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List of Form Descriptions
OPRS Going Green: instructions for printing double sided documents.
OPRS accepts and encourages double-sided printing of certain materials.Here are the requirements:
- Each set of documents must begin on a new page. For example, Page 1 of Appendix B cannot begin on the reverse side of the last page of Appendix U.
- Documents that cannot be double-sided:
- Original consent forms
- Authorizations
- Recruitment materials, and
- Any document that requires an IRB Approval Stamp
- Also, the number of copies has been reduced:
- Expedited Review: one original and one copy
- Convened Review: one original and 20 copies
| Form | Description |
| 1571 Investigational New Drug Application | Submit this form to the Food and Drug Administration to request authorization to administer an investigational drug to humans. |
| 1572- Statement of Investigator | This form must be completed and submitted to the sponsor before an investigator can participate in research involving the investigational new drug. The sponsor will incorporate this information into the Investigational New Drug Application which is then submitted to the FDA. |
| Five days after the administration of an investigational agent under emergency use conditions, FDA regulations require the submission of a follow-up report to the IRB. Complete this application to fulfill this requirement. | |
| Amendments | If you are making changes to your research (i.e. changes to the protocol, procedures, informed consent form, HIPAA Authorization form, recruitment materials, adding research personnel, etc.) then you must submit the Amendment to Previously Approved Research Form for IRB review and approval before your changes may be implemented. |
| Appendix A1 - use of Drugs or Biologic Products in Researc | If you plan to use drugs or biologic products in your research then you must submit this appendix. |
| Appendix A2 - Use of Medical Devices | If you plan to use a medical device in your research then you must submit this appendix. |
| Appendix B - Involving Children as Subjects in Research | If children will be included as a subject group in your research, submit this appendix since additional regulations must be met in order to adequately protect this vulnerable subject group. |
| Appendix C - Involving Prisoners as Subjects in Research | To include prisoners as a subject group in your research this appendix must be submitted to the IRB in order to ensure compliance with the additional regulations that have been established to adequately protect this vulnerable subject population. |
| Appendix D - Databases, DNA,Tissues,Sample,Banks |
Submit this appendix if you will be storing or banking data, tissue or other samples for your current research protocol or for future research. |
| Appendix E - Drug Study Registration Form | Submit one form for each FDA approved and investigational drug that will be used in your research since these drugs must be registered with the Investigational Drug Service. |
| Appendix F - Unit,Departmental Review Committee | If you have been chosen to be a part of the Department Review Committee for a research protocol then you must submit this form after reviewing the investigator’s protocol. You may request revisions until you have determined that the research has merit and the procedures adequately safeguard the subject’ rights and welfare. |
| Appendix G - Clinical Research Center (CRC) | If you wish to use resources from the Clinical Research Center then you must submit this form which will be reviewed by the CRC Scientific Advisory Committee (SAC) for scientific merit and resource utilization. |
| Appendix H - HIPAA Compliance Application | Submit this form if you intend to use, access, or disclose protected health information as part of your research. |
| Appendix I - Use of International Performance Sites for Human Subject Research | This form must be completed and submitted in order to include international performance sites for human subjects research outside of the USA. |
| Appendix J - Debriefing for Research Involving the Use of Deception | Submit this form if your research involves deception but keep in mind that once the research has been completed, the subject must be notified of the purpose of the research, the reason for the deception and the subject must be given the opportunity to withdraw their data from the research. |
| Appendix K - Performance Sites | If you plan to conduct human subjects research at a site outside of UIC but within the USA then you must submit this form and identify and describe the roles and responsibilities of each additional performance site that will engage in research with UIC. |
| Appendix L1 - Institutional Review Board (IRB), Independent Ethics Committee (IEC) Authorization Agreement | If you will be conducting research with another institution/entity and wish to establish UIC as the IRB of record for your research protocol then you must submit this form. Appendix L1 is an agreement between UIC and the non-UIC site where the non-UIC site will rely on the UIC IRB for review, approval and oversight of the research protocol. |
| Appendix L2 - Individual Investigator | This appendix should be submitted for an individual non-UIC investigator as opposed to a non-UIC site. Appendix L2 is similar to Appendix L1 in that the individual investigator agrees to rely on the UIC IRB for review, approval and oversight of the research protocol but the non-UIC investigator must also agree to abide by all the policies and regulations set forth by the UIC IRB, the Belmont Report and the Department of Health and Human Services. |
| Appendix N - Research Involving Investigational Devices | If you are an investigator and the Sponsor for a clinical trial involving an investigational device, you must submit this appendix acknowledging that you understand and agree to adhere to the FDA-mandated responsibilities of a Sponsor-Investigator. |
| Appendix O - Research Involving Investigational Drugs | If you are an investigator and the Sponsor for a clinical trial involving an investigational drug or biologic, you must submit this appendix acknowledging that you understand and agree to adhere to the FDA-mandated responsibilities of a Sponsor-Investigator. |
| Appendix P - Additional Co-Investigators, Key Research Personnel | List all members of the research team that are involved in this project on Appendix P and submit it to OPRS. |
| Appendix S - Use of School Classroom as a Performance Site for Human Subject Research | Submit this form if your human subjects research will include the use of a school classroom as a performance site. |
| Appendix U - Pregnant Women, Fetuses, and Neonates as Subjects in Research | If pregnant women, fetuses, or neonates will be a subject group in your research this appendix must be submitted to the IRB in order to ensure compliance with the additional regulations that have been established to adequately protect these vulnerable subject populations. |
| Appendix V - Research Involving Investigational Devices | If decisionally-impaired individuals will be included in your research, submit this appendix to provide the additional information needed by the IRB to ensure the appropriate inclusion and the adequate protection of this vulnerable subject group. |
| Appendix Z - Additional Funding Sources for Human Subjects Research | If you have new or multiple additional funding sources then you must submit this form which will provide details regarding the additional funding source not listed on the Initial Review Application for either the biomedical sciences or the social and behavioral sciences. |
| Assent to Participate in Research | This form includes template language that should be included when creating an assent form that will be used to obtain assent from subjects that are children between the ages of 7 and 17 years olds. Submit this form for IRB review and approval. |
| Authorization to Use and Disclose Health Information - English | For UIC entities: If you intend to use or disclose any protected health information such as that found in medical records then customize the HIPAA Authorization template for your protocol and submit it to the IRB for review and approval as this form will require the subject’s signature in order to access his/her information. |
| Authorization to Use and Disclose Health Information - Spanish | For UIC entities: If you will be enrolling Spanish-speaking subjects and intend to use or disclose any protected health information such as that found in medical records then customize the HIPAA Authorization – Spanish template for your protocol and submit it to the IRB for review and approval as this form will require the subject’s signature in order to access his/her information. |
| Authorization to Use and Disclose Psychotherapy Notes | For UIC entities: Use this template if you will be asking for subjects’ permission to access their psychotherapy notes which are maintained separate from the medical record and are recorded by a mental health professional that is documenting or analyzing a conversation during private counseling sessions or group/joint/family counseling sessions. |
| Behavioral Research | This form includes template language provided by OPRS which is a great tool for guidance on how to write an Informed Consent Form for behavioral sciences research. |
| Biomedical Consent for minimal-risk research with HIPAA elements | Use this template to create a combined informed consent and HIPAA Authorization form. |
| Biomedical Research - English | This form includes template language provided by OPRS which is a great tool for guidance on how to write an Informed Consent Form for biomedical research. |
| Biomedical Research - Spanish | If you will be enrolling Spanish-speaking subjects, follow this consent template for biomedical research. |
| Claim of Exemption | Submit this form if your research will involve human subjects, data or tissues but the research is exempt from the federal regulations under 45 CFR 46 and continuing IRB oversight. |
| Continuing Review | Submit this form if you wish to keep your research protocol open in order to enroll subjects, complete subject follow-up or data analysis or if you are awaiting approval of any publications based on this research. |
| Departmental CE Attendance List | For use by a department presenting an educational program for OPRS Human Subjects Protection Continuing Education credit. |
| Departmental CE Request | Submit this form if you are a department seeking approval from OPRS for an educational program or presentation in order to meet the OPRS Human Subjects Protection Continuing Education requirement. |
| Designate RiSCWeb Access for Active Protocols to Research Personnel | This form will allow you to list key research personnel that you wish to have access to protocol information and all OPRS/IRB correspondence for your protocol on RiSCWeb, OPRS’ web-based protocol support tool. |
| Determination of Whether an Activity Represents Human Subjects Research | As the principal investigator, if you are not sure if your research meets the definition of human subjects research then you may submit this form to receive a human subjects research determination from OPRS. |
| Development, Center,Training Grant Application | If your application for a grant, cooperative agreement or other application and plans are not specified for human subjects research as part of the aims of the application then you must complete and submit this form. This will include core or center grants, training grants and development only applications. |
| Event Requiring Prompt Reporting to the Institutional Review Board | Submit this form to OPRS if an adverse event or unanticipated problem that meets the criteria of an Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO) has occurred since these incidents may impact the rights, safety or welfare of the subjects or others involved in the research. Please read the instructions for more detailed information. |
| External Data Use Agreement | If you wish to allow an entity outside of UIC to use a limited data set, you must complete this form and submit it to OPRS. |
| Final Research Report | If your research has been completed or terminated, please submit the final report and remember to include any appropriate documents such as reports from the FDA or sponsors that were not previously submitted especially those regarding notification of study closure and/or publications to date that have resulted from the research. |
| HIPAA drop-in language for consent | This document contains drop-in language that should be used when creating the combined informed consent and HIPAA Authorization form. |
| HIPAA drop-in language for consent - Spanish | This document contains drop-in language that should be used when creating the Spanish version of the combined informed consent and HIPAA Authorization form. |
| Independent Physician Certification: Emergency Use Of A Test Article Without Informed Consent | |
| Individual CE Request | If you have attended an educational program or presentation and would like to receive Human Subjects Protection Continuing Education credits then submit this form for OPRS approval. |
| Initial Review Application Health and Biological Sciences | If your research is not exempt from the federal regulations and continuing IRB oversight then you must complete this initial review application if your research falls under the health and biological sciences category. |
| Initial Review Application Social and Behavioral Sciences | If your research is not exempt from the federal regulations and continuing IRB oversight then you must complete this initial review application if your research falls under the social and behavioral sciences category. |
| Internal Data Use Agreement | As a UIC investigator, if you wish to use a limited data set from a department within UIC then you must complete this form and submit it to OPRS. |
| Notification of Emergency Use of a Test Article | If you intend to administer an investigational drugs, agents, biologics, or medical devices in an emergent situation (insufficient time to obtain IRB approval) to treat a life threatening or severely debilitating condition, submit this application to obtain acknowledgement of the intended use. |
| Protocol Exception | If you need to request a temporary protocol change or alteration that is prospectively approved by your sponsor or funding agency and by the IRB prior to its initiation in the research then submit this form. |
| Research Directory Listing | This form is to request that your currently approved research protocol be added to the Research Directory on the OPRS Research Participant Website. |
Short form for persons who do not read English |
If you anticipate approaching non-English speaking individuals as potential subjects and will not be translating the informed consent document into another language then you can use the short form and oral presentation method as a way to consent individuals that do not speak English. Keep in mind that if a target population is non-English speaking then a formal consent form must be translated into the target population’s language. |
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