Worcester State University
Human Subjects Review Board
Criteria for Approval
Revised: 7.16.2014
Proposal Number:
Reviewer:
Researcher:
Faculty Advisor:
Title of Study:
Please review the proposed protocol in accordance with the Worcester State University policies and
procedures and the federal regulations regarding the protection of human subjects. Indicate whether each
of the following points of review is appropriately addressed.
HUMAN SUBJECT POPULATION:
Is the population of participants a protected
one?
Yes
No
N/A
Comments
Yes
No
N/A
Comments
pregnant women, fetuses, or neonates as
participants
prisoners as participants
children as participants
RESEARCH METHODS AND PROCEDURES:
Is the study methodology appropriate to the
risks and benefits of the study?
CONSENT OF PARTICIPATING AGENCIES:
Are other agencies parts of the research
process?
If so, has consent been given by them for this
procedure?
RECRUITMENT OF SUBJECTS:
Is recruitment of participants equitable?
inclusion and exclusion criteria
recruitment methods
purpose of the research
research setting
INFORMED CONSENT PROCEDURES
(including CONSENT FORM):
Is informed consent sought from each
prospective participant or participant’s
representative?
Waived or altered?
Requirement for written documentation
will be waived?
Documented in writing?
1
Yes
No
N/A
Comments
Is all of the following appropriately addressed
in the consent form (as is necessary)?
General Information
Study Description
Procedures
Risks/Benefits
Confidentiality
Compensation for Subjects
Participation and Withdrawal
Study Contacts
Rights of Research Subjects
Signatures
Waiver or Alteration of Consent Form
Do the details of the consent form match the
details mentioned in the application?
Yes
No
N/A
Comments
RISKS:
Risks to participants are minimized by using
procedures which are consistent with sound
research design and which do not
unnecessarily expose participants to risk.
Can alternative procedures answer the
scientific question and reduce the likelihood
or magnitude of harm?
Can fewer procedures answer the scientific
question and reduce the likelihood or
magnitude of harm?
Consider physical, psychological, social,
legal, and economic risks.
Risks to participants are minimized whenever
appropriate, by using procedures already
being performed on the participants.
Are procedures that will answer the
research question being done anyway?
If so, can the data from these procedures
be used to reduce the likelihood or
magnitude of harm
Consider physical, psychological, social,
legal, and economic risks.
Risks to participants are reasonable in
relation to anticipated benefits, if any, to
participants, and the importance of the
knowledge that may reasonably be expected
to result.
Is the research likely to achieve its
proposed aims?
Is the importance of the aims clear?
2
Consider physical, psychological, legal,
social, and economic risks.
Consider direct potential benefits to
participants, if any.
The research involves more than minimal risk.
The research plan makes adequate provision
for monitoring the data collected to ensure
the safety of participants.
When will the data be monitored?
What data will be monitored?
Who will be doing the monitoring?
PRIVACY &CONFIDENTIALITY
Participants have expectation of privacy
Yes
No
N/A
Comments
Yes
No
N/A
Comments
Will participants think that the information
sought is any of the researcher’s business?
Will participants be comfortable in the
research setting?
There are adequate provisions to protect the
privacy of participants.
Do procedures for identifying participants
minimize any invasion of privacy?
Are the research procedures designed to
provide for privacy?
Confidentiality pledged
There is legal or ethical requirement to
maintain confidentiality
RESEARCH RECORDS:
Data release will cause risk or harm
There are adequate provisions to protect the
confidentiality of the data.
Restricted access (Locks/passwords)
Certificates of confidentiality
Error inoculation/Random responses
(inserting random error into the dataset
while still allowing useful statistical
analysis)
Bracketing/Top Coding (replacing a variable
with a variable with less information/
replacing values above a certain level with
a threshold value)
Ethical editing or qualitative descriptions
Data brokering (third party holds data and
identifiers)
RISK of COERCION:
Participants are likely to be vulnerable to
coercion or undue influence
Additional safeguards have been included in
the study to protect the rights and welfare of
participants likely to be vulnerable to
coercion or undue influence
3
BENEFITS:
If mentioned, are the benefits reasonable
relative to the risks?
Are they reasonable relative to the study
overall?
STUDY DURATION:
Is the length of the study appropriate to its
purpose?
SURVEY INSTRUMENTS:
Are all instruments reported and included in
the protocol?
DEBRIEFING OF SUBJECTS:
Is the debriefing process included as
necessary?
INVESTIGATOR QUALIFICATIONS:
Is the primary investigator qualified to do the
research?
PROPOSAL TO FUNDING AGENCY:
If the study is funded, is this information
included?
Additional comments/suggestions/questions of reviewer:
The research is:
Approvable
Deferred
Not approvable
________________________________________
________________________
Signature
Date
4