Institutional Review Board
Office of Research Integrity | Oregon State University
B308 Kerr Administration Building, Corvallis, OR 97331-2140
Telephone (541) 737-8008
irb@oregonstate.edu | http://research.oregonstate.edu/irb
Pre-Review Supplemental Worksheet: SPECIAL ELEMENTS
Study ID
Study Title
Principal Investigator
Submission Type
Pre-Reviewer
(Select)
(Select)
Date of Pre-Review
SPECIAL ELEMENTS
The study involves which of the following elements:
Research involving the internet
Stored data or samples for future use
Deception
International research
Complete only the relevant sections below.
1. RESEARCH INVOLVING THE INTERNET
YES
NO
N/A
COMMENTS
YES
NO
N/A
COMMENTS
YES
NO
Are there adequate provisions for informed
consent/documentation of consent or is a waiver requested?
a) Does the consent-related information for subjects include the
risks related to providing and collecting information via the
internet?
b) Are there adequate procedures for protecting the privacy of
subjects?
c) Are there adequate procedures for protecting the
confidentiality of subjects?
d) Is there adequate technical expertise involved?
2. STORED DATA OR BIOLOGICAL SAMPLES FOR FUTURE USE
a) Are there adequate procedures in place to control the receipt,
storage and release of data or samples?
b) Are there adequate procedures in place for informed consent?
c) Does the consent form make clear whether subject may
withdraw their samples and/or data in the future?
3. DECEPTION
COMMENTS
a) Does the study design meet all of the criteria for a waiver of
consent?
b) Investigator has provided all of the following:
 Justification for the deception
 A description of the manner of deception and how the deception will take place
OSU IRB FWA000003920
1
IRB Form | v. date March 2015









An explanation as to why deception is necessary to this protocol
Justification for the deception
A description of the manner of deception and how the deception will take place
An explanation as to why deception is necessary to this protocol
A description of whether the deception results in any increased risk to participants
A indication of whether the deception may affect a subject’s willingness to participate in research
A description of the post-study debriefing that includes offering the participant the option to withdraw their
data from the study. If an exception to the requirement for a debriefing is requested, the study must be reviewed
by the full board.
A description of any previous use of deception in similar research and a summary of any actual harms or
reactions from participants to the use of deception
A description of alternatives to deception that were considered and an explanation as to why these alternatives
were rejected
4. INTERNATIONAL RESEARCH
YES
NO
N/A
COMMENTS
a) Are there adequate procedures in place to obtain consent
appropriate to the local context?
b) Does the research have or will the research obtain adequate
expertise in the local context?
c) Does the IRB need to obtain outside consultation with regard to
the local context?
d) Does the study involve lab tests occurring outside the United
States?
a. If yes, is the testing standard used within the country
provided? (i.e. in U.S. CLIA certification applies)
b. If yes, is the validity of the test being used provided if
different from the U.S. standard of care?
e) Does this study involve non-English speaking subjects?
If “no”, this section is complete.
f)
Is the investigators proficiency in the subjects’ native language
described?
g) If the investigator is not proficient in this language, will a
translator/interpreter be used?
h) Have the qualifications of the translator/interpreter been
described?
i)
Are issues of confidentiality related to the use of a
translator/interpreter described? For example, is the selected
translator in a position of authority? Is it appropriate for the
selected translator to handle the information that will be
shared?
j)
Are instructions to translators regarding privacy and
2
IRB Form | v. date March 2015
confidentiality adequately described?
k) Is consent being obtained from the subject in a language that is
understandable to them?
l)
Are adequate procedures in place to assess the subjects
understanding of the consent information?
m) If a translator is utilized during the consent process, is their
signature being obtained on the consent form?
n) Are translated documents being provided to subjects?
o) If yes, does the translator have graduate degree in languages,
or are they a native speaker, or professional translator?
p) If no, has a back translation been provided for each of the
translated documents?
3
IRB Form | v. date March 2015