Human Subjects Research Protocol Restart Application (July ...



Human Subjects Research Protocol Restart Application (July 2020)Start of Block: Default Question BlockHuman Subjects Research Protocol Restart Application ? The Human Subjects Research Protocol Restart Application is required as the first step of the process to receive permission to restart (or start) in-person interactions with research participants on a specific protocol. Studies for which there is no in-person interaction, studies that can be modified by submitting a change in research to the IRB to permanently alter the study so that it may proceed without in-person interaction, and COVID-19 related research are exempt from this re-opening process. Submission of your application will put you in a queue to have your request reviewed by the Human Subjects Research Protocol Restart Committee (the HSRPRC). The HSRPRC must approve your study to move forward to the IRB for permission to restart human subjects research. The committee will be reviewing applications rapidly, and we are committed to working as quickly as possible to provide you with a decision. Given the need to integrate with the Phased University-wide plan for Research Restart as well as expected capacity constraints throughout our system, we cannot commence all human subjects research simultaneously and therefore, a prioritization process is required. As soon as a decision is reached, you will be contacted via email with a letter indicating that you have been granted permission to move ahead with your IRB submission to restart your research immediately, or you will be asked to wait until you are contacted by the HSRPRC with permission to proceed. The HSRPRC permission to proceed must be uploaded as part of your Change in Research submission to restart human subjects research submitted to the IRB. If you have any questions, please contact Sumati Murli (smurli@jhmi.edu).Page BreakDid your study receive approval by the IRB as a Tier 1 study on or after 4/3/2020 to allow for continuation of in-person activities/new enrollment?Yes No Page BreakDo any of the following categories apply to your protocol? (If none of these categories apply, please check 'None of the above')Study has no in-person interaction Study has been or will be (prior to resumption) modified by submitting a Change in Research to the IRB to permanently alter the study, so it may proceed without ANY in-person interaction at any time (e.g. receive permission from the IRB to use remote consenting processes which was the only required in-person interaction, or switched in-person visits to remote only) Study involves COVID-19 related research None of the above Page BreakPlease answer the following questions:YesNoHave you reviewed the JHU SOM Clinical Research Visit Guidelines during the COVID Pandemic? Click?here for a copy of the guidelines. Do you pledge that your study team will review the JHU SOM Clinical Research Visit Guidelines during the COVID Pandemic prior to scheduling in-person visits with your research participants? Please review the following: PPE Recommendation during the COVID-19 Pandemic for Ambulatory Settings Do you pledge to ensure that your study team has access to all the PPE required to safely conduct this study following current HEIC guidelines prior to scheduling in-person visits with your research participants? Page BreakGeneral Study InformationPI Last Name ________________________________________________PI First Name ________________________________________________Department ________________________________________________Email address ________________________________________________IRB Number (please use the format “IRB12345678” or “NA_12345678”) ________________________________________________Protocol Title ________________________________________________Study sponsor:Investigator-initiated (please specify funding source): ________________________________________________Externally sponsored (please specify): ________________________________________________Page BreakPlease pick the category that best describes your study:Therapeutic trials conducted in Johns Hopkins-managed facilities with the prospect of direct benefit where no standard of care options are available. Therapeutic trials conducted in Johns Hopkins-managed facilities with the prospect of direct benefit where standard of care options are available. Interventional studies (e.g. supportive care, behavioral interventions) conducted in Johns Hopkins-managed facilities with the prospect of direct benefit. Therapeutic trials or interventional studies conducted in non-Johns Hopkins managed facilities with the prospect of direct benefit. Observational or other minimal risk studies where ALL in-person procedures occur during routine standard of care clinical visits or during research visits previously approved to restart which have minimal participant interaction in terms of duration or activity (e.g., collection of blood or other biospecimens, research quality vital signs). Observational or other minimal risk studies that require research only visits in Johns Hopkins clinical facilities, occur in non-clinical Johns Hopkins facilities or occur in external (non-Johns Hopkins managed) facilities. Observational or other minimal risk studies with participant interaction involving groups of greater than 2 research participants that do not share a household at one time. Other (please describe): ________________________________________________Display This Question:If Please pick the category that best describes your study: = Therapeutic trials conducted in Johns Hopkins-managed facilities with the prospect of direct benefit where no standard of care options are available.Or Please pick the category that best describes your study: = Therapeutic trials conducted in Johns Hopkins-managed facilities with the prospect of direct benefit where standard of care options are available.Without the therapeutic intervention, what are the current standard of care/options for these patients?________________________________________________________________Display This Question:If Please pick the category that best describes your study: = Observational or other minimal risk studies where ALL in-person procedures occur during routine standard of care clinical visits or during research visits previously approved to restart which have minimal participant interaction in terms of duration or activity (e.g., collection of blood or other biospecimens, research quality vital signs).Please describe the type of in-person procedure(s) required during the visit, including estimated duration of the research activity and whether the participant will need to go to multiple locations to complete the procedures: ?________________________________________________________________Display This Question:If Please pick the category that best describes your study: = Observational or other minimal risk studies that require research only visits in Johns Hopkins clinical facilities, occur in non-clinical Johns Hopkins facilities or occur in external (non-Johns Hopkins managed) facilities.Please choose which of the following describes where the research will occur (please pick ALL that apply):Research only visits in Johns Hopkins clinical facilities Non-clinical Johns Hopkins facilities External (non-Johns Hopkins managed) facilities Participant homes Display This Question:If Please pick the category that best describes your study: = Observational or other minimal risk studies that require research only visits in Johns Hopkins clinical facilities, occur in non-clinical Johns Hopkins facilities or occur in external (non-Johns Hopkins managed) facilities.Please describe the type of in-person procedure(s) required during each visit, including estimated duration of the research activity and where it will occur (please specify whether the research participants will need to go to multiple locations to complete the procedures): ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Please pick the category that best describes your study: = Observational or other minimal risk studies that require research only visits in Johns Hopkins clinical facilities, occur in non-clinical Johns Hopkins facilities or occur in external (non-Johns Hopkins managed) facilities.How many research staff will interact with the participant at each visit:________________________________________________________________Display This Question:If Please pick the category that best describes your study: = Observational or other minimal risk studies that require research only visits in Johns Hopkins clinical facilities, occur in non-clinical Johns Hopkins facilities or occur in external (non-Johns Hopkins managed) facilities.What is the total time that the participant will be within 6 feet of these staff members: ?________________________________________________________________Page BreakPlease provide a brief summary of the research questions under study and why you selected the classification above (max. 3 sentences):________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakAre there any specific considerations that the Committee should be aware of with regards to prioritizing the restart of this research, such as those listed below? (Check all that apply)Research participant accrual is required to meet time-critical milestones on a grant where delay will put the grant in near-term jeopardy Data from the study is required to prepare a near term (within 6 months) grant submission There are limited remaining slots in the study with competitive enrollment Resumption of in-person visits is critical for ensuring research participant safety on treatment Other (please describe) ________________________________________________None of the above Page BreakWill all of your in-person?research activities take place during routine standard of care (SOC) clinical visits/hospitalizations?Yes No Display This Question:If Will all of your in-person research activities take place during routine standard of care (SOC) c... = NoWhat is the number of research-only visits required per?research participant?over the next 12 months?________________________________________________________________Will you be modifying your study in any way to minimize risk to research participants and study team members?Yes No Display This Question:If Will you be modifying your study in any way to minimize risk to research participants and study t... = YesPlease describe all accommodations you are making to minimize risk to research participants and study team members, e.g. reducing time spent with research participants during research visits by adding flexibility for telemedicine or remote consenting, or reducing the number of mandatory tests.________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Will you be modifying your study in any way to minimize risk to research participants and study t... = NoPlease explain why you do not plan to modify your study to reduce risk to research participants or study team members, e.g. changes are not supported by the study sponsor. Note that the absence of any study modification to reduce risk may increase the scrutiny that your study is under at the IRB and increase the likelihood of a need for convened review of your proposal to restart research. ?________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakDoes your protocol involve any aerosol-generating procedures? Yes No Display This Question:If Does your protocol involve any aerosol-generating procedures? = YesPlease describe the aerosol-generating procedure: Why it is required, where it will be conducted, and what precautions will be taken during the procedure?________________________________________________________________Page BreakEnrollmentEnter Response:Approximate date study opened to enrollment at Johns Hopkins (month/year) # Participants enrolled at Johns Hopkins since study opened Total # remaining to be accrued at Johns Hopkins to meet targeted accrual # Participants previously enrolled at Johns Hopkins who are currently receiving the study intervention or require in-person visits for protocol mandated testing/follow-up # Participants expected to be enrolled at Johns Hopkins per month over next 3 months Page BreakDo you expect any barriers in the targeted?research participant?population due to COVID-19 for new recruitment or continued participation (excluding any challenges that will be addressed with an amendment to the protocol)?Yes No Not sure Please explain your answer above (why or why not)?________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakDoes your study require support services from any of the following departments as part of the protocol? (Check ALL that apply)Clinical Research Units (CRUs) Radiology (including the F. M. Kirby Center; excluding standard of care assessments, e.g. that would be done regardless of study participation) Pathology (excluding standard of care labs, e.g. that would be done regardless of study participation) Anesthesiology Cardiology (including cardiac imaging like echocardiograms) Pulmonary (including PFTs) JHHS Nursing (excluding nurses employed by the study team or CRUs) Investigational Drug Service (IDS) Other (please describe): ________________________________________________No support services required Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Clinical Research Units (CRUs)From which of the following CRUs will your study require support? (Check all that apply)PCRU Adult CRU (JHH) Adult CRU (Bayview outpatient) Adult CRU (Bayview inpatient) Cardiovascular, Exercise and Body Composition Core Display This Question:If From which of the following CRUs will your study require support? (Check all that apply) = PCRUOr From which of the following CRUs will your study require support? (Check all that apply) = Adult CRU (JHH)Or From which of the following CRUs will your study require support? (Check all that apply) = Adult CRU (Bayview outpatient)Or From which of the following CRUs will your study require support? (Check all that apply) = Adult CRU (Bayview inpatient)Or From which of the following CRUs will your study require support? (Check all that apply) = Cardiovascular, Exercise and Body Composition CorePlease provide a brief description of the CRU support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Radiology (including the F. M. Kirby Center; excluding standard of care assessments, e.g. that would be done regardless of study participation)Please provide a brief description of the Radiology support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Pathology (excluding standard of care labs, e.g. that would be done regardless of study participation)Please provide a brief description of the Pathology support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = AnesthesiologyPlease provide a brief description of the Anesthesiology support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Cardiology (including cardiac imaging like echocardiograms)Please provide a brief description of the Cardiology support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Pulmonary (including PFTs)Please provide a brief description of the Pulmonary support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = JHHS Nursing (excluding nurses employed by the study team or CRUs)Please provide a brief description of the Nursing support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Investigational Drug Service (IDS)Please provide a brief description of the IDS support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Display This Question:If Does your study require support services from any of the following departments as part of the pro... = Other (please describe):Please provide a brief description of the Other support required and the approximate time points per?research participant?in the protocol over the next 12 months:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakWhere will the research participants be seen? (Check ALL that apply)CRUs JHH Inpatient JHOC Wilmer Greenspring Station JHBMC Sibley Suburban HCGH Kennedy Krieger Institute JHACH Home visits JHHS non-clinical sites (please describe) ________________________________________________Extramural (to JHHS) Sites (e.g. Prohealth) (please describe) ________________________________________________Other (please describe) ________________________________________________Display This Question:If Where will the research participants be seen? (Check ALL that apply) = Home visitsOr Where will the research participants be seen? (Check ALL that apply) = JHHS non-clinical sites (please describe)Or Where will the research participants be seen? (Check ALL that apply) = Extramural (to JHHS) Sites (e.g. Prohealth) (please describe)Or Where will the research participants be seen? (Check ALL that apply) = Other (please describe)Please note that the expectation is that research done outside of Johns Hopkins clinical facilities should follow HEIC clinical standards for research participant and study team member safety. Please explain why this research must be done outside of Johns Hopkins clinical facilities and how you are mitigating risk in conducting research done in this setting.________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakHave you ensured that the sites where your research participants will be seen have the capacity to support the research you propose to conduct?Yes No Other comments (optional):________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Page BreakEnd of Block: Default Question Block ................
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