Research Approval Process

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Institutional Review Board (IRB) – Human Subject Research

Human Subject Research is federally regulated to insure protection for all human subjects. The Institutional Review Board (IRB #00000616) of the University of Illinois College of Medicine at Rockford has a separate Federalwide Assurance (FWA #00005607), from U. S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), and reviews all human subjects’ protocols conducted on or by faculty and students associated with the COM-R.

Defining Human Subject Research

Human Subject Research is federally regulated to insure protection for all human subjects. The Institutional Review Board (IRB #00000616) of the University of Illinois College of Medicine at Rockford has a separate Federalwide Assurance (FWA #00005607),from U. S. Department of Health and Human Services (HHS), Office for Human Research Protections (OHRP), and reviews all human subjects’ protocols conducted on or by faculty and students associated with the COM-R.

What is human subject research?

There are two federal agencies that provide the definitions of “human subject research.”

DHHS definitions:

  1. “Research” as defined by DHHS regulations means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]
  2. “Human Subject” as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]

FDA definitions:

  1. “Research” as defined by FDA regulations, means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]
  2. “Human Subject” as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]

Policy and Procedure Manual

Are you conducting human subjects research as defined by DHHS and FDA? Decision Trees provided by the Office for Human Subject Research Protections will help you determine if an activity is research involving human subjects that must be reviewed by the IRB.

These charts are general, and not specific to many situations. They also do not address requirements from other agencies, such as the Food and Drug Administration (FDA), The National Institutes of Health (NIH) or other state and local governments.

Guidance is available through the Office of Research Support Services at the College of Medicine at Rockford.

Chart A: Is Activity Research Involving Human Subjects?

Chart B: Is the Human Subjects Research Eligible for Exemption?

Chart C: May the IRB Review be done in by Expedited Procedures?

Chart D: May the IRB Continuing Review be done by Expedited Procedures?

The University of Illinois at Rockford requires online training for all persons planning to participate in human subject research reviewed by their Institutional Review Board (IRB).

The Collaborative IRB Training Initiative (CITI) provides the initial (basic) human research training. This web-based course will take two to three hours to complete, depending on an individual’s prior knowledge and experience with research, ethical principles and regulations about human subject protections. The training can be started, stopped and resumed at any point.

This online training requirement must be met before research personnel can participate in any research activities for Exempt, Expedited or Full IRB reviews.

This training can also be submitted for continuing education credit for physicians, nurses and psychologists through the AMA, APA/CEP and CNE. Click CE credits at CITI for more information.

Definition of Key Research Personnel:

Key research personnel include all persons who will have a significant role in the design or conduct of the research, and includes (at a minimum) all Principal Investigators, Co-Investigators, Student Advisors, any individuals who are individually named on a grant or contract application, or who are listed on an FDA form 1572 (conducted at COM-R), named as contact persons in the recruitment documents or informed consent documents for research, or who provide supervision of the persons who are obtaining informed consent to participate in research.

Any individuals, including student researchers and coordinators, who are involved with the research by handling protected health information, or are using the research information/data set as part of their research, should be included as research personnel on a protocol application.

Step 1: CITI Training Instructions for Initial or Continuing Education

The CITI web-based training course is a collaborative effort between multiple institutions. It is hosted by the University of Miami.

To Register:

  1. Go to www.citiprogram.org and select “Register for the CITI Course.”
  2. Under “Participating Institutions” select: University of Illinois College of Medicine at Rockford.
  3. Register for CITI

Instructions:

  1. Complete “Biomedical Research Investigators” or “Social and Behavioral Research Investigators” Modules. Biomedical Research Investigators training is recommended unless you plan on primarily working with Social and Behavioral Research.
    • Those that have previously taken either of those courses should indicate so in Question 2. This will provide a Refresher Course instead of the original training. DO NOT CHECK A COURSE YOU HAVE NOT TAKEN as the refresher course is NOT a substitute for the complete modules. Refresher courses will not be accepted unless accompanied by a completion certificate of the original course taken.
  2. Complete the quiz at the end of each of the required modules.
  3. Achieve an overall passing score of 80 percent on these quizzes.

Note: Good Clinical Practice, Responsible Conduct of Research, and Students in Research are not IRB requirements, but may be program requirements for you. Please check with your program to see if you are required to do any of these supplemental courses.

Step 2: Reporting Completion of Training

  1. Go to: IRBNet.org
  2. Create an account by clicking ‘New User Registration.’
  3. Login and go to user profile.
  4. Choose add a training and credential record.
  5. Choose the appropriate document type and the date earned.
  6. Attach the associated completion report that was emailed to you upon course completion.
  7. After you have attached your document, click ‘Submit’ under training and credentials in the user profile page.
  8. Choose University of Illinois College of Medicine at Rockford IRB as your Board and submit.

Continuing Education

The University of Illinois College of Medicine at Rockford requires every person listed on a human subject research protocol to perform continuing education credits every two years. Please log on to the: Collaborative Institutional Training Initiative (CITI)

Web site to complete your continuing education requirements. Load the renewal report as described in Step 2.

Conducting human subject research at any of the University of Illinois College of Medicine at Rockford clinics requires IRB review and approval. Any person working on a clinical research project must complete the required online training and must be listed on the approved protocol. This includes key research personnel that assist in recruitment, consent, data collection and analysis.

These clinics include:

  • L. P. Johnson Family Health Center

Research by faculty, staff, and students

Any College of Medicine at Rockford faculty, staff or student that is actively engaged in research should contact the College’s Research Support Services office for information on the policy and procedures regarding human subject research by COM-R employees. Please note that faculty, staff, and students actively engaged in a research activity with an outside institution must follow the guidelines concerning the use of an employee’s university association in publication, which requires COM-R IRB approval. For further information please contact the RSS office or refer to the COM-R Policy and Procedure Manual.

Health Services Research and HIPAA

FDA and Running Clinical Trials

UIC Center for Clinical and Translational Science

UIC Clinical Interface Core

The Guidebook is divided into the following chapters:

Introduction

Provides a basic understanding of the background and purposes of the IRB review system. It should be particularly useful for new IRB members and investigators just beginning their clinical research. The Introduction includes a description of The Belmont Report, providing a summary of the principles set forth in this seminal policy statement on the protection of human subjects of research.

Chapter 1

Institutional Administration. Directed primarily at institutional administrators and IRB chairpersons. It will also be of interest to others on the IRB, clinical investigators, and sponsors of research who wish to consider how the IRB relates to other institutional offices.

Chapter 2

Regulations and Policies. Assists in resolving uncertainties about the intent or interpretation of regulatory provisions. It should also be a useful reference for initial reviewers of research proposals.

Chapter 3

Basic IRB Review. Presents the major focal points of IRB review: informed consent, risk/benefit analysis, privacy and confidentiality, selection of subjects, and incentives for participation. It goes beyond the regulations in suggesting how the regulations might be applied in various situations.

Chapter 4

Considerations of Research Design. Provides descriptions of, and information on, the reasons for using certain experimental designs. The ethical issues raised by such uses are also explored.

Chapter 5

Biomedical and Behavioral Research: An Overview. Describes certain kinds of research by subject matter and their various goals and methods in a general, introductory way, pointing out the ethical concerns each raises and providing references for further reading. This chapter will be of most benefit to nonscientists on the IRB and to scientist-reviewers confronting a research proposal in an unfamiliar discipline.

Chapter 6

Special Classes of Subjects. Provides an analysis of the ethical issues that arise in research involving classes of particularly vulnerable research subjects. Regulations exist for some classes of subjects; for others, no regulations are in place.

Appendices

Glossary of Terms


Biologic Resource Committee (BRC) – Animal Research

Federal regulations require any institution that uses animals in research to adhere to strict procedures to insure the humane treatment for all research animals. The Office of Laboratory Animal Welfare (OLAW) provides guidance and understanding concerning the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals. The Biologic Resource Committee (BRC) at COM-R oversees all animal protocols to ensure compliance with these regulatory agencies.

For all information concerning submission and protocol review, please use the College’s intranet services.

All new investigators get initial training from the laboratory animal care supervisor who can be reached at (815) 395-5796.

Supplemental educational training may also be conducted through the online training resource developed by the Office of the Vice Chancellor for Research. This training is found on the UIC Learning Management System. To receive CE credit for these training modules from HSPP, please email a copy of the certificate to the Office for the Protection of Research Subjects AND Patrick McIntyre at the COM-R.  In addition, animal specie specific supplemental training modules may be accessed at:

Collaborative IRB Training Initiative (CITI)

The CITI web-based training course is a collaborative effort between multiple institutions. It is hosted by the University of Miami.

To Register:

  1. Go to www.citiprogram.org and select “Register for the CITI Course.”
  2. Under “All Others” select: University of Illinois College of Medicine at Rockford.
  3. Register for CITI by establishing your unique username and password.
  4. Enter your demographic information.
  5. After you submit your demographic information, you will be asked to select the focus of your research.
  6. If your research focuses mainly in the behavioral or social sciences, you should choose the Social/Behavioral modules (SBR).
  7. If your research focuses mainly in the biomedical or biological sciences, you should choose the Biomedical modules (Biomed).

For assistance please contact Research Support Services at (815) 395-5942.


Institutional Biosafety Committee (IBC) – Bio-safety Research

The Institutional Biosafety Committee (IBC) is responsible for reviewing and approving all research involving rDNA and/or infectious agents or toxins. The goal of the IBC office is to facilitate the protocol writing/review process for the investigator and to ensure compliance of rDNA and infectious agent research with federal regulations. Protocols are reviewed on a monthly or “as needed” basis with meetings scheduled at least quarterly. The deadline for submissions is the last day of the month for review in the following month. The Office of Research lends administrative assistance to the COM-R IBC.

For more information on biosafety, visit the CDC – Biosafety Web site

For assistance, questions or application forms, contact:
Patrick McIntyre
(815) 395-5942
[email protected]


Radiation Safety – Use of Radioactive Materials

Step 1: Authorization of Use of Radioactive Isotopes at COM-R
Submit Form 106 – Request for Amendment of NRC License – New User for each member of the lab that will be performing this research. He/she must provide a detailed history concerning their training and previous work history in using radioactive materials. All researchers wanting to use radioactive materials must be certified by Radiology / Nuclear Medicine and the Radiation Safety Office. Once the Radiation Safety Committee has approved the user, they then have to submit the details of the protocol concerning the isotopes to be used.

Step 2: Registration of Instruments and Machines Producing Ionizing Radiation

Submit Form 107 – Application for Procurement and Use of Radioactive Materials-4, that details radioisotope procurement and use. The RSC reviews one form per every isotope that will be used. Please see Form 107 – Instructions to Radioisotope Procurement and Use prior to submitting Form 107.

Useful Links:

The Office of Health and Safety Information

Illinois Nuclear Radiation Safety Information

Radiation Safety Manual 2009