1. Presentation prepared for GCSU ENGAGE INSTITUTION REVIEW BOARD (IRB): FUNCTION AND SERVICE Tsu-Ming Chiang, Chair Whitney Heppner, Vice Chair Qiana Wilson, Legal Rep

2. Introduction - Overview  Introduction of IRB (Tsu-Ming)  Function and Roles  GC-IRB Portal  Introduction of IRBnet (Whitney)  Legal office and its role(s) (Qiana)  Q& A

3. What is IRB?  It is a committee that performs ethical reviews of proposed research  1. to protect the rights and welfare of human research subjects.  2.Ensure human subjects volunteer to participate in research are provided with legally effective informed consent.  3.Safeguard wellbeing of human subjects by minimizing the potential risks and maximizing the benefit before research is conducted.

4. Who needs to submit IRB  Every research involves human participants.  There are different levels of review  Full Review – controversial and sensitive research requires full board to review and vote.  Regular Review – 2 reviewers in related fields + chair  Expedited Review – with justification for expedition, depends on the research, 1-2 reviewers may be assigned.  Exempt – if proposals meet criteria (but proposals still need to be submitted for record). IRB chairs will make ultimate decision based on the project description.

5. Components IRB are reviewing  1. Research procedure and materials safeguard human participants wellbeing.  2. Voluntary consent to participate in research.  3.Informed consent to participate in research.  4.Protection of privacy and confidentiality  5.The right to withdraw from research participation without penalty.  Decision Tree provided by Human Health Services  http://www.hhs.gov/ohrp/policy/checklists/decisioncha rts.html http://www.hhs.gov/ohrp/policy/checklists/decisioncha rts.html

6. Exempt Categories Category I  Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Category II  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

7. Exempt Categories Category III  Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category II (2), if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research. Category IV  Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

8. Exempt Categories Category V  Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. Category IV  Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

9. In House GC-IRB Portal  First Version is scheduled to launch in late November to replace existing IRBnet, using UNIFY as Log in.  Two test runs with real applications were submitted. It is in fine- tuning stage.

10. IRBnet.org (current submission system) Basic steps: 1. Create an account 2. Check your user profile  Add training & credentials file(s) to your account  E.g., NIH “protecting human research participants” http://phrp.nihtraining.com/ http://phrp.nihtraining.com/ 3. Create New Project 4. Add Documents to the Project Package  Download appropriate documents from this page  Type directly in them  Save them and upload them  You may also be uploading additional documents that are relevant (surveys, scripts, etc.)

11. IRBnet.org (current submission system) 5. Add Documents to the Project Package (cont.)  Types of documents  Classroom Project? add “Class Project Instructor Exemption Form” (also read class project FAQ)  Traditional Research Project? (at a minimum) add “New protocol submission form” 6. Link Training Records to this package 7. Share this package with co-investigators 8. Sign the package 9. Submit the package

12. IRBnet.org (current submission system) Other tips:  Projects and Packages  Revisions and Modifications  Mark revisions complete  Create new package for modifications  Exempt studies must be logged in the system  Submit a complete protocol form  Community research  Include a letter from the cooperating organization or site where you will collect data as a document associated with your project package (on letterhead, signed by an official)  Read the “Checklist for submissions” available in the “forms and templates” on the left menu

13. Legal Office Role(s) and Support  1. Provide guidance on federal and state regulations that are specifically relevant to the operation of the IRB.  2. Provide guidance on matters that arise during the course of reviewing an IRB application for research.  a. FERPA/HIPAA  b. Records Retention  c. Intellectual Property  d. Risks Management  e. Consent  f. Confidentiality/Privacy  3. Ensure policies and procedures are in line with HHS regulations and guidelines.  4. Provide support to IRB members and University offices that may encounter requests related to human subjects research.

14. Conclusion  IRB consists of members across different disciplines conducting research with human participants. If you are conducting such research, you are welcome to be a part of the team.  IRB is here to help you protect human participants and in compliance with federal regulation.  As a new team, we are attempting to make the process as easy, intuitive and efficient as possible. A new system and webpage instruction are in the work to make the process easier for you!

15. Questions/Discussions  Question or Comments  Email:  tm.chiang@gcsu.edu tm.chiang@gcsu.edu  whitney.heppner@gcsu.edu whitney.heppner@gcsu.edu  qiana.wilson@gcsu.edu qiana.wilson@gcsu.edu