To supplement the Toolkit documents, the Investigator Manual is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution. The manual is comprehensive and covers everything from who can serve as PI and the IRB review process, to investigator responsibilities post-approval.
Throughout this document “institution” refers to the University of Wisconsin-Madison.
Purpose
This document, HRP-103 – INVESTIGATOR MANUAL, is designed to guide you through policies and procedures related to the conduct of Human Research that are specific to this institution.
General information regarding Human Research protections and relevant federal regulations and guidance is incorporated into the required human protections training. For additional information see the Training Required to Conduct Human Participant Research page.
HRPP Toolkit Library
Along with this manual, current Human Research-related policies, SOPs, Worksheets, Checklists and Templates may be found in the HRPP Toolkit Library.
- SOPs describe HRPP processes
- Worksheets are reference documents outlining regulatory and institutional criteria for specific items (e.g., FERPA, criteria for approval, assessing recruitment materials)
- Checklists are used by HRPP staff and the IRB to document regulatory determinations. Checklists do NOT need to be completed by study teams.
Collectively, these documents comprise the Toolkit Library and create a complete picture of Human Research Protection Program (“HRPP”) and Institutional Review Board (“IRB”) expectations and a guide to seeking IRB review and approval. All documents in the Toolkit Library are used by HRPP staff and IRB members to enhance compliance with federal, state and local requirements for conducting research and protecting human participants.
We encourage you to use all of these resources to assist in you in preparing your application and conducting your research study.
To ensure you are always referencing the most current version of Toolkit and related documents, please access them in real time from the IRB website rather than downloading and storing them on your computer.
Human Research Protection Program
HRP-101 – HUMAN RESEARCH PROTECTION PROGRAM PLAN describes this institution’s overall plan to protect subjects in Human Research.
- The mission of the Human Research Protection Program.
- The ethical principles that the institution follows governing the conduct of Human Research.
- The applicable laws that govern Human Research.
- When the institution becomes “engaged in Human Research” and when someone is acting as an agent of the institution conducting Human Research.
- The types of Human Research that may not be conducted.
- The roles and responsibilities of individuals within the institution.
Defining Human Participant Research
HRP-101 – HUMAN RESEARCH PROTECTION PROGRAM PLAN defines the activities that this institution considers to be “Human Research.” A decision tree for determining whether an activity is Human Research can be found in HRP-310 – WORKSHEET – Human Research Determination. Use this worksheet for guidance as to whether an activity meets either the DHHS or FDA definition of Human Research, keeping in mind that the IRB makes the ultimate determination in questionable cases as to whether an activity constitutes Human Research subject to IRB oversight.
You are responsible not to conduct Human Research without prior IRB review and approval (or an institutional review and determination of exempt Human Research). If you have questions about whether an activity is Human Research, contact the IRB Office who will assist you in determining whether an activity is Human Research. Additionally, you can use the Quality Improvement/Program Evaluation Tool to self-certify whether your project constitutes Human Research. See Quality Improvement Projects for more information.
Self Experimentation of Researchers
The Common Rule and Food and Drug Administration (FDA) do not regard research on oneself as different from research involving other human subjects. Prior to commencing any research activities involving self-experimentation (e.g., blood draws, equipment testing), an Initial Review Application must be submitted to and approved by an appropriate UW-Madison IRB. The IRB will review the application to ensure the activities do not raise any ethical concerns and that adequate protections are in place.
The Common Rule and FDA regulations also require that informed consent be obtained from all research participants unless certain conditions are met. The IRB recommends researchers provide with their Initial Review Application a document that will serve as the basis for documentation of informed consent for participation in human subjects research when the experimentation involves the researcher. HRP-511 – TEMPLATE – Self Experimentation Consent Template can be used to draft this document.
Getting Help & Answers to Questions
If you have questions, please contact us. All contact information is available here.
If you have questions, concerns, complaints, allegations of undue influence, allegations or findings of noncompliance, or input regarding the Human Research Protection Program that cannot be addressed by contacting the IRB Office, follow the directions in HRP-101 – HUMAN RESEARCH PROTECTION PROGRAM PLAN.