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June 2, 2014 - East Tennessee State University

June 2, 2014

William R. Duncan, Ph.D.
Vice Provost for Research
East Tennessee State University
Office of Research & Sponsored Programs Administration
P.O. Box 70565
Johnson City, TN 37614

Re:   Human Research Subject Protections Under Federalwide Assurance FWA-2703

Research Project: Long Term Monitoring Study
Principal Investigator: Dr. Mike Stone
Protocol Number: c06-033s

Dear Dr. Duncan:

Thank you for your October 18, 2012 report in response to our September 10, 2012 request that  East Tennessee State University (ETSU) respond to questions and concerns regarding compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  Based on our review of your response, we make the following determinations regarding the above-referenced research:

Determinations regarding the above-referenced research:

1) The complainant alleged that student athletes undergo testing of various physical performance characteristics by doctoral students who use the data for research purposes.  Some of this testing, the complainant alleged, such as blood draws or other tissue sampling and maximal effort testing, are only done for research purposes, not normal sport testing for athletic purposes. However, student athletes are not given the option to decline this research testing.  We expressed concern that the investigators for these studies perhaps failed to obtain the legally effective informed consent of subjects or of the institutional review board (IRB) to appropriately waive the requirements to obtain informed consent, as required by HHS regulations at 45 CFR 45.116.  We note the following from your March 7 and October 18, 2012 reports:
a) You stated that the research conducted under the Long Term Monitoring Study only involves the use of data collected as part of a standard athletic monitoring program.
b) The study, including the informed consent document, was initially reviewed by the ETSU Social Science IRB in 2006 and received expedited approval.   The study has been reviewed annually and several modifications were reviewed and approved.
c) Prior to initial review, at the request of the IRB Chair, the IRB engaged an external consultant to review this protocol, including the procedures, to determine if the monitoring procedures were standard practice. The external consultant indicated that the “athlete monitoring” procedures are all standard practice in Physical Education and Athletics environments.
 

Based on the documentation provided in your March 7 and October 18, 2012 correspondence, we make no finding regarding this allegation (except as noted below regarding failure to obtain parental permission for two subjects).

2) The complainant alleged that student athletes undergo testing of various physical performance characteristics by doctoral students who use the data for research purposes. The same doctoral students are often team coaches, so some of the student athletes might believe that if they do not agree to have the test results used for research purposes, they will not be able to play and will lose their athletic scholarships.  If they are taking a course being taught by the doctoral student, they might also be concerned that they might receive a lower grade if they don’t participate in the research.  OHRP expressed concern that the enrollment procedures for these studies perhaps do not minimize possibility of coercion or undue influence, in contravention of HHS regulations at 45 CFR 45.116. We note the following from your reports:
a) In interviews, graduate students were asked if they had seen the athletes undergoing the consent process. One graduate student responded, "they clearly explain they can opt out or opt in to have data used," and "[I] never have gotten [the] sense that they are uneasy." A second graduate student stated, "I don't think there is any issues with that" (consenting) and "I get good questions from them."
b) While ETSU did not find any evidence of coercion or undue influence, you agree that the consent process should be structured to further minimize the possibility of undue influence.

Corrective Action:   We acknowledge your statement that in the future, ETSU will require that the person obtaining informed consent must be a member of the study staff who is not part of the sport team the members of which are being asked to provide their informed consent.  ETSU will additionally require that the researcher ensure that the team coach is not present during the consenting process. ETSU will also require the principal investigator (PI) to ensure that the consent form will be available at least 24 hours prior to the discussion so that the athletes have sufficient time to review it and consider whether or not they want to participate. ETSU will randomly select subjects enrolled in the future and interview them to determine whether there was any pressure to enroll.  We determine that the corrective actions adequately address the concern.  

3) The complainant alleged that these studies involving testing of student athletes are done under "Blanket IRB Approval," and that new tests can be added to a generic study without any additional IRB review and approval or informed consent. OHRP expressed concern that these research studies are perhaps being conducted without IRB review or approval, in contravention of HHS regulations at 45 CFR 46.103(b) and 45 CFR 46.109(a).
a) Your review of the program indicated your conclusion that some studies were conducted without IRB review and approval.  These included:
i. Kavanaugh, A., et. al. The acute effect of whole body vibration on 30 meter fly sprint performance in NCAA division I sprinters and jumpers. This abstract describes the study of whole body vibration (WBV), in which the athletes stand on a machine with a vibrating platform, which has been shown to be an effective means of increasing bone mineral accumulation in certain populations.  It involves randomized treatment sessions including WBV before and after sprint sessions and a control condition of no vibration.  Each subject participated in three separate trials using randomized treatment sessions over 12 weeks. The control condition consisted of no vibration, while WBV treatment 1 (Tl) and treatment 2 (T2) incorporated vibration.
ii. Kavanaugh, A. The Effect of 4 months whole body vibration on bone mineral density of Division I cross country/distance runners. This abstract describes a random assignment of athletes to either a control group or an experimental group, which performed 3 sets of 30 second WBV treatments five days a week. Mondays, Wednesdays, and Fridays the experimental group stood on the vibration unit with knee at 130o angle while Tuesdays and Thursdays they supported themselves in the pushup position with arms locked.  DXA (dual energy x-ray absorptiometry) was used to measure bone mineral density and content.
iii. Haff, G. Comparison of traditional versus DUP training among Division-I (D-I) collegiate track and field athletes: an exploratory study.  This abstract describes a pilot study to compare TRA (traditional form of periodization or dividing training goals into blocks of time) and DUP (daily undulating periodization, using different loads, reps, and sets in a resistance training program on different days of the week), and randomly divided athletes into TRA or DUP groups.  Groups were rotated every two weeks.
iv. Painter, K. B., et. al.  Strength gains: Block Versus Daily Undulating Periodization Weight Training Among Track and Field Athletes. International Journal of Sports Physiology and Performance, 2012, 7, 161 – 169.  This publication describes a study in which thirty-one athletes were assigned to either a 10-wk block training periodization (several levels of variation, including the use of heavy and light days of training in which the amount of work performed [volume load] is reduced for the light day) or daily undulating periodization training group (repetitions were altered each training session throughout the training week creating greater variation in training stimulus).  Measurements were made at zero weeks, after four weeks, eight weeks and eleven weeks.
b) Your review also revealed that the data in the monitoring database were individually identifiable and that the specific projects using that database were not submitted to the IRB for review and approval.

We have determined that research was conducted without prior IRB review and approval as required by HHS regulations at 45 CFR 46.103(b) and 45 CFR 46.109(a).

Corrective Action:  We acknowledge your statement that ETSU has terminated the c06-33s study and that the PI has agreed to halt all human subject research activities in which he is PI.  Audits, which will include review of abstracts/articles, will be conducted for each of these studies.  The PI will submit a new data collection protocol consistent with the above action step and be required to submit additional protocols for specific uses of the data for research purposes.  ETSU will require the PI, Dr. Mike Stone and graduate students associated with c06-033s to undergo additional training and will establish an oversight board with appropriate expertise to oversee the decisions of the Sport Performance Enhancement Group (SPEG) group.  The PI will submit a list of participants on the four research studies that were conducted without IRB approval (abstracts by Kavanaugh, Kavanaugh and Haff and article by Painter as noted above). ETSU will attempt to contact those individuals in writing and notify them of their participation in research without IRB approval.

Required Actions:  Please provide the informed consent documents for the four studies noted above that were conducted without IRB review approval.  Please also provide the letter that was sent to the subjects in those studies, and indicate how many of the subjects were contacted and any concerns that the subjects expressed.  Please provide the new procedures for studies involving use of existing data collected for non research purposes referenced in your October 18 2012 letter.

4) We note that the ETSU IRB staff audited the Informed Consent Documents for the Long Term Monitoring Study as a result of these allegations.  The audit revealed that signed parental permissions could not be located for two subjects who were under 18 years of age.  In addition, some minor documentation problems were noted (e.g., not all consent pages were initialed, dates were missing).  
We have determined that parental permission was either not appropriately obtained or documented for some subjects, as required by HHS regulations at 45 CFR 46.116 and 45 CFR 46.408(b).  

Corrective Action:  We acknowledge your statement that the PI agreed to suspend enrollment and data collection until ETSU has developed an action plan to prevent similar occurrences in the future. We also acknowledge your statement that one of the subjects who did not have parental permission signed a consent form the following year, as this athlete was then 18; the other subject’s data will not be used for research purposes and the PI will destroy the data.  Other corrective actions include: the principal investigator will strengthen the language in the consent form for study c06-033s that refusal to participate in the study will not impact their grades if they enroll in classes taught by Sports Science staff; IRB members will observe the consent process for this study randomly three times in the next year; a standard check list for the individual obtaining consent will be developed to ensure that assents and parental permissions are obtained when necessary; further educational programs for IRB members will be conducted to ensure there is always a thorough review of circumstances related to the consent process in research involving students; and,  a new brochure will be developed for students who are considering participating in research.  We determine that the corrective actions adequately address the determination.  

Please provide us with responses to the above required actions by July 14, 2014. We appreciate your institution’s continued commitment to the protection of human research subjects.  

Sincerely,
 

Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland  20852
Telephone: 240-453-8132
FAX:    240-453-6909
E-mail: Kristina.Borror@hhs.gov

cc:   
Ms. Frances J. Olive, Director, ETSU Office of Research & Sponsored Programs Administration
Ms. Chris Ayres, Chair, ETSU IRB #1
Dr. George Youngberg, Chair, ETSU IRB #2