U9D1 -68 - PLEASE FOLLOW ALL INSTRUCTIONS AS OUTLINED BELOW.....& SEE ATTACHMENTS.....Ethical Issues in Qualitative Research

IRB A-Z Handbook A Comprehensive Guide to the IRB Process

Version 3.1 effective February 2016

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TABLE OF CONTENTS

Table of Contents .................................................................................................... 3 INTRODUCTION TO THE IRB A TO Z HANDBOOK ..................................................... 5 Part I: Prepare for IRB Review ................................................................................ 6 Developing a Human Research Protection Plan ....................................................... 8 Documenting the Plan in Your IRB Submission Materials ................................................. 8

Determining Submission Requirements ................................................................... 9 Selecting the IRB Application ....................................................................................... 9 Determining Supporting Documentation ........................................................................ 9 Selecting the Informed Consent or Assent Form Templates ........................................... 10 Identifying Instrument Requirement(s) ....................................................................... 11

Instrument Permissions ......................................................................... 11 Recruitment Materials ............................................................................................... 12 Obtaining Research Site Permissions .......................................................................... 12

Contracts or Data Usage Agreements ..................................................... 13 What if I can’t get permission before IRB review? .................................... 13

Completing The Application ................................................................................ 15 Registering and Activating an Account ........................................................................ 15 Starting an application .............................................................................................. 16 .............................................................................................................................. 16 Drafting the Recruitment Material(s) ........................................................................... 16 Drafting the Informed Consent or Assent Form(s) ........................................................ 16 Assessing and Revising Submission Materials ............................................................... 17

Assessing IRB Submission Materials ....................................................... 17 Revising IRB Submission Materials ......................................................... 17

Part ii: IRB SUBMISSION AND REVIEW .............................................................. 18 Submit IRB Application ......................................................................................... 18 Completing IRB Office Screening Process .................................................................... 19

IRB REview ........................................................................................................... 20 Introduction to the Levels of Review ........................................................................... 20

Exempt Review ....................................................................................... 20 Expedited Review ................................................................................... 20 Full Review ............................................................................................ 20

Receiving the IRB Decision Letter ............................................................................... 21 IRB Decisions .......................................................................................................... 21 Revising Your Study in Response to IRB Decision ......................................................... 22

Deferred ................................................................................................ 22 Approved with Conditions ........................................................................ 22

Obtaining IRB Approval or Exemption ......................................................................... 23 Reviewing the IRB Approval Letter ............................................................................. 23

Part iii: POST-IRB APPROVAL PROCEDURES .......................................................... 24 Ensuring Ongoing Compliance .................................................................................... 24

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Requesting Modifications to IRB-approved Studies ............................................... 25 Submitting a Modification Request Package ................................................................. 25 Implementing the Modification ................................................................................... 25

Undergoing Continuing Review ............................................................................. 26 Submitting a Continuing Review Package .................................................................... 26 Obtaining Continuing IRB Approval ............................................................................. 26

Reporting Adverse Events or Unanticipated Problems ........................................... 27 Reporting Noncompliance .......................................................................................... 27

Closing Your Study ................................................................................................ 28 Notifying the IRB of Study Closure ............................................................................. 28

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INTRODUCTION TO THE IRB A TO Z HANDBOOK The Institutional Review Board (IRB) reviews research that involves human participants in order to ensure that it is conducted ethically and that the rights of participants are protected.

The IRB process is intended to ensure that researchers comply with federal, state, and international regulations as well as ethical principles and responsible practices. The IRB supports research by partnering with the researcher to promote research integrity, while also working to maintain public trust in research. Nevertheless, the IRB process, like many processes that are subject to regulatory oversight, may sometimes appear bureaucratic and even daunting.

The goal of the IRB A to Z Handbook is to support you in navigating this challenging, yet critically important process. Consider this handbook your step-by-step guide to navigating the IRB process from point A to point Z.

This handbook covers the following topics:

• Preparing for IRB review

• Submitting your IRB application and supporting materials

• Understanding the IRB review process

• Making revisions to your materials as required by the IRB

• Ensuring continuing compliance with regulations and policy

• Closing your study upon completion

All of the flow charts are interactive, as is the Table of Contents. There are also several links included in this handbook which will take you to additional resources in iGuide that help researchers design, review, conduct, and share research. By following this handbook, reviewing additional recommended resources in iGuide, and paying careful attention to detail, you will be well positioned for success in the IRB process.

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PART I: PREPARE FOR IRB REVIEW Careful preparation for IRB review will ensure your success in the process. Understanding and having clear expectations of the IRB process will position you for success. You should also pay careful attention to details in how you will protect participants as part of your study and in your IRB application.

This section is intended to take you step by step through the process of preparing for IRB review. Here is a highlight of topics to be covered in this section:

• Developing a Human Research Protection Plan

• As part of your research design process, you should begin to develop a plan for how you will protect the rights of your participants and the confidentiality of their data and records.

• In preparing for IRB review, you will need to identify which application, and supporting documents will be required for IRB submission.

• Completing IRB Materials

• Careful attention to detail in preparing your IRB application and supporting documents ensures your success in the process.

• Assessing and Revising IRB Materials

The IRB process is an iterative one that often requires multiple revisions to ensure the quality and accuracy of the submission materials.

We encourage you to start from the beginning and spend time reviewing each section to ensure you are well prepared to submit a package to the IRB.

Remember that you have to obtain IRB approval prior to recruiting participants and collecting any data.

Develop Human Research Protection

Plan

Determine IRB Submission

Requirements

Complete IRB Application Forms and Supporting Documents

Assess & Revise IRB Materials

Submit IRB Application IRB Screening Undergo IRB Review Obtain IRB Approval

Follow Post-IRB Approval Procedures:

Amendments and Continuing Review

Submit Study Closures

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Develop Human Research

Protection Plan

Determine IRB Submission

Requirements

Complete IRB Application Forms

and Supporting Documents

Assess & Revise IRB Materials

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DEVELOPING A HUMAN RESEARCH PROTECTION PLAN Before you begin the IRB process, it is important to know what the IRB is looking for when it reviews a study. The IRB conducts ethical reviews of research studies to ensure that human participants are protected. The IRB focuses on

• Protecting the privacy of participants and confidentiality of their data or records

• Respecting the autonomy and dignity of participants

• Ensuring that decisions concerning participation are voluntary

• Minimizing risks while maximizing benefits to participants

• Ensuring participants have adequate information to make informed decisions

• Ensuring that the benefits and risks of research are equally distributed

• Protecting vulnerable populations

Specifically, the IRB reviews the study to ensure that it adheres to regulatory criteria for ethical research with human participants.

Documenting the Plan in Your IRB Submission Materials Researchers attentive to ethical concerns and participant protections as they design their studies will find the IRB process goes quicker and requires fewer revisions. More often, however, researchers who begin work on their IRB submission materials realize that some details of the plan still need to be fine-tuned and that more attention is needed to the logistics or “nuts and bolts” of their research process.

IRB review requires that researchers provide specific and concrete details concerning their process from start to finish. For example, it is not enough for a researcher to indicate that “teachers will be recruited to participate in the study.” The IRB requires detailed information such as how many teachers will be recruited, how their contact information will be obtained, how they will be approached including the specific scripts or written documents to be used, and how their voluntary consent will be obtained. While the desire to progress quickly through the milestones is understandable, it often leads to researchers rushing their IRB application. Though it may take a bit longer to complete the IRB application, the more attention to detail in the application, the lower the likelihood of multiple revisions necessary.

Note that should you have questions or concerns during the development of your study procedures, you can consult with the IRB. You may schedule an appointment with the IRB to discuss concerns over your study design.

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DETERMINING SUBMISSION REQUIREMENTS Once you know more about what your research will entail and what kind of Human Research Protection Plan will need to be in place, you must determine which IRB Application you will need to submit and be prepared to provide supporting documentation pertaining to your research.

This section will help you identify the documents that you will need for submission.

Before you can complete the IRB Application, ensure that you’ve registered with IRBManager in order to access the forms.

Selecting the IRB Application As you prepare for IRB submission, you will need to determine which IRB application to complete. It is critical that you select the right application as you begin your IRB process as selecting the incorrect applications will result in delays in obtaining IRB approval.

University’s IRB has several different IRB Applications, but most researchers will complete the IRB Application or the Records Based Research Application as the others are program specific:

• IRB Application: If your study involves collecting data from people, you will need to complete the general IRB application. If your study involves collecting data from people as well as analyzing records, you need to complete the IRB Application. You will be asked questions about records during the application.

• Records Based Research Application: If you are only going to analyze records that exist at the time of IRB submission, you must complete an IRB Records-Based Research application. Note that this does not apply to records that will be created during the study.

• DNP IRB Application: All DNP learners must complete and submit this application.

• PsyD Screening Form: Learners in the Doctor of Psychology use this form to determine which IRB application or form is necessary. Only PsyD learners are to use this form.

• EdD Capstone Screening Form: Learners in the Doctorate of Education program who are completing a Capstone project (as opposed to a dissertation) must complete this form. Only EdD Capstone learners are to use this form.

The IRBs forms can be found in IRBManager in the left hand menu (you will need to be logged in to access and complete the form as it is a web based form).

Determining Supporting Documentation Documents required of all researchers:

• Copy of your school approved Research Plan, Scientific Merit Review Form, or Proposal depending on your program.

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Research involving collecting data from people will require you to submit the following to the IRB:

• Informed Consent Forms (including minor assent, parental permission forms)

• Recruitment Materials

• Data collection tools (instruments)

You may be required to submit the following depending on the nature of your research:

• Instrument Permissions

• Site Permission Forms

• Permission to use private data

Selecting the Informed Consent or Assent Form Templates If your research study involves human participants, you must have a process in place to ensure that they receive adequate information about your study in order to make an informed decision as to whether to participate. This process must be designed so that participants are able to decide without undue influence. Even the use of participant records containing identifiers typically requires a process to ensure that individuals have an opportunity to choose who has access to private information and how it will be used. Informed consent is the process of obtaining consent and is document via the informed consent form. These processes are referred to as “informed consent” for adults or “assent” for children/minors.

The informed consent form is used to convey the required information to potential participants and is generally documented through a signature on this form. University’s IRB requires all researchers to use informed consent/assent form templates. The templates have been designed to assist you in providing the appropriate information to participants in accordance with the requirements of the federal regulations for informed consent.

It is important to remember that you may not obtain informed consent from any participants until you have received IRB approval for your research study.

The consent template that you need to provide to the IRB will be determined by the nature of your research and how consent will be obtained. Be certain to consult the Informed Consent Form Directions for instructions on how to complete the forms. The university provides the following templates located on iGuide:

• Adult Informed Consent Template: If your research involves interactions with adult participants and your informed consent procedures include obtaining signed informed consent, this template should be used.

• Adult Informed Consent Template for Internet Survey Use: If your research involves an online survey or questionnaire and your informed consent procedures do not include obtaining hand-signed informed consent, you should use this template.

• Adult Informed Consent Template—Waiver of Documentation of Consent: Sometimes a research study can qualify for a waiver of documentation of

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consent. In such cases, the researcher will still inform participants about the study and obtain their consent to participate, but the consent will not be documented via a signed form. Requests for a waiver must meet the criteria described in the federal regulations. Only the IRB can make the final determination regarding the appropriateness of a waiver.

• Parental Permission Form: If your research study involves children or minors, parental permission (and child assent) is most likely required. You should consult the local and state laws where the research will take place for any unique requirements.

• Minor Assent:

• Child Assent Templates (7-11) and Minor Assent Template (ages 12-17) are based on the ages of the potential participants. If your study design includes both, you must use both templates.

• It is important that you check the local and state laws where the research will take place for any specific definitions regarding children, legal representatives, and any other requirements.

• Children under the age of 7 are generally thought to be too young to document their assent. If your study includes children under 7, you should use verbal and nonverbal clues to indicate consent and not the assent form document.

Identifying Instrument Requirement(s) If your research involves collecting data from people, you will need to submit a copy of all of the data collection tools to the IRB (often these are collectively referred to as instruments at University). An instrument may include, but is not limited to, an inventory or scale, survey, interview guide, and/or observation protocol.

Instrument Permissions

If you are using a instrument that currently exists and/or modifying an existing instrument, you are required to obtain written permission from the owner of that instrument. Note the following pertaining to instrument permissions:

• If you are modifying the instrument, the permission letter must specifically state that you may modify the instrument.

• If you are purchasing the instrument for use in your study, the purchase agreement serves as the permissions letter

• If the instrument is in the public domain, you must submit proof to the IRB of the public domain status

• Written permission is required for IRB Approval. Due to copyright laws, researchers may not use instruments without written permission (unless in the public domain, which is rare) and is not waived under any circumstances. If the creator of the instrument is deceased, ownership then transfers to the estate.

• Note that instruments may not be reprinted in the dissertation unless you also have written authorization from the instrument owner (owners may be the creator of the instrument, published, or company). Permission must be specifically obtained to modify the instrument.

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• Instrument permissions may be submitted in the form of an email, though researchers should create a pdf of the email or provide screenshots of the approval email as outlook files will not open appropriately for the IRB.

Recruitment Materials Failing to provide copies of the draft recruitment materials is the leading cause of delays in the IRB process. Researchers are required to submit drafts of all recruitment materials you intend to use in your study. For example, if you’ll recruit in person as well as post flyers you must include both the verbal recruitment script as well as the flyer.

Examples of types of recruitment materials include:

• Verbal recruitment scripts

• Email recruitment messages or letters sent via mail.

• Internet recruitment postings

• Flyers

Note that if you are using SurveyMonkey’s Audience Feature or a similar service, the IRB is aware that they use their own recruitment materials and you do not need to provide these.

Obtaining Research Site Permissions Site Permission is likely necessary for the following:

• Using an organization’s directory for recruitment

• Having an organization send recruitment notices on your behalf

• Posting flyers in private spaces

• Posting recruitment notices online in non-publicly accessible spaces (closed LinkedIn groups, closed Facebook groups, websites not owned by the researcher)

• Placing messages in newsletters.

• Collecting data from employees, volunteers of an organization if that organization will be used for recruitment or if the topic of the research collects information regarding non-public policies and practices of the organization.

• Analyzing non-public data

You must have site permission before final IRB approval. You should seek permission from all of your research sites before you submit to the IRB, but if site permissions are still outstanding when you reach the IRB milestone, you may submit the IRB Application without site permissions.

If the site requires approval from University’s IRB prior to providing site permission, you may submit your application and indicate that conditional approval is needed.

As you prepare to request permission, do a little research about the site by seeking information online or connecting with a contact person at the site. Determine if site has

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a formal or informal process for seeking permission to conduct research and whether the site has an IRB of its own.

Anticipate how long it will take to get permission from all of your research sites. Their timelines could affect your IRB application process. It may take just a few weeks to obtain all of the permissions you need. However, sometimes it can take much longer, potentially even several months.

When you request a permission letter, ask the research site to provide a letter that is

• Written on the institution or organization’s official letterhead

• Signed by appropriate official within the organization that has the authority to grant permission.

• Dated within 6 months of IRB submission.

• Provides specific information as to what you have permission to do at or with the research site

We recommend that you draft a letter to be used by the site. The site can make changes to your letter as needed. Consult the site permission letter template on iGuide for guidance. Note that this template is meant to provide you with suggested language not to be an editable document.

Contracts or Data Usage Agreements

If the research site or owner of the data requires that University or your mentor signs an agreement for you to conduct the research, you must submit a copy of that document in advance to the IRB for review. Note that neither mentors nor learners are not authorized signatories at University and may not sign on behalf of the institution. The IRB will review the document to ensure there are no provisions that may endanger the rights of participants. The IRB will co-ordinate the legal review of the document and obtain the necessary signature. It is advised that researchers provide copies of these documents as soon as possible to the IRB as in very rare instances the University is unable to sign agreements due to conditions within the contract.

What if I can’t get permission before IRB review?

Sometimes a research site will ask for IRB approval before granting permission. However, as you recall, IRB asks for the research site permission before granting approval. If you run into this situation, don’t panic. Simply indicate this in your IRB application and submit for review.

Once your study is under IRB review at and the IRB determines it meets the criteria for IRB approval, you’ll receive conditional approval. Then:

• Go back to the research site(s) with documentation of conditional approval, obtain a letter of site permission(s), and submit the permission letter(s) to IRB.

• Once you have submitted the permission letter, IRB Office staff will determine whether you have met the conditions for approval.

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• Once full IRB approval is granted, you will be able to start your research activities.

Sometimes the research site will require additional revisions to the research study before granting permission. If this happens, you will need to submit those revisions to IRB for review and approval.

Permission is not always required, and figuring out who can give permission is not always easy. If you need assistance, contact the IRB Office.

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COMPLETING THE APPLICATION Once you’ve developed your Human Research Protection Plan and identified what documents are needed for your IRB submission, you are ready to complete your IRB materials.

You will likely need to revise these documents several times to ensure that they are accurate, complete, and clear. Always double-check each form and document just prior to submission to make sure that all of the documents in your package are in alignment and that the information you have provided is consistent from document to document.

In order to demonstrate to the IRB that your plan for protecting human participants is adequate, your forms must be intelligible to the reviewer (a person who may not have expertise in your specific area of research) and must demonstrate that your study meets the regulatory criteria for approval. The reviewer will look for evidence that your decisions are based on thoughtful attention to responsible and ethical practices and a clear assessment of risk, and that you have adequate rationale for your recruitment strategies, informed consent processes, study procedures, data management plans, and so on.

Before you start completing your IRB application and supplemental forms, here are some general tips to enhance your success:

• Complete a few sections at a time. Do not try to complete the entire application in one sitting, as it will be hard to maintain adequate focus and attention to detail.

• Read each question carefully and reflect on your response before answering. Consult your Human Research Protection Plan.

• Write your response as if you are addressing a member of the general public who is well educated but does not have expertise in your field. Avoid jargon; strive for clarity and comprehensibility.

• If you run out of space, consider ways to be more concise. Space is limited on the application. It is not recommended that you cut and paste from your Research Plan/Scientific Merit Review form. If you still need more space, use the Additional Information Question and Documents at the end of the application to provide that information.

• Check with your mentor and search iGuide if you don’t know how to answer a question. If both you and your mentor are confused contact the IRB Office.

Registering and Activating an Account In order to submit your IRB materials via IRBManager, you will first need to register and activate an account. Here are some general tips when registering:

• Use your preferred email account. You will receive notifications and decision letters via email. It is vital that you use an email account that you check.

• Make sure that your mentor also has an account

• Register only once

• Instructions on how to register

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Starting an application After you have registered for IRBManager, it’s time to beginning your IRB application. IRBManager uses xForms (these are web based form). Therefore you must be logged into IRBManager in order to complete your IRB application.

From the left hand actions menu, choose the appropriate application. Refer to the previous chapter about choosing the correct IRB Application.

When you complete this form

• Read the help text on the right to the questions for assistance completing the application.

• Answer each question on each screen.

• IRBManager will autosave your form as you move from screen to screen. Yet, if you need to stop working on your application click ‘save for later’ at the bottom of the application prior to closing your browser to ensure you’ve saved your work.

Drafting the Recruitment Material(s) Learn more about best practices in recruitment on iGuide and how to create recruitment flyers, advertisements, or letters.

Remember to be brief in your recruitment forms. Potential participants are unlikely to read a long email, letter, or flyer about the research. The recruitment materials should include the high-level important information as detailed on iGuide. The Informed Consent Form will provide in-depth information about participation in the study.

Drafting the Informed Consent or Assent Form(s) University provides informed consent/assent form templates to guide your drafting. Here are some general directions when drafting your forms.

• Use the Informed Consent Forms instructions

• Informed Consent forms are separate from recruitment materials and mustn’t be used for recruitment

• Be certain you’ve chosen the correct templates and that you provide multiple forms if your study includes multiple participants. For example, if your study involves teachers, minors, and administrators, be certain to provide a form for each group

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• If your study design as multiple data collection methods, you should provide an informed consent form for each type of data collection. For example, if your study includes interviews, focus groups, and observations, you should include a form for each type of activity unless ALL participants will participant in all types of data collection.

Assessing and Revising Submission Materials Success in the IRB process depends on the quality and consistency of your submission materials. You will and should revise your documents several times. Work with your mentor to revise before submitting your IRB application.

Assessing IRB Submission Materials

When reviewing your documents, ask yourself:

• Are my responses clear and consistent? Do they make sense?

• Could someone from the general public understand my responses?

• Do all the documents reflect the same information?

• Am I missing any documents that are required for IRB review?

Revising IRB Submission Materials

Here are some general tips when making revisions to your documents:

• Avoid creating multiple versions of your supporting documents (recruitment materials, consent forms, etc). This creates confusion and can lead to future non-compliance if you use an outdated, unapproved version of a form.

• Check for alignment between documents. Double check any section that contains numbers— the amount of time participants will spend in study activities, the amount of incentives, the number of participants to be recruited—as discrepancies are common.

• Ensure that the “track changes” feature in Word documents has been turned off and all changes are integrated into the document.

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PART II: IRB SUBMISSION AND REVIEW

Once you have completed all of the forms and supporting documents, you are ready for the next step in the IRB process. In this section we cover the steps involved in submitting an IRB application and what to expect in IRB review. This includes information on

• When and how to submit an IRB application

• How to complete IRB Office requirements

• What happens in IRB review

• What to do when you obtain IRB approval

Submit IRB Application IRB Screening

Undergo IRB Review

Obtain IRB Approval

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SUBMIT IRB APPLICATION After you’ve completed the IRB Application, click on the submit button to send it to the IRB. If your mentor wants to review the application prior to your submission, create a pdf, save it locally, and then email a copy of the application to your mentor. Wait for your mentor’s feedback and make any necessary changes before submitting to the IRB.

Once you’ve submitted, you and your mentor will receive confirmation that you submitted your application to the IRB.

Completing IRB Office Screening Process Once your application and supporting documents are received, the IRB Office performs an assessment, often referred to as “screening.” The screening process ensures that the reviewer has enough information to conduct a review and to ensure the correct documents were uploaded with the application. If you filled out your application thoroughly and uploaded the appropriate documents, you should move through screening quickly.

If additional documents are needed or if it appears you’ve uploaded incorrect documents, the IRB Office will add a note to your application and return the application to you. You will receive an email stating that the application was returned to you. Review the notes on the application and provide the appropriate information and/or correct documents.

The IRB Office staff rescreens your package generally within 5 business days. You will receive an automatic notice from IRBManager indicating that your study is under review.

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IRB REVIEW This section will provide you insight into the IRB review process. You will learn more about

• Each level of review

• How long the review might take

• Types of decisions that are made

• What to do when you receive a decision regarding your study

Introduction to the Levels of Review While you are not expected to know the differences between each level of review or how to interpret the federal regulations, this guide provides information about what occurs within each level of the IRB review process. There are three levels of review:

• Exempt Review

• Expedited Review

• Full Review

Exempt Review

In order to be reviewed at the exempt level, studies must be minimal risk and meet the criteria for at least one of the six categories listed as exempt in the federal regulations governing research. A big difference between exempt review and the other levels is that an exempt research study does not require ongoing monitoring or continuing review. However, exempt studies at University must be reviewed by the IRB and must still have well defined recruitment, consent and other procedures. From an IRB process perspective, your study will undergo the same details of review as expedited review.

The IRB staff will determine whether your research study can be reviewed at the exempt level.

Expedited Review

In order to be reviewed at the Expedited level, studies must be minimal risk and meet the criteria for at least one of the nine categories listed as expedited in the federal regulations governing research. Unlike an exempt study, an expedited study requires ongoing monitoring and/or continuing review. You do not need to identify in the IRB application that your study qualifies for expedited review. Instead, the IRB Office staff will determine whether your research study can be reviewed under the expedited review process.

Full Review

Research that does not meet the criteria for exempt or expedited review must be reviewed by the full IRB Committee. This includes all research that involves more than minimal risk to participants. Studies involving sensitive topics and/or vulnerable participants are generally subject to full review. Studies involving prisoners or deception are always subject to full review.

While exempt and expedited reviews may be conducted by one or more members of the committee, a review by the full committee requires a convened meeting of the committee.

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According to the federal regulations, studies that are greater than minimal risk to participants must have clear benefits that justify those risks. This means that the IRB committee must be particularly attentive to the scientific merit of the study, since only studies with the potential to contribute meaningfully to knowledge in the field may justify potential risks. Additionally, the IRB must make every effort to assist the researcher in minimizing any risks to participants. As a result, review by the full IRB committee generally takes much longer compared to exempt and expedited reviews. Most researchers spend more than eight weeks in the full review process, depending on the quality of the submission and the nature of the ethical concerns presented by the study.

Receiving the IRB Decision Letter Once your study has been reviewed, the IRB creates an IRB Decision letter. This letter details the outcome of your review. Additionally, if the review requires changes to your application, the IRB Decision Letter details those required changes.

Once the decision letter has been created, you and your mentor will receive a copy of the Decision Letter via email. A copy of the letter will also be in IRBManager.

Here are some general tips to keep in mind when you receive notification of a decision:

• Be aware of the meaning of each decision and the next steps you will need to take based on the determination.

• Carefully review the decision letter.

• Contact your mentor to review the decision and consider next steps.

IRB Decisions The following are definitions for the various decisions that are granted by the IRB. It is a good idea to familiarize yourself with the various decisions, as you may receive more than one decision during the IRB review of your research study.

IRB Decisions and their definitions:

• Approved: You have received IRB approval.

• Approved with conditions: The IRB has determined that the study meets approval criteria. However a research site permission letter or a minor change is required before full IRB approval can be granted (refer back to the section, Obtaining Research Site Permission and to the Human Research Protections Standard Operating Procedures for more information).

• Deferred: The IRB has deferred your study for revisions. The IRB requires revisions to the study materials or procedures.

• Not Approved: The Full IRB Committee disapproved your research study.

• Tabled without Action: The package was not reviewed by the full IRB, either because additional experts must be consulted prior to deliberation or the committee did not have enough time to review the study at the meeting.

• Deferred to IRB of Record: On rare occasions if a research site has an IRB, University can defer the review to the site’s IRB. This requires an agreement

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between the two IRB’s that agree on the site IRB as the IRB of Record. If such an agreement is made, the status of the research is Deferred to IRB of Record.

Revising Your Study in Response to IRB Decision Your study will likely need to be revised before IRB approval is granted. Revisions are requested in order to ensure the protection of your participants as well as your compliance with the research regulations and should be an anticipated part of the IRB process.

Deferred

• Studies that require revisions are deferred. Studies that have been deferred must be revised, resubmitted, and reviewed again by the IRB.

• If your study is deferred, the IRB Decision Letter will be emailed to you and a copy in IRBManager. The form and email will contain instructions for submitting your revisions.

• Carefully read the IRB Decision Letter with your mentor, noting the reviewer’s comments, questions, and concerns. Reviewers try to provide concrete feedback concerning required changes and highlight areas of concern for you to address.

• Once your application is submitted to the IRB, you are unable to make changes. As changes are required for the deferral, the IRB Office will return your IRB Application to you. You must update the IRB application based on the decision letter. DO NOT create a new application. If you create a new application, that application will be returned to you as a new application creates a new study in IRBManager. For ease of use and for compliance reasons, your study must be tracked from beginning to end in the same application.

Approved with Conditions

• Studies requiring only minor revisions may be approved with conditions. These conditions must be met before full approval is granted. In most cases, the IRB Office Staff can determine whether the conditions have been met and no additional review is required.

• The IRB Office will return your IRB Application to you. You must update the IRB application and attachments to provide the information necessary for full approval. DO NOT create a new application. If you create a new application, that application will be returned to you as a new application creates a new study in IRBManager. For ease of use and for compliance reasons, your study must be tracked from beginning to end in the same application.

Multiple rounds of review and revision are sometimes required to ensure that a study can be approved. Following each submission of the application, the application will be assigned for review. Upon completion of the review, an IRB Decision Letter is created, sent to you, and a copy remains in IRBManager. Therefore you may have multiple decision letters. Be certain to note the date of each decision letter when reviewing them. This cyclical process will continue until approval has been obtained.

From time to time researchers appear to struggle in making the revisions necessary for IRB approval. In such cases, the IRB may notify your specialization chair, research chair, and dissertation advisor to ensure you have the support needed to be successful. A conference call may be scheduled to develop a plan to ensure your success in the IRB process.

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IRB A-Z HANDBOOK

Obtaining IRB Approval or Exemption Once you receive email notification that your study is approved you have made it through the initial IRB submission and review process!

Once you’re done celebrating, it is important that you read and review the following documents:

• The decision letter

• The rest of the IRB A to Z Handbook

These documents and the handbook include important information regarding the steps you must take after approval in order to stay in compliance with the research regulations.

Reviewing the IRB Approval Letter Once your research study has received approval, the IRB Office will publish an IRB Approval letter. The IRB Approval Letter contains important information about your study including the approval period (if applicable), information about modifications, notification of policy requirements, and other vital disclosures. In order to stay compliant and avoid unnecessary complications, it is critical that you and your mentor review the information provided in the letter.

Additionally note that your school may require that you pass additional milestones (such as pre-data collection call or writing of dissertation chapters) before you collect data. It is vital that you consult with your program requirements to avoid non-compliance policy that may result in delays to your research.

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IRB A-Z HANDBOOK

PART III: POST-IRB APPROVAL PROCEDURES

Ensuring Ongoing Compliance Although obtaining IRB approval is a major milestone, efforts to protect participants and ensure compliance must continue as long as you are engaged in research. The IRB will continue to monitor your study and you may be required to take action to ensure ongoing approval. Ongoing communication with the IRB is critical, particularly if you need to make any changes to your study, report a problem or participant concern, or seek continuing approval. In this section you will learn more about

• Requesting Modifications to IRB-approved Studies

• Undergoing Continuing Review

• Reporting Adverse Events or Unanticipated Problems

• Study Closure Procedures

Follow Post-IRB Approval

Procedures: Amendments and Continuing Review

Submit Study Closures

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IRB A-Z HANDBOOK

REQUESTING MODIFICATIONS TO IRB-APPROVED STUDIES If you need to make a change to your IRB approved study, you should first contact the IRB Office by emailing the IRB Office. Include specific details concerning the changes you would like to make. It is important to contact the IRB Office because some changes require IRB review and approval before you can actually implement them. The IRB Office will determine whether your proposed modification must be reviewed and approved by the IRB prior to implementation.

More significant modifications may require review by the IRB. If your study involves greater than minimal risk to participants, your modification will likely need to be reviewed by the full IRB committee during a convened meeting.

Submitting a Modification Request Package If you are asked to submit an IRB Modification Form, available follow these procedures:

• Complete the IRB Modification Form.

• Prepare any necessary supporting forms or documents. For example, if you are modifying your recruitment strategy, include your revised recruitment materials. If you are adding a new research site, include a letter of site permission.

• Assess your submission materials to ensure that they are complete, coherent and that you’ve provided all applicable documents.

• Submit the application.

Implementing the Modification Once the IRB completes the review of your modification request, the IRB Office creates a decision letter. You will receive a copy of this via email and a copy will be available in IRBManager evaluation form and decision letter, and you will receive an auto-generated email from IRBManager. This is the same type of notification you saw during the original IRB review of your research study.

It is important that you and your mentor read the decision letter. This letter provide information regarding any conditions that must be met or followed before approval of the modification can be granted or once the modification is approved.

The modification cannot be implemented until the IRB has approved the modification.

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IRB A-Z HANDBOOK

UNDERGOING CONTINUING REVIEW Your IRB approval letter will indicate whether your research study has an IRB approval period. This period ranges from a few months to a year. If you are still collecting data (if your study was determined Greater Than Minimal Risk then you must have IRB approval through data analysis as well) and your study is about to expire, you must apply for continuing review.

You will receive an auto-email from IRBManager 30 days in advance notifying you that your approval is about to expire. You’ll receive a follow up reminder 5 days before expiration as well. Once you submit the continuing review application, the auto-generated notices will stop.

It is important that you plan ahead; it can take a week for the continuing review to be completed, and you may be asked to provide additional information or documents including updated site permission letters and scanned consent forms.

Submitting a Continuing Review Package If you are applying for continuing review, complete the following steps:

• Complete a Continuing Review Form

• Prepare any necessary supporting forms or documents. You will need to submit updated site permission letters (if your site approval is more than a year old) and copies of your recruitment and consent forms if you are still recruiting and collecting data.

• Submit the Continuing Review Application

Obtaining Continuing IRB Approval When the IRB reviewer completes the evaluation, the IRB Office will publish the evaluation, and you will receive an email with the decision letter attached from the IRB Office.

It is important that you and your mentor read the evaluation form and decision letter. These documents provide information regarding any conditions that must be met or followed before approval can be granted or following continuing IRB approval.

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IRB A-Z HANDBOOK

REPORTING ADVERSE EVENTS OR UNANTICIPATED PROBLEMS You may run into a situation where a participant experience distress or something goes unexpectedly wrong (for example, you didn’t expect to have a participant express serious emotional or psychological distress during the course of the research study). For more information consult iGuide. If you encounter an unanticipated problem or adverse event, you must notify the IRB Office by email.

The Research Education and Compliance Specialist will investigate all reports of possible adverse events and/or unanticipated problems.

Reporting Noncompliance Every member of the research community, including staff, is required to report any observed, suspected, or apparent noncompliance to the IRB. If you accidentally engage in activities that are not in compliance with your IRB-approved protocol, cease your research activities and contact the IRB Office immediately. The Research Education and Compliance Specialist will conduct and inquiry and assess whether any actions are needed to protect participants and whether you are able to continue with your study. We recognize that research can be tricky and that mistakes happen, and self-reported violations are given favorable consideration.

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IRB A-Z HANDBOOK

CLOSING YOUR STUDY The completion of the study is a change in research activity that must be reported to the IRB. Although participants will no longer be “at risk,” notifying the IRB of the study’s conclusion allows it to close its files and provides information that the IRB may use in the evaluation and approval of related studies. Continuing oversight from the IRB is no longer necessary once a study is closed. Failure to cease research activities following study closure will result in a form of noncompliance requiring corrective action.

Closure of a study occurs when either of the following criteria is met:

• The researcher has completed data collection and data analysis, and acknowledges that he or she will no longer contact participants, enroll participants, collect further data for the study, or engage in analysis of identifiable participant data. In this scenario, the researcher must complete the IRB Study Closure Form.

• IRB approval of the study has expired, and the researcher has not submitted a Continuing Review Form within the appropriate time frame. In this scenario, RIO Staff will close out the study and notify the researcher that all research activities as described above must cease.

Notifying the IRB of Study Closure If your study was reviewed at the expedited level and you are no longer collecting data, email the IRB Office to notify us that the study may be closed.

If your study was reviewed by the Full IRB Board (the full review level), email the IRB when your study is done for additional requirements regarding study closures.