UNMHSC GENERAL CLINICAL RESEARCH CENTER
Procedure/Intervention Risk Classification List
Use this list to determine what level of risk is associated with each procedure and intervention that is used in the research
Low Risk
Procedures/Interventions

Allergy skin testing

Analysis of existing
records or specimens

Anthropometric/body
measurements

DEXA/X-Ray/CAT Scan

Exercise testing

Healthy adult blood draw
<550 cc/ 8 weeks (nonpregnant, > 110 lbs)
Moderate Risk
Procedures/Interventions


Bio-specimen storage for future
undetermined research (Specify
in DSMP what will be banked;
include storage of genetic material)
Collection of sensitive
information:
 HIV status
 Abuse
 Alcohol/Illegal Drug Use
 Engages in Illegal activities

Conscious sedation

Diagnostic imaging using contrast
History and Physical Exam

Discontinuation of routine medications
IV/Oral glucose tolerance
testing

Establishing cell lines from
human subjects

Medical record review


MRI/MR spectroscopy/fMRI

Non-healthy adult blood
draw < 50cc/ 8 weeks



Non-invasive sampling (ie.
Buccal smears, urine, or
sputum collection) (Specify
sample collection in DSMP)


FDA approved drug or device
with moderate or heavy side
effect profile (Specify drug in
DSMP)
High Risk
Procedures/Interventions

Arterial cannulation

Cardiac catheterization

Central Venous Access

Experimental device
implantation: (Specify device
and include IDE #)

Experimental drug or
vaccine:
(Specify drug and include
IND #)

Gene transfer/gene therapy

General Anesthesia

Interventional radiology
(Specify procedure on
DSMP)

Invasive Sampling such as
organ biopsy other than skin,
muscle or fat
(Specify
procedure on DSMP)

Investigator initiated
multi-center clinical trial

Manufacturing of agent at
Genetic testing that could
reveal a genetic condition
Healthy adult blood draw
550 cc in 8 weeks
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
Observation

Patient identifiers will be
stored




Phase I or Phase II drug
study

Insulin induced hypoglycemia


Intravenous Infusion(s)
Placebo use in a serious
disease or condition that has
a standard treatment

Invasive Sampling such as
lumbar puncture,
amniocentesis, plasmapheresis,
bronchoalveolar lavage,biopsy
of skin, fat, muscle (Specify
procedure on DSMP)

Surgical procedure
or intervention (Specify
procedure on DSMP)

Invasive testing (EMG,
endoscopy, bronchoscopy,
angiogram, insulin or euglycemic
clamp, insulin modified
glucose tolerance test)
(Specify test on DSMP)

Investigator initiated IND
be high risk based on
subject population)

Investigator initiated single
center randomized trial

Low risk intervention in a
high-risk population

Medication challenge test
 Allergen inhalation challenge
 Methacholine challenge
 ACTH challenge

Use of well-tolerated FDA
approved drug/device.
(Specify in DSMP)
Multi-center clinical trial using another
coordinating site

Other(than healthy) adult
blood draw > 50cc/ 8 weeks
Venipuncture/IV catheter
placement

Pediatric blood draw >3cc/kg
in an 8 week period

Placebo use in a non-serious disease or
Pediatric blood draw
< 3cc/kg in an 8-week period
Physical sensors applied to
body surface involving no
energy input into the body
(EKG/EEG/MEG/BIA)
(Specify procedure in DSMP)
Recording by:
 Video
 Audio
 Photographs
Special/Prescribed Diets

Specimens to be sent to a
non-UNM laboratory.
(Specify lab on DSMP)

Spriometry/ PFT’s

Tests, interview(s), or
questionnaires of a nonsensitive nature (includes
psychological testing)





UNM
Herbal supplements with
moderate risk profile. (Specify
herb in DSMP)


(non-pregnant, >110 lbs)
Ultrasound/Doppler
Use of a database to recruit
subjects
 Research database
 Clinical database
(May
Vital Signs
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

Vitamin or herbal
supplement(s) with low AE
profile (Specify in DSMP)
condition that has a standard treatment

Other moderate-risk test, procedure,
or intervention not
listed above. (Specify in DSMP)
Other low-risk test,
procedure, or intervention
not listed above. (Specify in
DSMP)

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Other high-risk test,
procedure, or intervention
not listed above. (Specify in
DSMP)
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