Office for the Protection of Research Subjects | USC

Time 2020-07-29 11:04:22

Web Name: Office for the Protection of Research Subjects | USC

WebSite: http://oprs.usc.edu

ID:38504

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the,Protection,Office,

Description:

Welcome Office for the Protection of Research Subjects (OPRS)Develops program-wide policies for the conduct and review of human subjects research at USC, provides education and training and oversees the Institutional Review Boards, which reviews projects involving human subjects research.COVID-19 Research Ramp-UpCurrent Phase: 2A3 (3 stands for 30% capacity)As we make decisions on how to respond to the COVID-19 infections we want to begin by stating that our primary concern is the safety of our research participants and the research team members who work for University of Southern California and Keck Medicine of USC. Our secondary goal is to preserve the scientific integrity of the research protocols.As of June 8, 2020, USC has been in the process of returning faculty and staff to work in a safe and phased manner as the COVID-19 pandemic abates. The current phase, Phase 2, only allows for on campus activities with strict physical distancing protocols in place (e.g., research, clinical education, essential Keck healthcare operations). Most operations remain remote/virtual. During this phase, community/field-based research involving direct interaction (e.g., interviews, focus groups, surveys, observations, home visits to administer therapy) with participants is not allowed.As researchers it is your responsibility to ensure those with whom you will have direct in-person participant interaction are fully informed about the risks, not necessarily associated with research participation, but of entering into a setting with others who may be carrying the virus. The research team must follow the USC Guidelines for Resuming Research Operations and the USC COVID-19 Research Ramp Up Table indicating the ramp-up phase the university has entered into.For new studies that include direct in-person interaction with participants, before submitting to the IRB, your school-level ramp up plan must be approved and in place. In addition, you must have your approved PI-level plan from your school (e.g., Dornsife, KSOM, Rossier, Viterbi) to move forward with your own research. New studies already submitted to the IRB without attestations and a PI-level plan approval notice notice (e.g., email or letter) will be returned to the PI so that the attestation(s) and PI-level plan approval notice can be submitted.The Keck School has resumed clinical research involving direct contact with human study participants that takes place on campus and that was paused at the start of the COVID-19 pandemic. Clinical studies that remained active through the initial stage of the pandemic will continue as well, following requirements for Phase 2A. Each PI must submit a plan for conducting clinical research in Phase 2A through the KSOM Research Resumption Portal. This applies to all studies-new, resuming and ongoing. Please refer to this guidance document for more information.Protocols submitted before the school-level and PI-level plans have been approved will be returned to the researcher and will not be reviewed by the IRB. Protocols submitted for research that involves community/field-based activities will not be accepted until the University enters Phase 3 and schools have integrated University guidelines into their school level plans and provided guidance to their investigators.Studies previously approved by the IRB that intend to resume direct in-person interaction with participants and that take place on campus must have an approved PI-level plan from your school and must submit that plan to the IRB prior to restarting research activities.Attestation, Approval Letter, and Information SheetSee Table 1 to determine whether you are required to submit 1) an attestation signed by the PI and an attestation signed by all members of the study team and 2) your PI-level plan approval notice (e.g., email or letter) to the IRB. You will also be expected to distribute an information sheet specific to COVID-19 to participants before interacting with them in person.Table 1. Requirements for all studies, based on level of review (exempt, expedited, full board) and allowable during Phase 2 of the Research Ramp Up(Click on image to enlarge)For studies that were previously approved by the IRB and that require the above, the “Attest to COVID-19 Policies” activity will appear on the study landing page in iStar.For new studies that require the above, page 9 of the application has a new question that will guide researchers to the activity.PIs will have a required field to upload their PI level plan approval notice. This field is hidden and not required for anyone who is not the PI.Please view the Attestation Guidance document and our FAQs for more information.COVID-19 studies will not be pulled from the queue and will be reviewed in the order received.The Office of Research website provides guidelines for the safe, cautious, and phased ramp-up of USC research activities during COVID-19 as well as FAQs related to research.Below are answers to frequently asked questions. We update this list of questions regularly so you should check back if you are looking for the answer to a question and you do not see it posted here.COVID-19 Research Ramp-Up FAQs (as of 7/28)AttestationsIf at least one person on a study will be consenting/engaging in direct in-person interaction with participants (indicated in 2.1 AND 9.1.1 of the iStar application), the “Attest to COVID-19 Policies” activity will appear on the study landing page. Once the attestation has been completed, it will apply across all studies for which that person expects to obtain consent or have direct in-person interaction with participants.Please note that you will have to complete the attestation again in iStar even if you had previously submitted it.USC studies will be halted from executing any “Submit” activities until all individuals (who need to attest) have attested. On approved studies, there will be a box with the names of individuals who have not yet signed their attestations (on existing non-exempt studies).Once all individuals required to do so have signed their attestation, an email will get sent out to the PI/Faculty Advisor/Study Coordinator.Please refer to the Attestation Guidance document and Attestation FAQs for more information.PI-level Plan Approval NoticeWhat is the process for submitting a PI-level plan approval notice? Each PI is responsible for submitting a plan that is reviewed at the level of his/her/zir department and then school, to ensure comprehensive adherence to the school’s Provost approved school-level plan, including those related to participant and study personnel safety practices.Once a PI receives approval from his/her/zir respective school (e.g., email or letter) that plan approval notice must be uploaded in iStar prior to submitting an application to the IRB. If there are no in-person activities conducted, please select no in response to the question “Will anyone on this study have direct in-person interaction with participants?” (Section 9.1.1).For currently approved studies if in person activities are conducted, the PI, Co-Investigator, Faculty Advisor, Study Coordinator or Study Contact can upload the PI Level Plan Approval via the attestation procedure in the study home page.Revisions have been made in iStar to allow the PI Level Plan Approvals to be linked to the PI. Rather than uploading the plan approval for each study where the PI is listed, the plan approvals now require a single upload. Because of this, any plan approvals previously uploaded, will have to be re-uploaded by a member of the study team. We apologize for any inconvenience caused and hope the one-time upload process will simplify matters for all users.Please refer to the Attestation Guidance document for more information.What is the process of resuming research at Keck?Each PI must submit a plan for conducting research in Phase 2A through the KSOM Research Resumption Portal. This applies to all studies new, resuming, and ongoing. Once the PI receives an approval notice through the portal, that will need to be submitted to the IRB. Please note that studies that remained active through the initial stage of the pandemic will not need to submit to the approval notice to the IRB.Please refer to this guidance document for more information.What if I am changing my study procedures to send drugs and/or devices to the participant s home? Research activities where the investigator is sending drugs and/or devices through the mail to a participant for home use are considered “remote” research. The study team must articulate the safety measures it will take to ensure whatever it is sending is safe for the participant to receive (inside the envelope or package, not the actual envelope or package). The study team also must indicate what safety measures it will take when it receives anything back from the participants to ensure what it receives back does not present a risk for members of the study team.Because these qualify as “remote” data collection, these specific types of activities do not require a PI-level plan or attestation(s). This does not include activities where a member of the team or a home health nurse would go into someone’s home to conduct research related activities or to drop off or pick up research related materials. Those remain as Phase 3 activities.What if I temporarily paused direct in-person research activities without communicating that action to the IRB and I now want to resume those activities?You are required to obtain a school-level plan and submit the plan approval notice to the IRB along with the attestation for any and all personnel who will be consenting and having direct in-person interaction with participants . Follow the instructions above with respect to how to complete both of these actions.If you paused direct in-person research activities on an industry sponsored clinical trial because the sponsor requested you do so, you are required to submit the plan approval notice to the IRB along with the attestation for any and all personnel who will be consenting and having direct in-person interaction with participants . Follow the instructions above with respect to how to complete both of these actions.What is the process of resuming research at LAC-DHS?The Los Angeles County Department of Health Services’ Research Oversight Board continues to require all research activities at LAC-DHS to be paused at this time with few exceptions.If you have a study that you would like to continue at LAC-DHS, you must complete this form to request continuation of study activities. You can use the same link to request continuation of more than one study. This requirement is not related to the USC IRB and is specific to LAC-DHS.Please note that if you have not received specific approval to continue your research project(s) through this mechanism, you should not be conducting research at LAC+USC.Where do I find the Coronavirus Screening Questionnaire or Wellness Assessment?You can access the Coronavirus Screening Questionnaire here and it is also available at KSOM. The Wellness Assessment is what is being used in TrojanCheck.How do I access the required TrojanLearn course?All researchers (as well as USC employees) must complete the TrojanLearn module on COVID-19 prior to returning to campus.Accessing TrojanLearn training through the USC Employee Gateway:Login to TrojanLearnGo to the Search bar at the top right of the screen and type in: Health, Hygiene and Safety.Select the version that applies to you: Health, Hygiene and Safety for Employees, Research Employee, or Research StudentClick “Launch” to launch the training module.How do I access TrojanCheck?Research team members must use TrojanCheck to access campus:Create an advanced reservation for the building(s) to be accessedComplete the wellness assessment on the day of the visitRecord check-in and check-out times for each location visitTrojanCheck Resources https://keepteaching.usc.edu/resources/trojan-check-resources/Please note that Undergraduate students and volunteers are not permitted on campus to participate in research during phase 2A. USC graduate students, medical students, residents, and fellows may participate, following all applicable policies and procedures. Please reach out to your Faculty Advisor for further information.Procedure for Visitors to Campus During Phase 2Visitors of any sort should be called out in each school’s Restart plan and reviewed/approved accordingly.During Phase 2, any non-USC visitor approved for campus entry should complete this form found here on a daily basis and file it with the host department. Each visitor will also be required to register and make a building-specific visitor reservation via iVIP (https://visitor.usc.edu).ContactWhat do I do if I become aware of study activity that puts study participants at risk?If you become aware of study activities or practices that you feel put study participants at risk in any way contact OPRS at oprs@usc.edu or visit the website Complaints, Concerns and Report of Misconduct.Who do I contact for additional information?For general questions, please reach out to Julie Slayton jslayton@usc.eduFor study specific questions, please use the “Send Message to IRB” button in iStar or email the IRB analyst assigned to your study.

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