IRB Form One.docx - Revie · Web viewonline ethics . training . ... Consult the IRB website or IRB…

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<p>IRB Form One.docx</p> <p>Policies and Procedures: Institutional Review Board (IRB)</p> <p>Approved 5/10/05, revised 5/16/07, revised 4/28/10, revised 9/24/10, revised 8/14/14, revised 8/10/15</p> <p>College of St. Benedict and St. Johns University</p> <p>Institutional Review Board (IRB)</p> <p>IRB Form 1 (Full or Expedited Review)</p> <p>Directions for Submission of Application: Please answer all questions completely. Responding to each question on this application fulfills one of the requirements for the ethical conduct of researchers. If a question does not pertain to your study, indicate not applicable (NA) following the question. DO NOT DELETE OR MODIFY questions from this application. </p> <p>Project Title: __________________________________________________________</p> <p>Principal Investigators Name: ____________________________________________</p> <p>Department/Affiliation: _________________________________________________</p> <p>Email address: _________________________________________________________</p> <p>Anticipated Start Date for the Research: ___________________________________ </p> <p>Note: IRB approval is good for 1 year. If the research extends beyond 1 year, a renewal form (IRB Form 3) must be submitted. </p> <p>Is the Principal Investigator a student? _____Yes _____ No</p> <p>If the Principal Investigator is a student, a Faculty Advisor must be listed. In addition, the IRB application must be submitted to the IRB chair by the Faculty Advisor.</p> <p>Faculty Advisors Name: _________________________________________________</p> <p>Department: _________________________________________________________</p> <p>Email address: ________________________________________________________</p> <p>List all Co-investigators:</p> <p>NameEmail AddressStudent, Faculty, or Other</p> <p>IMPORTANT: All student researchers working on this project must complete the online ethics training course called Students in Research through the Collaborative Institutional Training Initiative (CITI) before they can be involved in data collection. See the IRB website for instructions on how to access the training, or contact the IRB chair at for more information.</p> <p>Part I: Discerning the Type of Review: Full or Expedited? </p> <p>NOTE: Before completing the section below, check to make sure your research is not exempt from IRB review. Consult the IRB website or IRB Form 2 (for exempt research) for information about the types of research that may be exempt. If you believe your research is exempt from IRB review, submit Form 2 to the IRB chair.</p> <p>If your research does not qualify for exemption under any of the criteria listed on Form 2, place a check next to the type of review you believe is appropriate for your project:</p> <p>_____ EXPEDITED REVIEW</p> <p>Surveys considered minimal risk, research on individual or group behavior or characteristics where research does not cause stress to subject and confidentiality is maintained, research involving deception that poses no more than minimal risk, performance of non-invasive tests, collection of data using noninvasive procedures, collection of blood samples by finger stick or venipuncture by trained personnel, research using existing documents, records, pathological specimens, or diagnostic specimens.</p> <p>_____ FULL REVIEW</p> <p>Research with greater than minimal risk, research of a sensitive nature, research with vulnerable populations (children, prisoners, pregnant women, cognitively impaired individuals, non-English or English as second language speakers, or economically/educationally disadvantaged individuals), research involving invasive procedures, research inducing physical pain or potential injury.</p> <p>Does your research involve any of the following? (please check all that apply)</p> <p>____ Greater than minimal risk</p> <p>____ Research of a sensitive nature</p> <p>____ Research with vulnerable populations</p> <p>____ Research involving invasive procedures or inducing pain or potential injury</p> <p>Part II: Project Description</p> <p>Federal rules require that the IRB include individuals with varied backgrounds and education. Therefore, this section is to be written in clear and simple language using terms understandable across disciplines.</p> <p>1. List your research question(s).</p> <p>2. Citing previous research, describe the relevant literature and/or theory that supports your research question and design. (Note: This section should be approximately 1 page in length.) </p> <p>Part III: Study Population and Sample Characteristics</p> <p>3. How many subjects will participate in the research? </p> <p>4. What are the ages of the potential participants? (Check all that apply)</p> <p>_____0-7 years _____8-17 years_____18-65 years _____ &gt;65 years</p> <p>Note: Ages 0-7 require full review and a legal guardian informed consent; ages 8-17 requires full review and a child assent form along with the legal guardian informed consent form; ages 18 and older require an adult informed consent form unless a waiver is indicated.</p> <p>5. Some populations are considered vulnerable to coercion or require special protections. Will any of these populations be invited to participate in the research? (Check all that apply.)</p> <p>_____ children (under age 18)</p> <p>_____ prisoners</p> <p>_____ pregnant women</p> <p>_____ cognitively impaired individuals</p> <p>_____ non-English speakers</p> <p>_____ economically/educationally disadvantaged individuals</p> <p>_____ other (please describe): </p> <p>If you checked any of the boxes in Question #5, Provide rationale for using these vulnerable populations and detail the safeguards that will be included in the research to protect their rights and welfare.</p> <p>Part IV: Participant Identification and Recruitment</p> <p>6. How will potential participants be identified and recruited? (please check all that apply)</p> <p>____ PRIA (Psychology Signup Pool)</p> <p>____ Email/Facebook/Social Media</p> <p>____ Physical Flyers</p> <p>____ Personal Requests</p> <p>____ Other (explain)</p> <p>Include below or in an addendum the text of any email or PRIA announcements, and/or an electronic copy of advertisements, bulletin board notices, telephone scripts, and other recruitment materials. </p> <p>7. Will compensation be provided to participants? </p> <p>_____No </p> <p>_____Yes (please describe) </p> <p>NOTE: incentives (payment or gifts for participation) are taxable and require adherence to business office guidelines. Indicate how you will address the taxability of incentives.</p> <p>8. Are you working with an individual (athletic director, coach, supervisor, etc.) or group to access potential participants for this study? </p> <p>____No</p> <p>____Yes (Please list the individuals or groups)</p> <p>NOTE: a letter of agreement must be submitted to the IRB chairperson from the cooperating individual or organization. A simple online form for obtaining letters of agreement can be found at </p> <p>Part V: Methods, Materials, and Procedures</p> <p>The purpose of this section is to give the IRB a complete understanding of the processes involved in conducting this research. This helps to ensure that the rights of study participants are protected.</p> <p>9.</p> <p> Describe the research procedures. What will participants do while participating in this study? List tasks/activities that participants will be asked to complete in a step-by-step manner. You may use a numbered list or bullets to help describe your procedures. </p> <p> Within the description, include all materials and equipment you will use for data collection (videotape, audiotape, surveys, lab equipment, etc.). </p> <p> Include an estimated time it will take participants to complete each task/activity.</p> <p> Also include a brief explanation of how each activity will help to answer your research questions listed earlier.</p> <p>Note: If you will be using survey or interview methods in your research, please submit an electronic copy of surveys, interview questions, or handouts with your application (a link to the survey or other materials is not sufficient files containing the complete materials must be emailed to the IRB chair.)</p> <p>Part VI: Data Collection and Anonymity</p> <p>10. Will any of the data collected include names or other identifiers (including video or audio recordings of the participants) that indicate who is in the study?</p> <p> _____No (see below)</p> <p> _____Yes (see below).</p> <p>If you answered No, above:</p> <p>The raw data is anonymous and can normally be kept indefinitely. If you plan to destroy the data, please explain why here. Otherwise, proceed to the next section.</p> <p>If you answered Yes, above:</p> <p>Please explain why these identifiers are necessary:</p> <p>11. How will non-anonymous data (including names, photos, audio or video recordings) be collected, and stored? Describe in detail the procedure and how participants identity will be protected throughout.</p> <p>12. If codes are used to substitute for participant names, describe the process for assigning the codes, who will have access to the codes, and who will secure and maintain the code list. (For example, coding might be used to link survey data about an individual with that individuals lab data this links two sets of data).</p> <p>13. While any anonymous data can normally be kept indefinitely, the raw data and coding key from this research, which contains identifying information, should be destroyed in as timely a manner as possible. When will all data containing participant identifiers be destroyed?</p> <p>_____when the study is complete</p> <p>_____within three (3) years</p> <p>_____other: </p> <p> Provide rationale for the length of time selected above: </p> <p>Part VII: Risks and Benefits</p> <p>An important ethical principle is that research must balance risk and benefits to participants and society. </p> <p>14. Will the research present any risks to participants? _____No _____ Yes</p> <p>If you answered Yes, please describe the actual and potential risks, discomforts and inconveniences for the participants. </p> <p>In addition, indicate whether or not the risks you have identified constitute more than minimal risk, in your opinion. Minimal risk is defined as that in which the harm or discomfort anticipated in the research is no greater than that encountered in daily life or during routine physical/psychological examinations or tests.</p> <p>15. List precautions that will be taken to minimize or prevent potential risks, inconveniences, and discomforts (anonymous data collection, emergency response, etc.).</p> <p>16. Will deceptive techniques be used in the study? _____No _____Yes </p> <p>If you answered Yes, explain why the deception is necessary and when and how it will be revealed to participants. Also, provide the debriefing statement that will be used, either as a separate attachment or as part of describing the research procedures under Question #9 above.</p> <p>17. List potential benefits (if any) participants may experience as a result of participating in the research. If no direct benefits are likely, put NA.</p> <p>18. List potential benefits (if any) to society that may be expected from this research beyond the direct knowledge gained from the results of study. </p> <p>Part VIII: Informed Consent</p> <p>Informed consent is a process that typically involves: </p> <p>1) presenting information that enables individuals to knowledgeably and voluntarily decide whether or not to participate in the research; </p> <p>2) responding to the participant's concerns/questions during the research and communicating any new findings that may affect the participant's willingness to continue participating; and </p> <p>3) documenting consent with a written form signed by the participant (secured and maintained for 3 years unless otherwise stipulated by the IRB). </p> <p>Indicate below which consent documents will be used. CHECK all that apply.</p> <p>EMAIL a copy of the consent form as a Word document to the IRB chair. </p> <p>A template is located on the IRB web site.</p> <p>A) Indicate which consent documents will be used, and email a copy of each to the IRB chair.</p> <p>_____ A cover letter/page accompanying a confidential or anonymous survey that is not explicitly signed by the participant, but continuation and subsequent participation in the research is deemed consent.</p> <p>_____ An informed consent form to be signed by adult participants (ages 18 and older).</p> <p>_____ An informed consent form to be signed by participants parents, guardians or legally authorized representatives (for participants under 18 or participants who cannot legally consent for themselves)</p> <p>_____ An assent form to be signed by participants under 18 or participants who cannot legally consent for themselves</p> <p>_____ Other (please explain):</p> <p>B) Unless you checked only the first option above, describe the procedures that will be used to obtain informed consent (and child assent, if applicable). </p> <p>Part IX: Locations and Collaborations outside of CSB/SJU</p> <p>19. If you are collaborating with an individual from another institution, the research must be submitted to that institutions IRB as well, and a copy of the approval letter must be submitted.</p> <p>_____Collaboration letter submitted</p> <p>_____Collaboration letter has been solicited</p> <p>_____Collaboration letter not applicable</p> <p>Please list the institution(s) or organization(s) with whom are you collaborating: </p> <p>20. Are there any potential or confirmed funding sources for this research project? </p> <p>___ No </p> <p>___ Yes Provide name(s) of funding source(s): </p> <p>If you answered Yes above, will the funding source(s) regulate recruitment, data collection, analysis, or reporting of this study in any way? </p> <p>____No</p> <p>____Yes (explain):</p> <p>Part X: Certification Statement</p> <p>By electronically signing below, I certify/agree that:</p> <p> I have read and will comply with the Policies and Procedures of the IRB, including those designated under the Ethical Conduct of Research.</p> <p> The information in this application is correct.</p> <p> I will conduct the research in accordance with all submitted statements, except when changes are needed to eliminate an immediate, apparent hazard to participants.</p> <p> I will obtain written approval of significant deviations from the originally approved protocol or consent document(s) prior to making any changes.</p> <p> I will promptly report to the IRB unexpected or otherwise significant adverse events that occur in the course of the research. I will make reasonable effort to alleviate the effects of adverse events.</p> <p> I will report to the IRB and the participants any significant new findings that develop during the course of the study that may affect the risks and benefits to participants.</p> <p> I will use an informed consent process when required that ensures that potential research participants fully understand the purpose of the research study, the nature of the procedures they are asked to undergo, the potential risks of these procedures, and their rights as a study volunteer. I will ensure that co-investigators and other assisting with the research are fully informed of these procedures.</p> <p> I will not begin any part of the research until final written approval is granted....</p>