IRB Submission Procedures

Introduction

The Institutional Review Board (IRB) is responsible for helping ensure that activities involving human participants are conducted ethically and in accordance with applicable federal regulations and institutional requirements. The IRB review process is designed to protect the rights, safety, privacy, and welfare of individuals who participate in research. Not every project involving people or information about people constitutes human subjects research requiring IRB approval. Activities such as certain program evaluations, quality improvement initiatives, literature reviews, or projects using fully de-identified information may fall outside the definition of human subjects research. However, investigators should not make the final determination themselves when there is uncertainty. Projects should be submitted for the appropriate institutional determination before the activity begins.

This document is intended to help investigators consider the characteristics of their project and anticipate the type of review that may be required. The checklist progresses through four possible pathways ( An IRB Checklist is available to help with determination ):

1. Administrative Review – IRB Chair Review
   (e.g., non-human subjects research, class projects, etc.)
2. Exempt Research – IRB Chair Review
3. Expedited Research – IRB Chair or IRB Committee Member Review
4. Full Board Research – Review by the IRB Committee

The final determination regarding whether an activity constitutes human subjects research and the appropriate level of IRB review is made by the IRB or its authorized designee.

SVSU-Affiliated Research

Individuals who are affiliated with Saginaw Valley State University (SVSU) and are conducting research as an SVSU faculty member, staff member, student, or other institutional representative must submit the research to the SVSU Institutional Review Board (IRB) for review or determination, when applicable, regardless of where the research activities or data collection occur.

Approval or review by another institution's IRB does not, by itself, eliminate the investigator's responsibility to submit the project to the SVSU IRB. Likewise, research that does not involve collecting data at SVSU may still require submission if an SVSU-affiliated investigator is engaged in the research.

Types of IRB Applications

The IRB provides two application pathways depending on the purpose and intended use of the activity involving human participants.

General IRB Application.

The General IRB Application should be used for research involving human participants that is designed to develop or contribute to generalizable knowledge. This includes faculty, staff, student, thesis, dissertation, and other research projects in which the findings may be analyzed, presented, published, disseminated, or otherwise shared beyond the immediate educational or classroom setting.

The General IRB Application should be used when research activities involve the systematic collection or analysis of information from or about human participants for purposes that extend beyond teaching and learning. This may include, but is not limited to, surveys, interviews, focus groups, observations, interventions, behavioral or social science research, analysis of identifiable or coded private information, and research involving existing datasets or records.

SVSU-affiliated investigators are responsible for submitting applicable research to the SVSU IRB regardless of where the research is conducted or where data are collected. The requirement to submit applies even when data are collected at another institution, through a community or external organization, online, or through an existing dataset. Approval or review by another institution's IRB does not, by itself, eliminate the requirement for an SVSU-affiliated investigator to submit the project to the SVSU IRB.

When another institution or organization serves as the reviewing IRB, the investigator should identify the external IRB in the SVSU submission and provide documentation of the external IRB's approval or determination, as applicable. The SVSU IRB will determine whether additional SVSU review, reliance documentation, or other institutional requirements apply.

The General IRB Application should be submitted before recruitment of human participants, collection of research data, or other research activities begin, unless the SVSU IRB has provided other specific direction.

Projects submitted through the General IRB Application will be reviewed by the SVSU IRB and may be determined to qualify for Exempt, Expedited, or Full Board review , as applicable. Investigators should not independently determine that a project is exempt or does not require IRB review when there is uncertainty; the appropriate determination should be made through the SVSU IRB process.

If the purpose, activities, or dissemination plans of a project change after an initial determination or approval, the investigator is responsible for contacting the SVSU IRB to determine whether an amendment, new application, or additional review is required.

Classroom Project Application

The Classroom Project Application is intended for course-based activities involving human participants that are conducted primarily for teaching and learning purposes.

These activities provide students with opportunities to learn or practice research-related skills, such as developing research questions, collecting information, administering surveys or interviews, analyzing data, or applying research methods. The activity is completed as part of a course, and there is no intent at the time the project is conducted to contribute to generalizable knowledge or to disseminate the findings outside the classroom or course-related setting.

Classroom projects may involve human participants; however, their primary purpose is educational rather than research intended for broader dissemination.

Group or Class Submissions 

When multiple students in a course are conducting similar or related classroom projects using a common research purpose, methodology, protocol, survey, interview process, or other standardized activity, the Classroom Project Application may be submitted as a single group or class application . The instructor may submit one application describing the overall classroom activity and the procedures students will follow. Individual students do not need to submit separate applications when their projects fall within the scope of the approved classroom application.

If an individual student project substantially differs from the approved classroom activity or involves additional participants, procedures, data collection methods, or research activities that are not covered by the group submission, the SVSU IRB may require an amendment or separate application.

If there is an intention to present, publish, disseminate, or otherwise use the findings beyond the educational purpose of the course, the project should be submitted through the General IRB Application before data collection begins.

When there is uncertainty about whether a classroom activity qualifies for a Classroom Project Application, investigators and instructors should contact the SVSU IRB before beginning the activity.

What Should Be Submitted to the IRB?

Investigators should submit sufficient information for the IRB in the application to understand what will be done, who will be involved, what information will be collected, and what risks or protections may apply.

Depending on the application (General or Class Project), a complete submission must include the required IRB application found in IRBNet within the Forms and Templates Section or on the SVSU IRB Website . The which includes:

• Submission information (name of PI, type of submission, etc.)
• A clear description of the purpose of the project.
• The research questions, aims, or objectives.
• A description of all study procedures.
• A description of the data that will be collected:

1. 1. Information regarding whether identifiable or sensitive information will be collected.
   2. Procedures for maintaining privacy and confidentiality.
   3. Data storage, security, access, retention, and destruction procedures.

• A description of the population and eligibility criteria.
• The proposed number of participants and determination of how to select number of participants.
• Any additional materials necessary for the IRB to understand the proposed activity and assess participant protections.
• Recruitment procedures and all recruitment materials.
• Information regarding compensation or incentives, when applicable.
• Documentation of permission or cooperation from outside organizations or research sites, when applicable.
• Information regarding funding or sponsorship, when applicable.
• Surveys, questionnaires, interview guides, focus group questions, assessments, or other data collection instruments.
• Informed consent, information sheets, parent permission, or assent documents, when applicable.

Investigators should submit the materials that participants will see, hear, receive, or complete. For example, if participants will receive an email invitation, view a recruitment flyer, complete an online survey, and review an electronic consent statement, each of those materials should be included with the submission.

Why Is This Information Required?

The purpose of the submission is not simply to assign a project to a review category. The information allows the IRB to evaluate the project as a whole and determine whether appropriate protections are in place for participants. In making its determination, the IRB considers several fundamental questions:

1. Does the activity involve human subjects?

   Projects involving interaction or intervention with individuals or the use of identifiable private information may meet the definition of human subjects research. In contrast, activities involving no interaction or intervention, no identifiable private information, fully de-identified data, or certain internal program evaluation or quality improvement activities may not constitute human subjects research.

2. Is the activity research?

   A project may involve people but still not constitute research for IRB purposes. An important consideration is whether the activity is a systematic investigation designed to develop or contribute to generalizable knowledge. For example, an internal evaluation intended solely to improve a local program may differ from a project designed to produce findings that extend beyond the immediate program or setting.

3. What level of risk is involved?

   If the project is human subjects research, the IRB must determine the appropriate review pathway. Anonymous surveys, public behavior observation, publicly available information, de-identified existing data, and certain normal educational practices may qualify for an exempt determination when no higher-risk elements are present.

   Minimal-risk research involving activities such as certain noninvasive procedures, audio or voice recordings, moderate exercise involving healthy adults, existing identifiable records or specimens, or behavioral research without significant stress or manipulation may be eligible for expedited review when no Full Board criteria are present.

   Research involving greater than minimal risk or other higher-risk considerations generally requires review by the Full Board. Examples include research involving potential psychological harm, sensitive topics or identifiable sensitive information, vulnerable populations, deception, non-standard clinical interventions, certain biological specimen collection, or circumstances in which an external sponsor requires Full Board review.

When should an IRB Submission Be Made?

IRB review and approval or determination must occur before research activities involving human participants begin. Make sure you provide sufficient time to get the application through the process. Investigators should not begin…

• Recruiting participants
• Obtaining consent
• Enrolling participants
• Conducting surveys, interviews, focus groups, or assessments
• Performing research interventions or procedures
• Collecting research data
• Accessing identifiable private information or records for research purposes

…until the required IRB determination or approval has been received.

Submission of an application does not constitute IRB approval. Investigators must wait until they receive written notification of the IRB's determination or approval before beginning the activities covered by the submission.

Initiating research activities involving human participants prior to receiving IRB approval constitutes noncompliance with institutional IRB requirements and applicable human-subjects research protections.

IRB approval must be obtained before initiating any research activities involving human participants. The IRB cannot provide retroactive approval for research that has already been conducted. This applies to classroom projects that do not meet the regulatory definition of research.

Logging Into IRBNet

Before preparing the application, investigators must create an account in IRBNet. Follow the steps below:

1. Go to IRBNet
2. In the top right corner you will see Login information. If you already have an account, even if with another institution, you should be able to log in. Once you log in you can link your account with your previous institution, or any other institution that you have worked with in the past. If you forgot your username and/or password, you can click on the ‘forgot your password’ link.
3. If you do not have an IRBNet account, click on New User Registration .
4. Once you are registered or have found your username and password, log into into IRBNet.
5. Once you are logged in, choose the ‘forms and templates’ tab on the left navigation menu. From the dropdown menu, you would select the documents for ‘researchers.’
6. These documents are numbered and should be reviewed in order of numbers from review of this document. These include things like clarification for informed consent, templates and application forms. More discussion about the informed consent documents to follow later in this document. In addition to the forms, there are how-to videos from IRBNet if you would like to view them prior to submission. Lastly there is information on training & credentials.

Determining the Appropriate Application and Level of Review

While the final determination regarding the appropriate level of IRB review rests with the IRB Chair, the information below is provided to help investigators identify the appropriate application and understand the level of review their project may require. Certain research activities may require Full Board review, which involves a longer review timeline. Investigators are encouraged to review these criteria carefully and allow sufficient time for IRB review and approval before beginning any research activities involving human participants.

1. Determine Whether the Activity May Be Not Human Subjects Research.

Begin by considering whether the project involves interaction or intervention with individuals or identifiable private information. Projects involving no interaction or intervention, no identifiable private information, fully de-identified data with no codes or links, certain internal program evaluation or quality improvement activities, or literature reviews/meta-analyses may fall outside human subjects research. These projects should be submitted for administrative review and confirmation when appropriate.

2. Consider Whether the Research May Qualify as Exempt.

If the project is human subjects research, determine whether it appears to fit an exempt category. Examples may include anonymous surveys or interviews, public behavior observation, publicly available information, de-identified existing data, or certain normal educational practices.

3. Exempt does not mean that the investigator may simply proceed without review.

Research believed to qualify for an exemption should be submitted so that the IRB Chair or authorized reviewer can make the exempt determination. Exempt research may also require an appropriate informed consent process depending on the nature of the study.

4. Consider Whether the Research May Qualify for Expedited Review.

Research that presents no more than minimal risk but does not qualify for an exempt determination may be eligible for expedited review. The checklist identifies examples such as certain noninvasive procedures, audio or voice recordings, moderate exercise involving healthy adults, existing records or specimens that may contain identifiers, and behavioral research without significant stress or manipulation. Expedited research is reviewed by the IRB Chair or an IRB Committee member, rather than automatically requiring consideration by the convened Full Board.

5. Full Board Review.

Research involving greater than minimal risk or other higher-risk circumstances should be submitted for Full Board review. Potential Full Board considerations include greater-than-minimal risk; psychological stress, discomfort, or harm; sensitive topics; identifiable sensitive information; risks to employability, reputation, or legal standing; certain vulnerable populations; deception or incomplete informed consent; non-standard clinical procedures; certain blood or biological specimen collection; or an external sponsor requirement for Full Board review. The Full Board review process allows the entire IRB Committee to evaluate the proposed research, its risks and anticipated benefits, and the safeguards provided for participants.

This information is intended to assist investigators in preparing the appropriate IRB submission; however, it does not replace formal IRB review or determination.

Investigators may indicate the review category they believe applies to their project. However, the IRB makes the final determination regarding whether an activity constitutes human subjects research and, when applicable, whether the project qualifies for administration, exempt, expedited, or Full Board review.

If you are uncertain whether your project requires IRB review, which application should be used, or which level of review may apply, please contact the IRB Chair for guidance before beginning the project or collecting data.

Studies requiring review by the convened Full Board may require additional time for review and processing. The time required will depend on the nature and complexity of the research, the completeness of the submission, and the timing and availability of a convened IRB meeting.

Researchers should anticipate that Full Board review may take approximately 1–2 months from the time a complete application is received, particularly when a convened meeting is required. Additional time may be necessary if the IRB requests modifications, clarification, or additional information before or following the meeting. The review timeline may therefore extend beyond the initial 1–2-month estimate when substantive revisions are required or when a revised application must be returned to the IRB for further consideration.

Steps for Submitting an Initial IRB Proposal

1. Register with IRBNet

• Create an IRBNet Account: Go to IRBNet and create a user account if you do not already have one.
• Affiliate with SVSU: Be sure to affiliate your IRBNet account with Saginaw Valley State University.

2. Complete Required Collaborative Institutional Training Initiative (CITI Program) Training and Obtain a Valid Certificate

• Complete Required Training: The Principal Investigator and all members of the research team who will be engaged in human subjects research must complete the required CITI Human Subjects Research training. More information regarding this training can be found on the SVSU IRB Website.
• Verify Training Is Current: CITI training must be current and valid at the time of the IRB submission.
• Obtain Your Certificate: Download the CITI completion certificate documenting successful completion of the required training.
• Include Certificates with the Submission: A valid CITI training certificate must be uploaded in IRBNet for the Principal Investigator and each research team member, as applicable.

Note: An IRB application may be considered incomplete if required CITI training certificates are missing or expired.

3. Prepare Required Documents

Gather and prepare all materials relevant to your project before beginning the submission process. Depending on the study, these may include:

• Appropriate IRB application
• Research proposal or protocol
• Informed consent document(s)
• Recruitment materials, including emails, flyers, advertisements, or social media posts
• Surveys, questionnaires, interview guides, or focus group questions
• Data collection instruments
• Letters of cooperation, site permission, and/or IRB approvals from other locations, when applicable
• Valid CITI training certificates for all required research team members
• Any other materials that participants will see or receive

All documents should be prepared as separate files and clearly labeled before beginning your IRBNet submission.

4. Create a New Project

• Log in to IRBNet: After logging in, select Create New Project from the menu on the left side of the screen.
• Enter Project Information: Complete the required project information. Fields marked with a red asterisk are required. Review the information for accuracy and select Continue.

5. Upload Your Documents in the Designer

• Access the Designer: After creating the project, you will be directed to the Designer page.
• Upload Documents: Select Add New Document and upload each required document separately. Use clear and descriptive file names, such as:
  • IRB Application
  • Research Protocol
  • Informed Consent
  • Recruitment Email
  • Recruitment Flyer
  • Participant Survey
  • Interview Questions
  • CITI Training Certificate – [Investigator Name]
• Use Current IRB Templates: Required forms, informed consent templates, and guidance documents should be obtained from the IRBNet document library. Investigators should use the most current version of all required institutional forms and templates.

Important: Investigators are required to use the approved institutional informed consent template when developing consent materials, including when requesting a waiver of documentation of informed consent, as applicable. Additional information regarding informed consent requirements and waivers is provided later in this document.

6. Share the Project

• Share Access: Select Share This Project from the menu on the left side of the screen.
• Add Research Team Members and Advisors: Share the project with all appropriate co-investigators, student researchers, faculty advisors, and others who are required to review or sign the submission.
• Confirm Appropriate Access: Ensure that individuals have the appropriate level of access needed to review, edit, or sign the project package.

7. Sign and Submit the Package

• Review the Complete Submission: Before signing, confirm that the application is complete and that all required supporting documents and valid CITI training certificates have been uploaded.
• Electronically Sign the Package: Select Sign This Package from the left menu. The Principal Investigator and any other individuals required by institutional policy, such as student investigators or faculty advisors, must provide their electronic signatures.
• Submit for IRB Review: After all required signatures have been obtained, submit the completed package through IRBNet for IRB review.

Please note: Creating a project, uploading documents, signing a package, or submitting an application does not constitute IRB approval. Research activities involving human participants may not begin until the investigator has received formal IRB approval or an official determination from the IRB, as applicable.

Submitting a Subsequent Package for an Existing IRB Project

Once a project has been submitted and reviewed through IRBNet, subsequent submissions related to that project should be submitted as a new package within the existing IRBNet project . Investigators should not create a new IRBNet project when submitting modifications or other changes to an existing study.

Using a subsequent package maintains the complete history of the project in one record and allows the IRB to track modifications, documents, approvals, and other changes over the life of the study.

1. Determine Whether a Subsequent Package Is Needed

A subsequent package should be created when submitting changes or additional information related to an existing IRB project. Examples may include:

• Modifications or amendments to the approved research protocol
• Changes to study procedures or methodology
• Addition or removal of investigators or research team members
• Changes to recruitment methods or materials
• Revised informed consent documents
• Changes to surveys, interview questions, questionnaires, or other study instruments
• Addition or removal of study sites
• Changes to the participant population or recruitment criteria
• Changes to the number of participants
• Changes to data collection, storage, security, or management procedures
• Responses to IRB requests requiring a subsequent submission
• Other changes to the previously approved project

2. Open the Existing Project in IRBNet

• Log in to IRBNet and locate the existing project under My Projects .
• Open the project associated with the currently approved study.
• Do not create a new project for a modification to an existing study.

Maintaining submissions under the same IRBNet project allows the IRB to preserve the complete review and approval history of the study.

3. Create a New/Subsequent Package

Within the existing project, create a new package for the proposed modification or other subsequent submission. IRBNet assigns packages sequentially within the project (for example, Package 1, Package 2, Package 3). Each package becomes part of the project's permanent history and allows investigators and the IRB to distinguish the original submission from later modifications and other submissions.

4. Clearly Describe the Proposed Changes

Provide a clear description of what is being changed and why the change is being requested .

The modification should identify:

• What was previously approved
• What is being changed
• The reason for the change
• Whether the change affects participants, recruitment, consent, study procedures, risks, benefits, confidentiality, or data management

The description should provide enough information for the IRB to readily identify and evaluate the proposed changes.

5. Upload Revised and Supporting Documents

Upload all documents affected by the proposed modification into the new package.

Examples may include:

• Modification/amendment form
• Revised research protocol
• Revised informed consent document
• Revised recruitment materials
• Revised surveys, questionnaires, interview guides, or other instruments
• Updated research team information
• Valid CITI training certificates for newly added research team members
• Updated site permission or letters of cooperation, when applicable
• Other documentation supporting the requested change

Clearly label revised documents so the IRB can readily identify them. When possible, investigators should clearly identify or highlight changes within revised documents. This assists the IRB in comparing the proposed materials with those previously approved and facilitates timely review.

6. Share, Sign, and Submit the Subsequent Package

As with the initial submission:

• Share the package with appropriate research team members, faculty advisors, or other required individuals.
• Obtain all required electronic signatures.
• Review the package to ensure that all required documents have been included.
• Submit the subsequent package through IRBNet for IRB review.

Creating or signing a subsequent package does not constitute IRB approval.

7. Wait for IRB Approval Before Implementing Changes

Proposed modifications may not be implemented until IRB approval has been received, unless a change is necessary to eliminate an immediate hazard to participants.

Investigators should continue to conduct the study according to the currently approved protocol while a modification is under review. Once the modification has been approved, investigators should conduct the research according to the newly approved protocol and documents.

Why Subsequent Packages Are Important

Submitting modifications and other changes as subsequent packages within the same IRBNet project creates a clear and continuous record of the study. This allows the IRB to track:

• The originally approved research
• Each modification or amendment
• What documents were changed
• When changes were submitted and approved
• The progression of the research over time
• The complete regulatory history of the project

Important: A subsequent package is used to modify or update the existing approved project. It should not be used to add a separate or substantively new study under existing IRB approval simply because the new study is related to the investigator's previous research. When the proposed activity represents a new study or substantially different research questions, population, methodology, or protocol, investigators should consult the IRB Chair to determine whether a new IRB application and project are required.

Anticipated IRB Review Timelines

The IRB strives to review submissions as efficiently as possible while ensuring appropriate protection for human participants. The timelines below are anticipated review periods for complete initial submissions and estimates should be considered rather than guaranteed turnaround times.

Important Considerations Regarding Review Timelines

The anticipated timelines above generally begin once a complete submission has been received. Incomplete applications, missing documents, expired or missing CITI training certificates, or other required information may delay the review process.

The IRB Chair generally conducts the initial review of projects that may qualify for Exempt or Expedited review, unless a conflict of interest or other circumstance requires assignment to another qualified IRB reviewer. Additional reviewers may also be consulted when the nature or complexity of the proposed research requires additional expertise.

Full Board submissions require review by the convened IRB. Therefore, the review timeline will depend upon the availability and scheduling of the Board, the complexity of the proposed research, and whether additional information or revisions are required before the Board can decide.

The IRB will make every effort to complete initial reviews within the anticipated timeframes; however, delays may occur based on reviewer availability, the complexity of the research, the need for additional expertise, the volume of submissions, academic calendar considerations, or the need for clarification or additional information from the investigator.

Revisions and Modifications May Extend the Timeline

These anticipated timelines apply to the initial review of a complete submission . If the IRB requests clarification, additional documentation, or modifications, the overall approval timeline will be extended. The length of the additional review period will depend upon:

• How quickly the investigator responds to the IRB's requested changes;
• The nature and extent of the revisions;
• Whether additional IRB review is necessary; and
• For Full Board studies, whether the revisions require consideration at a subsequent convened meeting.

Investigators should plan accordingly and submit applications well in advance of the anticipated start date for the research.

Research involving human participants may not begin until the investigator has received the required IRB approval or formal determination. An anticipated review timeline should not be considered an approval date, and investigators should not schedule participant recruitment or data collection based solely on these estimates .

Informed Consent Requirements

Informed consent is an important component of protecting individuals who participate in research. In general, informed consent must be obtained when research involves interaction or intervention with individuals or the collection, access, or use of identifiable private information or identifiable biospecimens, unless the IRB approves a waiver or alteration of informed consent.

Use the Appropriate SVSU Consent Template

Investigators are required to use the applicable SVSU informed consent template available in the IRBNet library. The templates are designed to include the appropriate elements of informed consent, parental permission, or child assent and to promote consistency across research studies.

Depending on the study population and how consent will be obtained, one or more of the following templates may be required:

Participant Informed Consent Template

Use the Participant Informed Consent Template when an adult participant will be asked to provide informed consent for their own participation in the research.

Participants should be provided with sufficient information about the study, including its purpose, procedures, potential risks and benefits, confidentiality protections, voluntary nature of participation, and whom to contact with questions or concerns.

When written documentation of consent is required, the participant signs the consent form before participating in research activities.

Parent/Guardian Permission Template

Use the Parent/Guardian Permission Template when research involves children and permission from a parent or legally authorized guardian is required.

Parental permission does not necessarily replace the child's involvement in the consent process. Depending upon the child's age, maturity, and ability to understand the research, child assent may also be required.

Child Assent Template

Use the Child Assent Template when children participating in the research are capable of understanding, at an age-appropriate level, what participation involves.

The assent process should explain the research in language appropriate to the child's age, maturity, and level of understanding and provide the child with an opportunity to agree to participate.

When applicable, research involving children may therefore require both parent/guardian permission and child assent.

The IRB will determine whether assent is required and whether the proposed assent process and documentation are appropriate for the population being studied.

Waiver of Signed Consent Template

Use the Waiver of Signed Consent Template when requesting permission not to obtain a participant's signature documenting informed consent.

A waiver of signed consent does not mean that informed consent is waived. Participants must still receive the information necessary to make an informed decision about participation and must agree to participate. Only the requirement to obtain a signature or other documentation of consent is being waived.

For example, an anonymous online survey may provide participants with consent information before the survey begins and ask them to indicate their agreement to participate or proceed to the survey without providing a written signature.

Investigators requesting a waiver of signed consent must provide the required justification, and the IRB must approve the waiver before it may be used .

Waiver or Alteration of Informed Consent

A waiver or alteration of informed consent is different from a waiver of signed consent. In this situation, the investigator is requesting that the IRB waive or alter some or all of the informed consent requirements.

Such requests are approved only when the applicable regulatory criteria are satisfied. Investigators must provide justification within the IRB application, and the IRB makes the final determination regarding whether a waiver or alteration may be granted.

Important Points for Investigators

• Use the current SVSU template(s) available in the IRBNet library rather than creating consent or assent documents from scratch.
• Select the template(s) appropriate for the study population and consent process.
• Research involving adults will generally use the Participant Informed Consent Template.
• Research involving children may require both the Parent/Guardian Permission Template and the Child Assent Template, as appropriate.
• Use the Waiver of Signed Consent Template when requesting to obtain consent without collecting a participant's signature.
• Modify templates only as appropriate for the study and according to the instructions provided within the template.
• Submit all applicable consent, parental permission, assent, and waiver documents with the IRB application.
• Investigators may request a waiver or alteration, but the IRB makes the final determination regarding whether the applicable criteria have been met.
• Changes to previously approved consent, permission, or assent materials must be submitted as a modification through a subsequent IRBNet package and approved before the revised materials are used.

A Simple Way to Remember

• Adult Participant → Participant Informed Consent Template
• Child Participant → Parent/Guardian Permission + Child Assent, when applicable
• Consent Obtained but No Signature → Waiver of Signed Consent Template
• Some or All of the Consent Process Waived or Altered → Specific IRB approval is required

Additional Information

For additional information regarding informed consent, parental permission, child assent, waivers, and applicable regulatory requirements, refer to the SVSU Informed Consent Guidance available in the IRBNet library. Or contact the IRB Chair, Marcia Ditmyer, mditmyer@svsu.edu and/or 989-964-4508.