APPLICATION FOR RENEWAL or REVISION
APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS
Biomedical, Health Sciences Institutional Review Board (BIRB)
Community Research Institutional Review Board (CRIRB)
Social Science, Behavioral, Education Institutional Review Board (SIRB)
207 Olds Hall, Michigan State University
East Lansing, MI 48824-1047
Phone:
(517) 355-2180
Fax:
(517) 432-4503
E-mail: [email protected]
Office Hours: M-F (8:00 A.M.-5:00 P.M.)
IRB#: 11-1215
ID# r041418
Title: Jeune athlete mondain: Global Opportunities for Aspiring Local Youth Engaged in Sports Review Category: EXPEDITED 2-7
Expiration Date: 3/1/2013
Responsible Project Investigator: Name: Steven Gold
ID#: XXX-XX-8291
Department: SOCIOLOGY College: SOCIAL SCIENCE Academic Rank: Professor
Mailing Address: 316 Berkey Hall Phone: 3-6352
Fax: 2-2856
Email: [email protected]
RENEWAL
1. Has there been a lapse in approval between your current project expiration date and the submission of this renewal application?
NO
2b. Is the project being performed at Ingham Regional Medical Center? NO
3a. Project is funded NO
3b. Previous funding has ended NA
3c. Previous funding source same NA
3d. New funding source NO
3e. (i) Select appropriate funding source(s). Multiple funding sources may be selected. If a funding source is selected, list the name(s) of the funding source(s) and the CGA number.
Funding Source Type If
funding source is selected, list the name(s) of the funding source CGA Number
NO U.S. Federal Government (e.g. Department, Agency) NO U.S. State Government (e.g. Department, Agency) NO Foreign Government
NO Industry Sponsored NO Foundation or Non-Profit
NO Internal Funds (e.g. MSU department) (ii) Are any of the funding sources pending? NO
4a. How many subjects have been enrolled in the last approval period by your study team? 14 4b. How many subjects have been enrolled to date (entire project period) by your study team? 14 4c. How many more subjects will be recruited in the next approval period by your study team? 14
If this is a collaborative, multi-site (e.g., national) project, complete d through f.
4d. How many total subjects have been enrolled in the last approval period? 14 4e. How many total subjects have been enrolled to date (entire project period)? 14 4f. How many more total subjects will be recruited in the next approval period? 14 5. Contact with subjects and data collection is complete and the research involves data
analyses only.
NO 6. Have any recruited subjects withdrawn from the research in the last approval period? NO
7. Have there been any unanticipated problems or adverse events in the last approval period?
NO 8. Have there been any complaints by the subjects or their representatives related to their
participation in this study in the last approval period?
NO
9a. Based on the study results, describe the risks (physical, psychological, social, legal, economic, or risks related to privacy and confidentiality) posed to subjects as a result of their participation in the study.
The risks are extremely minimal, however some of the participants know each other and gather in social settings together on occasion. There is a potential for subjects to casually discuss the study at these gatherings, although highly unlikely, in which case their anonymity may be compromised to those in their closest social circles. This potential to willingly divulge participation is very unlikely and poses virtually no social risk to participants.
9b. Does the description provided in question 9a indicate that there is an increased risk to subjects or others? This may include relevant recent literature, political or cultural changes in the study venue, new information from other studies, or participants’ reactions (physical or emotional) while on this study.
NO
10. Based on the study results, describe the benefits, if any, that subjects have received as a result of their participation in this study. Monetary or non-monetary compensation (e.g., cash, gift cards, etc.) is not considered a benefit to subjects.
The participants received no benefits during the study. I offered to purchase coffee for one participant and he declined. The only expected benefits the participants will receive is access to the published results when the study is complete.
11a. Provide a paragraph of your current research study in lay terms (e.g., brief abstract).
I will be observing and interviewing current and former basketball players who have played or are currently playing in Michigan. I will ask them questions about international basketball. The questions will be about professional basketball as a vocational option for youth to aspire to. I plan to study migration patterns and tendencies for young athletes who stay in, leave from, and return to Michigan throughout their life course. 11b. Please summarize your research study to date. Are there portions of your research study that
you have completed and are not requesting continued approval? Include any interim findings or amendments to the research in the last approval period.
I have only made initial contact with participants. I have not conducted any interviews or observations nor have I collected any data. I plan to do so during my next approval period.
12. Are there any relevant multi-center trial reports? NO
13. Is the approval period for this project two years (i.e. project was granted a two year approval as part of the demonstration project)?
NO 14. Will any investigational drugs or devices be stored or dispensed from the MSU Pharmacy? NO 15. Is there a data safety monitoring plan for this research study? NO 16. Is there any recent literature relevant to protection of human subjects for this research
study, especially information about associated risks? If yes, include with the renewal submission.
NO
1. Categories: Mark all categories of proposed changes below.
Administrative Changes
Funding NO
Project Title YES
Study Investigator(s) NO Data Analysis Only NO Study Changes / Amendments
Advertisement/Recruitment NO Consent NO Eligibility Criteria NO Instrument(s) YES Protocol/Design/Analysis NO Subject Incentive NO Target Population NO Protected Health Information NO
Other YES
2. Briefly describe the proposed revision(s) and rationale:
NEW PROJECT TITLE: Global Opportunities for Athletes Living in De-industrialized Michigan Cities RATIONALE: The new title more clearly represents the objective of the study. Unnecessary creativity was removed from the original title, i.e. "Jeune athlete mondain" was confusing and more focus needed to be on defining the locations under study, i.e. de-industrialized Michigan cities.
INSTRUMENTS CHANGED: Questions on the survey and interview are changed to more broadly
encompass the objective of the study. For example, questions about specific grade point average, height, and weight are unnecessary to the study objectives. Additionally, I will not ask players how their game fits into a global game. Instead, I will ask them questions about how and when they make the decision to attempt a professional career overseas. Overall, the questions will shift from athletic in nature to occupational and life course decisions. The focus is more on migration patterns than on the game of basketball itself.
OTHER: Venues added include East Lansing High School (Michigan, USA) and Everett High School (Lansing, Michigan, USA). These venues were chosen because of the access to two sets of high school athletes (basketball team at each location).
3. Does the proposed revision(s) increase the level of risk for harm or privacy protections for subjects?
NO
4. Does the proposed revision(s) require changes in the consent process? NO 5. Have any new funding sources been added to the project? NO
6. If needed, provide any special name/number/language that should appear in this revision's approval letter.
7. Is the approval period for this project two years (i.e. project was granted a two year approval as part of the demonstration project)?
NO ADDITIONAL DOCUMENTS/ATTACHMENTS
01. 2/10/2013 Consent Form (r041418_2-10-13_COMBINED-Consent.pdf) 02. 2/10/2013 Instrument (r041418_2-10-13_COMBINED-Instruments.pdf)
COMMENTS COMMENT AFTER REVIEW / EDIT BY IRB
STAFF (Viewable by PI) PI RESPONSE
Comment #7 Reviewer #
1/18/2013 8:12:41 1/18/2013 9:07:59 Dear Investigators:
Thank you for the renewal revision request. You will need to submit a letter of permission from the school principal or superintendent from the East Lansing school district. In addition, you will need to submit an IRB application to Lansing school district. NOTE: You need to submit both items to the MSU irb before you can conduct your research. Also, please forward a copy of your current consent form and the revised research instruments.
Thanks, Tonya
Thanks Tonya, these requirements will be fulfilled very soon. This is a short note to let you know I received your message and will begin the process of fulfilling these obligations as quickly as possible. Thank you again for your clear and prompt comments about my renewal application. John G
-Comment #8 Reviewer #
1/18/2013 13:26:50 2/10/2013 19:47:01 Dear Investigator:
Thank you for the reply. Please post a comment once you have forwarded the consent forms in order for your project to be forwarded to the reveiwer.
Thanks, Tonya
Dear Tonya,
Thank you for your comment. I have forwarded the necessary forms to East Lansing Public Schools and will do the same for Lansing Public Schools on 2/11/13. At your request, I am submitting the consent forms and revised research instruments as an email (with attachment) and as a link below due to the size of the file that may not send over email.
http://johngirdwood.com/wp- content/uploads/2013/02/COMBINED-Instruments-and-Consent.pdf
from East Lansing Public Schools and Lansing Public Schools. Please let me know if there are any revisions necessary on the consent forms and revised research instruments. Thank you very much,