Human Subjects Research: Institutional Review
Board
The IRB is the body charged with reviewing all research
involving human subjects conducted under the auspices of Wesleyan University.
This includes research conducted by faculty members, students, and staff, as
well as that conducted by outside researchers using Wesleyan individuals as
subjects. It includes federally funded research as well as research that is not
funded or is funded by other sources. Individuals proposing research using human
subjects must obtain approval from the IRB prior to commencing data collection.
The activity of research is defined as any systematic
investigation designed to contribute to a body of generalized public knowledge.
The use of human subjects in research refers to data collection through
interaction with individuals as well as any collection of identifiable private
information about individuals. The purpose of the IRB is to provide a single,
comprehensive standard of protection for human subjects in research at Wesleyan.
The intent is to ensure that investigators do not unduly put at risk or harm
humans who are the subjects of research, and that subjects are aware of their
rights as defined by federal regulations.
The safeguards provided by establishment of the IRB derive
from three ethical principles: respect for the personal dignity and autonomy of
all people, the obligation to protect persons from harm, and fairness in the
distribution of research benefits and burdens. These principles were first
articulated in the
Belmont Report
issued by the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research in 1979. The procedures for review by the
IRB adhere to the
Code of Federal Regulations
(Title 45, Part 46) of the U.S. Department of Health and Human Services.
For a better understanding of the history, purpose, goals,
and procedures of the IRB as established by the federal government, researchers
are strongly encouraged to consult the following sources. The Office for Human
Research Protections (OHRP) of the Department of Health and Human Services
provides free online
Human Subject Assurance Training. Specifically, three training modules are
offered at the site: (1) HHS Regulations and Institutional Responsibilities; (2)
Investigator Responsibilities and Informed Consent; and (3) Human Research
Protections Program. The Department also publishes
Protecting Human Subjects: Institutional Review Guidebook.
BOARD MEMBERS
The members of the board are appointed by the provost and
represent members of a wide range of disciplines at the university as well as
members of the community.
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Coordinator
Lisa Sacks
Administrative Assistant
North College 310
lsacks@wesleyan.edu
860/685-3428
Chair
Andrea Patalano
Associate Professor of Psychology
and Program in Neuroscience and Behavior
Judd Hall 404A
apatalano@wesleyan.edu
860/685-2310
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Wesleyan Affiliated Members
Cynthia Matthew
Visiting Scholar in Psychology
Judd Hall 218
cmatthew@wesleyan.edu
860/685-2942
Don Moon
Dean of Social Sciences and Interdisciplinary Programs
Professor of Government
North College 309
dmoon@wesleyan.edu
860/685-2707
Anu Sharma
Associate Professor of Anthropology and Feminist Studies
Anthropology 23
asharma@wesleyan.edu
860/685-3567
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Public Members
Marvin Farbman
4 Columbine Road
Middletown, CT 06457
mfarbman@wesleyan.edu
860/347-8338
Marci Swede
181 Elizabeth Lane
Middletown, CT 06457
mswede@wesleyan.edu
860/346-2748
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All submitted proposals are assigned by the IRB to one of
three review categories (Exempt, Expedited, or Full). The assigned review
category will guide the review process for the proposal. Note that the below
category descriptions are abbreviated summaries of federal guidelines.
Definitions of key terms are listed below the descriptions of these three
categories. Even if you believe your proposal is exempt, you must submit it so
that the board has the opportunity to make this determination.
Exempt (Level 1)
Each of the following situations is exempt from review:
Research practices that use normal educational practices in commonly accepted
educational settings; use of educational tests, surveys, interviews, or
observations of public behavior, unless subjects can be identified in any way
and disclosure would be harmful to criminal or civil liability, financial
standing, employability, or reputation (the latter is waived if subjects are
figures in public office); use of existing or collected specimens, data, or
records that are publically available or are not linked in any way to individual
subjects; and, any research that requires prior approval of federal agencies.
Proposals determined to be exempt are waived from further review for the
duration of the project.
Expedited (Level 2)
All research that poses minimal risk to participants can be
expedited. In addition to previously mentioned methods, this includes audio and
video recordings, laboratory behavioral tasks that do not stress subjects, and
clinically routine noninvasive procedures such as blood tests,
electroencephalography, functional magnetic resonance imaging, moderate
exercise, and body composition assessment. It does not include methods
involving electromagnetic exposure such as x-rays. These conditions do not
guarantee expedited review; full review is at the discretion of the board.
Expedited proposals are typically reviewed by both the chair and one member of
the board.
Full Review (Level 3)
All research that is not exempt or expedited is given full
review. This means that the proposal is reviewed by all members of the board
and must receive support from the majority of board members in order to be
approved. In addition to non-minimal risk methods, such circumstances as
requests for waivers of informed consent, inclusion of vulnerable populations,
and use of sensitive data sometimes prompt full review.
Definitions
Minimal risk. Minimal risk is the probability and
magnitude of harm or discomfort ordinarily encountered in daily life or during a
routine physical or psychological examination or test.
Vulnerable populations. Vulnerable populations include
children, prisoners, pregnant women, fetuses, the seriously ill, and mentally or
cognitively compromised adults.
Sensitive data. Sensitive data include behaviors that are
typically sensitive to individuals, such as drug or alcohol use, illegal
conduct, or sexual behavior, as well as information that could reasonably place
the subject at risk of criminal or civil liability or be damaging to the
subject’s financial standing, employability, or reputation.
New submissions
Researchers who are not affiliated with Wesleyan
University but are submitting a proposal should request a research proposal form
from Lisa Sacks (lsacks@wesleyan.edu)
and should return the completed form and accompanying materials to her by
email. All researchers who are affiliated with Wesleyan University
(i.e., most submissions) should obtain the form
Description of Research Project Involving Human Participants online
through WesFiles and should submit it and accompanying materials through
WesFiles (see instructions at the end of this webpage). Any difficulties or
questions should be directed to Lisa Sacks.
Proposal expiration and renewal
Research approved by the IRB that is continuing must be
re-reviewed on an annual basis by the IRB. The contact principle investigator
is expected to be aware of expiration dates and to initiate this re-review.
Even before re-review, throughout the year, any changes in research design must
be submitted to the IRB for approval and unanticipated or adverse consequences
of the research must be reported including but not limited to physical or
psychological injury to subjects, improper execution of research protocol, or
improper disclosure of private information. The instructions for renewing
applications are the same as those for submitting a new application except that
there is an
IRB Research Project Continuation Form
available
online for this purpose. When submitting this form
on WesFiles, please add it to the original project folder in the dropbox at:
https://wesfiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2. If this is a
renewal for a project that was not submitted via WesFiles, please create a new
folder following the instructions for new submissions.
Changes to protocol
If you wish to change the protocol of an approved IRB
proposal, please download, complete, and submit via WesFiles the
IRB Project Change of Protocol Form. You do this by adding the document
to your original submission folder at:
https://wesfiles.wesleyan.edu/xythoswfs/webview/_xy-5403941_2.
You should not collect data using the new protocol until it has been
approved. The procedure for reviewing changes will follow that for new
proposals. If this is a change of protocol for a project that was not submitted
via WesFiles, please create a new folder following the instructions for new
submissions.
Preparation of proposals
Click here for an example of
a complete proposal including a sample consent form, set of research
materials, and debriefing sheet. We highly recommend that you view the sample
materials if you are a new submitter. We also strongly encourage you to
complete the three modules of the online
Human Subject Assurance Training, or to review relevant portions of Chapters
III, IV, and VII of
Protecting Human Subjects: Institutional Review Guidebook so that you
understand the issues that are of central interest to the IRB and can then fully
address these issues in your proposal. If you are a student, you must document
in your submission form that your faculty advisor has read and approved your
proposal. Proposals that are incomplete will be returned without review.
Review time frame
The application will be sent to one member of the IRB for
review who will assign it to one of the three review levels (Exempt, Expedited,
or Full Review); the chair will also read all proposals and oversee the process.
(Members do not review proposals with which they have a conflict of interest.)
Unless the proposal is assigned to Full Review, the chair will return a decision
(Approve, Approve Pending Revisions, Revise and Resubmit, or Deny) that will be
communicated in an email to the principal investigator typically within 2 weeks
of proposal submission. If the proposal is assigned to Full Review, this will
be communicated to the investigator in the first email and a decision will be
provided in a second email within 2 additional weeks. When a proposal is
approved or denied, a formal letter will also be sent to the investigator;
requests for revisions will be sent through email only. Reviews will be
conducted throughout the year. However, slower turnaround times should be
anticipated during school break periods.
Types of decisions
There are four types of board decisions for non-exempt
proposals. Approve means that no further action is required and the
study can commence. Approve Pending Revisions means that the proposal
can be accepted by the board upon receipt of a set of specific changes.
Revise and Resubmit means that the proposal must be revised and resubmitted
based on feedback from the board before it can be properly and fully evaluated.
Deny means that the board has decided that the study cannot be
conducted. Denials can be appealed one time through a written letter of
argument along with any further supporting materials for a final review by the
full board but, if the denial stands, the work cannot be conducted.
1.
Download and complete
Description of Research Project Involving Human Participants and save it
to your computer.
2.
Create a folder on your computer and name it according to the following
convention:
YYYYMMDD-username-project
a. YYYYMMDD
is a date stamp. 20090901, for example if you are submitting on
September 1, 2009.
b. Username is your Wesleyan email address up to but not including the @ sign
c. Project is a short code for your project, primarily for your own reference.
Please use letters or
numbers only, no spaces.
d. Example: 20090923-jprof-apptest
3. Put all of your application documents
(i.e. completed Description of Research Project Involving
Human Participants
form, consent forms, survey instrument, and other accompanying documents)
in the folder that you created.
4. Point a web browser (i.e. Internet
Explorer or Firefox) to:
https://WesFiles.wesleyan.edu/xythoswfs/webview/_xy-5084904_2 and login if
you are required
to do so.
5. Click on the Upload
button in the upper
right portion of your screen
a. Make sure to choose the
Advanced Uploader
b. Browse to your folder and click
Open or
drag and drop your folder into the upload area
c. Click Start Upload
d. If your upload succeeds you will be
returned to the initial listing of dropbox contents where
you will see your new
folder
e. If your upload fails, please contact your
Desktop Support Person or your Academic Computing
Manager
f. Detailed uploading help is also available
at:
http://WesFiles.blogs.wesleyan.edu/how-to/upload/
6. Uploading the folder will initiate
processing automatically. For a short time, you will still be able to
delete files that you uploaded, but within a day that permission will be changed so
that you only
have read access to the materials you have submitted.
7.
You will see all of your own submissions
and only your own submissions in this folder.
If you are in doubt as to whether your own work falls under
the heading of human subjects research, please simply submit a proposal. A
purpose of the board is to make such decisions. Thank you for your efforts in
submitting complete and thorough applications and for your respect for the
review process.