ࡱ> {}xyz /bjbj=G=G [\_-_-E" " j$P@<?@2 (* * * $K&|&@T>V>V>V>V>V>V>,OAD>&'*%$|$1'M'>9,* * ><9,9,9,]'* * T>9,'>9,9,89'8>><?8D9,D 99,9|6:,'''>>9,'''?D'''''''''" :   88 - Human Research Protections Program Institutional Review Board (IRB) Protocol Application HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html"IRB principles: respect for persons,  HYPERLINK "http://polycentric.csupomona.edu/news.asp?id=987" beneficence, justice 88 (CPP) is committed both to research in the advancement of teaching and science and to the protection of the individuals involved in those efforts. Thereby, as part of the assurance filed with regulatory agencies including the federal governments Dept. of Health and Human Services (DHHS) and according to policies and guidelines from others like the State of California, 88 has designated a human subjects committee, called the Institutional Review Board or IRB, to review proposals where there is research involving living persons. This protocol application, when submitted to the IRB, will be evaluated in terms of its compliance with ethical standards and regulations regarding the treatment of subjects (participants) and the risk to benefit ratio. The type of review full, expedited, or exempt will be determined by the IRB. While individual researchers are ultimately responsible for their practices, the IRBs review is designed to provide objective input as additional protection for the subjects. Further, it is of benefit to those who could be held accountable for the research practices, i.e., the researchers and the University. All research conducted by students, faculty, sponsored individuals, or others must have prior IRB approval. THE TYPICAL IRB PROCESS CYCLE Step 1: Obtain training appropriate to your research (business, with minors, general IRB 101, etc.) using the CITI Course in the Protection of Human Research Subjects to understand the IRB regulations and ethical imperatives. See the IRB website,  HYPERLINK "http://www.cpp.edu/~research/irb/index.shtml" http://www.cpp.edu/~research/irb/index.shtml, and HYPERLINK "https://www.citiprogram.org"https://www.citiprogram.org. You may be asked to pursue additional training appropriate to your study. Step 2: Write/Develop your IRB protocol (you can use this Word document, but the content needs to be entered into the  HYPERLINK "https://compliance.cpp.edu/tickatlab/default.aspx" eIRB), which describes the goals and procedures of the research as it pertains specifically to the involvement of persons as subjects. Fill out each section in detail sufficient to explain all aspects of the research for the IRB reviewer to understand. Step 3: Submit as e-file(s) your completed protocol and any attachments (surveys, informed consent forms, recruiting flyers, authorizations, etc.) to the eIRB ( HYPERLINK "https://compliance.cpp.edu/tickatlab/default.aspx" https://compliance.cpp.edu/tickatlab/default.aspx) for the initial stage of administrative review. The eIRB software assigns a protocol number (e.g., 15-0001 for the year and the sequence) at this point. Please use this number on all correspondence with the IRB. Step 4: e-Sign the protocol. You as the PI (primary investigator) -- and all co-investigators -- must read and sign the Declaration by all Investigators before the review can begin. This serves as a check that the research group is in agreement with what has been submitted for review. Step 5: ?? Step 6: The compliance office, doing an administrative review, reads and evaluates the materials to ensure all needed items for IRB member review are present and regulations and policies have been satisfied. If not, there will be communication for the PI(s) to address what is missing. Step 7: When all administrative issues have been addressed, the protocol is sent out for IRB member review. Members are CPP faculty and unaffiliated individuals who will conduct an ethical review and may contribute a research opinion as well. Step 8: The reviewing member(s) can and do request changes from the PI(s) to secure approval. During this exchange, PIs should clarify their methods and subject protections with the reviewers. When those are satisfied, the IRB chair indicates approval in the eIRB, an approval memo is generated, and the study may commence. This approval is good for one year (typically). If the research is to continue beyond, the PI must submit a renewal before the approval expires. Step 9: Any changes or deviations to the approved protocol need to be sent to the IRB for re-review and approval. Once the protocol is received, and it is complete (see below), the review and approval process usually takes 12 to 16 business days. An approved protocol may be amended and it may be renewed. For that, or in the case of an adverse event, contact the compliance office. Short checklist to ensure your protocol is complete and ready for IRB review Review these steps before you submit your application on to the eIRB. Some items are different on the eIRB site. ____ For a more detailed checklist, go to the  HYPERLINK "http://www.cpp.edu/~research/irb/index.shtml" CPP IRB website. There you will also find sample protocols and consent forms, links to training materials, IRB policies and procedures, and other information. ____ Ensure that all fields (yellow in the MS Word document) are complete and that all questions have been answered from each section. Incomplete protocols will be returned. Refer to the information in italics provided in each section for clarification. Use the blue links to access additional information. ____ Proof-read all documents. It is highly recommended to have someone not involved in the writing of the protocol to look it over for clarity and typographical errors. Have someone test surveys and comprehend your ICF. Remember, first impressions make an impression both to the IRB reviewer and to the subject who might (or might not) participate. ____ Finalize any surveys, questionnaires, inventories, lists of interview questions, recruiting flyers, etc. that you will be using in your research. If these materials are still being developed (for example, a translated ICF), indicate that they are in development in the protocol. Final approval cannot be granted until all materials are received. ____ Check that all elements of the Informed Consent Form for adults (ICF) and Assent Form for minors are included as appropriate. ____ Do provide documentation of your training with this application. Training in the conduct of human subject research is critical and investigators must demonstrate their knowledge and awareness through the completion of appropriate coursework. For other assistance, contact the Compliance Associates in the Office of Research Compliance at  HYPERLINK "mailto:irb@cpp.edu" irb@cpp.edu, 909.869.3713 or the IRB administrator, Bruce W. Kennedy at  HYPERLINK "mailto:bkennedy@cpp.edu" bkennedy@cpp.edu, 909.869.4215. The office address is building 1, room 229. 88 - Human Research Protections Program Institutional Review Board (IRB) Investigator Information and Signature Page (version: January 5, 2015) HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html"IRB principles: respect for persons, beneficence, justice Primary (aka Principal) Investigator (PI) (faculty, staff, student, etc.)Other Investigators engaged in the research as applicable (your faculty advisor, co-PIs, facilitator, sponsor, collaborators, etc.)Your name: Your status: (indicate faculty, staff, student, unaffiliated, or something else)Your affiliation: (college/dept.)Phone contact: (office or cell)Email contact: (Cal Poly address preferred)Title of your IRB protocol:Original date submitted:___ new ___ amendment to protocol number: ___ renewal of protocol number: Any vulnerable subjects (risks)?___ minors ___ pregnant women ___ medically sensitive ___ prisoners ___ other: Any permissions needed? (see 5.G)___ CPP health center ___ place of employment ___ school principal or board ___ place of business ___ other:  DECLARATION BY ALL INVESTIGATORS: This proposal is guided by the ethical principles regarding research involving human subjects as set forth in the HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html"Belmont Report. I/We agree to abide by the policies and procedures of the IRB at CPP, including obtaining appropriate training in human subject research for myself and those involved in its conduct. I/We will not initiate any research associated with this proposal on or off campus until authorized by the IRB. I/We will report to the IRB about any adverse events or unanticipated problems (unexpected, possible greater risk, etc.) that occur. I/We will inform the IRB of a need to modify the study design requiring an amendment. I/We understand that approval, when granted, is valid for up to one year and will submit a renewal for its continuation if needed. send this signed page to the IRB office Building 1, Room 229Signature, certifying the above Date (PI) primary investigator: With the implementation of the eIRB process in 2014, signatures as hard copy are no longer needed. all others, including advisors: For historical purposes, this signature page is retained. It may continue to be used in teaching exercises and situations to illustrate the information needed for actual research protocol submissions to the eIRB. IRB office use review type: full IRB (risk involved) exempt PEIP SAE expedited/designated review (minimum risk/harm) not human subject research NAdate rcd: revised assigned to:training: PI othersapproval date:protocol #: eIRB #:renewal date:copies: chair file final: signed ICF approval-memo authorizations e-mailed This protocol has been reviewed and approved for conduct by the IRB, 88. Jeffery S. Mio PhD, Chair, IRB Date Answer each question in the sections below adequately enough so that ethical standards and human protection can be determined by an outside reviewer. Be sure to address all questions asked within each section, as this will help to speed the review and approval process of your protocol. 1. RESEARCH FOCUS AND CONCEPTS Research for IRB purposes is defined as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html"http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html A. Purpose of this study Why are you conducting this study? What are the goal(s), objective(s) and outcome(s)? What hypothesis or hypotheses are you testing or what are the research questions? Explain the rationale and impetus for your research project. Provide enough detail such that: a) the IRB member(s) reviewing your protocol will understand your research plan and b) it supports a judgment of the risks and benefits in order to approve the use of the research participants. PURPOSE: Specific Aim 1: Independent Variables: Dependent Variables: Specific Hypothesis 1: Specific Aim 2: (if applicable) Independent Variables: Dependent Variables: Specific Hypothesis 1: B. Relevance State specifically the relationship of your proposed research to other, previous scientific and/or scholarly investigations in the field or to existing best practices. What literature is related to your research? On what are you basing your own work, pertaining to the use of human subjects? What are you doing that builds on existing research findings/best practices? What work has come before and what have you learned from it to inform your own methods and questions? Provide full citations (APA or MLA reference styles are good). *Work cited must be included in this section. 2. METHODS It is important that the procedures to be applied some might call these treatments - to the human subjects are thoroughly explained and outlined. Those who will review and approve your study must fully understand what will take place during its conduct. Once approved, it is necessary that the procedures be carried out in the way they are officially described in this protocol. A. Summarize the overall design of your proposed study. Will you use an experimental, quasi-experimental, or correlational design? What are the independent variables, interventions, treatments, etc.? Experimental Design (do not include timeline here) B. Provide a step-by step outline of the activities included in this study. What events will occur and in what order? How will the information about the study be presented to the participants? Please note you are asked to describe the specific measures and data to be collected in Section 5 below. Late April-IRB approval Early May-send out survey through email Mid-May-collect results, analysis of data, prepare descriptive statistics Late May-use results to inform finalization of extended course outcomes. 3. SUBJECTS AND THEIR RECRUITMENT The terms subjects and participants are often interchangeable. A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information. (Dept. of Health and Human Services, 45CFR46) A. Briefly describe the characteristics of the subject group(s). Who in a population, from which you will sample, are you trying to study? What are you looking for in your subjects? What will you use to qualify them (e.g., age, gender, being a student or faculty member, being able to do a specific task, belonging to a certain group, etc.)? We are studying Sociology students at 88 who are 18 years old or older. * (This is the only criteria to qualify for this study example). B. How many subjects (or participants) will be involved in the research project? How did you determine your sample size? It is acceptable to have a range, but it must be a close approximation. For projects with surveys (e.g., electronic, phone, written, door-to-door canvassing), indicate the number to be recruited, the anticipated response rate, and thus the estimated final number of actual participants. Around 300-400 students across the Sociology courses should be taking the assessment. Sample size was determined by XYZ. * (This is the only criteria to qualify for this study example). C. What are the benefits, if any, to the subjects from their participation in the study? Most studies have some kind of benefit, even if they are purely educational. Will the subjects personally gain something through the research by being a subject? This information summarized must be included in the consent (and/or assent) form as well. If there is no direct benefit to the subject, this needs to be stated here. The benefits of participating in this study are as follows: 1. Receiving assessments for social skills. 2. Receiving 2 weeks of supervised behavior therapy. OR Though there will be no monetary compensation for the participants, they will be informed that their participation will help inform scholars, educational experts, and other students about the factors that greatly influence social skills. OR Though there will be no monetary compensation for the participants, they will also be informed that their participation will help inform scholars, educational experts, and other students about the factors that greatly influence social skills. * (This is the only criteria to qualify for this study example). D. Will the subjects be compensated? Will they be given something? If yes, in what way (token of appreciation, money, gift, cash card, course credit, food, lottery ticket, etc.)? This information summarized must be included in the consent (and/or assent) form as well. If there is no compensation, then state that clearly. $150 compensation upon completion OR There will be no monetary compensation for the participants. * (This is the only criteria to qualify for this study example). E. How will you gather your potential subjects to participate in the study? Where will you recruit them? (For example, will you recruit subjects using e-mails or flyers?) Include any recruitment materials you will be using with your application. As applicable, attach copies of flyers, e-mail or blog text, advertisements, etc., to be used for the recruitment of subjects. Review by the IRB is necessary for approval of your protocol. Include the statement as follows: The 88 Institutional Review Board has reviewed and approved for conduct this research involving human subjects under protocol YY - #### (meaning year and sequence number). Will translation of materials be necessary to other languages or to a different reading and comprehension level for recruiting purposes? Consider that children often need simplified language. Studies show that the average adult reads at a 5th to 8th grade level. A recruitment flyer (both electronic and paper form) will be used to recruit the subjects. A copy of the electronic flyer and paper form has been uploaded. Flyers will be distributed at events and through email. Or A copy of the recruitment email is attached. Translation will not be necessary. * (This is the only criteria to qualify for this study example). F. Describe your procedures for the recruitment of a representative sample of the population. Is your recruitment based upon race, ethnicity, gender, health status, or other characteristic? If this is not the case, discuss the reasons for not having such a balanced sample (such as, the research is focused on a certain subject group or its a case study). *Only if applicable. 4. VULNERABLE SUBJECTS When a subject has limitations, is coerced or manipulated, there is a loss of capability to volunteer, and the subject may be vulnerable. According to regulations, vulnerable subjects include prisoners, pregnant women, minors and fetuses. The IRB considers other kinds of vulnerability, for example, the possibility that bosses can coerce at the workplace and teachers can manipulate in the classroom. Research conducted with regulated vulnerable subjects requires demonstration of your training and experience with that specific population (include in section 8). A. Minors Will HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "subpartd"children, minors, or wards be recruited for this research? Children in most circumstances are those less than 18 years of age. Research with children involving no greater than minimal risk requires the permission of one parent and the assent of the child (45 CFR 46.404). Please note: Research involving minors is typically subject to full IRB review. Yes or No. The different vulnerable populations have been covered in the CITI training. Please review the CITI training if you have questions about vulnerable populations. B. Other kinds Explain research which involves other vulnerable subjects such as HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "subpartc"prisoners, HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" \l "subpartb"pregnant women, or culturally or medically vulnerable groups? Consider the circumstances, too. For example, a pregnant woman answering a survey about being a teacher may not be vulnerable, but she could be if its a study about baby furniture. If yes, specify what vulnerable population will be recruited. The different vulnerable populations have been covered in the CITI training. Please review the CITI training if you have questions about vulnerable populations. 5. DATA COLLECTION AND PROCEDURES Collection methodologies include, but are not limited to: surveys, interviews, focus groups, oral histories, participant observation, observations of public behavior, research in public schools, and the analysis of existing data. Data include: survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, previously collected (existing) information, etc. Personal and private data deemed by the IRB to be a risk to subjects if revealed include: gender, income, number of children, age, religion, ethnicity, e-mail addresses, and more. Even when labeled as demographic data, it is still personal and private and could potentially identify an individual. This is not to say such data should not be collected, but mechanisms must be described in this protocol to protect the interests of the subjects should they be (somehow) identified. The HIPAA Privacy Rule regulations [45 CFR 164.514(b)] list specific elements that are considered to be personal identifiers. These include: name and initials; street address, city, county, precinct, zip code, or equivalent geocodes; elements of dates (except year) directly related to an individual (date of birth, admission date, discharge date, date of death); elements of date including year for persons 90 or older; telephone and/or fax number; e-mail address; social security number; medical record or health plan identification number; account number; certificate and license number; vehicle identifier and serial number including license plate number; device identifier and serial number; web address (URL), internet IP address; biometric identifier including finger and voice print, full face photographic image and comparable image; other unique identifying number, characteristic, or code. A. List the data that you will collect from the subjects. What information (the variables) are you obtaining from the participants? In what format will you collect the data? The online survey is divided into 2 sections (variables). Section 1: Section 2:  B. Describe each of your studys measures, data collection tools/apparatus, and data collection procedures. Describe in detail all procedures to be done with human subjects. What types of test(s) will you perform on or with the subjects? How will you carry them out? The link will take them directly to the informed consent form stating the purpose of the study, risks and benefits, and other information that the student will need to make an informed consent. If the participant consents, he or she will click next to begging answering the online survey. * (This is the only criteria to qualify for this study example). C. If applicable, have you submitted a copy of the survey or questionnaire to the IRB? A copy (actual hard copy or PDF) of the survey should be provided for electronic surveys. If using a published survey with a copyright, do you need and have you provided permission to use it? If any changes are made to the survey after approval, the IRB must be notified. yes in development (only finalized surveys can be approved) not applicable D. If using a survey, will it be conducted online? Provide the URL for electronic survey. This would include SurveyMonkey or other professional internet-based data collection surveys. Your survey will be tested during IRB review; so discard those data before going live. The link to the survey is the following: https://cspomona.survey.com A PDF version of the survey and consent form are attached as well. * (This is the only criteria to qualify for this study example). E. Will you use any third (3rd) party online websites to collect data? If so, which websites will be utilized? This would include any social media websites where you post your survey link for potential subjects to access. For example, if you post a SurveyMonkey link to Facebook, your ability to control what information is exchanged over the internet could vary and be limited. What steps will you take to insure the privacy and security of data you collect online? How might you prevent someone under the age of 18 participating in a study designed for adults? The link to the survey is the following:  HYPERLINK "https://cspomona.survey.com" https://cspomona.survey.com * (This is the only criteria to qualify for this study example). F. What is the timeline for your research? When do you plan to conduct your study? Provide approximate beginning and ending dates. If there are multiple time periods, indicate the dates for each period. June 2015- September 31, 2015 * (This is the only criteria to qualify for this study example). G. Where will your research be conducted? What kind of authorization or permissions do you need? Will the research take place in another country? The IRB must receive authorization/permission verification prior to the approval of your protocol. Will you be conducting any experiments in a lab or classroom or collecting data in the field? The IRB needs evidence that you are permitted to conduct the research in other venues for the protection of you, your subjects, and institutions. For example, a signed letter or email authorizing a study at your work or in a business, or from a school principal or school board, or to use the CPP student health center will be required for protocol approval. Provide information about the human subjects procedures that apply for your international studies (see the CPP IRB Policies and Procedures document). The research will take place in the USA. Participants will come from Cal Poly Student body. * (This is the only criteria to qualify for this study example). H. For studies involving medical records, explain compliance with the HIPAA privacy rule (Health Insurance Portability and Accountability Act) and disclosure of protected health information (PHI). See HYPERLINK "http://www.csupomona.edu/~research/irb/Hints_help_examples.shtml"http://www.cpp.edu/~research/irb/Hints_help_examples.shtml for the Experimental subjects bill of rights Medical research consent form if any invasive procedures are to be performed. not applicable comment: 6. DATA SECURITY PROCEDURES Per California law, CC 1798.24, the researcher must provide a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information. A. Who will have access to and use the data? Describe who else will be involved in this research. What will their responsibilities be within the study? Will you have research assistants? All others involved and engaged in the research - including research assistants and associates - must complete CITI training before they may work with subjects. For example, a person who hands out ICFs to participants is considered to be engaged in research, while a statistician who analyzes the data is not engaged. Their CITI completion record must be included below in section 8: Researcher/PI Training. Please name PI, Co-PIs and research assistants that will have access to the data. * (This is the only criteria to qualify for this study example). B. How will the raw data be kept protected and secure? How will it be coded or identified? Will social security numbers or other personally identifiable information be used? What will become of the data at the end of the study (returned, destroyed, archived? Keep in mind that some demographic data are considered to be identifiers. If you are collecting data online, know that an IP address is considered to be an identifier. If data like audio and video tapes are kept for any reason (such as archiving for publication), the subject must be told of the purpose (e.g., conference presentations) and for how long, as part of the informed consent process. Also, if you are going to be using audio and video tapes there must be a section on the ICF for the subject to initial that they agree to being recorded. The subject has the option, after the study is over, to contact the researcher to withdraw permission for continued use. This information summarized must be included in the consent form. To keep the data protected and secured, the following steps will be followed: (1) The PI will delete the survey from surveymonkey to not leave record of the responses. (2) The data file will be stored in the PI personal computer that he only has access to. Also, the PI's personal computer is password protected. (3) The data file will be password protected and only the PI will have access to the file. * (This is the only criteria to qualify for this study example). C. How will the data, results, and conclusions be utilized? Do you plan to use it in a presentation, publication, or something else? Will the data be shared with any other researchers or funding agencies? Will these data appear in a published thesis or journal publication? This information summarized must be included in the consent form. The data will be used in aggregated form to present at conferences and/or to write manuscripts for publication consideration to sociological journals. * (This is the only criteria to qualify for this study example). 7. POTENTIAL RISKS AND THEIR ASSESSMENT Definition of risk: A potential harm, discomfort, or inconvenience associated with your research that a reasonable volunteer would be likely to consider significant in deciding whether or not to participate. Risks include legal, social, emotional, or psychological issues, physical or biological hazards, revealing an identity, damage to reputation, exposure of behavior or medical character, illness, injury, side effects of applied or consumed products, revealing or a loss of private information, etc. Risk comes at various orders of magnitude, ranging from mere inconvenience to perceptible bodily pain. A. What are the risks? Describe any potential harm, discomfort, or inconvenience, however minimal, as you would explain them to the subjects. It can be said that everything has a risk. Think carefully about what may potentially happen during your research. This information summarized must be included in the consent form. Describe any potential discomfort, or inconvenience, however minimal, as you would explain them to the subjects. We consider every research to have risk involved, however minimal this might be. This can range from risk of time inconvenience for the subject to great physical risk, for example. In your study, no great risk involved, it is more so of inconceivable risk involved. For example, you can state that, "Although extremely rare..." Keep in mind the potential discomfort or inconvenience that the interview might cause to the employees of the companies you are contacting. B. Describe your procedures for protecting against or minimizing the potential risks. Is a debriefing statement needed? Contact information for Counseling and Psychological Services (CAPS at CPP) might be necessary. Do you have procedures and contacts with medical emergency services for treadmill exercises or phlebotomy? Could someone else not affiliated with the study obtain the personal and private data that you collect? Should an adverse event like these occur something you dont anticipate or didnt plan on the IRB web site has a reporting form for this purpose. Procedures that will take place to minimize risks. C. Explain why these risks should be determined as reasonable in relation to the anticipated benefits, if any, while conducting research with the subjects. Include in your response the importance of the expected gain in generalizable knowledge, when evaluated against the risks. The potential of risk is minimal in this study. The data from this study will begin the discussion by providing empirical evidence about the different sub-types of language brokers. The literature in this topic is flourishing and answering this gap in the literature is important. * (This is the only criteria to qualify for this study example). D. Is your study anonymous or confidential? Why do you think so? The response should be consistent with that in section 6 about your procedures to assure the protection of subjects information, sensitive data, and privacy. In other words: If anonymous, how will you protect that status for the participants? If confidential, how will you protect the information and data from further release? See the CPP IRB HYPERLINK "http://www.cpp.edu/~research/irb/Documents/anonymous_confidential.doc"web page for a discussion of what is confidential and what is anonymous. This is a highly significant point to understand and consequently to explain in the protocol (for the Boards review) and in the informed consent form (for the subjects). Keep in mind that studies are either anonymous or confidential, almost never both. There are processes to de-identify data obtained in confidence, thereby making it anonymous. Please read the following guideline on anonymity and confidentiality to better address this question.  HYPERLINK "http://www.cpp.edu/~research/irb/Documents/anonymous_confidential.doc" http://www.cpp.edu/~research/irb/Documents/anonymous_confidential.doc 8. RESEARCHER (PI) TRAINING Both formal training and practical experience in research with human subjects are critical for the protection of the participants and minimization of risk that might be associated with the conduct of your study. Federal regulations require that investigators possess training. The CPP IRB adopted in 2006 the on-line HYPERLINK "https://www.citiprogram.org/default.asp"CITI program as required training in human subjects research (CITI training is valid for five years). All investigators submitting applications to the IRB must complete appropriate modules of CITI as a condition of approval of a protocol. Other formal training will be considered by the IRB on an individual basis. See HYPERLINK "https://www.citiprogram.org"https://www.citiprogram.org and the training section of the CPP IRB website. A. Describe the training possessed by you as the primary investigator. Include when it was obtained. Provide your CITI completion report number. Will you be obtaining any additional training related to this proposal? If you are a student, your advisor (faculty mentor) must possess training as well, which you are to describe in the next section (8B). Susie Samuels (PI) CITI Member ID# XXXXXXX CITI Research Basic course Passed on 12/04/2013 Report ID#XXXXXXX CITI research involving Minors Passed on 03/16/2015 Report ID#XXXXXXX Please consult the CITI course guide to complete the appropriate courses for the study that you wish to conduct.  HYPERLINK "http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls" http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls B. Describe the training possessed by others engaged with the study, including your co-investigators, research associates (RAs), collaborators, students, staff, faculty members, a students mentor or advisor, etc., from Cal Poly or elsewhere, working on this study. Other investigators who are engaged (see here for the CPP IRB guideline on engagement) with the subjects must sign the Declaration by all Investigators statement. Include when it was obtained. Provide CITI completion report number(s). Provide a copy of this report if training was obtained from a different institution. List and identify the role of each co-investigator, e.g. Billy Bronco, RA, research with minors report #012345, 13 Nov 2014; Dr. Hans Schmidt, collaborator at German University, e-signed, ethics training from German University attached Dr. Joel Smith (what is their role?) CITI Member ID# XXXXXXX CITI Research Basic course Passed on 12/04/2013 Report ID#XXXXXXX CITI research involving Minors Passed on 03/16/2015 Report ID#XXXXXXX *Note: The Pi must obtain the CITI reference numbers of all the research team members prior to submitting the protocol for review. Please consult the CITI course guide to complete the appropriate courses for the study that you wish to conduct.  HYPERLINK "http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls" http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls C. Describe the training being provided to research staff *not* engaged with subjects, but handling data. This section is typically used for research associates (RAs) who transcribe data, perform statistical analysis, etc., but are NOT engaged with the subjects. Their training may come from CITI or the PI may have an internal training document provided to RAs.Investigators who are engaged (see here  HYPERLINK "http://www.cpp.edu/%7Eresearch/irb/index.shtml" \t "_blank" http://www.cpp.edu/~research/irb/index.shtml for the CPP IRB guideline on engagement, section 14.17 "Clarification of investigator roles and level of engagement") with the subjects must e-sign the Declaration by all Investigators statement. Only if applicable. Juan Fernandez (what is their role?) CITI Member ID# XXXXXXX CITI Research Basic course Passed on 12/04/2013 Report ID#XXXXXXX CITI research involving Minors Passed on 03/16/2015 Report ID#XXXXXXX *Note: The Pi must obtain the CITI reference numbers of all the research team members prior to submitting the protocol for review. Please consult the CITI course guide to complete the appropriate courses for the study that you wish to conduct.  HYPERLINK "http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls" http://www.cpp.edu/~research/irb/Documents/CITImoduledesignations.xls 9. AFFILIATIONS These questions ask about how you are related to the institution and subjects where the research project is to be conducted. As examples: you are a teacher using your students in a classroom setting as your subjects, or you work for the company where a marketing survey is to be conducted, or you have a financial interest in a product being tested, or you are working with a colleague in another country. Each of these examples presents an element of risk. IRB reviewers will evaluate whether these risks are reasonable and whether they are sufficiently controlled, minimized, or eliminated by your procedures. A. Are you collaborating with another group such as a school, community association, government agency, etc.? Is IRB approval necessary, or being obtained, elsewhere (domestically or HYPERLINK "http://www.csupomona.edu/~research/irb/Hints_help_examples.shtml"internationally)? Is the study being sponsored or supported through a grant, contract, or other financial arrangement? Does the funding agency require IRB approval? Describe as appropriate. The IRB is required to collect such data for OHRP (Office for Human Research Protections) on studies funded by the DHHS (NIH, FDA, etc.). The 88 IRB can work with the ethical research boards at other institutions to negotiate approvals. The PI has obtained permission to do the study at.(if applicable). Documentation of this approval is attached. * (This is the only criteria to qualify for this study example). B. Personal gain As an investigator involved with the project, do you or any of your family members (e.g. spouse, child) have a financial or other self interest in this study? If yes, describe. For example: an MBA student may conduct a consumer survey about establishing a business (restaurant) she herself wants to open. In this case, there could be a need for disclosure of that fact in the informed consent form. There is no financial interest. This is a requirement of my MA degree. * (This is the only criteria to qualify for this study example). C. Are you a student? Is this project part of a classroom experience or a graduate program? Has your advisor/mentor reviewed your IRB application? Describe as appropriate. Student protocols cannot be reviewed by the IRB until there is evidence of 1) the advisors contribution to the protocol, 2) his/her training with human subjects, and 3) his/her e-signature on the eIRB protocol application. Also, see the 88 guideline on Undue Influence and Coercion in Protocol Consent within the IRB website for acceptable model ICF statements to use for degree completion. The PI is a Graduate student at 88, working with an advisor, Dr. Joel Smith This project is part of a graduate program. The advisor has reviewed the protocol. * (This is the only criteria to qualify for this study example). D. Do you have any kind of pre-existing relationships with the subjects (participants) or institutions involved in conducting this study? Is there a possibility that collection of data from either the participant or institution may be seen as a favor and/or coercive when they are being asked to volunteer information? As appropriate, please describe. State any type of relationship apart from the study itself. If you work for an off-campus organization or entity and need to keep its identity confidential, note that here. See the 88 guideline on Undue Influence and Coercion in Protocol Consent within the IRB website. There is no pre-existing relationship with the potential participants in the study. * (This is the only criteria to qualify for this study example). E. If you are not affiliated with 88, who is your co-PI or facilitator on campus? A co-PI applies when there is a collaborative research project being proposed in this protocol. A facilitator applies when there is a need for logistical support to conduct your study at 88. Not all studies need a facilitator, but the IRB may, upon review of your protocol, make it a condition for approval. See section 14.14 of the HYPERLINK "http://www.csupomona.edu/~research/irb/policies_procedures.shtml"IRB policies and procedures. Obtaining a facilitator is the responsibility of the PI(s). Describe as appropriate. Specify the name, email address, and phone number of either your co-PI(s) or facilitator. If applicable. F. If you are collaborating with another group such as a school, community association, government agency, etc., do you have official approval to conduct research at this site? The IRB will need written confirmation of this approval. If applicable. G. Though there may not be one, could there be the perception of a conflict of interest for either you, as the investigator, or for the subjects in this study? If so, how will you manage that? See  HYPERLINK "http://www.csupomona.edu/~policies/Administrative/conflict_of_interest_and_financial_disclosure.html" http://www.cpp.edu/~policies/Administrative/conflict_of_interest_and_financial_disclosure.html. Please visit the link above for more information regarding conflict of interest. 10. INFORMED CONSENT FORM FOR ADULTS AND ASSENT FOR MINORS The informed consent form (ICF) is the means by which you as the PI convey not only the research, but also the principles of human subjects protections to your subjects: respect, beneficence, and justice. There are examples on the IRB website. Complete the accompanying consent form(s) below. Include it as part of the URL in electronic surveys. Include it when submitting this protocol application for review. Include the assigned IRB protocol number in your ICFs. Be sure that your ICF meets all of the requirements in the ICF Checklist listed below. A. How will you obtain and document informed consent (for adults) or assent (for children)? Which study personnel will be involved in obtaining consent and/or assent? For certain types of research methods, like anonymous on-line surveys, it is possible to obtain a waiver of documentation of consent (implied or passive) from the subjects. Contact the IRB for a determination and the requirements. A justification must be provided to obtain the waiver during the IRB member review. Informed consent will be obtained via online survey. It is the first page the participant will look when accessing the survey. If the participant consents to participate, he/she is required to click the "next" button. By clicking next the participant has agreed with the informed consent. * (This is the only criteria to qualify for this study example). B. Will there be recruitment of subjects who cannot themselves provide informed consent? If so, how will informed consent be documented for this population? For example, the ability of minors to assent could be dependent upon their age and/or their circumstance. Persons in vulnerable situations could be impaired in their ability to understand the study and may not be able to consent. No minors or other vulnerable populations will be recruited. All participants must consent prior to entering the survey. * (This is the only criteria to qualify for this study example). C. Describe how you will maintain the consent forms received from the subjects? Where (the location) will they be kept? For how long/until when? Will they be kept separate from subject data and specimens? For anonymous studies, it is crucial to keep identifiers separated from the actual data. There will be no paper informed consent forms. When the participant clicks the "next" button at the beginning of the survey, it is recorded that they have consent. * (This is the only criteria to qualify for this study example). D. How many (versions of) consent and assent forms are you submitting? Have you reviewed the checklist below? The IRB requests the header on the following page be included in the ICF(s) of all 88 approved protocols. It is also provided in Spanish. Complete the ICF based upon the elements in the checklist below. A properly written ICF will include the following elements. You, as the primary investigator, are responsible for addressing each when writing your consent and/or assent form. Both federal and California regulations require the inclusion of these elements to adequately inform subjects when participating in research. Incomplete forms will be returned to you for revision. See the IRB website for examples. You may submit the ICF as part of this protocol application or you may send it as an attachment, but it must have the informational header below. One. * (This is the only criteria to qualify for this study example). Informed Consent Form Checklist Title of the protocol (same as on the front page of this application). Protocol number as assigned by the IRB (it will be provided after the protocol is submitted to the eIRB); it must appear distinctly (e.g., bolded, its own line). A telephone number and/or e-mail address of all primary investigator(s) of this proposal, including faculty members and students, who would be the point(s) of contact for the subjects. Affiliations (professional and institution) of the contacts and investigators; use full names, thus dont write 88 - use 88. Clarification of the contacts in research projects which involve multiple sites (there can be multiple offices of research for example). A statement that the study you are conducting involves research. An explanation of the purpose(s) of the research; why its being conducted by you. A description of what the subject must do as part of the research, what data will be collected, what will happen to the data after the active phase of interaction with the subject is completed. (It has been found useful to include blocks in the ICF for subjects to initial when audio or video taping, so as to further document that these methods will be conducted.) The expected duration of the subject's participation on the study (e.g., 50 mins in one day, four visits between May 1 and June 30). The information about the procedures must be presented in layman's terms (at the 5th grade reading level); it must fully explain to the subjects what they are expected to do. The entire consent and/or assent form may need to be translated into the subjects language of fluency. Identification of any procedures or methods which are experimental. A description of any reasonable and foreseeable risks or discomforts to the subject. Changes of pronoun as appropriate to the subjects (e.g., you will be asked ; your child will do ). A description of any benefits to the subject or others which may reasonably be expected (or not) from the research. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments would be available if injury occurs and, if so, what that would consist of and where further information may be obtained. California law, under Health & Safety Code Section 24172, requires that any person asked to take part as a subject in research involving a medical experiment, or any person asked to consent to such participation on behalf of another, is entitled to receive the HYPERLINK "http://ag.ca.gov/research/pdfs/bill_of_rights.pdf"Experimental Research Subjects Bill of Rights written in the language in which the person is fluent. An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and - as appropriate - to contact in the case of a research-related injury to the subject. A statement that participation is voluntary, that declining to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled. Printed name and signature lines for the subject/participation and the date signed. Printed name and signature lines for the primary investigators (e.g., faculty member or the student conducting the research) and perhaps research associates; and the date signed. A statement that the subject is entitled to receive a copy of the completed informed consent (or assent) form. 88 Informed Consent Form for Research Involving Human Subjects You are being invited to participate in a research study, which the 88 Institutional Review Board (IRB) has reviewed and approved for conduct by the investigators named here. This form is designed to provide you - as a human subject/participant - with information about this study. The investigator or his/her representative will describe this study to you and answer any of your questions. You are entitled to an Experimental Research Subjects Bill of Rights and a copy of this form. If you have any questions about your rights as a subject or participant, complaints about the informed consent process of this research study, or experience an adverse event (something goes wrong), please contact the Research Compliance Office within 88ޒs Office of Research at 909.869.4215. More information is available at the IRB website,  HYPERLINK "http://www.cpp.edu/~research/irb/index.shtml" http://www.cpp.edu/~research/irb/index.shtml. Below is this header in Spanish: Forma de Consentimiento Informada para Investigacin que Implica Sujetos Humanos Usted est invitado a participar en un estudio de investigacin que el Comit Examinador Institucional (CEI) de 88 ha revisado y aprobado para ser conducido por los investigadores nombrados aqu. Esta forma est diseada para proporcionarle informacin acerca de este estudio en su calidad de sujeto humano. El investigador o su representante le describirn este estudio y le contestarn cualquier pregunta que tenga. Usted tiene derecho a la Declaracin de Derechos del Sujeto que participe en una Investigacin Experimental y a recibir una copia de este documento. Si tiene alguna pregunta o quejas acerca del proceso descrito en dicho documento, por favor llame a la Oficina de la Conformidad que forma parte de la Oficina de Investigacin de la Universidad de 88 al 909.869.4215. Ms informacin esa disponible en sitio web del CEI en el  HYPERLINK "http://www.cpp.edu/~research/irb/index.shtml" http://www.cpp.edu/~research/irb/index.shtml.     IRB application, page  PAGE 12 of  NUMPAGES 13 I would use the same vocabulary as in the prompt: goal, objectives, outcomes I would add because here to be sure they get why they do or dont need translation. Many times here it will say, no translation needed but later it is evident that there is a need to have materials available in an alternate language. It would be beneficial to have them think this through a bit here. This seems confusing. I think the prompt is very clear, maybe an example of a bulleted list of variable examples? 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