1. Dining with Diabetes
IRB Training
2017

2. Training 2017
Importance of following Human Subjects procedures (review)
DWD IRB Expedited Review
New Protocol with Pending Approval

3. Importance of Following Human Subjects Procedures
We are meeting the requirements of basic ethical principles underlying the involvement of humans as research subjects
To preserve the public trust in research involving human subjects
To maintain personal privileges to conduct research as well as those of a Principal Investigator

4. DWD Expedited Review Three levels of review.
Exempt: what we have now; applies to all data we’ve already collected and are collecting using current evaluation tools
Expedited: what we have applied for; initial approval takes longer but simpler and quicker to make amendments
Will include a yearly “progress report”
New key personnel must be added prior to recruiting or consenting or collecting identifiers from participants
Full review (NA)

5. New IRB Application – Major Responsibilities of Protocol
Recruitment
Consent
Tracking of Personal Identifiers
Entering/Storing data

6. Recruitment Who can be recruited?
People 18 and older who have consented to the research portion (questionnaires)
How are they recruited?
When participants sign up for the program, they will be read a recruitment script (provided) or sent the recruitment letter (the same script but in a letter).
If a participant(s) calls the Extension office to sign up for a DWD program, key personnel will read him/her the recruitment script to notify them there will be an opportunity to be part of a research study evaluating the program.

7. Recruitment… How are they recruited?
When participants sign up for the program, they will be read a recruitment script (provided) or sent the recruitment letter (the same script but in a letter).
If a participant(s) calls the Extension office to sign up for a DWD program, key personnel will read him/her the recruitment script to notify them there will be an opportunity to be part of a research study evaluating the program.
If the person(s) shows up at the first class without any prior notice, he/she will be read the recruitment script to determine interest.
NOTE: Recruitment must be completed by someone listed as Key Personnel on the IRB approved application.

8. Informed Consent Informed Consent The Consent Process
Most people have the reasonable expectation that they be treated with respect as autonomous individuals. They also expect that they have a right to make decisions about what will and will not be done to their persons and about what information they will share with others.
The Consent Process
Informed consent is not a single event or just a form to be signed -- rather, it is an interactive educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include:
full disclosure of the nature of the research and the subject's participation,
adequate comprehension on the part of the potential subjects, and
the subject's voluntary choice to participate.

9. DWD Waiver of Documentation of Consent
Similar to how this is done currently
Prior to the start of any study procedures at the first lesson, the consent script (provided) will be read to the participants.
Participants will have time to ask questions and consider their participation prior to distributing the pre-intervention survey.

10. Tracking Participants Personal Identifiers
Participants’ privacy will be protected through careful and deliberate handling of the data collected during the study.
All surveys are non-identifiable.
Participants data will be tracked using a Participant List that is recorded and maintained by Key Personnel. A template Participant List will be provided.

11. Tracking Participants Personal Identifiers…
The Educator (or other Key Personnel) will assign a unique identifier to each participant. The Educator will write this identifier on the Participant Spreadsheet, along with the participant’s full name, phone number, and mailing address.
The Educator (or other Key Personnel) will fill in the Participant ID section of each questionnaire using this same unique identifier. Participants will not be told their unique identifier, and they do not need to keep track of it.

12. Tracking Participants Personal Identifiers…
The Participant List will be kept separate from the participant’s data.
The Participant List will be used for the purpose of the 3-6 month follow up data collection. After that, it will be destroyed.
Participant responses are confidential and only summaries of responses will be used in reports to various stakeholders or in academic manuscripts.

13. A Reminder about Entering/Storing Data
Each Educator (Key Personnel) carrying out programming will maintain their own data spreadsheet (information from the questionnaires) on the hard drive of the computer of one of the key personnel and backed up to that person’s private network drive.
Because questionnaires are non-identifiable (as long as the Participant List is kept separate), OSUE staff who are not Key Personnel may enter the data into a spreadsheet.

14. A Reminder about Entering/Storing Data…
Data from local programming may be compiled into one spreadsheet at the state level; the compiled spreadsheet will be maintained on the hard drive of the computer of one of the key personnel and backed up to that person’s private network drive.
All hard copies (paper) of the questionnaires will be stored in locked filing cabinets in offices of key personnel, both during and after the study concludes, as part of the grant records.
NOTE: These are the procedures to use until DWD has a centralized system of entering data, similar to RMRW or SNAP-Ed.

15. Minimizing Breach of Confidentiality
When a possible disclosure of subjects' responses is the primary source of potential harm, safeguarding the data from unauthorized access is the primary importance. This is why we will:
Collect data without identifiers.
Remove all direct identifiers as soon as possible.
Substitute codes for identifiers.
Maintain code lists and data files in separate secure locations.
Use accepted methods to protect against indirect identification, such as aggregate reporting or misleading identifiers.
Use and protect computer passwords.

16. 6 Month Follow Up The new surveys include:
pre-intervention (collected at the start of the first lesson after consent)
post-intervention (at the end of the third lesson), and
follow-up (6 months post-intervention)
The 6-month questionnaire may be completed in person (paper) or over the phone; it can be mailed to the participant with a SASE.
Anyone collecting data over the phone must be listed as Key Personnel.
The follow-up data cannot be sent or collected electronically without an IRB amendment.

17. Summary of the Scripts (all will be provided)
When person registers
Recruitment Script
Immediately prior to pre-test
(Session 1)
Consent Script
Passing out pre-test
(session 1)
Survey Script
Passing out post-test
(after session 3)
Distributing Follow-up test Survey Script

18. Key Personnel
If a person needs to be added as a Key Personnel, take these steps:
Notify Dan Remley at
Have the person complete the CITI training
Have the person complete Conflict of Interest (COI) form electronically
After all steps have been completed, Dan will request the addition of the new person as Key Personnel through IRB amendment forms.
The new person may begin Key Personnel functions after IRB approval of the amendment.

19. Contact Dan Remley at remley.4@osu.edu or 740-289-2071 extension 241
Questions
Contact Dan Remley at or extension 241