Calver, James
Greetings, road racers of Oregon!
You are invited to participate in a short one-time confidential
psychological research study, presented at the PIR Monday Night Race Series
between April 23 and May 21.
Tonight I will be set up by 3:45pm, and will accept participants until
8:00pm. The study will include two short surveys about attitudes toward
fitness and eating habits, followed by a brief cognitive measure, and
should only take between 10 - 12 minutes of your time on race day.
This study has been approved by the Institutional Review Board (IRB) of
Pacific University’s School of Graduate Psychology (SGP), and will take
place at selected Oregon Bicycle Racing Association (OBRA) sanctioned road
races between April and August, 2018.
The use of this confidential data will be to support a Doctoral
Dissertation assessing factors that may influence eating habits in road
bicycle racers.
In order to participate in the study, you must be at least 18 years of age,
possess a current OBRA road racing license, and be able to read and write
English. Exclusionary criteria include being younger than age 18, no
possession of an OBRA road racing license, inability to read and write
English, and recent (within the previous12 hours) heavy use of any illicit,
prescribed, or other drugs that could contribute to notable cognitive
impairment or alteration (cannabis, alcohol, stimulants, narcotics, etc).
Should you decide to take part in this confidential study, you will be
asked to complete a brief cognitive test and to answer questions about
attitudes towards fitness and eating habits. This study is being offered to
approximately 1,000 eligible participants. This study should take
approximately 10 - 12 minutes to complete. There is no additional cost to
you for taking part in this study.
*a. Anticipated Risks and Strategies to Minimize or Avoid Risk*
The minimal risk criterion is met due to the expectation that the
probability and magnitude of harm or discomfort anticipated in the research
(for subjects) will not be greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine
physical psychological examinations or tests. The items will constitute
between 10 - 12 minutes of time, and thus do not represent a significant
time burden to participants.
There are no known or expected risks to participating in this confidential
study. All collected data is confidential, and all informed consent
documents with identifying information will be kept separate from other
research data in a locked box. The principal investigator, research
assistants, and faculty advisor will be the only individuals with access to
the paper and electronic test data, ensuring protection of participants’
information and responses from outside individuals. No identifying
information of participants will be available to researchers or OBRA.
*b. Unknown Risks*
It is possible that some participants will experience emotional discomfort
from disclosing experiences with body dissatisfaction and disordered
eating. Participants may also experience some mild fatigue from performing
the cognitive tests. Neither of these effects would be considered as risks
greater than those encountered in daily life.
*c. Advantageous Clinical Alternatives*
This study does not involve experimental clinical investigations. There are
no known advantages or risks to taking part in this study.
In the event that you become sick, injured, distressed, or otherwise
uncomfortable as a result of your involvement in the research study, you
may stop your participation immediately. If such an event occurs, promptly
notify the principal investigator or the Pacific University Institutional
Review Board.
If the investigators become aware of a minor adverse event, the IRB office
will be notified promptly. For serious adverse events, the IRB office will
be notified within 24 hours. For any other adverse events, the
investigators will aim to notify the IRB office within the next normal
business day. IRB office notification of any adverse event will occur no
later than one week following the event.
If you experience or are directly affected by an adverse event, you will be
given the opportunity to withdraw any data collected from you during the
study up to June, 2018 when the final dissertation draft is defended.
However, doing so may potentially result in the anonymity of your data
being compromised.
*a. Benefit(s)*
There is no direct benefit to you as a study participant.
*b. Payment(s) or Reward(s)*
Participants will not be paid for their participation.
A Statement on Privacy:
Participation in this study, and its data and results, will be
completely confidential.
All informed consent documents with identifying information will be kept
separate from other research data in a locked box. The student Principal
Investigator, research assistants, and Faculty Advisor will be the only
individuals with access to the paper and electronic data, ensuring
protection of participants’ information and responses from outside
individuals, and all of these individuals have completed the necessary IRB
trainings. None of the data will be shared with OBRA. Study data will be
downloaded to the student Principle Investigator's password-protected
computer and stored in a password-protected file. Following analysis,
electronic data will be stored in the locked office of the Faculty Advisor
office space for a period of three years or for three years after
dissemination of the project is complete, whichever is longest. Only the
student Principal Investigator and Faculty Advisor will have access to the
study materials.
During your participation in this project it is important to understand
that you are not a Pacific University clinic patient or client, nor will
you be receiving a complete mental health or cognitive assessment as a
result of your participation in this study. If you are injured during your
participation in this study and it is not due to negligence by Pacific
University, the investigator(s), or any organization associated with the
research, you should not expect to receive compensation or medical care
from Pacific University, the investigator(s), or any organization
associated with the study. If you are injured and it directly is related to
your participation in this study as a research subject, please contact the
Pacific University Institutional Review Board at 503-352-1478.
Your decision whether or not to participate will not affect your current or
future relations with Pacific University, the Oregon Bicycle Racing
Association (OBRA), or USA Cycling. None of the data collected will be
shared with OBRA. If you decide to participate, you are free to not answer
any question or withdraw at any time without prejudice or negative
consequences. If you choose to withdraw after beginning the study, any
previously submitted data will be shredded within 24 hours in accordance
with laws to protect personal information (HIPAA) and will not be
incorporated in the study. If significant new findings develop (or are
discovered) during the course of this research that could impact your
decision to continue participation, such findings will be shared with you
and you will be given the opportunity to withdraw from the study.
The investigator(s) will be happy to answer any questions you may have at
any time during the course of the study. If you are not satisfied with the
answers you receive, please call the Pacific University Institutional
Review Board at 503-352-1478 to discuss your questions or concerns further.
If you have questions about your rights as a research subject, or if you
experience a research-related injury of any kind, please contact the
investigator(s) and/or the IRB office. All concerns and questions will be
kept in confidence.
The following resources are available for further information regarding
treatment and support for disordered eating:
The National Eating Disorders Association: https://www.natio
naleatingdisorders.org
The Academy for Eating Disorders: https://www.aedweb.org
Columbia River Eating Disorder Network: http://www.credn.org
Best regards,
D. James Calver, MS | Doctoral Candidate | Adult Track
Pacific University, School of Graduate Psychology
calv7205@pacificu.edu