{"id":32432,"date":"2023-10-13T03:10:40","date_gmt":"2023-10-13T03:10:40","guid":{"rendered":"https:\/\/www.process.st\/templates\/nih-protocol\/"},"modified":"2024-03-05T14:31:37","modified_gmt":"2024-03-05T14:31:37","slug":"nih-protocol","status":"publish","type":"post","link":"https:\/\/www.process.st\/templates\/nih-protocol\/","title":{"rendered":"NIH Protocol"},"content":{"rendered":"\n<section id=\"develop-a-research-proposal\"> \n <h2>Develop a research proposal<\/h2>\n <div class=\"text-content\">\n   This task involves creating a research proposal that outlines the objectives, methodology, and expected outcomes of the research. It is important to carefully consider the research question, study design, and feasibility. The research proposal lays the foundation for the entire project and serves as a guide throughout. Remember to include any necessary background information, citations, and potential challenges that may arise along the way. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Briefly describe your research question. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What is the objective of your research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What methodology will you use to conduct your research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What are the expected outcomes of your research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"identify-potential-risks-and-benefits-of-the-research\"> \n <h2>Identify potential risks and benefits of the research<\/h2>\n <div class=\"text-content\">\n   In this task, you will assess and document the potential risks and benefits associated with the research. Consider both physical and psychological risks to participants, as well as any potential benefits that may arise from the research. This information will help inform the informed consent process and ensure that participants are fully aware of the potential risks and benefits before deciding to participate. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What are potential physical risks of the research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What are potential psychological risks of the research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What potential benefits may arise from the research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"complete-training-on-research-ethics-and-regulatory-compliance\"> \n <h2>Complete training on research ethics and regulatory compliance<\/h2>\n <div class=\"text-content\">\n   This task involves completing training on research ethics and regulatory compliance. It is essential to understand the ethical considerations and legal requirements for conducting research involving human subjects. The training will provide guidance on obtaining informed consent, ensuring participant safety, and reporting adverse events or deviations from the approved protocol. \n <\/div> \n <div class=\"select-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Have you completed research ethics and regulatory compliance training? <\/label> <select disabled class=\"form-control\"> <option value=\"An option will be selected here\">An option will be selected here<\/option> <\/select> \n  <\/div> \n  <ul class=\"items\"> \n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       1 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      Yes \n    <\/div> <\/li>\n   <li class=\"item\"> \n    <div class=\"step-number-container\"> \n     <div class=\"step-number\">\n       2 \n     <\/div> \n    <\/div> \n    <div class=\"step-checkbox-container\"> \n     <div class=\"step-checkbox\"><\/div> \n    <\/div> \n    <div class=\"item-name-static\">\n      No \n    <\/div> <\/li> \n  <\/ul> \n <\/div> \n <div class=\"file-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Upload training completion certificate <\/label> \n   <div class=\"file-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-upload btn-icon\"><\/i> File will be uploaded here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"prepare-a-research-protocol-document\"> \n <h2>Prepare a research protocol document<\/h2>\n <div class=\"text-content\">\n   In this task, you will prepare a research protocol document that outlines the specific procedures and methodologies for conducting the research. This document should include detailed information on participant recruitment and selection criteria, data collection procedures, informed consent process, and analysis plan. The research protocol serves as a roadmap for conducting the research and ensures consistency throughout the study. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe the participant recruitment and selection criteria. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Outline the data collection procedures. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Explain the informed consent process. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe the analysis plan. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"submit-the-research-protocol-to-the-principal-investigator\"> \n <h2>Submit the research protocol to the principal investigator<\/h2>\n <div class=\"text-content\">\n   Upon completion of the research protocol document, it should be submitted to the principal investigator for review and approval. The principal investigator will assess the feasibility, ethical considerations, and overall quality of the research protocol. Any revisions or modifications required will be communicated back to the researcher. \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the principal investigator. <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select> \n  <\/div> \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date of submission <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-principal-investigator\"> \n <h2>Approval: Principal Investigator<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Submit the research protocol to the principal investigator<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"review-and-revise-the-protocol-as-needed\"> \n <h2>Review and revise the protocol as needed<\/h2>\n <div class=\"text-content\">\n   Based on feedback from the principal investigator, the researcher should review and revise the research protocol as needed. This may involve modifying the study design, addressing ethical concerns, or clarifying procedures. It is important to ensure that the research protocol meets all necessary requirements before proceeding to the next step. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe any revisions or modifications made to the research protocol. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"submit-the-revised-research-protocol-to-irb\"> \n <h2>Submit the revised research protocol to IRB<\/h2>\n <div class=\"text-content\">\n   Once the research protocol has been revised, it should be submitted to the Institutional Review Board (IRB) for approval. The IRB is responsible for ensuring that the research meets ethical standards and protects the rights and welfare of the participants. The IRB will assess the revised protocol and provide a decision. \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date of submission <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-irb\"> \n <h2>Approval: IRB<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Submit the revised research protocol to IRB<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"complete-the-informed-consent-document\"> \n <h2>Complete the informed consent document<\/h2>\n <div class=\"text-content\">\n   In this task, you will complete the informed consent document. The informed consent document outlines the purpose of the research, procedures, potential risks and benefits, and participant rights. It is important to use clear, non-technical language and provide ample opportunity for participants to ask questions or seek clarification. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Provide a brief overview of the research and its purpose. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe the procedures involved in the research. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Explain the potential risks and benefits of participating in the research. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Detail the rights and responsibilities of the participants. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"submit-the-informed-consent-document-to-irb-for-approval\"> \n <h2>Submit the informed consent document to IRB for approval<\/h2>\n <div class=\"text-content\">\n   Once the informed consent document has been completed, it should be submitted to the IRB for approval. The IRB will review the document to ensure that it provides adequate information for participants to make an informed decision and that it meets all ethical requirements. \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date of submission <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-informed-consent-document\"> \n <h2>Approval: Informed Consent Document<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Submit the informed consent document to IRB for approval<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"recruit-and-screen-study-participants\"> \n <h2>Recruit and screen study participants<\/h2>\n <div class=\"text-content\">\n   In this task, you will recruit and screen potential study participants. This may involve advertising the research, contacting potential participants, and conducting screening interviews or assessments. It is important to ensure that participants meet the eligibility criteria and fully understand the requirements and expectations of participating in the research. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe the recruitment methods used for participant selection. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Explain the screening process for potential participants. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"obtain-informed-consent-from-each-participant\"> \n <h2>Obtain informed consent from each participant<\/h2>\n <div class=\"text-content\">\n   For each participant, you will obtain their informed consent prior to their participation in the research. This involves providing them with the informed consent document, answering any questions or concerns they may have, and obtaining their signature or agreement to participate. \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the participant to obtain consent from. <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select> \n  <\/div> \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date informed consent obtained <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"conduct-the-research-according-to-the-approved-protocol\"> \n <h2>Conduct the research according to the approved protocol<\/h2>\n <div class=\"text-content\">\n   In this task, you will conduct the research according to the approved protocol. This involves following the specified procedures, collecting data, and ensuring participant safety and welfare throughout the study. It is important to adhere to the approved protocol to maintain the integrity and validity of the research. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe the procedures for data collection. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> How will participant safety and welfare be monitored during the study? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"report-any-deviations-or-adverse-events-to-the-principal-investigator-and-irb-immediately\"> \n <h2>Report any deviations or adverse events to the principal investigator and IRB immediately<\/h2>\n <div class=\"text-content\">\n   If any deviations from the approved protocol or adverse events occur during the research, it is crucial to report them immediately to the principal investigator and IRB. This ensures that appropriate actions can be taken to address the situation and to ensure the safety and well-being of the participants. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Describe any deviations or adverse events that have occurred. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"monitor-participant-safety-and-welfare-throughout-the-study\"> \n <h2>Monitor participant safety and welfare throughout the study<\/h2>\n <div class=\"text-content\">\n   Throughout the course of the study, it is important to monitor participant safety and welfare. This involves regularly checking in with participants, addressing any concerns or issues they may have, and ensuring that they are comfortable and well-informed about their participation in the research. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> How will participant safety and welfare be monitored throughout the study? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"summarize-and-analyse-research-data\"> \n <h2>Summarize and analyse research data<\/h2>\n <div class=\"text-content\">\n   Once all data has been collected, it needs to be summarized and analyzed. This task involves organizing and summarizing the collected data, applying appropriate statistical analysis methods, and drawing meaningful conclusions from the research findings. The data analysis should align with the research objectives and be presented in a clear and concise manner. \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Briefly describe the data analysis methods used. <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n <div class=\"textarea-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> What were the main findings of the research? <\/label> <textarea placeholder=\"Something will be typed here...\" rows=\"3\" disabled class=\"form-control\"><\/textarea> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"submit-a-final-report-to-the-principal-investigator-and-irb\"> \n <h2>Submit a final report to the principal investigator and IRB<\/h2>\n <div class=\"text-content\">\n   Upon completion of the data analysis, a final report should be prepared and submitted to the principal investigator and IRB. The report should summarize the research process, provide a detailed analysis of the findings, discuss any limitations or challenges encountered, and make recommendations for future research or improvements. The report serves as a record of the research and contributes to the body of knowledge in the field. \n <\/div> \n <div class=\"members-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Select the principal investigator. <\/label> <select disabled class=\"form-control\"> <option value=\"A member or group will be selected here\">A member or group will be selected here<\/option> <\/select> \n  <\/div> \n <\/div> \n <div class=\"date-field-content form-field-content\"> \n  <div class=\"form-group\"> <label> Date of submission <\/label> \n   <div class=\"date-container\"> <button type=\"button\" disabled class=\"btn btn-default\"> <i class=\"fa fa-calendar btn-icon\"><\/i> Date will be set here <\/button> \n   <\/div> \n  <\/div> \n <\/div> \n<\/section> \n<section id=\"approval-final-report\"> \n <h2>Approval: Final Report<\/h2>\n <div class=\"approval-content\"> \n  <div class=\"header\"> \n   <div class=\"list-title\">\n    Will be submitted for approval:\n   <\/div> \n  <\/div> \n  <div class=\"approval-rule-subject-tasks-list\"> \n   <ul class=\"list\"> \n    <li> \n     <div class=\"approval-rule-subject-tasks-list-item\"> \n      <div class=\"item\"> \n       <div class=\"container\"> <span class=\"title\">Submit a final report to the principal investigator and IRB<\/span> \n        <div class=\"body\">\n         Will be submitted\n        <\/div> \n       <\/div> \n      <\/div> \n     <\/div> <\/li> \n   <\/ul> \n  <\/div> \n <\/div> \n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>Develop a research proposal This task involves creating a research proposal that outlines the objectives, methodology, and expected outcomes of the research. It is important to carefully consider the research question, study design, and feasibility. The research proposal lays the foundation for the entire project and serves as a guide throughout. Remember to include any [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"ep_exclude_from_search":false,"cover_icon_emoji":"\ud83d\udd2c","cover_icon_url":"","tasks_count":"20","template_description":"","template_id":"ibLTzmNdxh-7oLyNG8ZIKw","task_0":"Develop a research proposal","task_slug_0":"develop-a-research-proposal","task_1":"Identify potential risks and benefits of the research","task_slug_1":"identify-potential-risks-and-benefits-of-the-research","task_2":"Complete training on research ethics and regulatory compliance","task_slug_2":"complete-training-on-research-ethics-and-regulatory-compliance","task_3":"Prepare a research protocol document","task_slug_3":"prepare-a-research-protocol-document","task_4":"Submit the research protocol to the principal 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