Research Participants Who Cannot Write

Q – If, for any reason, an English-speaking research participant is physically unable to sign a consent form (i.e., bandaged hands, loss of limbs, contact isolation, etc.), how should this individual’s consent to participate be documented?
A - The IRB will accept consent obtained in the following way as valid consent: The participant should be presented with a copy of the IRB-approved written consent document, the text should be read aloud by the person obtaining consent and the participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. The participant would give consent verbally. The person obtaining consent and one other person (not associated with the study) would then sign and date the document. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances.

Research Participants Who Cannot Read

Q-If, for any reason, an English-speaking research participant is not able to read a consent form (i.e., illiteracy, vision-impairment), how should this individual’s consent to participate be documented?
A-In cases where the research participant is not able to read, the informed consent dialogue becomes extremely important. An impartial witness should be present during the entire informed consent conversation. The text of the informed consent document and any other written information should be read aloud by the person obtaining consent. The participant should be encouraged to ask questions and allowed to have questions answered, as is usual during a normal consent process. If the research subject wishes to enroll in the study the subject may consent orally and if able, may sign and date the consent form. After the subject has consented, the witness signs and dates the consent form to attest that the subject received the information, the risks/benefits/alternatives were discussed, and informed consent was freely given. A complete and explicit description of why the participant was not able to sign the document should be included in the chart to provide a clear record of the event and the surrounding circumstances. For additional information, see Guidance for Industry – Documenting Informed Consent, Section 4.8.9 @ http://www.fda.gov/cder/guidance/959fnl.pdf

FDA MedWatch – Stiff Nights (marketed as dietary supplement) contains undeclared drug ingredient sulfoaildenafil

FDA notified consumers that Stiff Nights, a product sold as a dietary supplement, contains sulfoaildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Michigan. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.

CLICK HERE to read the MedWatch safety summary, including a link to the FDA News Release.

FDA MedWatch – Centurion Medical Products Premie Pack and Meconium Pack

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. These products were distributed from January 1, 2007 through September 22, 2009.

CLICK HERE to read the MedWatch safety summary, including a link to the FDA Class I Recall Notice, at:

Revised Form #1100 and Dose Escalation Template Language

The Health Sciences standard application and Dose Escalation Template Language have been revised to include additional information about therapeutic intent.

FDA MedWatch – Bodybuilding.com Brand Dietary Supplements – Sold on Internet

Bodybuilding.com and FDA notified healthcare professionals and patients of a nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company’s website, www.bodybuilding.com.

FDA believes that the recalled products contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

Customers who have any of the products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.
CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Byetta (exenatide) – Renal Failure

FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

- Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
- Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
- Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
- Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

CLICK HERE to read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:

FDA MedWatch – Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Cordis CROSSOVER Sheath Introducer – Recall

Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer, a long-coil reinforced,kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.

The recall was due to stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. Unplanned open surgery may be required to remove the retained segments or control bleeding.

CLICK HERE to read the MedWatch safety summary, including a link to the firm press release.

FDA MedWatch – Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall

Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release and previous August 2009 recall.