Researcher Information

1. Researcher Information Institutional Review Board (IRB) for Human Subjects

2. An Institutional Review Board (IRB) is not just a committee. It refers to both a required set of procedures and the offices and people who carry them out.

3. What is the IRB? • The main purpose of the IRB is to ensure the ethical treatment of human participants in research. • The Institutional Review Board of Wesley College operates under the U.S. Dept. of Health & Human Services regulations for the Protection of Human Subjects.

4. What is the IRB? • We operate under a federal wide assurance which is our certification of compliance with federal regulations. • The U.S Government describes how IRBs must operate in Title 45, Part 46 of the Code of Federal Regulations. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html • All research at Wesley College involving human subjects, federally funded or not, must be reviewed by the Wesley College IRB.

5. Why do we have IRBs? • The U.S. Government set up IRB regulations in response to notorious abuses of human subjects in several much publicized research projects. • To learn about the history go to http://phrp.nihtraining.com/history/03_history.php

6. The 1979 commission created a report entitledEthical Principles and Guidelines for the Protection of Human Subjects of Research. This report is often called the Belmont Report http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

7. How is “Research” Defined? For an activity to be research, it must fall under the Department for Health and Human Services definition: [a] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html Research also includes activities that fall under “clinical investigation” as defined by the Food and Drug Administration (FDA).

8. Examples of Research If there is a question as to whether or not the activity is research, consider the following: 1.Will the activity be disseminated via thesis/dissertation, conference or meeting, submission to or publication in a journal, or an internet posting? 2.Will the activity be listed as a scholarly or scientific activity on your resume or vita? If you answer “yes” to either of these questions, your activity should be reviewed as research by the IRB.

9. Examples of Research ● Surveys (paper or online), even if anonymous ● Pilot or feasibility projects ● Exploratory studies ● Student independent studies, directed projects, theses, or dissertations ● Oral histories designed to compare/contrast, draw conclusions, inform policy, or generalize findings or oral histories done with the intent to be archived for future research ●Formal investigations/experiments

10. Examples of Non-Research Projects • Searches of existing literature. • Classroom activities where the results are limited to class discussion and use. • Classroom activities that teach research methodologies or simulate research activities. • Program/Department evaluations where the results will be used only for modification and improvement of that program/department. • Any Faculty/Staff/Student project involving human “information” that is not intended to be shared in any public domain.

11. Protection of Human Subjects • Whenever possible, information should be coded with numbers to protect privacy and confidentiality. • The benefits of participating should outweigh any risks…and the risks should be minimal. • If identifiable data are collected (videotapes, etc.), written informed consent will be required. • If vulnerable participants are involved (pregnant women, children, individuals with cognitive impairments, prisoners), consult the IRB for suggestions about ensuring safe and ethical treatment.

12. So, if Your Project is Research… See flowchart on next slide for IRB application process at Wesley College. Applications are due to the IRB Committee by the second week of each month. The IRB takes action on applications the fourth week of each month. Recommendations will be to approve/not-approve/or revise.

13. Step 1 After completing IRB training, researcher (PI) submits IRB Application to School IRB Chair via e-mail Step 2 School IRB Chair reviews application and determines type of review required: (a) Exempt from Informed Consent, (b) Expedited, or (c) Full Board Review IRB Chair forwards to designated IRB Rep IRB Application Process Flowchart Exempt Expedited Full Board Review IRB Chair reviews and approves application Sends approval notification to PI/faculty advisor via e-mail School IRB Rep reviews application and fills out “Comments Form” … Rep forwards application and “Comments Form” to Chair or Chair-elect for final approval via e-mail Application sent to all IRB Reps Application reviewed at IRB meeting (approved/not approved/revise)

14. IRB Application Process Information IRB Review of Applications is classified into different “types,” depending on level of risk to the participant: See decision charts http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html • Exempt (from signed informed consent) • Expedited (requires signed informed consent) • Full Board Review NOTE: Only the IRB (not the researcher) can make the determination of which type of review an application will require.

15. IRB Application Process Information Your school IRB representative will conduct the initial review of your application. Your application will be categorized as Exempt, Expedited or Full Board Review based on the federal government decision trees. Use the table on the next slide to determine if you will need to obtain written informed consent. If you answer “Yes” to any of the items on the rightside of the table, you will need a written Informed Consent Form for participants to sign or parent permission for participants who are minors.

17. Completing the IRB application form • Click link for IRB application on the Wesley College website. • Complete the application form. It is a word document with fillable fields and clickable boxes. • Save the form as a word document. Please put your name and date in the File Name. • Send the application via e-mail to the Wesley College IRB.

18. Tips for successful completion of the IRB application • Complete the training Before you begin to fill out the application you and your faculty advisor might find it helpful to complete the training on the site below. http://phrp.nihtraining.com/users/login.php

19. Tips for successful completion of the IRB application 2. Read the application 3 times before you start to fill out the form. Before you begin to fill out the application read the form, identify the necessary information, and gather all the materials you need to provide a detailed IRB application.

20. Tips for successful completion of the IRB application 3. Do not sweat signatures. Get approvals. Typed names are acceptable in the signature boxes. Just be sure they have approved your application. Your faculty sponsor must send an email to the IRB indicating they reviewed your application.

21. Tips for successful completion of the IRB application 4. Send the application electronically. No hard copies please. Electronic copies contain date stamps and can be linked back to applicant.

22. Tips for successful completion of the IRB application 5. Review and edit. Applications with typing errors, spelling errors or grammar issues take longer to review. Make sure you submit all the required parts to the IRB application.

23. Tips for successful completion of the IRB application 6. Research site approval. Include a signed letter or memo of permission from the organization(s) where the research will be conducted. It should be signed and on the sites official letterhead.

24. Tips for successful completion of the IRB application 7. Give the facts. Tell WHY the study is being done. Tell HOW the study will be conducted. Give complete information on how participants were selected, notified of their rights, and supplied informed consent.

25. Tips for successful completion of the IRB application 8. Research instruments. Submit all instruments you will be using to gather data and carry out your research. Send a copy of all survey instruments, interview questions, or tests.

26. Tips for successful completion of the IRB application 9. Send informed consent forms Include informed consent form letters. Use consent forms from Wesley College IRB website. You ALWAYS need to inform subjects though you DO NOT always need their signature.

27. Tips for successful completion of the IRB application 10. Complete the form. Be sure all sections of the form are complete. Incomplete forms delay the review process.

28. Tips for successful completion of the IRB application 11. Start the project only AFTER you receive IRB approval. Allow at least 4 weeks from the time the applications are due in the application cycle for the review process to complete. Remember you may be asked for revisions. Applications are due the second week of each month (no reviews conducted in December).

29. For information on how to contact the Wesley College Institutional Review Board call theOffice of Academic Affairs302-736-2429 Institutional Review Board (IRB) for Human Subjects