Last Revised: 10.2015
Prior Version: 7.2007
Receiving and Reviewing Subject Complaints, Concerns and
Questions
Introduction
It is the right of research subjects to provide input, complain, voice a concern, or ask a question
about a research study and to have the complaint, concern or question resolved in a timely
manner.
The CWRU IRB Office recognizes that all research subjects have the following rights:
1.
Subjects should know that taking part in a research study is always a choice.
2.
Subjects have the right to know the purpose of the research.
3.
Subjects should be told about every procedure he/she will need to follow and that he/she
can ask questions at any time during the study.
4.
Subjects should be told of any possible risks, side effects, or problems from being in the
study.
5.
Subjects should be told of any possible benefits of being in the study.
6.
Subjects should be told whether there are costs of being in the study and whether he/she
will be paid for your participation.
7.
Subjects should be told who will see information collected about/from him/her and how it
will be kept confidential.
8.
Subjects should be told about any other choices available to him/her other than being in
the study. Alternatives must be presented if they exist.
9.
Subjects should be told if medical care is available and who will pay for such care if
injuries occur to him/her as a result of the study.
10.
Subjects have the right to refuse or withdraw from a study at any time.
Policy
Complaints, concerns, or questions may be raised by research subjects (past, present and
potential), family members, designated spokespersons or anyone interested in research to the
CWRU IRB phone, in writing or in person. IRB-approved consent documents include
information for contacting the Responsible Investigator and the CWRU IRB office should the
subject have questions about the subject’s rights and responsibilities and/or to report researchrelated problems. Each CWRU Office of Research Administration webpage include the
opportunity to provide feedback, input and suggestions. CWRU also implements an Integrity
Hotline, which is managed by an external entity that allows for reporting of any complaints about
university processes.
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Last Revised: 10.2015
Prior Version: 7.2007
Procedures
1.
Responsible Investigator (RI) Responsibilities/Procedures
a.
The Principal/ Responsible Investigator will address complaints, concerns, or
questions received from subjects or others as quickly as possible.
i.
If the complaint/concern of a subject or others indicates an unanticipated
risk or a change in the risk/benefit ratio associated with the study or the
complaint/concern cannot be resolved by the Responsible Investigator, it
must be reported to the IRB as soon as the Responsible Investigator
becomes aware of the issue.
ii.
If the complaint/concern does not indicate an unanticipated risk or a
change in the risk/benefit ratio associated with the study or the
complaint/concern can be resolved by the Responsible Investigator, the
information associated with the complaint/concern will be included as part
of the continuing review submission for review by the IRB. However,
investigators are encouraged to contact and work with the IRB Office.
b.
The Responsible Investigator is responsible for ensuring the IRB-approved
consent documents contain accurate information for contacting the Responsible
Investigator should the subject have questions or research-related problems and
contact information for the HRPP should the subject have questions about the
subject’s rights as a research subject or to report research-related problems.
2.
IRB Responsibilities/Procedures
a.
The IRB Office is responsible for initial review of the complaint, concern, or
question and communicating with person with the complaint, concern, or
question. The IRB Office will obtain and document the following information, as
appropriate:
i.
The person’s name and contact information. However, if the person
wishes to remain anonymous, the person will be advised that a thorough
review may not be possible and that without this information, follow-up
with the person would not be possible. Information will not leave the
office and will be handled confidentially.
ii.
The protocol number and title, and Responsible Investigator and staff
names
iii.
The person’s relationship to the study such as past participant, present
participant, potential participant, participant family member, etc.
iv.
A detailed explanation of the complaint, concern, or question.
v.
Who the person has contacted regarding the complaint, concern, or
question such as the RI, research staff or anyone else and when such
contact was made.
vi.
A description from the person of a proposed resolution of the
complaint/concern, if the person has such a proposal
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Prior Version: 7.2007
3.
b.
The IRB Office will communicate to the person that he/she will inquire into the
circumstances associated with the complaint, concern, or question and that a
response regarding the resolution of or a determination about the complaint,
concern, or question will provided promptly. The IRB Office will also inform the
person about the limits of confidentiality in regards to the inquiry including who
may be informed, what information may be reviewed, etc.
c.
The IRB Office will review study documents and other relevant information to
begin the initial review of the complaint, concern, or question. The Manager may
also contact the Responsible Investigator, either orally or in writing, to obtain
information in association with the initial review.
d.
After performing the initial review, the IRB Office will determine whether the
complaint, concern, or question is minor and can be handled administratively or
whether the complaint, concern, or question needs to be reviewed by the IRB
Chair and/or the IRB.
i.
If the complaint, concern, or question is determined to be minor including
those that do not involve potential risk to subjects or others or cause a
change in the risk/benefit ratio associated with the study such as the
subject not receiving approved compensation for participation, the review
and response for such complaints, concerns, or questions may be done at
the administrative level by the IRB Office. The report associated with the
complaint, concern, or question and response including corrective action
will be made a part of the project file and need not be provided to the IRB
Chair for review unless deemed appropriate by the IRB Manager.
ii.
If the complaint, concern, or question is determined to involve potential
risk to subjects or others, or cause a change in the risk/benefit ratio
associated with the study, the written report will be provided to the
appropriate IRB Chair for review.
iii.
If the complaint, concern, or question is determined to be an allegation of
noncompliance, the complaint, concern, or question will be reviewed as
outlined in the Non-Compliance SOP.
IRB Chair/IRB Review Procedures
After the IRB Office has provided the report and response regarding the complaint,
concern, or question to the IRB Chair, the IRB Chair will do the following:
i.
If the IRB Chair determines that the complaint, concern, or question does
not involve potential risk to subjects or others, or cause a change in the
risk/benefit ratio associated with the study, the Chair may accept the report
and inform the IRB Office of said acceptance. Any report and acceptance
of the report will be made a part the project file.
ii.
If the IRB Chair determines that the complaint, concern, or question does
involve potential risk to subjects or others or cause a change in the
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Prior Version: 7.2007
iii.
iv.
v.
vi.
risk/benefit ratio associated with the study, the IRB Chair may determine
the complaint, concern, or question requires review by the full Committee
and the IRB Office will place the issue on the next appropriate meeting
agenda for IRB review.
If the IRB Chair determines that the complaint, concern, or question
would have an immediate effect to the health, welfare and/or rights of
subjects, the IRB Chair will instruct the IRB Office to contact the
Responsible Investigator of the study to establish procedures for the
protection of subjects pending review by the IRB.
If the complaint, concern, or question is reported to the IRB by the
Responsible Investigator, the complaint, concern, or question will be
reviewed as outlined in the Event Reporting SOP.
If the IRB determines that the complaint, concern, or question is an
unanticipated problem(s) involving risks to others; serious or continuing
noncompliance; or results in suspension or termination of IRB approval,
the determination and appropriate information must be reported to the
Institutional Official and all other pertinent agencies.
The Responsible Investigator will be informed in writing of the results of
the review of the complaint, concern, or question by IRB promptly.
References and/or Regulatory Citations:
45 CFR 46
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