Oregon State University

Suggested Language for Common Risks

The purpose of this document is to assist investigators and research personnel in drafting language for common risks. The instructions are in blue and suggested language is in black. 

 

Breach of Confidentiality:  There is a chance that we could accidentally disclose information that identifies you.

 

Focus Groups: We will ask members of the focus group to maintain the confidentiality of comments made during the discussion.  However, there is still a risk that comments you make during the discussion may be shared outside of the group.

 

Unforeseeable risks: There may be risks related to the study procedures that are not yet known to the researchers.

 

Internet and/or email:  The security and confidentiality of information collected from you online cannot be guaranteed.  Confidentiality will be kept to the extent permitted by the technology being used.  Information collected online can be intercepted, corrupted, lost, destroyed, arrive late or incomplete, or contain viruses. 

 

Pregnancy: Insert explanation of any study activities that may involve risks to the subject, or to an embryo or fetus if the subject is or may become pregnant. 

 

Sample language: If you are a woman of childbearing potential, we will do a pregnancy test before {describe the testing or intervention method}.   This study involves activities that are not safe for pregnant women. – AND/OR – There may be a risk of harm to an unborn child.  You must use an effective form of pregnancy prevention while you are enrolled in this study.  We will discuss the risk with you in more detail.  Notify the study team immediately if you think or know that you have become pregnant during the course of this study.

 

Studies involving radiation exposure: Describe the equipment that will be used, how much radiation dose subjects will receive for each set of scans performed and for the cumulative dose from the study using mrems and a lay comparison.

 

Pregnancy and studies involving radiation exposure:  If you are a woman, you may not participate in {the aspect of the study causing the radiation exposure/bone scan} if you are pregnant or suspect you may be pregnant.   If you are a woman of childbearing potential, {the aspect of the study causing the radiation exposure/bone scan} must be performed within the first few days of the beginning of your last menses to reduce the risk of performing the scan on a developing embryo.  Notify the study team immediately if you think or know that you have become pregnant during the course of this study.

Blood draws: The risks of having blood drawn from your arm include some pain when the needle goes in and a small risk of bruising and/or infection at that site.  Some people get lightheaded, nauseous, or faint.  You are less likely to have these problems if you drink at least 2 glasses of water and have a snack before the blood draw{Modify for fasting draws}.  The American Red Cross recommends that you do not donate more than 1 pint (32 tablespoons) of blood within a 2 month period.  Tell the study team if you have recently had your blood drawn for any reason.

VO2max Testing

  • Acute exercise may present a risk of sudden death
  • Cardiovascular event (i.e., heart attack or cardiac arrhythmia)
    • Overall risk of cardiac events is about 6 events per 10,000 tests
  • Serious injury
  • Falling
  • Physical discomfort from the test and equipment
  • Fatigue
  • Muscle aches, cramps, joint pain
  • Muscle strain and/or joint injury
  • Delayed muscle soreness
  • Abnormal blood pressure/heart rate
  • Shortness of breath
  • Lightheadedness, fainting
  • Dizziness
  • Nausea

Contact Info

Institutional Review Board (IRB)

irb@oregonstate.edu
p. 541-737-8008
f. 541-737-3093

Office of Research Integrity
Research Office
Oregon State University
A312 Kerr Administration
Corvallis, Oregon 97331-2140
Copyright ©  2014 Oregon State University
Disclaimer