerical Services 2. Department of Corrections Facilities/Equipment 3. Department of Corrections Case Records (Specify below) 4. Department of Corrections Computerized Records (Specify below) 5. Department of Corrections Assistance in recruiting Research Subjects (Specify below) 6. Other (Specify below) For each category checked above, please describe the specific contributions requested. For case records or computerized records, please describe the parameters of the data request (i.e., study group, time periods, geographic areas, data elements, etc.) (Attach additional pages if necessary) I certify that I have discussed this proposal with Department of Corrections administrators and that, to the best of my knowledge, this form accurately describes the contributions requested for this research project. Principal Investigator/Researcher (Type Name) Signature_______________________________________________ Telephone Administrator or Data Coordinator to whom page E2 will be sent Telephone Rev. (12/06) 16 DOC 260.050 Attachment 1 FORM E2 STATE OF WASHINGTON COOPERATIVE PROJECT CONTRIBUTIONS REQUESTED FROM DEPARTMENT OF CORRECTIONS ADMINISTRATORS/SUPERINTENDENT/SUPERVISOR Project Title: TO BE COMPLETED BY THE DEPARTMENT OF CORRECTIONS ADMINISTRATOR : On the basis of your plans and your discussions with the researcher and the information provided on Form E1, please estimate the costs of supporting this research project. If the contributions being requested are unclear, or if additional information is needed, please contact the Research Review Committee Chair. Please complete and sign Form E2. Send to Department of Corrections Research Review Committee, Chair. Estimated Costs of Department of Corrections Contributions: 1. Professional Services 2. Clerical Services 3. Computer Services (including staff-time) 4. Consumable Supplies 5. Other (Specify): Type Name: Signature _________________________________________________________ Department of Corrections Administrator/Superintendent/Supervisor Telephone Rev. (12/06) 17 DOC 260.050 Attachment 1 FORM F PROJECT DESCRIPTION 1. Use as many continuation pages as needed. Please number pages consecutively. OR 2. Attach materials that you have submitted to your funding agency, institutional review board, or a copy of your thesis if this information will provide clear responses to the 20 questions being asked in the Form F Instructions (see page 6-7). Note: Identify the section/page in your document where each piece of requested information can be found. Identify any questions that are N/A. Rev. (12/06) 18 DOC 260.050 Attachment 1 FORM G STATE OF WASHINGTON DEPARTMENT CORRECTIONS DESCRIPTION OF RISKS AND SAFEGUARDS FOR SUBJECTS IN THIS RESEARCH PROJECT Use as many continuation pages as needed. Please number pages consecutively. Risks to Subjects: Subject Recruitment: Targeted Population: Confidentiality: ___________________________________________________________ Signature of Principal Investigator/Researcher Date __________ ___________________________________________________ Print or Type Name Rev. (12/06) 19 DOC 260.050 Attachment 1 FORM G (additional signature page) Signature of All Investigator/Researchers: ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date ___________________________ Investigator/Researcher (Please Type Name) ___________________________ _________ Signature _____________ Date Rev. (12/06) 20 DOC 260.050 Attachment 1 FORM H STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS INFORMED CONSENT DOCUMENTS Use as many continuation pages as needed. Please number pages consecutively. Consent Documents – Check all recruitment and consent documents proposed for this research; indicate readability level using Flesch-Kincaid test in Microsoft Word or equivalent measure; attach copies of all consent documents and all documents to this form. Flesch-Kincaid Reading Level Consent Form(s) ______________________ Contact Letter(s) ________________________ Recruitment Script(s) ________________________ Telephone Script(s) ________________________ Advertisement(s) ________________________ Web Page(s) ________________________ Other: ________________ ________________________ Non-English Speaking Subjects: If subjects will be recruited from non-English speaking populations, describe your plans for communicating with potential subjects and for translating consent documents into their native language: Rev. (12/06) 21 DOC 260.050 Attachment 1 ATTACHMENT H1 SAMPLE – CONSENT FORMAT (Use simple direct language appropriate for the intended readers) CONSENT FORM TITLE OF RESEARCH PROJECT Investigator/Researchers: (List names, academic/staff positions, university/agency affiliation, complete address and telephone numbers of Investigator/Researchers and co-Investigator/Researchers) Investigator/Researcher's Statement: PURPOSE AND BENEFITS State that this is a research activity. Identify the sponsor of the study. Describe the purpose of the research and the questions the study is intended to answer. Describe the expected benefits to individual subjects and/or society. PROCEDURES Describe the procedures involved. Identify any procedures that are experimental. Describe the time involved for each procedure, the total amount of time involved, and the duration of the subjects’ involvement in the research. If random assignment is involved, state that subjects will be assigned by chance to one of a number of groups, and describe the differences between the groups. Identify where the study procedures will take place, and who will administer the procedures. As appropriate, list and/or describe the specimens to be taken and the names and doses of substances to be given. Describe questionnaires and interviews to be administered, and provide examples of the most personal and sensitive questions to be asked. State that subjects may refuse to answer any question or item. Describe any medical, social service or computerized records needed, and specify any plans to video or audio tape subjects. RISKS, STRESS, AND DISCOMFORT Describe the physical, psychological, social, and/or economic risks of the research in terms of type, probability, magnitude and duration. Include a description of possible stress, discomforts or the invasion of privacy that might result. OTHER INFORMATION If applicable, describe the alternative procedures or standard of care that might benefit the subject. State whether study data will be confidential (linked to identifiers) or anonymous (no links). Indicate who will have access to identifiable data and how long identifiable data will be retained until destroyed. Describe procedures for protecting confidentiality of study data. As appropriate, state that while study data will remain confidential, the law requires that information about suspected abuse of children or dependent adults must be reported. State that study participation is voluntary, and that subjects may refuse to participate or may withdraw from the study at any time without penalty or loss of benefits to which they are otherwise entitled. Include a description of any payments subjects may receive for participation. Indicate any costs subjects may immediately or ultimately have to bear. If appropriate, explain whether any medical treatments are available if injury occurs, and if so, what they consist of and whether their cost will be borne by the researcher or the subject. Indicate that the subject may contact the Investigator/Researchers toll-free or by collect call if they have any questions about the research. ____________________________________________ Signature of Investigator/Researcher Rev. (12/06) 22 ___________ Date DOC 260.050 Attachment 1 Participant’s Statement: "The study described above has been explained to me. I voluntarily consent to participate in this activity. I have been told that I can refuse to answer any question or withdraw from the study at any time without penalty. I have had an opportunity to ask questions. I have been told that future questions I may have about the research or about my rights as a participant will be answered by one of the Investigator/Researchers listed above." _____________________________________________ Signature of Participant ___________ Date _____________________________________________ Witness Signature (if appropriate) ___________ Date Copies to: Rev. (12/06) Participant Investigator/Researcher's file 23 DOC 260.050 Attachment 1 FORM I STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS WAIVER OF INFORMED CONSENT Research Involving Records Only – No Contacts with Human Subjects: Waiver of consent for disclosure of state agency records. Information Supporting Request for Waiver: Rev. (12/06) 24 DOC 260.050 Attachment 1 FORM J Approval Expiration Date __________ STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS REVIEW OF ONGOING RESEARCH PROJECT(S) AND PROJECT COMPLETION Project Title: Principal Investigator/Researcher: Address: Telephone: FAX: Email: Investigator/Researchers must provide documentation of completion of appropriate education and training in the protection of human subjects with their progress reports for continuing review. 1. Status of Project: Include major accomplishments, significant events or study findings, dissertation activities, etc. Use additional sheets as necessary. 2. Summarize Study Amendments During this Past Year: Describe any revisions in the study design and/or study procedures, such as the number and/or size of study groups, changes in recruitment procedures, materials and/or consent forms, revisions to instruments, requests for additional data, etc. Use additional sheets as necessary. 3. Anticipated Completion Date for your project: INVESTIGATOR/RESEARCHER’S STATEMENT: As Principal Investigator/Researcher, I acknowledge that I am responsible for reporting any emergent problems, serious adverse events or reactions, or proposed study modifications, and that no modifications will be put into effect without prior Research Review Committee approval. I affirm that this research is being conducted in compliance with all Departmental-approved procedures and requirements, and that this research will not proceed beyond the expiration date of study approval unless continuation approval is extended. I affirm that this progress report is an accurate and complete description of my research. Signature of Principal Investigator/Researcher Date Return entire packet to: Anmarie Aylward, Chair Department of Corrections Research Review Committee P.O. Box 41127 Olympia, WA 98504-1127 Rev. (12/06) 25 DOC 260.050 Attachment 1 STATE OF WASHINGTON DEPARTMENT OF CORRECTIONS CONFIDENTIALITY CONTRACT I, , understand and agree that, PRINT NAME in the performance of my research project as a Principal Investigator/Researcher, I am obligated to treat any and all offender or employee records to which I have access or might have access, through whatever means, as confidential and privileged. Furthermore: I understand that disclosure of the identified information will only be approved if disclosure is compatible with state and federal laws and regulations. I understand that any violation of confidentiality of offender or employee records or information may result in termination of the research project and that action may be taken by a prosecuting attorney if the breach of confidentiality violates state laws and regulations. I agree that information requested in an identifiable form for use of a statistical or research activity will not be used to contact, in any way, any person identified in that information outside of the parameters of the project. SIGNATURE Rev. (12/06) DATE 26 DOC 260.050 Attachment 1