ࡱ> ^`]e )bjbj{{ 4Rn\n\l!Q 0008hdD0/p(>.B Y/[/[/[/[/[/[/$1r4V/NNN/H/NRY/NY/+ - /rF-,E//0/A,44( -4 -<NNNNNNN//hXNNN/NNNN4NNNNNNNNN > : Guideline for Writing a Protocol Exemption Requests (RSRB Protocol Template Final v. 11/02/2018) IMPORTANT NOTE: If it is determined that your study does not meet the review level of exempt, additional protocol elements may be required. Please contact the RSRB office if you have questions regarding exempt determinations. For record/specimen reviews, see the  HYPERLINK "http://www.rochester.edu/ohsp/rsrb/docTemplates/protocolTemplates.html" Protocol Template Specimen and Record Review. --------------------------------------DELETE THIS LINE AND ABOVE------------------------------- Title: Principal Investigator/Advisor: Purpose of the Study: State the purpose of the study. What is your research question? What is the intent (if any) to disseminate the information resulting from the study? Background: What is the justification and rationale for the proposed study? If known, provide a summary of prior experience and/or history important to understand the proposed study. Include relevant literature citations. Study Population: How many subjects are needed to conduct the study? Is the subject population of the appropriate size to achieve meaningful scientific and statistical results? What is the gender and age range of subjects? What are the inclusion and exclusion criteria that define who will be eligible and who will not be eligible for the study (should support the purpose of the study)? If vulnerable populations are included (e.g. children, elderly, students, employees, persons with decisional incapacity), provide justification for inclusion and any extra protections in place examples below: URMC employees and or students are considered vulnerable subjects and the following should be considered: Professors not involved in requesting participation. Students (individuals or groups) should not be selected solely on the basis of convenience when they would not otherwise be appropriate for inclusion. Recruitment of students must be designed to minimize the possibility of undue influence through methods that require a student interested in participation to initiate contact with the investigator (e.g. email invite, general announcement etc.). Employees supervisors not involved in requesting participation For Online Platforms such as Mechanical Turk (Mturk), will subjects be tracked by tasks completed or by a user/worker ID #? Note that tracking by tasks may account for fewer subjects completing multiple tasks, whereas tracking by a user or worker ID # should better indicate the actual number of subjects participating. Recruitment: Include all the methods that will be used for identifying or recruiting the study population (e.g. flyers, emails, in-person, websites, announcements, social media, SONA, or Mechanical Turk)? Refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/703a_GDL_Recruitment_Methods_Materials.pdf" Guideline for Recruitment Methods and Materials. If this study involves secondary analysis of pre-existing data, indicate the database(s) to be used or where the data is coming from and how eligible subjects will be identified from the database(s). Consent: What process will be used for determining a subjects willingness to participate in the research? See  HYPERLINK "http://www.rochester.edu/ohsp/rsrb/docTemplates/consentFormTemplates.html" RSRB Consent Form Templates. Providing an information sheet, if applicable. When appropriate, use of an introductory script to describe study requirements, indication this is research, and that participation is voluntary (e.g. for on-line platforms, surveys). Consent form/assent form or assent script/parent permission, if applicable. Does your study collect PHI (Protected Health Information)? Provide how you will comply with HIPAA (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_702_HIPAA.pdf" Policy 702 HIPAA Privacy Rule). Note: If this is a secondary analysis of pre-existing data, it is not necessary to include information about determination and documentation of a subjects willingness to participate. Study Activities: Provide a detailed description of all study activities: Pilot study, multi-site? Where will study activities take place? (e.g., on-line, research location, classroom)? Note: If a non-UR site, include name of organization/collaborator. What is the duration of the study (e.g., one semester, one year, until enrollment is reached)? Who will conduct each activity? What information is being collected? Note: The type of questions/variables to be collected should align with the measure(s) or interview guide(s) uploaded in Local Study Documents section of the application. Describe the activities to be performed (e.g., survey, focus group, interview, experiment). Will you use audio and or video recordings, photographs, or other data recording devices? How long will each activity (e.g., survey, focus group/interview, task or experiment) take? If the study involves more than one visit, provide details regarding each visit/time-point. If alternatives to participation are offered, clarify this process. Students who receive extra credit for participation in research must also have the option of an alternative for earning extra credit. For example, professors can provide assignments with a research focus that have the same time commitment as the research study. Include how students are notified of alternative options. Extra credit must still be provided if subject withdrawal occurs before study completion. Provide details regarding any compensation to subjects (refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/703c_GDL_Subject_Payment.pdf" Guideline for Subject Payment): What type of compensation will be provided to subjects (e.g., gift card, cash, check, class credit or on-line platform payment)? How will subjects be paid (e.g., electronically, in-person, or mailed to subjects home address)? When will subjects be paid (e.g., following completion of the research activity, once the data collection process for all subjects is complete)? If a lottery system, when will drawing take place (e.g., end of study, every 2 weeks)? How will winner be notified and how will they receive winning(s) (e.g., phone email)? If using SONA, clarify SONA identifier will be used to award class credit only. If it will be linked to the data, provide details in section 8 below. Risks and Benefits of Participation: Risks: What are the potential risks of each study activity? Risks can include loss of confidentiality, discomfort with nature of research activity, use of e-mail communication. Explain how risks will be minimized. Note: If any potential physical, psychological, sociological, economical or legal risks are included, explain how these risks will be minimized (e.g., referral to University Counseling Center at 275-3113, referrals links for on-line studies)? Benefits: What are the possible benefits from participation in the research? If there are no possible benefits, state no benefit. Note: Payment is not a benefit. Data Analysis: What are the statistical methods that will be used to analyze the data obtained during the study? NOTE. Methods should support the research question and all data collection methods. Data Storage and Confidentiality: Provide detailed description of the data collected: Are recording devices being used? If so, describe what type/if encrypted, and how they will be used. At what time point (immediate, days etc.) will data be transferred to secure server and by what mechanism? logo data should be stored on a UR server. Include any other storage locations and whether information is encrypted. Who will have access to the data? Will audio-recorded data be transcribed using pseudonyms and destroyed once transcription is complete? If not, how long will recordings (audio or video) be retained? Will any stored data be identifiable? If so, how will privacy and confidentiality be maintained (e.g., link of identifiers stored separately through use of study key, deleted once data collection/analysis is complete, payment/extra credit is awarded, or deleted once recruitment process is complete)? How long will data be stored? Will it be destroyed at a certain time point? 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