ࡱ> _ +bjbj @V9b9bc#E 66666JJJ8t<Jh2(> $ȩ 6''' 66"###'66#'##^#0(.יhӤ80h?PP#P6#''#''''' '''h''''P''''''''' B : Guideline for Writing a logo Protocol Biospecimens and Record Review (RSRB Protocol Template Final v. 02/19/2019) Note: You may delete sections that are not applicable to your research. For multi-site research, if the study will utilize a reliance agreement or single IRB, refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_504_RSRB_Reliance_Review.pdf" OHSP Policy on IRB Reliance and Collaborative logo for additional guidance on study start up requirements for IRB review and approval. Investigators conducting research in foreign countries should refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Guideline_Conducting_International_logo.pdf" Guideline for Conducting International logo and the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Guideline_for_GDPR_QA_for_researchers_with_graphics.pdf" Guideline for the European Unions General Data Protection Regulation to ensure that items are addressed and additional protocol elements are considered and adequately described. NOTE: This template is to be used as a guideline for writing a protocol involving research use of subject specimens/records/data. For additional guidance refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_501_Levels_of_RSRB_Review.pdf" Policy 501 Levels of RSRB Review. --------------------------------------DELETE THIS LINE AND ABOVE------------------------------- Study Title Principal Investigator Name PURPOSE OF STUDY Describe the purpose, specific aims, or objectives. State the hypothesis to be tested or the research questions that will guide the study. If the study has more than one phase, clearly map out the different phases. Indicate if this a pilot or feasibility study. BACKGROUND AND RATIONALE Briefly describe the following: The relevant current context of the study and gaps in current knowledge. Provide the scientific or scholarly background for, rationale for, and significance for the proposed research based on the existing literature. Include applicable references at the end of the protocol. STUDY DESIGN: Provide a description of the design of the study, to include the following information, as applicable (Note: Include description of *secondary uses of information/specimens, as applicable): Is the identifiable ^private information or identifiable biospecimens Publically Available? (publically available is defined as information shared without conditions on use) Is data from non-public sources recorded in a manner that is de-identified by the study team (de-identified defined as no onecould readily ascertain subjects' identities, either directly or through linked identifiers, based on the research dataset)? Does the research involve only information collection and analysis of identifiable health information, protected under HIPAA regulations? Note: To determine whether you are recording identifiable information, refer to the URMC and Affiliates  HYPERLINK "http://intranet.urmc-sh.rochester.edu/policy/hipaa/Privacy/P30.pdf" HIPAA Privacy Policy 0P30. Indicate the period of time (duration) for when the data/specimens will be collected or were originally collected (mm/dd/yyyy to mm/dd/yyyy) or if there will be prospective collection (no end date). If there is no end date and the research proposes a waiver of consent/HIPAA authorization, provide justification as to why consent/authorization cannot be obtained in Sections 6 and 9 below, as applicable. Identify the data points, including any identifiers, which will be collected to meet the purpose of the study? Include a copy of the data collection sheet in the click IRB application under Local Site Documents Q4 Study Measurement Documents. *Secondary means the re-use of identifiable information and identifiable biospecimens that are collected from some other primary or initial activity. In other words, data that were not collected for the purpose of the specific proposed study. ^Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). SUBJECT POPULATION Describe the study population, including total number of records/samples to be accessed. Note: If a number of biospecimens/records will be reviewed with the expectation that you will collect/use data only from a sampling of them, state that here (e.g., We anticipate reviewing approximately X records/biospecimens. Of those records/biospecimens it is anticipated that approximately X subjects will meet the eligibility criterion.) Describe how subject data/specimens will be identified. Note: Only investigators with routine access to prospective subjects (or subject records) may recruit those individuals directly (routine access meaning the investigator already has a clinical/academic reason to know/review a patients record or is known to the prospective subject). Investigators who do not have routine access to prospective subjects may not contact subjects directly; they must work through the individual(s) with routine access. INCLUSION AND EXCLUSION CRITERIA List the criteria (such as age range, gender, race, diagnoses, lab values, etc.) that define what subject records/specimens qualify for use in the study. CONSENT PROCESS If requesting a Waiver of Consent, include the following information: Why is the study minimal risk? Why cant the study be carried out without the waiver? Why the waiver will not affect the rights and welfare of subjects? Will subjects be provided with additional pertinent information after participation? If Written Consent will be obtained, include the following information: Where and when will consent be obtained? Who will obtain consent? How will investigators ensure the potential subject comprehends the information presented? If consent to contact for future research will be an option, describe here (refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Guideline_logo_Involving_Repositories.pdf" Guideline for logo Involving Databases, Repositories and Registries). RISKS OF STUDY What are the potential risks of conducting this study (e.g., confidentiality breach is a risk associated with record review research or collection of biospecimens)? POTENTIAL BENEFITS What are the possible benefits from participation in the research? If there are no possible benefits, state no benefit. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA If your project falls under HIPAA regulations (either at the UR or at another location), the use, storage, or transmission of these data must comply with HIPPA regulations (see  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_702_HIPAA.pdf" Policy 702 HIPAA Privacy Rule). Indicate how the research team has access to the sources of information about subjects. Describe the steps that will be taken to maintain the confidentiality of the information collected during the study: Where and how will data (or biospecimens) be stored and, if applicable, how will they be transferred outside of the University? If they will be transferred, how will they be identified? Note: Electronic storage of data in both domestic and international research must be secured using adequate protections ( HYPERLINK "http://www.rochester.edu/it/policy/index.html" University IT Policies). Who is responsible for receipt or transmission of the data (or biospecimens)? What steps that will be taken to secure the data during storage, use, and transmission (e.g., training, authorization of access, password protection, encryption, physical controls, certificates of confidentiality, separation of identifiers and data)? Who will have access to the stored data (or biospecimens)? How long will the data (or biospecimens) be stored? Note: RSRB policy is 3 years after the completion of the study. If HIPAA applies, it is 6 years after completion of the study. If requesting a Waiver or Altered HIPAA Authorization to Use or Disclose PHI, include the following information: Provide justification that the use and disclosure of PHI involves no more than minimal risk to privacy of the individuals. Explain why the research cant be carried out without the waiver or alteration. Include a statement to confirm that PHI will not be reused or disclosed to any other person or entity except (i) as required by law, (ii) for authorized oversight of the research study, or (iii) for other research for which the use of disclosure of PHI would be permitted by the HIPAA Privacy Rule. DATA ANALYSIS PLAN What are the statistical methods that will be used to analyze the data obtained during the study?     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