Researcher Information

1. Researcher Information Institutional Review Board for Human Subjects

2. What is the IRB? • The main purpose of the IRB is to ensure the ethical treatment of human participants in research. • All research at Samford University involving human subjects, federally funded or not, must be reviewed by the Samford IRB.

3. 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 generalizable knowledge. Research also includes activities that fall under “clinical investigation” as defined by the Food and Drug Administration (FDA).

4. Examples of Research If there is a question as to whether or not the activity is research, consider the following: • Will the activity be disseminated via thesis/dissertation, conference or meeting, submission to or publication in a journal, or an internet posting? • Will the activity be listed as a scholarly or scientific activity on your vita? If you answer “yes” to either of these questions, your activity should be reviewed as research by the IRB. NOTE: Should you decide that your activity is not research and does not require IRB review and approval, you cannot later publish the data or otherwise distribute the results publically.

5. Examples of Research ● Formal investigations/experiments ● 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 ● Surveys (paper or online), even if anonymous

6. Examples of Non-Research Projects • 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. • Searches of existing literature.

7. 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.

8. So, if Your Project is Research… • Click link for IRB application on the Samford IRB home page • Complete the application form…it is a word document with fillable fields and clickable boxes • Save form as a word document (put your name and date in the File Name) • Send application via e-mail to your school IRB representative See flowchart on next slide for process

9. Step 1 After completing IRB training, researcher (PI) submits IRB Application to School IRB Rep via e-mail (See IRB website for list of school representatives) Step 2School IRB Rep reviews application and determines type of review required: (a) Exempt from Informed Consent, (b) Expedited, or (c) Full Board Review Samford University IRB Application Process Flowchart Exempt Expedited Full Board Review School IRB Rep 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 School IRB Rep submits application to IRB Chair Application sent to all IRB Reps Application reviewed at IRB meeting (approved/not approved/revise)

10. IRB Application Process Information IRB Review of Applications is classified into different “types,” depending on level of risk to the participant: • 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.

11. IRB Application Process Information Your school IRB representative will conduct the initial review of your application. If you feel your study meets the requirements for Exempt Review, you should complete the “Request for Waiver of Informed Consent” section of the application. 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.

13. IRB Application Process Information All researchers involved with a project are required to submit documentation of the online IRB training. After completion of the training, researchers should save the certificate of completion and attach it to the IRB application or put certificate number on application form. Certificates are valid for three years. NOTE: All faculty advisors are considered co-principal investigators with student researchers and are therefore required to complete the online IRB training.

14. Samford University IRB Website Please visit the IRB web site for forms, templates, and information regarding protection of human subjects in research. http://www4.samford.edu/IRB/ -------------------------------------------------------------- The IRB review process may take up to one month after your application is initially submitted, so you should plan accordingly.