Types of studies involving biological samples that
do not require IRB approval
- Collection of blood samples by finger stick, heel stick,
ear stick, or venipuncture from healthy non-pregnant adults who
weigh at least 110 pounds (not more than 550 ml in an 8 week
period) or from other adults or children where the amount drawn
may not exceed 3 ml per kg body weight over an 8 week period;
- Collection of biological specimens for research purposes
by non-invansive means (such as hair/nail clippings; deciduous
teeth when they fall out; excretion and external secretions (including
sweat); saliva collected without stimulation or through stimulation
with chewing gum; placenta removed at delivery; amniotic fluid
obtained at time of membrane rupture during delivery; dental
plaque and calculus in a way similar to a routine dental exam;
mucosal/skin cells collected by cheek scraping or swabs, skin
swabs, or mouth wash);
- Collection of data through non-invasive procedures routinely
employed in clinical practice (but excluding x-rays or microwaves,
and any procedure requiring sedation or anesthesia);