Bloodborne Pathogens FAQ

 

Does MSU have any institutional policies on safety or precautions with blood draws or research involving bloodborne pathogens?

Yes. The Institutional Biosafety Committee (IBC) in collaboration with Environmental Safety and Sustainability Office has oversight of activities involving blood draws or bloodborne materials. Projects involving these activities must register with the IBC using the process described here

What blood draw research might fall under the expedited review process?

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Which research team members can perform blood draws?

While the IRB does not require researchers to hold phlebotomy certificates, those who are not trained as a phlebotomist must provide proof of skill through other verified training methods.

Please provide evidence of this training for each research team member as an attachment in your Cayuse submission.

What should I include in my consent form as risks due to blood draws?

We appreciate Dr. Hosick in granting us to permission to adapt the study materials for Montclair State University IRB’s benefit and further education on the website.

The following are examples of consent language you may use, if applicable:

“Blood draws, when correctly performed, have few complications.  But even when performed correctly, the following incidents may occur; infection, fainting, dizziness, brushing at site of blood draw, or excessive bleeding.  If you have experienced any of these complications in the past, please make the phlebotomist aware before the blood draw. If you experience any complications before or after the blood draw, please alert the research team and/or your general physician.”

For catheter blood draws:

A pre-exercise blood draw will be taken from a vein in the antecubital space. During this blood draw you will have a catheter placed into a vein in your arm. This catheter will allow multiple blood samples to be taken without sticking your arm multiple times. In the event that the catheter is not able to collect all remaining blood samples one additional catheter may be placed in the opposite arm. If this catheter is unable to collect the remaining blood samples data collection will stop. You will not be stuck more than two times for this study. The blood draws will be performed by a trained individual. All standard safety and sterile procedures will be used during all blood draws. All standard safety and sterile procedures will be used during all blood draws.  If minor bruising does develop as a result of the blood draws, ice and compression will be applied to the area.

For consent language on risks:

You will also be asked to provide blood samples during the experimental trials. The blood draws will be conducted by a trained individual. Center for Disease Control and Prevention and University standards for safety and sterile procedures will be used during all blood draws. If minor bruising does develop as a result of the blood draws, ice and compression will be applied to the area. Also, the total amount of blood drawn (approximately 30 ml) is small and should have no adverse effects.