There are risks associated with every research study. We manage these risks in various ways, such as defining relevant participation criteria, designing an efficient study (including only necessary procedures), training research team members in proper procedures, using proven techniques and protocols, and obtaining Institutional Review Board (IRB) approval.
IRBs are formed pursuant to and operate under US Food and Drug Administration regulations. IRBs are comprised of professionals who review and monitor research involving human participants. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect both the rights and welfare of human study participants. Because an IRB has the authority to approve or disapprove research studies, it serves a critical role in risk identification and minimization.
To help you make an informed decision on whether or not to participate in our study, we summarize below the risks that are reasonably foreseeable based on our study procedures. These risks are also detailed in the Informed Consent Agreement that you will execute if you choose to participate.
Gastrointestinal and Related Issues
- Omega-3 supplements have been produced and consumed for decades and have minimal side-effects, the most common of which are “gastrointestinal distress” (indigestion) and “fish burps.” Both of these side effects are mitigated by:
- Improvements in the technology associated with the production of omega-3 supplements (e.g., their coating)
- Consuming the supplements with meals/foods that contain fat (i.e., do not consume them on an empty stomach)
- Consuming these supplements with 8oz of water or other beverage to facilitate digestion and absorption
- Numerous studies spanning multiple decades have been completed, including several with doses of omega-3 exceeding 5 grams per day, with no reported serious adverse events ( for reference, our study dose = 4 grams per day)
- A DEXA scan is a painless procedure that exposes you to low-dose radiation.
- The radiation levels used in a DEXA scan are lower than those experienced in normal daily living (atmospheric exposure–being outdoors) and significantly lower than those of other x-rays to which you have been exposed (e.g., chest or other body part x-rays).
- Blood draw via fingertip stick is relatively painless but may result in momentary discomfort at the site of the lancet insertion (near your fingertip, usually on the index, middle, or ring finger).
- Blood collected via venipuncture (near the bend in your elbow) usually results in momentary pain during needle insertion and when the needle is removed (when pressure is applied to facilitate blood clotting).
- As with any procedure where the skin is punctured, there is a risk of infection. We minimize this risk by employing standard procedures that include cleaning and disinfecting the insertion site. Additionally, following the procedure and immediately upon removing the needle, a sterile gauze pad will be placed on the site of insertion.
- It is possible for bruising to occur at the site of needle insertion.
- Some individuals have become dizzy, light-headed, or have fainted as a result of venipuncture. Consequently, we only draw blood from individuals who are seated or lying down to mitigate the risk of any of these events from occurring.
- Some participants have found that the mask worn during the treadmill procedure is uncomfortable.
- The treadmill is a common piece of exercise equipment. Although it is possible to be injured using a treadmill, injury usually occurs when the machine is misused (i.e., when a user “jumps the rails”). Because inclusion criteria comprise familiarity and experience using a treadmill, we believe your risk of injury from using the treadmill is minimal.
- There is always the risk of a cardiac event when exercising vigorously. To the extent possible, these risks are mitigated through our inclusion criteria (which include minimum and average levels of regular exercise of at least moderate intensity) and the use of a physical activity readiness questionnaire (the PAR-Q+).
- Our ability to help mitigate these risks is dependent on your representation that you meet all of the study inclusion-exclusion criteria and the accuracy and completeness of your responses to our questionnaires and intake forms.
If you have questions about any of these potential risks, don’t hesitate to reach out to us using the “CONTACT” button below.