Forms, Documents and Resources
- Office for the Protection of Research Subjects (OPRS)
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Document Name | Link to Document | Type | Summary |
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Adverse Event Tracking Log Template | Adverse Event Tracking Log.doc38 KB | Templates, Tools | This log should be used to track adverse events throughout the course of the study and to document the PI’s determination if the event(s) require prompt reporting to the IRB as a possible Unanticipated Problem. |
Amendment Application - Instructions and Key Points | Amendment Applications - Instructions and Key Points_0.pdf2.38 MB | Guidance | Brief overview with key points for submitting an amendment application in IRBOnline. |
Amendment Questions with Notes | Amendment Application Training.pdf434.8 KB | Guidance | This document includes a list of the questions from the Amendment Application in IRBOnline and includes commentary to assist with understanding what types of responses OPRS and IRB are requesting. |
Assent Document Template | Assent Document Template29.17 KB | Forms, Templates | An Assent document is used for children aged 7-17 or cognitively impaired adults who are unable to provide legal consent, but allows them to provide their understanding and agreement to research participation. |
Behavioral Science Self-Assessment Worksheet | Behavioral Science Self-Assessment Worksheet.docx100.71 KB | Tools | This worksheet can be used by researchers to conduct a self-audit of any social or behavioral science project. This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit. |
Carle Exempt Application Mapping Table | Exempt Application Mapping Table Carle to UIUC.pdf96.93 KB | Guidance | If UIUC faculty, staff, or students (including CI MED students) are required to submit an Exempt application to the Carle IRB, an application must also be submitted to UIUC via IRBOnline. Use this table map what responses from the Carle application can be directly input into the IRBOnline New Study Application. The table also includes other tips and recommendations to make the application process easier. |
Certificate of Translation Form | Certificate of Translation Form94.02 KB | Forms | For research conducted in languages other than English, the Illinois IRB must have all versions of the research material [e.g. consents, recruitment, instruments, etc.] in both English and non-English to be retained in the research file. |
Consent and Authorization Document Template | Consent and Authorization Document Template40.03 KB | Forms, Templates | This template includes Authorization for the use of Protected Health Information. This template should be used for research conducted with HIPAA-protected data. |
Consent Checklist | Consent Checklist.docx25.3 KB | Checklists | This checklist can be used to ensure all consent requirements are included in your consent document. The Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative should be used to document informed consent. A written copy should be given to the person signing the informed consent document. |
Consent Cover Letter Template | Consent Cover Letter Template23.8 KB | Forms, Templates | This template should be used as a consent document for simple survey or questionnaire research. This document should be used when a signature will not be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
Consent Document Template | Consent Document Template35.18 KB | Forms, Templates | This is a standard consent document template to be used for adult participants in social behavioral or biomedical research. This standard template is geared towards minimal risk research. Please review the Supplemental Consent Language document for additional consent requirements for greater than minimal risk research and other study-specific requirements. |
Create a New Project | Create a Project.pdf203.27 KB | Comments on how to create a new project. |
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Data or Biospecimen Repository Management Plan Template | Data or Biospecimen Repository Management Plan Template.docx37.56 KB | Templates | All research data and biospecimen banks/repositories managed by the University of Illinois Urbana-Champaign must have a management plan to receive IRB approval for the collection and use of the data and biospecimens for future research. Using the template below, attach your management plan to your IRB application. Attach the document under “Other Documents” in the Documents section. |
Debriefing Document Template | Debriefing Document Template.docx22.57 KB | Forms, Templates | A debriefing document is needed when a study involves deception, incomplete disclosure, or studies designed in such a way that providing complete background information will invalidate the study. The debriefing document is provided to the participant following their participation to give them full information about the study. An Alteration of Consent is required in order to use deception or incomplete disclosure in research. Submit a Waiver of Informed Consent Form as it includes the Alteration of Consent request. |
Delegation Log Template 1 | Delegation Log Template 1.docx27.57 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Delegation Log Template 2 | Delegation Log Template 2.doc54.5 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Delegation Log Template 3 | Delegation Log Template 3.docx20.13 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Department of Defense Supplement Form | Dept of Defense supplement form version D0123.docx76.02 KB | Forms | This form should be completed and submitted as part of the IRB application for any project that has involvement in any capacity from the Department of Defense. |
Deviation Log Template | Deviation Log Template.docx76.2 KB | Tools, Templates | This log should be used to track deviations from the protocol, IRB policies, or regulations. The PI’s determination can also be documented as to whether the deviation meets the IRB’s prompt reporting criteria. |
Documentation of Informed Consent Checklist 1 | Documentation of Consent Checklist 1.docx22.21 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Documentation of Informed Consent Checklist 2 | Documentation of Consent Checklist 2.docx28.69 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Documentation of Informed Consent Checklist 3 | Documentation of Consent Checklist 3.pdf301.91 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Final Project Report Form | Final Project Report Form90.69 KB | Forms | The completion or termination of a study is a change in activity and must be reported to the IRB. At the time a study is complete or discontinued, the investigator must submit a Final Project Report. |
Form for Reporting a Research Complaint or Concern | Form for Reporting a Research Complaint or Concern58.37 KB | Forms | This form can be used by participants, research staff, and others to report potential complaints or concerns about research. Individuals can choose to remain anonymous. You also have the option of being known to OPRS, but anonymous to the researcher. This form should not be used by a researcher informing OPRS about a complaint made by a research participant. In that case, the researcher should follow standard reporting guidelines by using a Report Form application. |
Health Sciences and Biomedical Self-Assessment Worksheet | Health Sciences and Biomedical Self-Assessment Worksheet.doc372.5 KB | Tools | This worksheet can be used by researchers to conduct a self-audit of any health science or biomedical research project. This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit. |
Information Sheet Template | Information Sheet Template36.31 KB | Forms, Templates | This template can be used to obtain informed consent without a signature. This template is similar to the Consent Cover Letter template, but includes more details for potentially more involved research than one simple survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
IRBOnline Tip Sheet for Transitioning Approved Projects | Tip Sheet Study Transition v12524.pdf50.7 KB | Guidance | This document provides tips for transitioning an existing, active project to the IRBOnline system. |
Note to File Template | Note to File Template.docx88 KB | Tools, Templates | This template can be used to document various events or issues that occur throughout the course of a research study. |
Old Protocol Form Mapping Table to New Study Application - IRBOnline | Protocol Form Mapping Table to New Study Application.pdf86.85 KB | Guidance | Use this mapping table for existing applications submitted on the Protocol Form version 03/02/2022 to map the responses to the New Study Application in IRBOnline. |
OPRS Audit Worksheets | Audit Worksheets.docx88.66 KB | Tools | These worksheets will be used by OPRS to conduct any audits/Post-Approval Monitoring of research projects. Not all items or all pages are applicable to every project. These worksheets are provided to assist researchers with preparation for a monitoring visit, for use in conducting their own monitoring, and for general research compliance. |
Document Name | Link to Document | Type | Summary |
---|---|---|---|
Assent Document Template | Assent Document Template29.17 KB | Forms, Templates | An Assent document is used for children aged 7-17 or cognitively impaired adults who are unable to provide legal consent, but allows them to provide their understanding and agreement to research participation. |
Certificate of Translation Form | Certificate of Translation Form94.02 KB | Forms | For research conducted in languages other than English, the Illinois IRB must have all versions of the research material [e.g. consents, recruitment, instruments, etc.] in both English and non-English to be retained in the research file. |
Consent and Authorization Document Template | Consent and Authorization Document Template40.03 KB | Forms, Templates | This template includes Authorization for the use of Protected Health Information. This template should be used for research conducted with HIPAA-protected data. |
Consent Cover Letter Template | Consent Cover Letter Template23.8 KB | Forms, Templates | This template should be used as a consent document for simple survey or questionnaire research. This document should be used when a signature will not be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
Consent Document Template | Consent Document Template35.18 KB | Forms, Templates | This is a standard consent document template to be used for adult participants in social behavioral or biomedical research. This standard template is geared towards minimal risk research. Please review the Supplemental Consent Language document for additional consent requirements for greater than minimal risk research and other study-specific requirements. |
Debriefing Document Template | Debriefing Document Template.docx22.57 KB | Forms, Templates | A debriefing document is needed when a study involves deception, incomplete disclosure, or studies designed in such a way that providing complete background information will invalidate the study. The debriefing document is provided to the participant following their participation to give them full information about the study. An Alteration of Consent is required in order to use deception or incomplete disclosure in research. Submit a Waiver of Informed Consent Form as it includes the Alteration of Consent request. |
Department of Defense Supplement Form | Dept of Defense supplement form version D0123.docx76.02 KB | Forms | This form should be completed and submitted as part of the IRB application for any project that has involvement in any capacity from the Department of Defense. |
Final Project Report Form | Final Project Report Form90.69 KB | Forms | The completion or termination of a study is a change in activity and must be reported to the IRB. At the time a study is complete or discontinued, the investigator must submit a Final Project Report. |
Form for Reporting a Research Complaint or Concern | Form for Reporting a Research Complaint or Concern58.37 KB | Forms | This form can be used by participants, research staff, and others to report potential complaints or concerns about research. Individuals can choose to remain anonymous. You also have the option of being known to OPRS, but anonymous to the researcher. This form should not be used by a researcher informing OPRS about a complaint made by a research participant. In that case, the researcher should follow standard reporting guidelines by using a Report Form application. |
Information Sheet Template | Information Sheet Template36.31 KB | Forms, Templates | This template can be used to obtain informed consent without a signature. This template is similar to the Consent Cover Letter template, but includes more details for potentially more involved research than one simple survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
Parental Permission Template | Parental Permission Template36.1 KB | Forms, Templates | The Parental Permission form is the consent document that is used when the research participant is a child and the consent is being provided by the parent/guardian. |
Participating Site Application Form | Participating Site Application Form K0123.docx54.25 KB | Forms | The Participating Site Application Form is used when UIUC will be acting as the IRB for an external site. A site might be another university, a hospital, a company, a community center, or an individual. One Participating Site Application Form should be used for each university, company, etc. that is being added to an IRB application. A Reliance Consultation is required before adding a site to an IRB application. Submit a Reliance Consultation Request if you need to schedule a consultation. |
Physician Approval of Radiation Use | Physician Approval of Radiation Use Form89.29 KB | Forms | State radiation safety regulations require that all radiation administered to humans must be “authorized by a licensed practitioner of the healing arts.” This includes research as well as medical care. |
PI Departmental Approval Form | Departmental Approval Fillable Form .pdf124 KB | Forms | The Campus Administrative Manual defines who is eligible to act as PI of a study. https://cam.illinois.edu/policies/rp-06/ As per this policy, upon approval by the applicable academic dean, institute director, or campus administrative officer, an individual in certain other positions may be permitted to act as PI. Use this form to document approval by the applicable academic dean, institute director, or campus administrative officer. Once completed and signed, attach this form in the Documents section of the study application in IRBOnline under the "Other Documents" field. The PI's name must be listed on the signed form in order for OPRS to approve the project. Additionally, a signed form must be attached to each new study application in order for an individual to be approved as PI for each study application. Additional submissions related to a previously approved study do not require a new form to be attached (i.e. an amendment application does not require a new PI Departmental Approval Form if the PI was previously approved on the new study application and a PI Departmental Approval Form was previously attached). |
Principal Investigator Departure Form | Principal Investigator Departure Form2.51 MB | Forms | This form should be submitted as soon as an investigator becomes aware they are leaving the University of Illinois at Urbana-Champaign and are engaged in human subjects research on active IRB protocols. |
Research Team Form | Research Team Form102.81 KB | Forms | List all individuals engaged in the research study who are affiliated with the University of Illinois Urbana-Champaign. |
Supplemental Consent Language | Supplemental Consent Language37.52 KB | Forms, Templates | This document contains additional consent template language that can be added to consent documents depending on specific situations. Specifically, this document includes all consent requirements for Greater than Minimal Risk research. This document also includes a Table of Contents for ease of use finding the language you need. |
Witness Signature Page | Witness Signature Page.docx19.4 KB | Forms | The witness signature page is intended to be used in unanticipated situations when a participant is able to give full consent for participation in a research study, however, a witness to the consent process is necessary. Such situations may include:
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Document Name | Link to Document | Type | Summary |
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Amendment Application - Instructions and Key Points | Amendment Applications - Instructions and Key Points_0.pdf2.38 MB | Guidance | Brief overview with key points for submitting an amendment application in IRBOnline. |
Amendment Questions with Notes | Amendment Application Training.pdf434.8 KB | Guidance | This document includes a list of the questions from the Amendment Application in IRBOnline and includes commentary to assist with understanding what types of responses OPRS and IRB are requesting. |
Carle Exempt Application Mapping Table | Exempt Application Mapping Table Carle to UIUC.pdf96.93 KB | Guidance | If UIUC faculty, staff, or students (including CI MED students) are required to submit an Exempt application to the Carle IRB, an application must also be submitted to UIUC via IRBOnline. Use this table map what responses from the Carle application can be directly input into the IRBOnline New Study Application. The table also includes other tips and recommendations to make the application process easier. |
IRBOnline Tip Sheet for Transitioning Approved Projects | Tip Sheet Study Transition v12524.pdf50.7 KB | Guidance | This document provides tips for transitioning an existing, active project to the IRBOnline system. |
Old Protocol Form Mapping Table to New Study Application - IRBOnline | Protocol Form Mapping Table to New Study Application.pdf86.85 KB | Guidance | Use this mapping table for existing applications submitted on the Protocol Form version 03/02/2022 to map the responses to the New Study Application in IRBOnline. |
RGD: Advertisements | RGD - Advertisements K1622.pdf262.53 KB | Guidance | The IRB reviews recruitment methods, including advertisements, to ensure that they do not interfere with the equitable selection of participants. The IRB reviews proposed advertisements and solicitations for research participation to ensure that they do not violate the regulatory requirements of consent. |
RGD: Assent | RGD - Assent L2922.pdf250.71 KB | Guidance | Assent means a participant's affirmative agreement to participate in research. Assent is used for children or adults with diminished decision-making capacity when the participant is unable to provide legal consent, which is provided by the parent or legally authorized representative. |
RGD: Basic Physiological Research | RGD - Basic Physiological Research K2922.pdf237.67 KB | Guidance | Research defined as “Basic Physiological Research” is considered to fall outside of the IDE regulations and is therefore not defined within FDA regulation. Although the IDE regulations do not apply to this type of research, IRB approval and informed consent should be obtained prior to initiation of the study. |
RGD: Certificates of Confidentiality | RGD - Certificates of Confidentiality PDF259.43 KB | Guidance | Certificates of Confidentiality (CoCs) are intended to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive information to anyone not connected to the research except when the subject consents, or in a few other specific situations. |
RGD: Compensation of Research Subjects | RGD - Compensation of Research Subjects B2823.pdf251.51 KB | Guidance | The IRB reviews payment arrangements to research participants (compensation) to ensure an equitable selection of subjects by only approving payment methods that are not coercive and do not present undue influence. |
RGD: Concise Summary | RGD - Concise Summary PDF222.8 KB | Guidance | The revised “common rule” (effective January 21, 2019) requires that key information be included in |
RGD: Department of Defense Research | RGD - Department of Defense Research D0723.pdf248.57 KB | Guidance | This pdf provides guidance for researchers and IRBs about special requirements for conducting and reviewing human subjects research involving any component of the Department of Defense (DoD). |
RGD: Elements of a Data Monitoring Plan | RGD - Elements of a Data Monitoring Plan L2922.pdf313.14 KB | Guidance | Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adhere to the approved investigative plan and the validity of data collected (White 2007). |
RGD: Elements of a Safety Monitoring Plan | RGD - Elements of a Safety Monitoring Plan L2922.pdf265.63 KB | Guidance | Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White |
RGD: Exempt Research | RGD - Exempt Research version A0923.pdf332.6 KB | Guidance | Exempt studies are minimal risk and fit within a set of established exemption categories. Exemption determinations are made by the IRB and may not be made by the individual investigator. |
RGD: Exercise Testing in Research | RGD - Exercise Testing in Research K2922.pdf222.12 KB | Guidance | When exercise testing is used as part of a research study, investigators must provide the IRB with information regarding the safety plan. |
RGD: Expedited Review of Research | RGD - Expedited Review of Research PDF189.14 KB | Guidance | Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. |
RGD: Gender Inclusive Language in Research | RGD - Gender Inclusive Language in Research K2922.pdf238.74 KB | Guidance | When researchers ask questions about sex, gender identity, and/or sexual orientation, there must be an understanding of what is being asked and what information is sought. |
RGD: HIPAA Privacy Rule & Authorization | RGD - HIPAA Privacy Rule Authorization PDF344.57 KB | Guidance | To protect patient privacy, “covered entities” (all health plans, health care “clearinghouses,” and health care providers) must obtain specific, written authorization from a patient to use or disclose PHI. Patients must also be notified about their right to restrict the use and disclosure of such information. |
RGD: IND Exemption Criteria | RGD - IND Exemption Criteria K2922.pdf227.64 KB | Guidance | This checklist will assist investigators in determining if an IND is needed from the FDA in order to conduct a clinical trial using a drug or biologic. The IRB may determine that an IND is not necessary based on the criteria below. However, the IRB may also require that the investigator request and exemption from the FDA, which requires the submission of an IND application. |
RGD: Letters of Support | RGD - Letters of Support A2423.pdf205.71 KB | Guidance | This guidance pertains to when the IRB requests letter of support from an authorized individual at proposed research site(s) as part of the review process. A letter of support indicates to the IRB that individuals who may be impacted by, or who have an interest in, the research are generally supportive of the project. |
RGD: Multimedia Recordings | RGD - Multimedia Recordings K2922.pdf244.87 KB | Guidance | Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive. |
RGD: New Study Application Annotated | IRBOnline Annotated New Study Application.pdf408.34 KB | Guidance | This document provides comments and suggestions to assist with completion of the New Study Application Form from the IRBOnline system. Notes and suggestions are provided as both "answers" to the application questions as well as "Comments" in the .pdf document. Please be sure you allow the viewing of comments in your PDF viewer. Also, please note that IRBOnline utilizes a smart form system so that only applicable sections are required based upon how previous questions are answered. However, for this guidance document all questions are included, these are not all of the questions a regular application would require. |
RGD: Payments To Research Personnel | RGD - Payments To Research Personnel pdf174.54 KB | Guidance | The IRB does not allow the use of finder’s fees or bonus payments made specifically to individuals, such as investigators and study staff, who are conducting the research. Exceptions must be reviewed by the IRB in order to determine that the use of such methods does not create coercion or undue influence. |
RGD: Privacy and Confidentiality | RGD - Privacy and Confidentiality D0823.pdf236.97 KB | Guidance | This guidance provides information about IRB considerations for privacy and confidentiality in research. |
RGD: Recruitment and Enrollment of Employees | RGD - Recruitment Enrollment Employees version L1322.pdf246.15 KB | Guidance | Employees may be exposed to a greater risk of invasion of privacy than other research participants who have no association with the sponsoring institution. |
RGD: Recruitment Methods | RGD - Recruitment Methods D1223.pdf251.35 KB | Guidance | The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent. |
RGD: Research Conducted in Post-Secondary Schools | RGD - Research Conducted in Post Secondary Schools B1324.pdf263.73 KB | Guidance | Students attending an institution of higher learning are not directly mentioned in the federal regulations as a vulnerable population. However, the University of Illinois Urbana-Champaign IRB considers students of the research institution to be a vulnerable population because students may be vulnerable to coercion or undue influence. |
RGD: Research Design | RGD - Research Design K2922.pdf263.66 KB | Guidance | It is the obligation of the IRB to consider the study design and overall quality of a study in order to effectively evaluate the risk-benefit ratio. If the IRB cannot determine that the risk-benefit ratio of a study is acceptable, it cannot approve the protocol under applicable ethical codes and regulations. |
RGD: Research Involving Children | RGD - Research Involving Children D0723.pdf270.11 KB | Guidance | The IRB must consider the general criteria for IRB approval for all studies, including those that involve children. Federal regulations require additional safeguards when approving research involving children. |
Document Name | Link to Document | Type | Summary |
---|---|---|---|
Adverse Event Tracking Log Template | Adverse Event Tracking Log.doc38 KB | Templates, Tools | This log should be used to track adverse events throughout the course of the study and to document the PI’s determination if the event(s) require prompt reporting to the IRB as a possible Unanticipated Problem. |
Assent Document Template | Assent Document Template29.17 KB | Forms, Templates | An Assent document is used for children aged 7-17 or cognitively impaired adults who are unable to provide legal consent, but allows them to provide their understanding and agreement to research participation. |
Consent and Authorization Document Template | Consent and Authorization Document Template40.03 KB | Forms, Templates | This template includes Authorization for the use of Protected Health Information. This template should be used for research conducted with HIPAA-protected data. |
Consent Cover Letter Template | Consent Cover Letter Template23.8 KB | Forms, Templates | This template should be used as a consent document for simple survey or questionnaire research. This document should be used when a signature will not be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
Consent Document Template | Consent Document Template35.18 KB | Forms, Templates | This is a standard consent document template to be used for adult participants in social behavioral or biomedical research. This standard template is geared towards minimal risk research. Please review the Supplemental Consent Language document for additional consent requirements for greater than minimal risk research and other study-specific requirements. |
Data or Biospecimen Repository Management Plan Template | Data or Biospecimen Repository Management Plan Template.docx37.56 KB | Templates | All research data and biospecimen banks/repositories managed by the University of Illinois Urbana-Champaign must have a management plan to receive IRB approval for the collection and use of the data and biospecimens for future research. Using the template below, attach your management plan to your IRB application. Attach the document under “Other Documents” in the Documents section. |
Debriefing Document Template | Debriefing Document Template.docx22.57 KB | Forms, Templates | A debriefing document is needed when a study involves deception, incomplete disclosure, or studies designed in such a way that providing complete background information will invalidate the study. The debriefing document is provided to the participant following their participation to give them full information about the study. An Alteration of Consent is required in order to use deception or incomplete disclosure in research. Submit a Waiver of Informed Consent Form as it includes the Alteration of Consent request. |
Delegation Log Template 1 | Delegation Log Template 1.docx27.57 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Delegation Log Template 2 | Delegation Log Template 2.doc54.5 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Delegation Log Template 3 | Delegation Log Template 3.docx20.13 KB | Tools, Templates | One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available. |
Deviation Log Template | Deviation Log Template.docx76.2 KB | Tools, Templates | This log should be used to track deviations from the protocol, IRB policies, or regulations. The PI’s determination can also be documented as to whether the deviation meets the IRB’s prompt reporting criteria. |
Documentation of Informed Consent Checklist 1 | Documentation of Consent Checklist 1.docx22.21 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Documentation of Informed Consent Checklist 2 | Documentation of Consent Checklist 2.docx28.69 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Documentation of Informed Consent Checklist 3 | Documentation of Consent Checklist 3.pdf301.91 KB | Templates, Tools | This is a sample template that can be used to document the informed consent process. |
Information Sheet Template | Information Sheet Template36.31 KB | Forms, Templates | This template can be used to obtain informed consent without a signature. This template is similar to the Consent Cover Letter template, but includes more details for potentially more involved research than one simple survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form. |
Note to File Template | Note to File Template.docx88 KB | Tools, Templates | This template can be used to document various events or issues that occur throughout the course of a research study. |
Parental Permission Template | Parental Permission Template36.1 KB | Forms, Templates | The Parental Permission form is the consent document that is used when the research participant is a child and the consent is being provided by the parent/guardian. |
Sample Blood Draw Log | Sample Blood Draw Log.xlsx12.16 KB | Tools, Templates | This log can be used to document blood draw attempts. In some cases the IRB may require this log to be completed and submitted as part of the data or safety monitoring plan. |
Screening Enrollment Withdrawal Log Template | Screening Enrollment Withdrawal Log Template.docx83.57 KB | Tools, Templates | This log should be used to document participant screening/eligibility, enrollment, and withdrawal from the research study. |
Supplemental Consent Language | Supplemental Consent Language37.52 KB | Forms, Templates | This document contains additional consent template language that can be added to consent documents depending on specific situations. Specifically, this document includes all consent requirements for Greater than Minimal Risk research. This document also includes a Table of Contents for ease of use finding the language you need. |
Telephone Contact Form Template | Telephone Contact Form Template.docx75.08 KB | Tools, Templates | This log can be used to document planned or unplanned contact with research participants. |
Training Log Template | Training Log Template.docx76.44 KB | Tools, Templates | This log should be used to document study-specific trainings of the research team (e.g. training on study protocol). |
Document Name | Link to Document | Type | Summary |
---|---|---|---|
Consent Checklist | Consent Checklist.docx25.3 KB | Checklists | This checklist can be used to ensure all consent requirements are included in your consent document. The Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative should be used to document informed consent. A written copy should be given to the person signing the informed consent document. |