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 egarza20@ccc.edu wblair@ccc.edu dreid-hart@ccc.edu tholmes@ccc.edu mhardy13@ccc.edu mdement@ccc.edu rmurden@ccc.edu 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 emoore20@ccc.edu kwilliamson13@ccc.edu acabrales@ccc.edu Phone Number (312) 838-7528 (312) 553-5654 (773) 602-5365 sbeamon3@ccc.edu sprayor@ccc.edu mroberts39@ccc.edu gsilva24@ccc.edu TBA (312) 850-7038 (773) 291-6210 (773) 907-4462 (773) 481-8186 (312) 553-2721