Risk Assessment

The Research Subject Advocate Program (RSA)

Risk Assessment

The DSMP should specify the procedures employed to maximize participant safety throughout the study. Each plan should be tailored to fit the estimated degree of risk to the participant as well as the size and complexity of the study. Therefore, it is necessary to estimate the level of risk associated with the protocol, as this will drive the type of monitoring needed and the level of oversight required. In general, the risk assessment is performed by the IRB and may involve the following categories

Minimal/Low Risk Studies: (Check all that apply) Studies of this risk level are limited to those that involve innocuous procedures but no therapeutic agent. It is usually sufficient for the PI to monitor these studies and the plan should include a minimum of annual progress reporting.
	Observation Studies	Scans (performed solely for research purposes) DEXA, MRI, MRS, CTs, EKGs
	Survey/questionaire/diary	Contrast dye
	Nutrition Studies	Oral glucose tolerance test
	Sleep Studies	Stable isotope infusions
	Pharmacokinetic Studies	Peripheral intravenous catheter
	Medical Record Studies	Collection & analysis of exhaled gases
	Post-marketing Phase IV Drug studies	Pulmonary function tests
	Use of existing tissue, specimens or data (medical record)	Photographs
	Retrospective review of health information without subject identifiers	Intramuscular injections
	Prospective collection of biological specimens for research purposes by non-invasive means	Non-randomization
	Fasting	Survey/questionnaire/diary, non-sensitive topics
	Indirect calorimetry	Study drug _______________
	Exercise testing	Other ____________________
	Collection of blood samples by venipuncture, heel stick, fingerstick, earstick, other
	Collection of Urine, feces, saliva, secretions
	Standard Medical Evaluation for screening

Moderate/More than Minimal Risk Studies: (Check all that apply) Studies of this risk level require a more detailed plan for patient safety monitoring and may include studies investigating a ‘safe’ therapeutic agent. These studies may require additional monitoring by a qualified medical monitor, safety officer, or an ad hoc safety committee.

Placebo controlled studies

Treatment Studies: HIV/AIDS; Hepatitis Cancer COPD

Randomization

Clinical trials with available safety data in humans: Phase I Phase II

Studies that include a “Washout” period or placebo use in an otherwise treatable disease.

Investigator-initiated studies involving drugs or devices requiring an IND application (21CFR Part 312) IND# _______________

Research on sensitive or private topics

Arterial Catheter Venous Catheter

Biopsies Skin Muscle Bone Liver Other ____________

Conscious sedation used for catheter placement and biopsies

Studies involving regional anesthesia

Industry sponsored Phase III clinical trial (requires a DSMB)

Studies in which the risk of Serious Adverse Event originating from underlying condition of enrolled subject is > 5%

Vulnerable population (children, pregnant women, elderly, psychologically or neurologically impaired, prisoner, fetus)

High/Significant Risk Studies: (Check all that apply) These studies require a minimum of semi-annual reports plus additional monitoring measures as determined by the PI or IRB, which may include monitoring by a 3 member Data Safety Management Board (DSMB), monitoring by a qualified medical monitor, or external oversight by an ad hoc safety committee.
	New chemical entities or class of test article having a high expectation of toxicity
	Phase I and/or Phase II Clinical trials involving blinding without available safety data in humans
	Investigator-initiated, multicenter clinical trial (requires DSMB)
	Studies involving any investigational drug or device that utilizes a significant invasive procedure or which safety/data toxicity in humans is lacking
	Studies involving the manufacturing of agents on campus
	Multicenter randomized moderate or high risk study
	Emergency studies with waiver of informed consent
	Gene transfer experiments involving DNA molecules
	Xenotransplantation
	Vulnerable population (children, pregnant women, elderly, psychologically or neurologically impaired, prisoner, fetus)

ASSESS THE RISK LEVEL: (The GCRC Advisory Committee (GAC) ultimately decides this)

Minimal/Low Moderate High

Updated: 03/30/04