For Researchers Conducting Research at Woman’s Hospital For External Collaborators Interested in collaborating? The Woman’s Hospital Research Center has a strong commitment to inclusive research. Complete this form with your contact information and research. Dr. Elizabeth Sutton, Director of Scientific Research, Elizabeth.Sutton@womans.org, will respond to all submissions. For Employees All human subjects research conducted at Woman's should be submitted to the Research and Development (R&D) Committee and the Institutional Review Board (IRB) for review. For information about submitting a research study for IRB review, download How to submit a research study to the IRB » Contact Woman’s Human Research Protection Program Research investigators can access our P&P, forms and templates and get answers to questions by emailing research@womans.org or calling 225-231-5275. Policies Downloadable PDF files: HRPP Plan & Scope Engagement in Research HRPP Scope and Components ICH-GCP (Good Clinical Practice) IRB Appointments and Evaluation of Members IRB Composition and Management Determination if a Proposed Activity is Research IRB Minutes IRB Records and Retention Meetings and Agenda Notification of IRB Decisions Protocol Submission Research Submission Requirements Education & Training Education & Training Requirements Review of Research Adverse Event Reporting / Unanticipated Problems Case Reports and Case Series Completion and Closure to Subject Entry Continuing Review of Approved Research Data Safety and Monitoring Emergency Use of a Test Article Exempt Review / Limited IRB Review Expedited Review Expired IRB Approval / Re-submission of Expired Studies IRB Review and Determinations Limited Data Sets and Data Use Agreements LSU Residency Research Policy Protocol Deviations Registries, Databases, and Repositories Research and Development Committee Revisions and Amendments to Approved Studies Single IRB of Record for Cooperative Research Termination and Suspension of Research Use of Coded Biological Specimens and Data Verification that There Have Been No Material Changes Since Last IRB Review Informed Consent & Recruiting Advertisements Assent of Children and Parental Permission Compensation to Research Subjects Informed Consent Form Elements and Requirements Non-English Speaking Subjects / Short Form Consent Form for Non-English Speakers Required Institutional Language Review of Data Preparatory to Research Screening and Recruitment Text Messaging for Recruitment Waiver of Informed Consent / Documentation of Consent Special Populations Enrolling Men/Women of Childbearing Age Research Involving Children Research Involving Pregnant Women, Fetuses, and Neonates IND/IDE Studies Compassionate Use Humanitarian Use Devices Investigational Devices Investigational New Drug (IND) Research Study Drugs and Supplements Research Compliance Allegations of Noncompliance Allegations of Research Misconduct Audits and Monitoring Complaints From Research Subjects Conflict of Interest Policy Conflict of Interest – Organizational Conflict of Interest Guidance Study Records Retention Privacy & Confidentiality Certificates of Confidentiality Decedents - Protected Health Information FDA 21 Part 11 Requirements for Electronic Records HIPAA Privacy and Confidentiality Waiver of HIPAA Authorization Forms Accounting of Disclosure for <50 participants Accounting of Disclosure for >50 participants Adverse Event Reporting Form Amendment to Current Study or Submission of New Findings Submission Form Assent Form Template Consent Form Template Consent Form Template – Cover Sheet Continuing Review Application Contract Template Data Use Agreement Department Approval Form Electronic Authorization to Release Health Information (HIPAA) External IRB Reliance Application Financial Interest Disclosure Initial Submission Form for new studies Investigator Agreement IRB Reliance Application Material Transfer Agreement Protocol Deviation Report Form Protocol Template Representation of Preparatory to Research Activities Short Form Consent Form – English Short Form Consent Form - Spanish Waiver of Consent Form Waiver of Documentation for Consent Definitions Definitions [pdf] Checklists Checklist for Emergency Use of a Test Article Checklist for research on children Checklist for research on pregnant women ICH-GCP E(6) Checklist for Clinical Trials Contracts – Required Language Investigator Handbook Investigator Handbook [pdf] Meetings and Deadlines Woman’s Hospital Foundation Research and Development Committee and Institutional Review Board Meetings and Deadlines 2020 [Word doc] » 2021 [Word doc] »