Getting Your IRB Application Approved

Getting Your IRB Application Approved PowerPoint PPT Presentation


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Survey: What do you Want in a Pastor?. How is the new church leadership received following 30 years under one previous pastor?7. What is your first impression of the new pastor?8. Does the new pastor seem credible / trustworthy?9. What talents/traits do you see in the new pastor that are good? Or bad?Survey was to be collected on church premises.

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Getting Your IRB Application Approved

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1. Getting Your IRB Application Approved Northeastern State University Institutional Review Board

2. Survey: What do you Want in a Pastor? How is the new church leadership received following 30 years under one previous pastor? 7. What is your first impression of the new pastor? 8. Does the new pastor seem credible / trustworthy? 9. What talents/traits do you see in the new pastor that are good? Or bad? Survey was to be collected on church premises

3. Interview with an Expert on Cell Mutation “Name, background and contact information (of the expert) is to be included in the research paper to give credibility to the information obtained from the participant”

4. Survey of Special Education Teachers Effectiveness of Special Education Programs 4. Is it successful to teach a tenth grade student tenth grade material if her or she performs regularly at a fourth grade level on evaluative tests? 5. Is it effective to teach a student performing at grade level and one who is performing five grade levels behind in the same classroom? 6. Are evaluation procedures for special education students are too lax?

5. Interviews of Victims of Sexual Abuse For a class project Student had no psychological training Student knew the victims through her church Pastor in church was counselor to victims

6. One More ….. Student does survey on use of a Reading Instructor at her school Surveys are returned to her mailbox Other faculty members open the returns Reading Instructor is upset, feels his job is threatened

7. Great Moments in Bad Timing Professor Bekkering,   I am a graduate student in NSU’s Master’s in Higher Education Administration and Student Services program. This semester, I am enrolled in Dr. Some Instructor’ HIEDxxxx Program Development, Assessment, and Evaluation course. One of our projects is to come up with a topic in higher education that we would like to assess and, well, assess it. I have chosen to assess NSU’s student services offered to on-campus students and student services offered to online students in an attempt to discover any discrepancies. As part of my project, I will survey students only in courses that are offered both on-campus and online. Your on-campus IS 3063 - Principles of Information Systems (section 1846) course meets this condition.  The survey is available through the link below. Will you please send to me the email addresses of the students in your on-campus IS 3063 - Principles of Information Systems (section 1846) course, so that I may send out the survey? If you prefer, you can send the survey to your students instead of releasing your students’ email addresses, I just don’t want to impose on any professor’s time.  Please let me know what will work best for you. I look forward to hearing from you and appreciate your timely response.  Student Services Survey: https://www.surveymonkey.com/s/nsustudentservices   Thank you,   Some Student NSU Graduate Student [email protected]   Program: Higher Education Administration and Student Services Course: HIED5643 Program Development, Assessment, and Evaluation

8. Principles of IRB Review Minimize risk to human subjects Ensure all participant are fully informed about the research, the benefits and the risks Ensure all subjects give their consent to participate Promote equity in human subjects research

9. What Constitutes Research? It can be very difficult to determine what constitutes human subjects research. The common rule offers the following definitions as guidance for determining human subjects research. The definitions are intentionally broad to include a wide range of research. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge. Activities meeting this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes, or called “development,” “demonstration, “ “ instruction,” or another term. For example, some demonstration and service programs may include research activities

10. Protection IRB review and approval protects Human subjects Our first priority The student The faculty sponsor The university If something goes wrong, SOMEONE will be held accountable No one is lucky forever If nothing goes wrong, it’s just a mitigating factor

11. Faculty Sponsors Students Not allowed to do research independently Not even on own job if for course work They act in capacity of students, not teachers or administrators Faculty sponsors Required to provide adequate supervision NO “rubberstamping” Distant supervision vs. close supervision

12. Potential Consequences for Faculty Sponsors Charges of research misconduct Negative effect on performance reviews Promotion Tenure Salary increases Loss of graduate faculty status

13. How to Apply Website: http://arapaho.nsuok.edu/~irb/ Download the latest application form By email: send to [email protected] . Signature page and site permissions have to be mailed (we need paper originals) On paper: submit three copies, with at least one bearing original signatures, to : Graduate College, Administration building room 122, NSU Tahlequah

14. Confidentiality vs. Anonimity Anonymity: I don’t know who you are No names, nothing that could identify participant Anonymous web surveys (http://survey.nsuok.edu , ask Rick Shelton to set up account) Return in sealed envelope, open returns when all data in IRB decides if there is potential to discover identities Confidentiality: I know who you are, but I promise not to tell Emailing surveys and returning with “reply” Survey of five colleague teachers with demographic data Handwritten responses of students in your class Etc.

15. Basic Elements of Informed Consent Explanation of the purpose of the research Expected duration of participation Procedures to be followed Expected benefits, foreseeable risks and discomforts Cost and compensation Confidentiality or anonymity Where to ask question Voluntary participation, right to refuse, right to withdraw Use the sample form from our website!

16. Notes on the Basic Elements Expected benefits: if there are none, just say “none” Foreseeable risks and discomforts: if you don’t anticipate them, just say “there are no foreseeable risks” Cost and compensation: OK to say “there is no cost or compensation for participation in the study” Confidentiality or anonymity: promise only one. They are mutually exclusive Where to ask question: include IRB contact information Voluntary participation, right to refuse, right to withdraw: see examples on Standard Model Consent Form

17. Who Gives Consent? Adult participants: can give consent (“My signature below indicates that I have read the information above and that I agree to participate in this study“) High School: parents have to give consent (“My signature below indicates that I have read the information above and that I allow my child to participate in this study.”), children have to give assent (“My signature below indicates that I have read the information above and that I agree to participate in this study“) Elementary School: parents have to give consent (“My signature below indicates that I have read the information above and that I allow my child to participate in this study.”), children can not be expected to give written consent – provide an age-appropriate oral script you will read to them

18. Documentation of Informed Consent Signed written consent Separate written consent document(s) that has/have to be signed Or: a short form written consent (not all elements, classroom projects) But: you have to provide a witness, both researcher and witness have to sign, etc etc We seldom if ever approve this for research classes Exception to signed written consent: Truly anonymous No minors or other vulnerable groups Still have to provide all the elements How do you prove that? Include all elements at the top of the questionnaire! Modified instructions: “Completing the questions and returning the questionnaire …..”; web surveys with consent above the questions: “Completing the questions and clicking on the submit button ….”: web surveys with an introductory page: “Following the link to the questions below, ….”

19. Waiver of Informed Consent The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement for informed consent provided the IRB finds and documents that: the research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects the research could not practicably be carried out without the waiver or alteration and whenever appropriate, the subjects will be provided with additional pertinent information after participation; or the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs; and the research could not practicably be carried out without the waiver or alteration. We will not do that in research classes. Students in those classes are supposed to learn how to conduct proper research.

20. Site Permissions Any locations outside NSU Written permission on organization letterhead Not NSU letterhead! Signed by appropriate official Not an intern! Check the wording Best: “give permission to ABC to conduct research for the project XXX” Or you may get permission to do interviews but not the surveys you wanted to do

21. Note This Cover letters can not be used for proving informed consent If you give some reward or compensation, provide alternative method to get it Paper data: keep in locked file cabinet, shred after study completed. Digital data: keep on password protected computer, delete files after study completed. Tapes: keep in locked file cabinet, erase after study completed If you need to make changes, don’t send the whole revised application form

22. Resources IRB website: http://arapaho.nsuok.edu/~irb/ IRB policies (incl. informed consent elements): http://arapaho.nsuok.edu/~irb/policies.html Frequently asked questions: http://arapaho.nsuok.edu/~irb/FAQs.html IRB members listed at the top of the application form http://arapaho.nsuok.edu/~irb/IRBapplication.doc Sample informed consent form http://arapaho.nsuok.edu/~irb/getapplication.html

23. Specific for Optometry If you apply for a grant, include the grant application Disclose contra-indications in informed consent (discomforts and risks section) Instruct participants what to do if adverse reactions occur Contact own physician? Optometrist in college?

24. Specific for Optometry In informed consent, use laymen language NSAIDS, off-label use, hyperopia, instillation, discharge, over-corrected myopia If you recruit orally, include a recruitment script Specify coding systems for confidentiality (repeated measures) Destroy list of names and codes afterward

25. Specific for Optometry If use Optometry facilities after hours, include permission from Dr. Welch Use medication bottles for one participant only Screening for inclusion in study: rejected participants still eligible for reward Dismissed vs. released from study

26. Specific for Optometry Using materials (lenses) or supplies (solutions): make clear if participants can keep or not Withdrawing from study – no medical supervision?

27. In Conclusion Thank you for your attention Don’t hesitate to ask or ask for help We want to be a resource for research at NSU Our email: [email protected]

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