ࡱ> ')$%& =bjbj  4, , $P\Vt>~"%%%> > > > > > >$iBEtD>%$$%%D>Y>*(*(*(%>*(%>*(*(:,,B-hn/M%~ - >o>0>-.E*'EB-"d-E/%%*(%%%%%D>D>*(%%%>%%%%E%%%%%%%%%, L:  IRB APPLICATION TEMPLATE Section I: Protocol Description Study Title. Principal Investigator (person conducting the research). Professional title and email. Write an original, brief, non-technical description of the purpose of your research. Include a narrative that explains the major parts of your study and how the data will advance your research hypothesis or question. NOTE: This section should be easy to read for someone not familiar with your academic discipline. Provide relevant background information and scientific justification for your study. You may provide citations as necessary. Please adhere to a 350-word limit (not including citations). State your research question(s). Your planned research protocol should be one that can realistically address your research question(s). Provide the inclusion criteria for the participant population (e.g., by gender, class, race, occupation, or age). Provide a rationale for selecting this population for research purposes. Federal guidelines state that research cannot exclude any classes of participants without scientific justification. Indicate who will be excluded from your study and why (e.g., persons under 18 years of age). Provide the maximum number of participants you plan to enroll for each participant population and justify the sample size. Describe your recruitment methods. How and where will participants be recruited (e.g., flyers, announcements, word-of-mouth, snowballing, etc.)? Submit a copy of all recruitment letters, scripts, emails, flyers, or social media posts you plan to use to recruit participants for your study as separate documents with your application. You will need to include your IRB Protocol number (e.g., 18-123) on all recruitment materials, including announcements, online posts, and email text, etc. Describe the location, setting, and timing of data collection (e.g., face-to-face interview at a mutually convenient location, at the start of the semester). Include the state, city, school district, etc. Note: If you are recruiting participants from institutions other than 51Թ include a site permission form (template located in Mentor/Documentation) or a pending IRB approval from the institution(s) with this submission. If you are conducting any part of your research within NYC DEPARTMENT OF EDUCATION (DOE) Schools, it is required that you receive approval from 51Թ IRB prior to submitting your application to the Department of Education IRB (DOE IRB). Section II: description of study activities & procedures List what your participants will be asked to do during your study and your data collection process (e.g., fill out a 25-question, closed-ended, paper survey). Note: Submit copies of all instruments, surveys, interview questions, observation checklists, etc. that you plan to use for data collection as separate documents. Indicate whether data are collected as part of an initial participant screening or the actual study. If you have multiple participant groups (e.g., parents, teachers, and students or control groups and experimental groups), please specify which group you are asking to complete which task(s). If applicable, submit separate translated copies of all questionnaires, interview questions, consent forms, and recruitment materials, for each participant population. Upload a copy of the back-translation (translation into the target language and back into English) document using Google-Translate to validate translation accuracy. Alternatively, the translator can sign the translation verification form in Mentor/Documentation. Please check the box(s) that best describes the specific nature of your data. In Microsoft Word, double-click the box or type an X to mark your selection. FORMCHECKBOX I will personally collect new data. FORMCHECKBOX I will access existing data. FORMCHECKBOX Somebody else will collect the data via proxy (please explain). FORMCHECKBOX I will use a web-based data collection site (e.g., Amazons Mechanical Turk (MTurk) or ResearchMatch). FORMCHECKBOX Other (please explain). Please check the box(s) that best describe your study activities. In Microsoft Word, double-click the box or type an X to mark your selection. FORMCHECKBOX Audio recordings FORMCHECKBOX Clinical trials, Experiments, or Randomized Controlled Trials FORMCHECKBOX Documents and Records FORMCHECKBOX Ethnographies, Oral History, and Case Studies FORMCHECKBOX Interviews or Focus Group Sessions FORMCHECKBOX Online (e.g., Qualtrics, RedCap, or other web-based collection method) FORMCHECKBOX Observations FORMCHECKBOX Program Evaluations FORMCHECKBOX Other (please explain) FORMCHECKBOX Video recordings Please list the activity, occurrence, and duration in which your participants will be engaging. Name of Task or Procedure (e.g., individual audio recorded interview)Number of occurrences (e.g., twice)Activity Duration (e.g., 30 minutes, each time)Total time per participant (e.g., one day, two interviews, 60 minutes total)Describe the data collectedTotal hours of participation for all tasks: Total duration of participation (e.g., days, months, and/or years): If you will be audio/video recording, please state how you will ensure that all participants have consented to be recorded. How will you ensure that individuals who are not participating in your study (e.g., other children in a classroom) will not also be recorded? State whether participants will be compensated for their participation. NOTE: If you plan to use a lottery system, please state odds of winning here and in the consent form. Also, if you will be offering course credit for study participation, you must discuss this here and include the alternative assignment for those who decline to participate in the study. Will compensation be pro-rated if the participant does not complete all aspects of the study? If you pay participants after their participation, please make it clear how you will link names/contact information confidentially to any record of the compensation. Will deception be used? If so, please provide a rationale for its use. NOTE: Upload a debriefing script as a separate document. Include a statement that gives your participants the opportunity to withdraw their participation at that time. Studies involving deception are given Full Board Review unless the deception is minor and risks are minimal. Will you have a control group, or a comparison group? If so, please describe your procedures and explain the purpose of using a control group. Will you need bilingual interpreters or interviewers, and if so, what will you do to ensure participant confidentiality? What are your procedures for recruiting interpreters and interviewers? Section III: description of research risks & Benefits Describe the potential risks to your participants. Risks can be physical, psychological, economic, or social. What is the likelihood of these risks occurring, and/or their seriousness (e.g., exposure of sensitive data)? How will you work to minimize these risks? NOTE: The IRB regards no research involving human participants as risk-free.You may describe minimal risks for your study (such as discomfort, boredom, fatigue, etc.), or state that the research will involve minimal risk, similar to an activity (named) that participants would perform in their daily lives. What are your plans for ensuring necessary intervention in the event of a distressed participant and/or your referral sources if there is a need for psychological and/or physical treatment/assistance? What qualifications and preparations enable you to estimate and minimize risk to participants? Describe any possible direct benefits to your participants. Most research will not have any direct benefits to participants. Occasionally, a study design will include a diagnosis, evaluation, screening, counseling or training, etc., that has a concrete benefit to participants, independent of the nature or results of a research study. Section IV: Confidentiality procedures & Participant Privacy Please check the box(s) that best describes your data. Note: Sensitive data potentially poses substantial threat to research subjects and can become problematic for the researcher, researched collection, and/or the dissemination of research data (Lee & Renzetti, 1990). Substantial threat may include threat to reputation, employment, or access to resources. Sensitive data may include studies of domestic violence, immigration status, political activism, homicide, death, trauma, assault, and/or mental, sexual, or physical health (Lee, R. M., & Renzetti, C. M. (1990). The problems of researching sensitive topics: An overview and introduction. The American Behavioral Scientist, 33(5), 510528).  FORMCHECKBOX Completely anonymous data (both sensitive and non-sensitive) FORMCHECKBOX Non-sensitive data with identifiers FORMCHECKBOX Sensitive data with identifiers FORMCHECKBOX Other (please explain) For data with identifiers please describe your method for de-identifying the data to maintain confidentiality. Note: The term de-identified data refers to subject data from which all information that could reasonably be used to identify the subject has been removed or replaced. For example, the researcher may use the safe-harbor method to remove specified identifiers (name, address, phone, or any other unique identifier, etc.) from a dataset; the partially de-identified method to remove most, but not all identifiers from the data set (may require a data use agreement); or the generation of variables method to replace study subjects identifiers, like using a unique code or pseudonym. To be truly de-identified data, the investigator cannot have codes that link to identifiers. If you are working with sensitive identifiable data, please explain why identifiers are necessary to carry out your research. Sensitive identifiable data should never be sent as an email attachment. NOTE: If you are collecting private, identifiable heath information as part of your research, please see our website  HYPERLINK "http://www.tc.edu/irb" www.tc.edu/irb under Forms and Guidelines for the Health Insurance Portability and Accountability Act (HIPAA) document. section V: Data security Please respond to the following sections. Please check the box(s) that best describes how you will transfer your data. FORMCHECKBOX I will use a Virtual Private Network (VPN) for secure data transfer or other form of encryption (e.g., 51Թs secure remote network access). FORMCHECKBOX Not applicable (e.g., data will not be accessed remotely or transferred. It will exist only on a locally stored password-protected hard drive).  Please check the box(s) that best describes how you will store your data.  FORMCHECKBOX On a password-protected local or external computer hard drive. FORMCHECKBOX On 51Թs local password-protected network. FORMCHECKBOX On 51Թs Google Drive, in a password-protected folder. FORMCHECKBOX In 51Թs Dropbox (faculty only). FORMCHECKBOX Other (e.g., cloud-based, password-protected storage) (please explain). Please check the box(s) to affirm your data security plans.  FORMCHECKBOX I will encrypt my data (e.g., conceal data by converting it into a code). FORMCHECKBOX I will use anti malware protections and automatic software updates. FORMCHECKBOX I will block unauthorized access to my data (e.g., firewall). FORMCHECKBOX I will disable file and media sharing if I do not need it. FORMCHECKBOX I will delete old files from cloud-based backups and local hard drives.  FORMCHECKBOX I will take care of privacy settings immediately upon setup. 51Թ classifies all data associated with ongoing research studies as confidential, meaning only project staff, academic advisors, collaborators and other individuals at the college on a need-to-know basis may have access to it. Confidential data at a minimum should be stored on a password-protected computer, or in a password-protected file or folder if the computer is shared. Paper and other physical media should be kept under lock and key. All computers accessing data should have anti-virus software installed. Please check the box below:  FORMCHECKBOX  Yes, I acknowledge and understand how 51Թ classifies research data. section vI: Informed Consent ProceduresInformed consent is a process, not just a form. What are your procedures for obtaining a participants informed consent to take part in the research? How will you describe your research to potential participants? What will you do to ensure participants understanding of the study and what it involves? Use this section to provide a request for a full or partial waiver of informed consent, and justify this request. Indicate not applicable, if you are not requesting a waiver. Note: You may cite criteria from the following link regarding Federal regulations and guidelines: HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "46.116"www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116 Note for Researchers: Templates are available in Mentor/Documentation. Drafts of forms will not be accepted. Please proofread all files.      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