ࡱ> g ubjbj Dr\r\l?FF!!!!!!!!8 "&#!#^%(%%%a&>&& =??????$p~c!&a&a&&&c!!%%xy+y+y+&!%!%=y+&=y+y+t%(0M'R^)0{F'(!@&&y+&&&&&cc})&&&&&&&&&&&&&&&&F> : Guideline for Writing a Research Protocol Social, Behavioral, and Educational Research (RSRB Protocol Template Final v. 01/22/2019) 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 Research 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_Research.pdf" Guideline for Conducting International Research 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 additional protocol elements are considered and adequately described. --------------------------------------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. Describe the significance of the research including potential benefit for individual subjects or society at large (i.e., how the research might contribute to generalizable knowledge). Describe how public health and social welfare might be enhanced, if applicable. Include applicable references at the end of the protocol. ADMINISTRATIVE ORGANIZATION Describe the participating UR medical center department/units, UR River Campus classrooms or labs, other participating research locations, participating sites (for multi-site research), central laboratories, data management center, and coordinating center, as applicable. A research location is defined as a location where UR faculty will collaborate with and conduct research at locations outside of the University of Rochester, such as: local schools, community centers, public venues, etc. Highland and FF Thompson would also be included as a research location. A participating site (psite) is defined as an institution/organization/university which is not part of the UR and is engaged in the research. Sites are reserved for when the RSRB will be the Reviewing IRB (or IRB of Record) for a non-UR site. See  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/504b_GDL_UR_Reviewing_IRB.pdf" Guideline and Flow Charts for When the University of Rochester is the Reviewing IRB STUDY DESIGN Provide a description of the following: The design of the study, including indication whether subjects will be randomly assigned to study interventions or activities, as applicable. Study outcomes/endpoints SUBJECT POPULATION Describe the study population (see Inclusion of Vulnerable Populations below), including total number of subjects to be enrolled and/or data records/samples to be accessed. If more than one site is involved, describe the total number of subjects at each site. Total to be enrolled should include the number of evaluable subjects (i.e., those who meet eligibility criteria), as well as the number of anticipated screen failures necessary to obtain the enrollment goal. A subject is considered in the total count once informed consent has been obtained (as applicable). If evaluable subjects who withdraw from the study will be replaced to meet the enrollment goal, this should also be stated here. Inclusion of Vulnerable Populations: Students/Employees: If the research involves individuals who are vulnerable or susceptible to coercion or undue influence, describe additional safeguards included to protect rights and welfare of these individuals. Refer to  HYPERLINK "https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html" HHS Informed Consent FAQs for information on what it means to minimize possibility of coercion or undue influence. Children: If the research involves persons who have not attained the legal age for consent to treatments or procedures involved in the research (children), refer to the OHSP policy for  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_601_Research_Involving_Children.pdf" Research Involving Children to ensure sufficient information is provided. Pregnant Women: If the research involves pregnant women where the research activities are expected to affect the pregnancy, or if the research involves neonates of uncertain viability or nonviable neonates where the research activities are expected to affect the neonates, refer to the OHSP policy for  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_602_Research_Involving_Pregnant_Woman.pdf" Research Involving Pregnant Women, Human Fetuses and Neonates to ensure sufficient information is provided. Prisoners: If the research involves prisoners, review the OHSP policy for  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_603_Research_Involving_Prisoners.pdf" Research Involving Prisoners to ensure sufficient information is provided. Decisionally Impaired Adults: If the research involves adults with decisional impairments, review the OHSP policy for  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_604_Research_Involving_Decisionally_Impaired_Adults.pdf" Research Involving Adults with Decisional Impairment to ensure that you have provided sufficient information. INCLUSION AND EXCLUSION CRITERIA List the criteria (such as age range, gender, race, diagnoses, lab values, language, etc.) that define who will be eligible to participate. Ensure criteria addresses if the subject must be able to consent for themselves, and whether non-English speaking individuals will be included. RECRUITMENT METHODS Describe how potential subjects will be identified, as well as when/where/how potential subjects will be recruited (include the types of strategies and materials that will be used for recruitment). Review the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/703a_GDL_Recruitment_Methods_Materials.pdf" OHSP Guideline for Recruitment Methods and Materials for additional information about the recruitment process and related documents. 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 (i.e., no cold calls); they must work through the individual(s) with routine access. Mturk users include the following information: Be clear about compensation and bonuses. How long it will take for researchers to approve a HIT (i.e., how long it takes for Mturk users to receive payment). Clearly and accurately state the time required to complete the task. Consider confidentiality of participation. The default should be that the subjects MTurk worker IDs is not collected. If it is necessary to collect worker IDs, then the researchers should ensure that worker IDs are kept confidential and secure, are not linked back to survey data, and are deleted after use. If the subject will complete a screener in order to qualify for study, include if they will be paid for the time it takes to complete the screener or not. Include if the screener data will be kept/linked to study data or destroyed. If any extraneous software is required to complete the task, this should be stated in the description (e.g. this task requires JavaScript or inquisit). Describe plan for review of responses, as applicable (i.e., whether responses will be accepted or rejected and whether unapproved responses will be included in the study dataset). CONSENT PROCESS Describe the consent process, including the following, as applicable: How will informed consent and HIPAA Authorization be documented (refer to the RSRB  HYPERLINK "http://www.rochester.edu/ohsp/documents/rsrb/word/Consent_Form_Template_NonBiomedical.doc" Non-Biomedical Consent Template)? Note that compliance with HIPAA Authorization is applicable for research that is conducted under a URMC and Affiliates covered entity and protected health information (PHI) is collected ( HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_702_HIPAA.pdf" Policy 702 HIPAA Privacy Rule). (see below for waiver requests) Where and when will consent be obtained? Who will obtain consent? How will investigators ensure the potential subject comprehends the information presented? How will coercion or undue influence will be minimized? Will the potential subject be provided sufficient time to consider their participation? Will the subject be provided a signed copy of the consent form? If a witness signature line is included on the consent form, describe whether a witness to the consent process is mandatory or optional (and if optional, under what circumstances should they be used). Identify who may act as a witness. How will investigators ensure ongoing consent, if appropriate? This may include re-consent for longitudinal studies or if there are multiple stages to a study over time. 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_Research_Involving_Repositories.pdf" Guideline for Research Involving Databases, Repositories and Registries). Written Documentation of Consent and HIPAA Authorization (refer to the  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/701_GDL_Informed_Consent.pdf" Guideline for Informed Consent): If obtaining consent (and HIPAA Authorization, if applicable) using a written signed consent document, refer to the RSRB  HYPERLINK "http://www.rochester.edu/ohsp/documents/rsrb/word/Consent_Form_Template_NonBiomedical.doc" Social/Behavioral/Educational Consent Template). Requests for Waiving Documentation of Consent (or Parent Permission) must address at least one the following (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_701_Informed_Consent.pdf" Policy 701 Informed Consent): Validate that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, OR Validate that the research is no greater than minimal risk and involves procedures for which written consent is normally not required outside the research context. Note: If the study involves Family Educational Rights and Privacy Act (FERPA), the study might not qualify for waiving signed consent. Requests for Waiving or Altering Elements of Informed Consent (or Parent Permission) must address the following (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_701_Informed_Consent.pdf" Policy 701 Informed Consent): Verify that the wavier wont affect rights and welfare of subjects. Explain why written consent cannot be obtained from subjects. Describe how and when subjects will be provided additional information after participation, if appropriate. Note: If the study involves Family Educational Rights and Privacy Act (FERPA), the study might not qualify for a waiver of consent. Requests for Waiving or Altering HIPAA Authorization must address the following (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_702_HIPAA.pdf" Policy 702 HIPAA Privacy Rule): Indicate if authorization will not be obtained, elements of authorization are being altered (e.g., use of an information sheet), or a partial waiver for recruitment purposes is being requested. Explain why written authorization cannot be obtained from subjects. Explain why the study cannot be conducted without the use or disclosure of protected health information (PHI). Describe the plan to protect identifiers from improper use and disclosureANDindicate if identifiers will be destroyed at the earliest opportunity consistent with the research (if not destroyed, provide the health or research justification for retaining the identifiers, or that retention is required by law). State 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 or disclosure of PHI would be permitted by the HIPAA Privacy Rule. Consent Process for Minors/Children (under 18 years of age): Describe how parental permission will be obtained If applicable, describe the process for obtaining assent of the subjects Consent Process for Adults with Decisional Impairment: Describe the process to determine whether an individual is capable of consent. If the individual is not capable of giving consent to participate, indicate who will be authorized to give consent (e.g., power of attorney for health care, court appointed guardian for health care decisions, spouse, adult child.) The RSRB allows the person obtaining assent to document assent on the consent document; therefore, a separate assent document is not required. If subjects may lose decision-making ability during the study, describe the process for the subject to identify the Research Proxy, when this will be done, how the Research Proxy will be notified, and how the Research Proxy will be involved in the study. Also describe how decision-making ability will be monitored over the course of the study. Consent Process for Non-English Speaking Subjects: If there are Non-English speaking subjects who will be enrolled, describe the process to ensure that the oral and written information provided to those subjects will be in the language understandable to those potential subjects. Indicate the language that will be used by those obtaining consent. If a translator will be used during recruitment, consent, data collection, or data analysis specify how an appropriate translator will be identified and what the provisions will be for protecting the confidentiality of subjects. Consent Process through On-line Platforms (e.g., surveys): The first page of the on-line platform should contain contents of the RSRB approved information sheet; no signature is required (request and justification for waiver of documentation of consent and HIPAA Authorization required above). Consent Process for Deception Research: Explain the process for providing  HYPERLINK "http://www.rochester.edu/ohsp/documents/rsrb/word/Consent_to_Procedures_Template.doc" Consent to Procedures that will be used to explain the study and the  HYPERLINK "http://www.rochester.edu/ohsp/documents/rsrb/word/Consent_to_Data_Use_Template.doc" Consent to Data Use debriefing form that will be used by researchers. Certificate of Confidentiality: If the study involves the use of a Certificate of Confidentiality, describe here. Note: If the study is funded by the National Institute of Health (NIH), the CoC is automatically included as part of the notice of award. Language regarding the Certificate of Confidentiality must be included in the consent form. STUDY PROCEDURES Provide a description of all research procedures and activities. When developing study procedures, consider minimizing or eliminating the collection of identifying information where possible and, when applicable, provide justification as to why identifiers need to be retained. Screening procedures Which screening tests/procedures are part of standard care and which are for research purposes only? What happens with screen failures (including any data gathered during screening)? Source of records, measures, stimuli, or experiments that will be used for data collection (e.g., medical records, pathology, student records, surveys, URL for online research). Indicate if any research data will be included in the subjects medical record (e.g., lab test results, indication of study participation). Describe randomization procedures, if applicable. Duration of individuals participation in the study and overall anticipated duration of the study. Describe what data will be collected at each visit/session; include approximate duration of time to complete each measure/task (using a table to outline the schedule of activities may be useful to summarize this information). Describe plans for return of research results, if applicable Indicate research results that will be provided back to the subject (e.g., lab results, psychological or neurological assessment results, genetic test results) When they will be provided (e.g., not until the study is completed, at the time the Investigator receives the result, etc.) Describe how incidental findings that might have health consequences for the individual subject will be managed, as applicable Describe genetic/genomic research activities, if applicable Description and purpose of the test Whether genetic counseling will be provided to the subject Indicate individual(s) or organization(s) to whom test results may be disclosed Indicate whether test results will be provided to the subject Whether any additional testing will be conducted Whether samples will be destroyed at the end of the testing process Studies involving deception: Deception occurs whensubjects are not given information about the real purpose or the nature ofthe research. Describe what information will be withheld from subjects and provide justification for the deception. Explain the process to debrief subjects (i.e., when subjects will be debriefed, who will debrief them, and how they will be debriefed) Note: For online studies, the debriefing process should occur as soon as a participant has completed the research activity. As an added measure, it may be necessary to send an email out to all participants after the study is completed to ensure that all participants (those that completed and those that may have stopped mid-way) receive a debriefing form. Indicate whether use of deception is likely to cause the subject psychological discomfort (e.g., stress, loss of self-esteem due to manipulations, embarrassment at being deceived or guilty at having been induced to commit regretted acts) while the deception takes place. Explain how this risk will be minimized during the experiment and after the experiment is completed (i.e., full debriefing). AUDIO/VIDEO RECORDINGS Describe the type of recording or device being utilized and the purpose of the recordings as applies to the research (e.g., data analysis, verification, teaching tool for educational purpose). Describe how and where the recordings are stored, who has access to them, and if/when they will be destroyed. If recordings are done with a personal device (e.g., cell phone or iPad), indicate how long it will take before the recordings are transferred to a secure server and how the original recordings will be managed (i.e., destroyed, stored, shared). RISKS TO SUBJECTS Describe the reasonably foreseeable risks, discomforts, hazards, or inconveniences related to the subjects participation in the research. For each risk identified, describe the probability, magnitude, duration, and methods of mitigating the risk. Potential risks and discomforts must be minimized to the greatest extent possible by using procedures such as appropriate training of personnel, withdrawal of the subject upon evidence of difficulty or adverse event; and referral for treatment, counseling or other necessary follow-up. Consider physical, psychological, social, legal, and economic risks as well as community or group harms (e.g., breach of confidentiality is a common risk in social and behavioral research). If applicable, describe risks to others who are not participants (e.g., group harms, harms to society). Provide a description of alternative courses of action which are available should the subject elect not to participate in the study. If there are no alternatives available to the subject, this should be stated. POTENTIAL BENEFITS TO SUBJECTS Describe the potential benefits that individual subjects might experience from taking part in the research. If there are no anticipated benefits, this should be stated. Do not include subject payments or benefits to society or others. COSTS FOR PARTICIPATION Describe and justify any costs that participants may be responsible for because of participation in the research. PAYMENT FOR PARTICIPATION Describe the payment method (gift card, lottery, cash, check) and include how much money or what gifts will be provided and for what activities, as well as when (timing) compensation will be provided. If lottery will be used, provide the odds of winning (1 out 50) and whether multiple drawings will occur over the course of the study. If study is not funded, include the source providing the payment. Describe how compensation will be prorated if there are multiple research activities or if a participant withdraws from the study before finishing. Describe any reimbursement that might be provided (e.g., travel expenses such as hotel or mileage), as applicable, and the process for reimbursement (e.g., collection of receipt). SUBJECT WITHDRAWALS Describe anticipated circumstances under which participants will be withdrawn by the investigator from the research without their consent (e.g., non-compliance, termination of funding). Describe procedures that will be followed if subjects withdraw from the research, if applicable. Will they stop treatment and continue to be followed? Can they withdraw from some of the procedures, but not all? Will long-term follow up data continue to be collected, if so what? Describe the use of data after withdrawal. Indicate whether subjects withdrawn from the study will be replaced. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA Describe the steps that will be taken to protect subjects privacy. Privacy refers to a persons desire to place limits on with whom they interact or to whom they provide personal information. Indicate how the research team has access to the sources of information about subjects. If subjects will be re-contacted for any reason, describe this process and explain why subjects might need to be re-contacted. If subject will be re-contacted, this must be disclosed in the consent form. Describe the steps that will be taken to maintain the confidentiality of the data and information collected during the study: Where and how will data (or samples) 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). How long will the data (or samples) 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. Who will have access to the stored data (or samples)? Who is responsible for receipt or transmission of the data (or samples)? 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)? If internet based research is planned within the protocol, the level of encryption used by the online survey tool must be described as a protection against the risks of loss of confidentiality  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Guideline_for_Internet_Based_Research.pdf" (see Guideline on Computer and Internet Based Research).  Describe any data/sample sharing, if applicable: What will be shared and is the information identifiable (if identifiable, provide justification), Who will have access (e.g., other researchers), What shared data/samples will be used for (e.g. research purposes, teaching, etc.), What additional privacy and confidentiality protections in place for what is shared? DATA / SAMPLE STORAGE FOR FUTURE USE If data (or samples) will be stored for future use, describe the following: Why the data (or samples) will be stored for future use, Where the data (or samples) will be stored (if outside the UR be sure to identify the location/entity), How stored information will be identified, How long data (or samples) will be stored, The plan for managing long-term storage of the data, if applicable, Who will have access to the stored data (or samples), Procedures to release data (or samples), including: the process to request a release, approvals required for release, who can submit a request, and how requested data will be identified. DATA AND SAFETY MONITORING PLAN Describe the plan to periodically evaluate the information collected regarding risks or harms to determine whether subjects remain safe (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_506_Data_Safety_Monitoring.pdf" OHSP Policy 506 Data & Safety Monitoring). Include the following, as appropriate: Provide a definition of adverse events, serious adverse events, and any other types of events that will be monitored (refer to  HYPERLINK "http://www.rochester.edu/ohsp/documents/ohsp/pdf/policiesAndGuidance/Policy_801_Reporting_Research_Events.pdf" OHSP Policy 801 Reporting Research Events). The frequency of adverse event/safety data monitoring and collection, including when safety data collection starts. What information / data are reviewed, including safety data, untoward events, and efficacy data? How will adverse event/safety information will be collected (e.g., case report forms, at study visits, telephone calls with subjects)? Describe the plan for reporting safety information, including to whom (e.g., safety monitoring board, IRB) and the frequency for reporting. Describe any conditions where the research team may intervene and what the plan is for intervening (e.g., if a subject identifies harm to self or others). Describe any stopping rules with regard to efficacy or safety that might trigger an immediate suspension of the research. For example, if depression or suicidality data are collected, what is the plan for monitoring severity? Note: The plan might include establishing a data monitoring committee and a plan for reporting findings to the RSRB and the sponsor. It also could include referral to an appropriate resource or monitoring by the Investigator. DATA ANALYSIS PLAN Describe the statistical/analytical methods to be used for the research data, as appropriate, to meet the goals of the study purpose and any specific endpoints identified. REFERENCES List references cited within the protocol, as applicable.     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