CCC IRB FORM 121 – Informed Consent Guidelines and Template

advertisement
Informed Consent
Guidelines & Sample
Template
(CCC IRB Form 121)
Informed Consent for Participants in Research Projects Involving Human Subjects
Researchers whose projects involve human subjects (as determined by the Institutional Review Board) must obtain a
signed informed consent form from all participants in the study. A template of an informed consent form, which the
researcher(s) can modify at their discretion, is on the second page. The following outlines the elements required for
obtaining informed consent.
Elements of Informed Consent
1. Purpose of this research project
2. Description of methodology and duration of participant involvement
3. Statement informing participant of all risks and benefits involved inherent in their participation
4. Statement of anonymity and data confidentiality
5. Statement regarding compensation for participation (if applicable)
6. Statement regarding the right of the participant to withdraw from the study at any time without negative
consequences
7. An offer to answer any questions or concerns the participant may have
8. Statement that participant is 18 years of age or older
9. Contact information to report alleged research misconduct:
a.
For student subjects/participants: Dean of Students at respective college
b.
For faculty and staff subject/participants: Human Resources Administrator at the college level. At the
District Office, the Research Integrity Officer
10. Signature of the participant
11. Date
Note: To use the sample template on page 2, read through the document and insert the relevant text. Read and
remove text in blue and red before giving the form to participants.
Informed Consent
Sample Template
(CCC IRB Form 121)
Title of Project: _____________________________________________________________________
Investigator(s): ____________________________________
Name
____________________________________
Name
_____________________________
E-mail / Phone number
_____________________________
E-mail / Phone number
1. Purpose of this Research Project
Subjects should be informed in clear, concise language about the nature of the study and the purpose for conducting the
research, including whether results may be used for publication, dissertation, etc. The total number of subjects involved
and a brief description of the subject pool (age range, health status, etc.) should also be provided.
The investigator(s) are conducting a study to determine (insert text here). In this study, you will be asked to (insert text
here). Your participation should take (insert text here) minutes.
2. Description of Methodology and Duration of Participant Involvement
At the end of this section, the participant must have a clear understanding of what will be expected of them. Use of an
itemized list is sometimes useful for this section.
Should you agree to participate, you will be asked to (insert text here on participant’s role; the tasks, activities or
functions they will be expected to perform; the number of times they are expected to appear; over what period of time;
etc.).
The research will take place (insert text here). The instrumentation that will be used (insert text here). The conditions
involved (insert text here).
3. Statement of Risks and/or Benefits
Risks
Risks to the subject from the research must be reasonable in relation to expected benefits to subjects, and/or the
importance of the knowledge that may be reasonably expected to result. Researchers must demonstrate sound research
design that evidences a balance between minimizing harms and maximizing any benefits that might accrue to study
participants.
a) Description of any known and anticipated risks to participants for the following categories:
1. Physical
2. Emotional
3. Legal
4. Social
5. Fiscal/Professional
b) Safeguards and plan to reduce or address risks
c) Description of benefits and/or compensation that subjects can expect (both direct or indirect)
d) Description of any larger societal benefits or gains in knowledge that may result from the study
The following include any risks or discomfort you may experience as a result of your participation in this study: (insert
text here).
Benefits
The tangible or intangible benefits, if any, to the subjects who participate must be described. If no benefits accrue to the
subjects, what are the larger societal benefits for conducting the research? An analysis of the risks to benefits must
clearly be on the benefits side.
The following include any benefits you may incur as a result of your participation in this study: (insert text here).
And/Or
Your participation in this study will benefit larger society in the following way (insert text here).
Include the following statement –
No promise or guarantee of benefits has been made to encourage you to participate.
4. Statement of anonymity and data confidentiality
Explain to subjects whether the data you collect from them will include information that identifies them (e.g., name, email address), or whether the data will be collected anonymously. If identifiers will be included, explain how data will be
used and stored in a confidential manner (for example, data coded; identifiable information stored separately, and
securely from coded data).
Describe who will have access to identifiable and/or de-identified data (e.g., collaborating Colleges/Universities, study
sponsor). You may state, "At no time will the researchers release identifiable results of the study to anyone other than
individuals working on the project without your written consent".
The data collected from you will include information that identifies you (e.g., name, e-mail address).
OR
The data collected from you will be anonymous.
Insert following statements:
In order to maintain anonymity and confidentiality, I/we have taken the following precautions: (insert text here).
(Insert text here) will have access to data collected in this study and will also follow precautions to maintain anonymity
and confidentiality.
Also, insert the following statement –
The City Colleges of Chicago (CCC) Institutional Review Board (IRB) may view the study’s data for auditing purposes. The
IRB is responsible for the oversight of the protection of human subjects involved in research.
Note: in some situations, it may be necessary for an investigator to break confidentiality. If a researcher has reason to
suspect that a person poses a threat of harm to others or him/herself, the researcher is required by Illinois State law to
notify the appropriate authorities. If applicable to this study, the conditions under which the investigator must break
confidentiality must be described.
5. Compensation
There is no requirement that subjects must be compensated for their participation in the study.
As a result of your participation in this study, you will be compensated with (insert text here). It will be paid to you
(insert when and where they will be paid) in (cash, gift card, raffle, check, etc.).
Note: if using a raffle system, the anticipated odds of winning must be provided.
OR
You will not be compensated for your participation in this study.
Leave the following sections as written. Do not alter.
6. Freedom to Withdraw
It is important for you to know that you are free to withdraw from this study at any time without penalty. You are free
not to answer any questions that you choose or respond to what is being asked of you without penalty.
Please note that there may be circumstances under which the investigator may determine that a subject should not
continue as a subject.
Should you withdraw or otherwise discontinue participation, you will be compensated for the portion of the project
completed in accordance with the Compensation section of this document (where applicable).
7. Questions/Concerns
Should you have any questions about this study, you may contact one of the research investigators whose contact
information is included at the beginning of this document.
Should you have any questions or concerns about the study’s conduct or your rights as a research subject, or need to
report a research-related injury or event, you may contact (Insert name and contact information of appropriate CCC
administrator as described above).
8. Subject’s Consent
I am 18 years of age or older and have read the Consent Form and conditions of this project. I understand the study
described above and have had all my questions answered. I hereby acknowledge the above and give my voluntary
consent:
_______________________________________________
Subject signature
_______________________________________________
Subject printed name
CCC IRB Form 121 (12-17-2013)
Date__________
CCC IRB Contact
Information for
Research Subjects
Deans of Student Services
(For Student Research Subjects)
Should you have any questions or concerns about the study’s conduct or your rights as a student research
subject/participant, to report alleged research misconduct, or to report a research-related injury or event, please
contact the following Dean of Student Services at your respective college.
College
Daley College
Harold Washington College
Kennedy-King College
Malcolm X College
Olive-Harvey College
Truman College
Wright College
Name
Eduardo Garza
Wendell Blair
De’Reese Reid-Hart
Tasha Williams
Mia Hardy
Marilyn Dement
Romell Murden
Email Address
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
Phone Number
(773) 838-7583
(312) 553-5662
(773) 602-5081
(312) 850-7120
(773) 291-6491
(773) 907-4755
(773) 481-8450
Human Resources Managers & District Office Contacts
(For Faculty and Staff Research Subjects)
Should you have any questions or concerns about the study’s conduct or your rights as a faculty/staff research
subject/participant, to report alleged research misconduct, or to report a research-related injury or event,
please contact the following Human Resources Manager at your respective college. If you are at the District
Office, the contact person is the Institutional Research Integrity Officer.
College
Daley College
Harold Washington College
Kennedy-King College
Malcolm X College
Olive-Harvey College
Truman College
Wright College
District Office – Office of the
Provost
Name
Elinore Moore
Kimberly Williamson
Araceli CabralesMedina
Stanley Beamon
Sharon Prayor
Michael Roberts
Griselda Silva
Institutional Research
Integrity Officer
Email Address
[email protected]
[email protected]
[email protected]
Phone Number
(312) 838-7528
(312) 553-5654
(773) 602-5365
[email protected]
[email protected]
[email protected]
[email protected]
TBA
(312) 850-7038
(773) 291-6210
(773) 907-4462
(773) 481-8186
(312) 553-2721
Download