<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=213807269037206&amp;ev=PageView&amp;noscript=1">
Compliance In Focus
Posted by Brandy Chittester on Tue, Jul 9, 2013

Healthy Control Volunteers - Using the FAIR Shake

Healthy Control VolunteersAccording to the National Institute of Health (NIH), nearly 3,500 people participate in the Clinical Research Healthy Volunteer Program (CHVP). The program, started in 1954, provides an opportunity for healthy volunteers, locally, nationally, even internationally, to participate in medical research studies to provide researchers with important information for comparison with people who have specific illnesses.

The NIH offers the reasons below as to why a person may consider volunteering for a clinical research trial, as participants may receive:

  • A free physical exam
  • Compensation; either cash, check, or gift card
  • Further understanding of clinical research
  • Expanded medical knowledge
  • Satisfaction of helping others that may be suffering from illness or disease

Lastly, a volunteer may have the opportunity to provide scientific information for developing new treatments.

The NIH offers about 300 studies for healthy volunteers, ranging from inpatient to outpatient trials, with varying lengths of participation for all genders and races. Different inclusion and exclusion criteria are required to be reviewed for consideration in various clinical research studies.

Recently, for an industry sponsored study, a question was raised regarding healthy volunteers and participation. Can a staff member of the institution conducting the clinical trial participate in a healthy volunteer study? Let’s take it to the regulations using the FAIR ShakeTM.

To help sites, sponsors, and investigators navigate through the regulations and secure compliance, IMARC monitors use the FAIR ShakeTM. The FAIR ShakeTM is an easy and comprehensive way to work through challenging situations in clinical research in which the solution or answer may not be clear and straightforward. The FAIR ShakeTM allows for IMARC monitors to be consistent, thorough monitors no matter what study, site, or problem they are working on. One answer at one site for one study might not be the same answer for another site for the same or different study. So how does IMARC keep it all straight?  Give your question The FAIR ShakeTM:

  • Federal Regulations
  • Agreements between the sponsor and investigator
  • Investigational Plan
  • Requirements of the IRB

Staff members participating in healthy volunteer research are not addressed in the regulations; however either permission or guidance of enrolling staff in these types of clinical trials could be outlined in the agreement between the sponsor and investigator. Furthermore, it may be addressed in the investigational plan in the inclusion or exclusion criteria. If the investigational plan allows for staff to volunteer, the IRB will have to approve it, as it may violate institutional standard operating procedures.

Have you ever been a staff member that volunteered for research at your institution?  What are your thoughts on volunteers that work directly with the investigator or are listed on the delegation log? Please share your thoughts here. 

Photo Credit: stina jonsson

Topics: National Institute of Health, Healthy Control Volunteers, The FAIR Shake


Posts by Topic: