Investigator Guidance

Investigator Guide - Human Subjects Research

• Chapters 1-5
• Appendices

Investigator/Staff Guidance

• Community Engaged Research

• Criteria for IRB review and approval (IRB Reviewer Reference Sheets - 01/03/11)
  
  
• FDA Inspections
  
  

• Guidelines for Writing a Research Protocol - A guide on how to prepare a full description of the planned research, or a research protocol. A research protocol provides the reader with background information of the problem under study, including the study rationale, a detailed plan for conducting the research involving human research participants, and a discussion of the potential importance of the research. 

• OHRP Educational Videos (HHS YouTube channel)
  • General Informed Consent Requirements
  • Research Use of Human Biological Specimens and Other Private Information
  • Reviewing and Reporting Unanticipated Problems and Adverse Events
  • IRB Membership
    
    
• On Being a Scientist: Third Edition (The National Academies Press)
  
  
• Human Participants in Research (ORRP) - An educational video that provides investigators, research staff, and students with an overview of federal and university requirements for human subjects research and Institutional Review Board review.

Office Hours

• Assistance for Researchers - Behavioral & Social Sciences
• Assistance for Researchers - Biomedical & Cancer Research

Sample Research Documents

• Verbal Consent Script and Contact Information Card

Student Researchers

• Web Guide to Research for Undergraduates (WebGuru) is an interactive web-based tool intended to assist undergraduates navigate the hurdles of an undergraduate research experience. It provides useful information related to a productive and rewarding undergraduate research experience. See http://www.webguru.neu.edu/index.php

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