Download Initial Expedited - LLU Research Affairs

Institutional Review Board
Expedited Review Checklist
/
/
IRB#
RESEARCH PROTECTION PROGRAMS
Loma Linda University  24887 Taylor Street, Suite 202  Loma Linda, CA 92350
(909) 558-4531 (voice) / (909) 558-0131 (fax)
Question
Yes
No
N/A
Comments
I. Does the activity meet the DHHS definition of Human Subjects research?
I.A. Is it Research?
1. Is the activity a systematic investigation, including research
development, testing, or evaluation?
2. Is the activity designed to develop or contribute to
generalizable knowledge?
 If “yes” to questions 1 and 2 above, the activity meets the DHHS definition of research. Go to Section I.B.
 If “no” to questions 1 or 2 above, the activity does not meet the DHHS definition of research. Go to section
II.
I.B. Is it Human Subjects research?
1. Are the data obtained about living individuals?
2. Are data collected through interaction or intervention with
individuals? (e.g., interviews, surveys, direct contact)?
3. Is identifiable individual private information being obtained
(e.g., chart reviews, info. from data or tissue repositories)?
4. Are data or specimens received by the investigator with
identifiable private information?
5. Are the data/specimens coded with a link back to the
individual?
 If “yes” to question 1 above AND “yes” to any of the questions from 2-5 in Section I.B., the activity is
considered human research. Go to section II of this form.
 If “yes” to ONLY question 1 and “no” to all other questions in Section B, or “no” to all questions in Section
I.B., the activity does not meet the DHHS definition of human subject research under DHHS regulations. Go to
section II. Or STOP if a letter of determination is requested by the PI/Sponsor.
II. Does the protocol meet the criteria for Exemption?
 If “yes,” fill out the Exempt Review Checklist, NOT this Expedited Review Checklist.
 If “no,” go to section III.
III. Does the Health Insurance Portability and Accountability Act (HIPAA) apply? For more
information on “Research Involving Private Information or Biological Specimens,” go to:
http://grants.nih.gov/grants/policy/hs/PrivateInfoOrBioSpecimensDecisionChart.pdf
1. Is the source of information from existing physician/clinic records, lab, pathology, and/or radiology results,
biological samples, or hospital/medical records (in and out patient)?
 If Yes, is the information recorded in the research records anonymously with no linking code? If yes, then
HIPAA does not apply, but institutional policy requires a Waiver of HIPAA Authorization.
 If No, HIPAA does not apply. Go to section IV.
IV.A. The only involvement of human subjects will be in one or more of the following categories:
Drug or medical device? Category 1
Research on drug(s) for which an investigational new drug application is NOT required.
(21CFR part 312)
Research on medical device(s) for which:
o An investigational device exemption application
(21CFR Part 812) is not required. OR
o The medical device is cleared/approved for marketing
and the medical device is being used in accordance with
Page 1 of 3
LLU IRB
6/4/15
its cleared/approved labeling.
Blood sample(collected by finger stick, heel stick, ear stick, or venipuncture)? Category 2
From healthy, nonpregnant adults who weigh at least 110 pounds.*
o Amounts drawn do not exceed 550 ml (18.6
ounces or 2.32 cups) in an 8 week period; AND
o Collection does not occur more frequently than 2
times per week
From other adults and children, considering 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.
o Amount may not exceed the lesser of 50 ml* or 3*
ml per kg in an 8 week period; AND
o Collection does not occur more frequently than 2
times per week.
*110 pounds = about 50 kg
*50 ml = about 10 teaspoons
*3 ml = about 0.6 teaspoons
Biological specimens? Category 3
Prospective; AND
For research purposes; AND
Noninvasive
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of
exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine
patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e)
uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or
wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic
fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and
subgingival dental plaque and calculus, provided the collection procedure is not more invasive than
routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted
prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or
mouth washings; (j) sputum collected after saline mist nebulization.
Noninvasive procedures? Category 4
Routinely employed in clinical practice; AND
Does NOT involve anesthesia or
sedation; AND
Does NOT involve x-rays or microwaves.
If medical device, is cleared/approved for marketing.
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and
do not involve input of significant amounts of energy into the subject or an invasion of the subject=s
privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d)
electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and
echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and
flexibility testing where appropriate given the age, weight, and health of the individual.
Materials (data, documents, records, or specimens)? Category 5
Collected or will be collected solely for nonresearch purposes (such as medical treatment
or diagnosis)
Data from voice, video, digital, or image recordings? Category 6
Collected for research purposes
Individual or group characteristics? Category 7
Page 2 of 3
LLU IRB
6/4/15
Examples of research: perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, social behavior, etc.
Methodologies: survey, interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance
IV.B. Of the seven categories above, Category ________ best represents the dominant feature of
the study (i.e., most significant risk potential for participants).
IV.C.
This protocol DOES NOT meet the criteria for Expedited Review. Go to the Exempt or Full
Board Review Checklists.
V. The following common stipulation(s) are applicable:
V.A.
Waiver of consent: 45 CFR 46.116(d)
V.B. Waiver of signed consent:
1.
45 CFR 46.117(c)(1) [when consent is the only record linking subject to study] OR
2.
45 CFR 46.117(c)(2) [involves no procedures for which written consent is normally
required outside of research context]
V.C.
Waiver of parental permission: 45 CFR 46.408(c) [for when parental permission is not a
reasonable requirement to protect subjects]
V.D.
Waiver of HIPAA Authorization: 45 CFR 160, 164
VI. Other comments:
VII. Reviewer’s attestation:
The project meets the organization’s ethical standards governing the conduct of research (e.g. acceptable riskbenefit relationship, equitable selection, informed consent, protections of privacy, maintenance of
confidentiality, and protections for vulnerable population.)
Signed
Page 3 of 3
Dated
LLU IRB
6/4/15