Protection of Human Subjects is one example of Compliance. Compliance Examples - Read here
PLEASE READ: TRAINING REQUIREMENT **
* Effective 2012*
All YSU faculty, students, and staff who are involved with Human Subjects research must complete TRAINING and be Certified. (Requirement - initiated Fall 2010).
TRAINING is available at the NIH site: http://phrp.nihtraining.com/users/login.php
Follow their instructions. Send your completed Certificate to our IRB secretary (Cheryl Coy).
Recommendation: New YSU investigators should start the training 2-3 weeks prior to a planned research project.
It is helpful to review the "IRB Training Workshop" (.ppt Presentation). Go to "Training" Page at this website.
I. INTRODUCTION: The IRB (Institutional Review Board) at YSU
The Protection of Human Subjects is governed by federal laws. Guidelines exist at:
Office for Human Research Protections (OHRP).
(see also: Title 45 of the Code of Federal Regulations (CFR) Part 46)
In order to comply, YSU protects human subjects through review of research protocols by the Institutional Review Board (IRB), formerly known as the Human Subjects Research Committee (HSRC).
YSU Board Policy #1014.01: “Integrity in Research – Use of Human Participants”.* (YSU Guidebook)
YSU has a "Federal Wide Assurance - FWA" (FWA 00018057) - from the U. S. Dept of Health and Human Services (Oct. 2011)
II. PROCESS AND PROCEDURES: (IRB Manual) - see below
- The IRB must review protocol submissions involving human subjects. The protocols MUST receive IRB approval BEFORE "participants are recruited" as part of the research project.
- The IRB meets monthly to review projects that require "Full Committee" review. Projects that can be expedited are reviewed on an ongoing basis.
IRB Meeting Schedule: Fall 2012: 1st Tuesday of each month.
Protocol Forms: Effective Jan. 1, 2012
All Investigators must complete the required Training and submit a Certificate of completion with the appropriate protocol Form.
The YSU Principal Investigator (PI) must submit the appropriate Protocol Form for review. This process should be undertaken 2-3 weeks before a project commences.
NOTE: Please enter (type) your Narrative elements into these on-line Forms directly. (The boxes on the forms will expand).
Please do not simply add a document as an "attachment" (e.g., with a note saying "see attached").
1. * To predetermine which form to use, review the following Instructions, and answer the Exempt screening questions.
"Instructions for Claim of Exemption"
2. If all answers are "no", then complete the Claim of Exemption Form. "Claim of Exemption" Form
3. If any answer is "yes", then the review must be by the IRB Committee. Complete the Full/Expedited Protocol Form.
"Full/Expedited Protocol" Form
* Guidance on Informed Consent. Format: Template (OHRP: CFR, Part 46. Checklist of Elements)
4. Modifications or Amendments: If a project requires an amendment or revisions, then complete the following form.
"Amendment/Modification of Research" Form
5. Adverse Events: If problems or difficulties are encountered during the course of a research project which could affect the safety or welfare of the subjects, then the PI must communicate the issue to the IRB.
Please complete this Report Form: "Adverse Protocol Report"
III. IRB MANUAL - Handbook.
"YSU-IRB for the Protection of Human Subjects"