Human Studies Program
Office of Research Compliance
Vice Chancellor for Research and Graduate Education
A Key to a Successful Approval of Your Research
Hosted by the Faculty Mentoring Program
and Preparing Future Faculty
March 5, 2015
Denise Lin-DeShetler, M.P.H., M.A.
Director
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Most
scientists
regarded
the
new
streamlined
peer-review process
as
'quite
an
improvement.'
Human Subjects
3/5/2015
2
Do I need IRB approval before conducting my
research project?
Criteria:
Is It Research?
Is It Human Subjects Research?
Human Studies Program
Is it a systematic investigation?
Quantitative Research Qualitative Research
Objectives
Hypothesis
Pre-/Post-test
Variables
Data collected
Research question(s)
Theory generating
Survey questions/ Interviews
Identifying patterns
Human Studies Program
For generalizable knowledge?
◦ Theses and Dissertations?
Yes, by definition
◦ Term Papers / Class projects
No, unless the intent is to publish or present
◦ Evaluations and Quality Assurance?
Maybe
◦ Funded Research?
Definitely!
Human Studies Program
Project to evaluate a particular program that teaches cultural sensitivity to
teachers in a middle school that includes a diverse student population.
No, as long as the purpose of the QI is to improve ONLY that program
Student who wants to present results of his project on food preferences of
farmers from a particular region at a national conference.
Yes, definitely
Project that evaluates a new curriculum conducted within a class at UH that
will be presented only within the department to investigate whether the
curriculum should be integrated into future classes within that department.
No, as long as the findings from that evaluation stays within the university
Human Studies Program
Does your project involve only the analysis of
publicly available data?
◦ If Yes, no need to get IRB approval
However, FAs: Even if your project does not need an
exempt or IRB approval, your graduate student
will still need a letter from HSP verifying that
your project does not meet the definition of
“Human Subjects Research” (per Graduate
Division requirement)
To get this letter, your student will need
to submit his/her project to the Human
Studies Program for verification using an
exempt application.
Human Studies Program
1. Does my research involve obtaining information about living
individuals?
2. Will the information be obtained through intervention or interaction
with these individuals?
3. Will the research involve access to private information from which
individuals can be identified directly or indirectly through a link or
code?
If No for all of the above, not human subjects research.
If yes to 1 &2 or 1 & 3, you need to apply for IRB approval
Human Studies Program
What forms do I use?
What do I need to include in the application?
How do I submit?
When can I expect an approval?
Human Studies Program
What forms do I use?
•Two different application forms for Exempt vs. Non-
exempt
What do I need to include in the application?
How do I submit?
When can I expect an approval?
Human Studies Program
Vulnerable populations
◦ Minors
◦ Prisoners
◦ Pregnant women
◦ Mentally-impaired
Personal Identifiable Information (PII)
◦ Risks: physical, emotional, financial, reputational, employment, etc.
Invasive Procedures
◦ Obtaining blood
◦ Interventional that could potentially bring about permanent effect (i.e., drugs,
devices, informational/ educational that may require counseling support)
Deception
Human Studies Program
3 IRB committees within the HSP
(https://manoa.hawaii.edu/researchcompliance/institutional-review-board-irb-0):
1. Biomedical Sciences IRB
2. Social and Behavioral Sciences IRB
3. Cooperative IRB
Assignment to the appropriate committee for review depends on the subject matter
of the non-exempt study.
Be aware that if your non-exempt study needs to be reviewed by full board, there
are deadlines for submitting application.
Human Studies Program
What forms do I use?
What do I need to include in the application?
How do I submit?
When can I expect an approval?
Human Studies Program
Signed application (also by advisor, if applicable)
Consent form (model on the website)
◦ Parental consent and assent
◦ Informational form
All participant materials in the language of the participant (if applicable)
CITI certificate of completion
◦ Advisors should also complete their CITI training too!
Anything the participant will see or hear
◦ Survey
◦ Interview questions
◦ Recruitment flyer and/or recruitment script (model on the website)
All questions on the application form are answered
◦ Description of Project – exempt
◦ Objectives, methods, risks, etc. – non-exempt
Human Studies Program
https://manoa.hawaii.edu/researchcompliance/templates
Follow model consent form formatting including section
headers
Use an active voice
The language and reading level should be 6
th
grade.
Include section before the signature line for subjects to choose
whether or not they want to be audio-taped, if applicable
Human Studies Program
A research project may be allowed to use a study information form
instead of a consent form if a combination of these 4 conditions are
met:
1. Research involves no more than minimal risk to the subjects;
2. Waiver or alteration of informed consent will not adversely affect the
rights and welfare of the subjects;
3. Reach could not practicably be carried out without the waiver or
alteration; and
4. Whenever appropriate, the subjects will be provided with additional
pertinent information after participation
Human Studies Program
Study Information Forms Have All Elements Of A Consent Form –
Just No Need For A Signature. Participants Keep A Copy Of The
Study Information Form
Anonymous online survey (ex.: survey monkey) where there
are no identifiers collected and no subsequent contact with
participants.
Research involving survey with large number of participants
collecting data on brand preference on shoes.
Interviewing victims of domestic violence about their
experience with domestic violence.
Human Studies Program
Oral Consent Script
◦ Must include all elements of a traditional informed consent
Purpose, activities, time commitment
Risks and benefits
Privacy and confidentiality
Voluntary
Qualification for use of oral consents:
Minimal risk and involves no procedures for which written
consent is normally required outside of the research
context; OR
Only record linking the subject and the research would be
the consent document and the principal risk would be
potential harm resulting from a breach of confidentiality
Human Studies Program
Informed Consent is a process of information
exchange that includes:
◦ Participant recruitment materials
◦ Verbal instructions
◦ Written materials
◦ Question / answer sessions
◦ Agreement - documented by a signature when
required
Human Studies Program
Collaborative Institutional Training Initiative (CITI)
https://www.citiprogram.org/
◦ Must submit certificate of successful completion with application in
order for application to be reviewed.
◦ CITI training is good for 3 years
Refresher course available for renewing
◦ For step-by-step instructions on registering and completing UH
required CITI training:
https://manoa.hawaii.edu/researchcompliance/get-training-0
Human Studies Program
◦ Must have University of Hawai’i listed as the institution
◦ For exempt research, must complete the Human Subjects Research basic
course (question 3) and Information Privacy and Security course (question
5) for “Exempt biomedical researchers and key personnel.”
If only using existing medical data for research, choose “exempt researchers
and key personnel – biomedical data and specimens only.”
◦ For non-exempt social & behavioral research (e.g., sociology, psychology,
SLS, education), must complete the Human Subjects Research basic course
(question 3) and Information Privacy and Security course (question 5) for
“Non-exempt social & behavioral sciences researchers and key
personnel.”
◦ For non-exempt biomedical research (e.g., medicine, psychiatry, nursing,
public health), must complete the Human Subjects Research basic course
(question 3) and Information Privacy and Security course (question 5) for
“Non-exempt biomedical researchers and key personnel.”
Human Studies Program
Human Studies Program
Supplemental Courses
◦ If your research involves recruitment of belonging to a “vulnerable
population” (or special setting), complete appropriate course or courses
under Question 4 of CITI:
Children (Biomed Focus)
Prisoners (Biomed Focus)
Pregnant Women, Fetuses, and Neonates
Children (Social & Behavioral Focus)
Prisoners (Social & Behavioral Focus)
Working with Elementary & Secondary Schools
Coming From Another Research Institution
◦ If you completed CITI training from another institution, you may be able to
transfer some modules over to the UH CITI training.
You would still have to add UH as a participating institution when you go into
your personal CITI account
What forms do I use?
What do I need to include in the application?
How do I submit?
When can I expect an approval?
Human Studies Program
SUBMISSION
Electronically submit to uhi[email protected]
For non-exempts only, ALSO submit 2 hard copies
to:
Human Studies Program
1960 East-West Road, Biomed Bldg B-104
Honolulu, HI 96822
TURNAROUND
(~approximate)
Exempts 2-3 weeks
Expedited 3-4 weeks
Full-Board 1-2 months
Human Studies Program
H an
StJd1es
Program
SUBMISSION
Busy Seasons
High volumes of applications during:
March – April
October – November
Be aware that turnaround time may take longer
during these busy seasons
COMING SOON!
eProtocol: electronic submission system
No more hard copy submissions
Human Studies Program
Missing one or the other of the following when conducting
research on minors:
◦ Assent form
◦ Parental consent form
Confusion between “anonymity” vs. “confidentiality” (individual
vs. data)
Missing recruitment flyer or script
Not including term “research” in the recruitment flyer
Not providing separate responses to the six questions to the
Description of Project in the exempt application
Human Studies Program
https://manoa.hawaii.edu/researchcompliance/human-studies
QUICKLINKS:
“Learning Commons – HSP”: information on required and
elective training for human subjects research
“Submit a New Protocol”: Application forms for new
protocols; guidance on review categories; instructions on how
to submit
“Modify a Protocol”: Application form to request
modifications on active protocol
“Renew a Protocol”: Application form to apply for continuing
review of active protocol
“Report a Protocol Violation or Unanticipated Problem”: forms
to report a protocol violation or unanticipated problem
Human Studies Program
https://manoa.hawaii.edu/researchcompliance/human-studies
QUICKLINKS:
“Institutional Review Board (IRB)”: calendar of submission
deadlines, meeting dates; defines what kind of protocols each
UH IRB reviews; coming soon – cooperative agreements
“Templates”: includes consent form templates, model
recruitment flyers
“Policies & Guidance”: general policies and procedures, SOPs,
general guidance on developing various items required for
human subjects research
“Industry-Sponsored Research”: IRB fee schedule for
industry-sponsored research; regulatory document tools for
research management; investigator brochure
Human Studies Program
https://manoa.hawaii.edu/researchcompliance/human-studies
QUICKLINKS:
“FAQs”
“Check Application Status”: allows PI to search HSP database
for real-time status of active studies
“Information for Research Participants”: resources for
research volunteers regarding their rights as participants and
what they need to know before and during participation.
“Other Resources”: links to federal, state and institutional
regulations and policies and procedures pertaining to
research involving human participants.
Human Studies Program
OHRP Decision Chart:
◦ http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
Full board application deadline calendar:
◦ https://manoa.hawaii.edu/researchcompliance/institutional-review-
board-irb-0
Important announcements and policy/ procedure
changes (Under “What’s New”):
◦ https://manoa.hawaii.edu/researchcompliance/
Human Studies Program
Complete the CITI training early, and have your advisor do it early too. You only have to do
it every three years, and will apply to all subsequent and concurrent research projects.
◦ If you anticipate doing research that have higher risk, do the more comprehensive training
module.
Use, use, use the consent form templates. They were created by the HSP and IRB for your
convenience.
Apply early!
◦ Be aware that other students will be submitting around the same time too, so turnaround
time increases with volume (October-November, March-April).
Make sure you let your advisor review before signing off your application. They are the
subject matter experts to your discipline.
For students conducting research using Hawai’i public school resources, consult HIDOE –
may need to apply for separate approval.
◦ For more details on HIDOE process and requirements:
https://manoa.hawaii.edu/researchcompliance/sites/manoa.hawaii.edu.researchcompliance/files/resourc
e/HIDOE_instructions.pdf
Human Studies Program
Human Studies Program
Contact Us:
UH Human Studies Program
University of Hawaii at Manoa
1960 East-West Road
Biomedical Building B-104
Telephone: 808.956.5007
E-mail: uhi[email protected]
Website:
https://manoa.hawaii.edu/researchcompliance/human-
studies
