Due 06/06/15 @5pm cst

IRB HANDBOOK

IRB A-Z Handbook

Effective September 16, 2013

Capella University

225 South Sixth Street, Ninth Floor Minneapolis, MN 55402

1

IRB HANDBOOK

Table of Contents

Introduction to the IRB A to Z Handbook ................................................................................ 3

Preparation for IRB Review ...................................................................................................... 4 Developing a Human Research Protection Plan 5 Documenting the Plan in Your IRB Submission Materials 5

Determining Submission Requirements ......................................................................... 5 Selecting the IRB Application 6 Selecting the Informed Consent or Assent Form Templates 7 Identifying Instrument Requirement(s) 8 Identifying Other Supporting Documents 8

Completing Application Forms, Letters, and Templates .................................................... 8 Completing the IRB Application 9 Drafting the Informed Consent or Assent Form(s) 10 Drafting the Recruitment Material(s) 10 Obtaining Research Site Permissions 10 What if I can’t get permission before IRB review? 11

Assessing and Revising Submission Materials ............................................................... 12 Assessing IRB Submission Materials 12 Revising IRB Submission Materials 12

IRB Submission and Review .................................................................................................. 13 Submitting Your IRB Application ................................................................................. 13

Registering and Activating an Account 13 Starting an application 13 Sending your application to your mentor 14

Completing IRB Office Screening Process .................................................................... 14 Undergoing IRB Review ............................................................................................. 15

Introduction to the Levels of Review 15 Receiving the IRB Decision Letter 16 IRB Decisions 16 Revising Your Study in Response to IRB Decision 17

Obtaining IRB Approval or Exemption ......................................................................... 18 Reviewing the IRB Approval Letter 19

Post-IRB Approval Procedures .............................................................................................. 20 Ensuring Ongoing Compliance .................................................................................... 20 Requesting Modifications to IRB-approved Studies........................................................ 20 Submitting a Modification Request Package ................................................................. 20

Implementing the Modification 21 Undergoing Continuing Review ................................................................................... 21

Submitting a Continuing Review Package 21 Reporting Adverse Events or Unanticipated Problems .................................................... 21

Reporting Noncompliance 22 Closing Your Study ................................................................................................... 22

Notifying the IRB of Study Closure 22

2

IRB HANDBOOK

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.

The following flow chart provides an overview of the topics this handbook covers, including

• 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 Capella 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.

We recommend that you start at beginning of this handbook—point A— and proceed systematically through each step of the guide until you reach the end—point Z. You might find out something helpful along the way!

3

IRB HANDBOOK

PREPARATION FOR IRB REVIEW

Careful preparation for IRB review will ensure your success in the process. By carefully reviewing this handbook, you are positioning yourself for success! Preparation includes developing an understanding of the IRB process and having clear expectations of what you will encounter along the way. Preparation also includes attention to how you will protect participants as part of your study and how you will assemble and craft your IRB submission materials.

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 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.

4

IRB HANDBOOK

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

When researchers are attentive to ethical concerns and participant protections as they design their studies, the IRB process becomes far less daunting. Indeed, extremely well- prepared researchers need only transpose their plans into the IRB application and supplemental documents.

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 very 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.

Some researchers, particularly those who prefer to focus on the big picture, find this level of attention to detail exasperating and frustrating. However, careful attention to detail at this stage of the process pays off: The IRB-approved protocol provides a precise road map for the researcher to follow while actually conducting the study.

Determining Submission Requirements

5

IRB HANDBOOK

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 what documents will be required for IRB submission. Required IRB submission documents include:

• IRB Application

• Informed Consent/Assent Forms

• Supporting Documents

These materials comprise your IRB submission “package.” Before online IRB submission, researchers actually compiled a package of materials to submit via postal mail to the IRB!

The IRB package contains a number of different forms and documents. You may be concerned that this is a lot of documents to prepare. We suggest that you take it one small step at a time, and that you take advantage of our checklists in order to approach the process in an organized manner. This section will help you identify the documents that you will need for submission.

Selecting the IRB Application

As you prepare for IRB submission, you will need to determine which IRB application to complete. The IRB Application is the primary document used to convey information concerning your Human Research Protection Plan to the IRB. It is critical that you select the right application as you begin your IRB process.

The IRB Application 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). Capella University’s IRB has two different IRB Applications:

• IRB Application

• IRB Records-Based Research Application

If you are only going to analyze records that exist at the time of IRB submission, such as standardized test results or clinical case files, you must complete an IRB Records-Based Research application.

If your study involves activities with participants such as interviews or surveys, you will need to complete the general IRB application.

Sometimes a study involves a review of existing records and activities with participants. In such case, you should complete the general IRB Application. You will be asked questions about records during the application.

6

IRB HANDBOOK

While the IRB Application is the primary document you will use to convey information to the IRB, it is just one of the many documents you will need for submission. The next sections describe the other forms and documents you will need to complete or create before you submit a package to the IRB.

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.

Informed consent is document through the signed informed consent form.

Capella University’s IRB requires all researchers to use Capella's 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 Capella's IRB approval for your research study.

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 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, at http://dhhs.gov/ohrp/; 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.

7

IRB HANDBOOK

Child Assent Template (ages 7-11)

If your research study involves children between the ages of 7 and 11 who have the ability to provide assent, this template should be used. 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.

Minor Assent Template (ages 12-17)

If the research involves minors between the ages of 12 and 17 who have the ability to provide assent, this template should be used. It is important that you check your local and state laws regarding any specific definitions regarding minors, legal representatives and custodians, and any other unique requirements.

Identifying Instrument Requirement(s)

Researchers generally rely on instruments to collect their research data. An instrument may include an inventory or scale, survey, interview script or observation checklist. If your study involves the use of an instrument, you must provide the following documents as part of your IRB package:

• A copy of the instrument(s).

• A letter granting permission for you to use the instrument. A permission letter is required for the use of existing instruments and must come from instrument authors or publishers. Permission must be specifically obtained to modify the instrument. If you are purchasing the instrument for use in your study, a purchase agreement may replace the permission letter.

Identifying Other Supporting Documents

Several additional supporting documents may be needed for IRB review. What is required depends on the nature of your research study. Documents can include

• Copy of your school approved Research Plan/Scientific Merit Review Form

• Drafts of Recruitment Materials

• Research Site Permission Letters

• Additional documentation for doctoral researchers

Completing Application Forms, Letters, and Templates

8

IRB HANDBOOK

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.

Completing the IRB Application

Many researchers imagine that the IRB application and supplemental forms are similar to those they have encountered in the doctor’s office or when applying for a license. Generally speaking, such forms can be completed in one sitting, without much advance preparation. Seldom is it necessary to make revisions, seek additional input, consider new ideas, or grapple with difficult ethical issues.

Unfortunately, researchers who have similar expectations concerning the IRB process are often distressed to realize that the development of an IRB submission package is likely to require more time and energy than it takes to file taxes (another process subject to state and federal regulations). IRB “forms” are hardly forms at all; rather, they are a series of guided questions that give you an opportunity to reflect on your Human Research Protection Plan in an organized and systematic way to ensure that you have adequately met the regulatory criteria for approval.

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 layperson who may not have expertise in your field) 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 or all of the supplemental forms 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 clear and concise responses.

9

IRB HANDBOOK

• 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 form or early chapters of your dissertation. If you still need more space, use the Additional Information Question and Documents at the end of the form 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.

Drafting the Informed Consent or Assent Form(s)

Capella University provides informed consent/assent form templates to guide your drafting. Here are some general directions when drafting your forms.

• Double-check your template. Are you using the right one?

• Enter text in the [bracketed] fields.

• Delete any brackets [ ] from the form(s).

• Remove any template directions from the form(s).

• Determine if the yellow-highlighted sections apply to your research study. If they do apply, remove the highlighting from the text. If they do not apply to your study, delete the highlighted statements.

• In areas where there is more than one option—indicated by an “OR”—choose the scenario that applies to your study. Delete the other options, including the “OR.”

• Make sure that the reading level is appropriate for your research population. Adult consent forms should be written at an 8th grade reading level. Adding text or editing the language will alter the readability of the form. You can find many no-cost reading tools on the Internet.

• You are creating a draft for IRB review. You cannot obtain informed consent or assent from any participants until you have received IRB approval from Capella University’s IRB.

• The informed consent form should be separate from your recruitment materials. If you are conducting research via an online survey, the informed consent information should be included as the first page of the online survey, not as part of the invitation to participate.

Drafting the Recruitment Material(s)

Review your recruitment method to determine how you will recruit participants. For example, will you engage in face-to-face recruitment during a meeting, post a flier, post an advertisement on a social media site, or use email? Regardless of the nature of your recruitment strategy, you must provide drafts of all recruitment materials for IRB review. This includes fliers, email scripts, phone scripts, face-to-face meeting scripts, online advertisements, social media postings, and so on. Learn more about best practices in recruitment on iGuide and how to create recruitment flyers, advertisements, or letters.

Obtaining Research Site Permissions

If your research will involve participants affiliated with a particular organization or association or if you will be engaging in recruitment or research activities at a research site

10

IRB HANDBOOK

(whether in a physical or online space), you will need to obtain permission from the site(s). You must have site permission before final IRB approval. For that reason, you should seek permission from all of your research sites before you submit to the IRB. If the site requires approval from Capella University’s IRB prior to providing site permission, you may submit your application and indicate that conditional approval is needed.

Permission is likely required if you are collecting information specifically from participants because of their affiliation with the site or if the data collected is likely to reveal information about the site or the practices of those affiliated with it. Permission may also be required if you will use an institution or organization’s

• directory for recruiting

• private property or space for interviews or other research activities

• private records for research

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 a formal or informal process for seeking permission to conduct research and whether the site has an IRB of its own. Also determine whether the site requires you to provide evidence of Capella’s IRB approval before granting permission.

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

• 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 a editable document.

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

Sometimes a research site will ask for Capella’s IRB approval before granting permission. However, as you recall, Capella’s 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 Capella 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 Capella’s IRB.

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

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

11

IRB HANDBOOK

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 Capella’s 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.

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?

Once you have performed this self-assessment, make any necessary changes and then send the application to your mentor. Your mentor may suggest revisions to improve your materials.

Revising IRB Submission Materials

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

• Avoid creating multiple versions of your documents. 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.

Coming Next…

Once you have verified with your mentor that the revisions are ready for IRB submission, you are ready to start the IRB submission process described in the next section.

12

IRB HANDBOOK

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

Submitting Your IRB Application

IRB applications are submitted via a third party online system called IRBManager, at . You do not need to be in iGuide or a courseroom to access IRBNet. All you have to do is type the web address in your Internet browser.

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

• You do not have to choose a user name. IRBManager will create it for you.

• Register only once

• Click here for instructions on how to register

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.

13

IRB HANDBOOK

From the left hand actions menu, choose the appropriate application. Unless you are analyzing existing information, this will be the 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.

Sending your application to your mentor

After you’ve completed the application, ensure that all the correct documents were uploaded; you will send your application to your mentor by signing and submitting the application. Your mentor will carefully review your materials to determine if the application can be submitted to the IRB. If additional information is required by your mentor, she/he will return the application to you. At that time, you will need to update your answers on the application and submit again to your mentor. You will receive an email that states your mentor returned the application to you.

If your mentor determines that the application is ready to be reviewed by the IRB, she/he will submit to the IRB. Only your mentor may submit 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

14

IRB HANDBOOK

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.

Then you will sign and submit the application again. This will send a copy to your mentor for evaluation. Your mentor will then submit the application to the IRB.

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.

Undergoing IRB Review

Once your package is ready and the IRB Office has sent your package to an IRB reviewer, you are one step closer to completing the IRB process! 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 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 Capella 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.

15

IRB HANDBOOK

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.

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.

The IRB Decision is processed by IRB Office Staff.

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.

16

IRB HANDBOOK

Decision Meaning

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.

Suspended Your IRB approval is suspended until further notice.

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.

Terminated The full IRB has terminated the study.

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.

17

IRB HANDBOOK

• 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.

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! Congratulations!

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 18

IRB 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.

The next section provides detail about the decision letter.

Reviewing the IRB Approval Letter

Once your research study has received approval, the IRB Office will publish an IRB Approval letter. In order to stay compliant and avoid unnecessary complications, it is critical that you and your mentor review the information provided in the letter.

Coming Next…

Getting IRB approval is a great accomplishment. When you start your research activities, there are a few additional steps to follow. The next section will provide directions on how to handle certain situations during the course of data collection and analysis.

19

IRB HANDBOOK

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

Requesting Modifications to IRB-approved Studies

If you need to make a change to your IRB approved study, information available at https://campus.capella.edu/web/dissertation-research/data-collection-and-compliance, 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.

20

IRB HANDBOOK

• 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 cree 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 IRBNet. 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.

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 and your study is about to expire, you must apply for continuing review.

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 as well as a copy of the consent form you have used to enroll participants in your study if applicable. If your study underwent full review, you will need to upload 2-3 copies of signed consent forms that were obtained. These samples will be kept confidential.

• 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 auto-generated email from IRBNet. 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 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.

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

21

IRB HANDBOOK

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.

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.

22

IRB HANDBOOK

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.

Closing your study is a great accomplishment. We congratulate you for successfully completing the IRB process from A to Z. We hope that this experience will provide you with tools for future research endeavors.

23