September 25, 2014 - East Tennessee State University

Dear Dr. Duncan:

Thank you for your July 10, 2014 report in response to our June 2, 2014 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 review of your response, we make the following determinations:

A. 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 failed to obtain the legally effective informed consent of subjects or that the institutional review board (IRB) failed to appropriately waive those requirements as required by 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/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 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 being conducted without IRB review and/or approval, in contravention of HHS regulations at 45 CFR 46.103(b) and 46.109(a).

a) Your review of the program indicated that some studies were conducted without IRB review and approval.  These included:

i. Kavanaugh, A. The acute effect of whole body vibration on 30 meter fly sprint performance, in NCAA division I sprinters and jumpers (references randomized treatment sessions and a control condition of no vibration)
ii. Kavanaugh, A. The Effect of 4 months whole body vibration on bone mineral density of Division I cross country/distance runners (describes a random assignment of athletes to either a control group or an experimental group)
iii. Haff, G. Comparison of traditional versus DUP training among Division-I (D-I) collegiate track and field athletes: an exploratory study (characterized as a pilot study to compare traditional versus DUP training, and randomly divided athletes into groups)
iv. Painter, K. B. (not yet published). Strength gains: Strength vs dup weight-training among track and field athletes. (accepted)

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.  ETSU will require that all future studies involving prospective collection of data that will exist for non-research purposes be limited solely to data collection, describe the data to be collected, and omit from the protocol and informed consent document the non-research procedures from the description of the procedures involved in the research. 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 this PI 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).  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.

3) 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).  It also appeared that investigators were obtaining consent who were not listed on the protocol as obtaining consent. We have determined that parental permission was 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 (PI) will strengthen the language in the informed consent document 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 informed consent process for this study randomly three times in the next year; development of a standard check list for the individual obtaining consent to ensure that assents and parental permissions are obtained when necessary; further educational programs for IRB members to ensure there is always a thorough review of circumstances related to the consent process in research involving students; and, development of a new brochure for students who are considering participating in research.

B. Resolved concerns

The following concerns we expressed in our June 2, 2014 letter have been adequately addressed by ETSU; we note these are not violations of the HHS regulations at 45 CFR part 46:

The complainant alleged that student athletes undergo testing of various physical performance characteristics by doctoral students who use the data for research purposes.  The complainant also alleged that the same doctoral students are often team coaches, so the student athletes 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.  There was also concern that, if students are taking a course being taught by the doctoral student, they will get a poorer grade if they don’t participate in the research.  OHRP expressed concern that the enrollment procedures for these studies 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 consent of the athletes being obtained. One graduate student responded, "they clearly explain they can opt out or opt in to have data used", "[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" (obtaining consent); "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 possible perception of undue influence.

Institution 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 for informed consent.  ETSU will additionally require that the researcher ensure that the team coach is not present during the consenting process. ETSU will additionally require the PI to ensure that the consent document will be available at least 24 hours prior to the discussion so that the athletes have sufficient time to review 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 concerns and determinations. At this time, there should be no need for further involvement by our office in this matter.  Please notify us if you identify new information which might alter this determination.
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: [email protected]

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