Feature Article

Preparing an IRB Application - Where Do I Begin?
November 2013 Issue

By Mary A. Banks, BS, BSN
BUMC IRB Director
Authors has nothing to disclose with regards to commercial support.

PRINT | CLOSE WINDOW

 

Introduction

 

“Let us watch well our beginnings, and results will manage themselves.” ~ Alexander Clark

You are an investigator or study coordinator.  You have been procrastinating for weeks, but now you know that the time has come…you need to sit down and write your INSPIR application!  But, you are hesitating because you are really not quite sure where to begin, either because this is your first IRB protocol, or you have submitted protocols previously which needed multiple corrections and modifications before they were approved by the IRB.  You are really anxious for this submission to go smoothly.  You know there are multiple resources available to assist you, but, the volume of information available makes sorting through it all very challenging.  

You are in luck!  The purpose of this article is to provide investigators with an overview of some of the numerous resources available to investigators who are writing their INSPIR protocols. Secondly, this article specifically advises investigators on how to select the most appropriate IRB review pathway for their protocols, thus increasing the chance that the IRB review process of their protocols will go smoothly.

Step One

One of the first questions you will need to tackle as you prepare to write your IRB (INSPIR) protocol is, “What type of IRB application should I be submitting?” Technically, there is only ONE INSPIR application.  However, since INSPIR is a “smart form”, the questions in the application are populated based on the answers you provide early in the application.  The selection options under Question 10.3 of the INSPIR application are the ones that most significantly determine the review pathway of the study and heavily determine which additional questions are placed on the INSPIR application.  If you answer Question 10.3 incorrectly, you could end up doing a much longer application than necessary.  Or, you could end up not providing the IRB with enough information to complete the review; and, therefore, the application would have to be returned to you for a complete “do-over”. 

Over the past few years, there have been a significant number of CR TIMES Feature Articles that have been written to assist investigators in determining the appropriate review pathway for their research.  Some of the most common types of research seen at BUMC are noted in the table below with a link to these CR TIMES articles. 

If you take the time to reference the articles which correspond with your research and follow the guidelines within the articles, you will go a long way towards ensuring that you are providing the information necessary for the IRB to review your protocol. If, after reading the articles, you still have questions about what type of review your research will qualify for, it will be well worth the time and effort to contact the CRRO (Clinical Research Resources Office at 617-638-8876 or www.bumc.bu.edu/crro) for assistance with this determination prior to completing your INSPIR application.

Here are some of the most common research scenarios, some possible review options, and where to find more information.

 

Research Activities and Review Type

 

Link to information about IRB review and determining research review categories 

 

Recipient Research

Does your study involve ONLY use of samples and/or data that are being obtained from a repository (you and your investigators are not collecting data or samples directly from subjects)?  

If so, your study MAY qualify for review as Not Human Subjects Research (NHSR) or Exempt review under Exempt Category 4. 

Does your research involve obtaining samples from established repositories such as dbGaP, i2b2 or BARC? Each of these repositories has special considerations/requirements which must be met.

Review path for this type of research can be NHSR, Exempt, Expedited or Full Board depending on whether data/samples are identifiable, who will receive the data, and the sensitivity of the data.

 

Research Repositories (Part I) - Understanding Recipient Research Proposals April 2013 Issue

Taking the Bite Out of the BARC: Getting Specimens from the BUMC Biospecimen Archive Research Core is Easier Than You Think! January 2012 Issue

I2b2 and the MDHR: New tools for rapid, easy access to clinical data for health outcome assessment and research December 2012 Issue

dbGaP - Sharing and Accessing Data January 2013 Issue

Is Exempt Review Right For You? September 2013 Issue

 

Clinical Record Review

Does your study involve the collection of information from subjects’ medical or dental records? 

The review path determination will be based on whether the data is being released by a repository, or whether the investigators have to review the clinical records to collect the data themselves. Also considered is the sensitivity of the data, and whether links will be retained to identifiers.

 

Exploring IRB Review Options for Clinical Record Review
October 2013 Issue

Going Retro?” - Exempt Category 4 Submissions for Retrospective Chart reviews, and other studies using existing data/samples

Research Repositories (Part I) - Understanding Recipient Research Proposals April 2013 Issue

Is Exempt Review Right For You? September 2013 Issue

Database Research: When is it Not Human Subject Research? When is it Exempt? When is it Expedited?

Accessing Data for Clinical Research: The Boston Medical Center Clinical Data Warehouse, a New Resource   February, 2007 Issue

 

Anonymous Surveys

Does your study involve anonymous surveys or interviews where subjects’ identities will not be recorded or linked to the research data?
If so, then the study MAY qualify for Exempt review under Category 2 depending on the subject population.

 

Survey says…Exempt! October 2012 Issue

Is Exempt Review Right For You? September 2013 Issue

 

Educational Research

Does your research involve research on the effectiveness of or comparison of instructional techniques, or research on educational strategies?

If so, it might qualify for Exempt review.

 

Is Exempt Review Right For You? September 2013 Issue

 

Investigational Drugs or Devices

Does your study involve investigational drugs or devices? 

If so, it is most likely that your study will require review by the IRB at a convened meeting (Full Board Review).

 

Expedited, Exempt, IRB Full Board? Determining the Type of IRB Review is “Risky Business”

 

Quality Assurance Studies

Some Quality Assurance projects don’t meet the definition of research and qualify for a determination as NHSR; while others are also research and need full IRB review.

 

Quality Assurance, Research, and Everything In Between April 2008 Issue

 

Obtaining Samples for Placement in a Repository

Does your study involve the collection of samples and/or data for placement in a repository?  Your study will likely require initial review by the convened (Full Board) IRB, especially if the data involves genetic research.

 

Research Repositories (Part II) - IRB Review of Repositories May 2013 Issue

 

Next Step: Completing the INSPIR Application

All IRB protocols at BUMC must be submitted via INSPIR (Integrated Network of Subject Protection In Research).   The IRB does not accept human subjects research protocols submitted via other methods.    For investigators who are unfamiliar with INSPIR, there is a lot of information on the IRB website with specific details about INSPIR. 

Investigators are encouraged to consult the detailed INSPIR instructions on the IRB website about how to complete initial INSPIR protocols, how to create consent forms, how to attach recruitment materials, etc.  

Questions 1-10 of INSPIR:  The following questions must be completed for all INSPIR applications for all studies, no matter the review path.  Next to the specific INSPIR questions are some links to CR TIMES articles or information on institutional websites which provide additional guidance as to how to answer the questions.

.

INSPIR Question

Links to additional information

3.1

Principal Investigator

Principal Investigator Oversight April 2010 Issue

The Responsibilities of the Investigator

The responsibilities of being a Principal Investigator
 

3.2

Study Staff

Human subjects training requirements
 

4.1 and 4.2;
9.0 and 10.4

 

External investigators and other external institutions:
Are external investigators engaged in research?

IRB Review: When is One Not Enough? May, 2006 Issue

On Being Engaged December 2010 Issue

Non-engaged in human subjects research agreement
 

6.0

Conflict of Interest

BUMC's Policy on Investigators' Conflicts of Interest: Updated Guidance June 2009 Issue

BUMC Office of Research Compliance
 

7.0

Research Funding

Follow the Money Sept 2009
 

9.0

Research involving other sites

Unique Challenges in Community-Based Participatory Research
November 2012 Issue

Research with other institutions

BUMC and WIRB review

The Boston HealthNet: “A Strategy to Recruit Boston's Diverse Populations
 

10.1 and 10.2

Emergency Use

When experimental treatment is not research: Emergency and Compassionate Use
 

10.5

International Research

Ethics Around the World: International Projects and the BUMC IRB December 2011 Issue
 

10.6

HIPAA

Privacy and Confidentiality Requirements in the Use and Disclosure of Information for Research - March 2013 Issue

HIPAA Algorithm from BUMC HIPAA website
 

10.7

Genetic Research

GWAS studies guidelines
 

10.8 and  10.11

Biological sample collection and repositories

Research Repositories (Part I) - Understanding Recipient Research Proposals April 2013 Issue

Research Repositories (Part II) - IRB Review of Repositories May 2013 Issue
 

10.9

Research and Investigational Drugs

The Right Prescription: Working with the Investigational Drug Service At Boston Medical Center May 2008 Issue

What's the Use? Understanding the Basics about INDs and IDEs - Part I-INDs February 2010 Issue
 

10.10

Investigational Devices

All About Class: IDE Requirements for Clinical Investigations March 2010 Issue
 

After completing Sections 1 to 10 in INSPIR, the rest of the application is populated with questions based on the answers to the questions above.  Therefore, the numbering of the sections in the applications will vary.   Question 12 on an Exempt application will not necessarily be the same question as Question 12 on an Expedited application.

The following table represents some key points in the IRB applications, and references links from previous CR TIMES issues regarding these topics.

 

Topics

Links to more information

 

Recruiting Subjects

 

New Options for Subject Recruitment - December 2007 Issue

Advertising and Recruitment Guidelines for Research Studies

Developing an Effective Recruitment Plan for Clinical Research Studies - February 2013 Issue

Using the Internet to Conduct Research and Recruit Subjects - June 2008 Issue

On Rewarding Subjects - September, 2006 Issue

Clinical Research Recruitment and Retention: Barriers and Strategies - October 2011 Issue

How to Advertise and Recruit at BU/BMC

Publicize Your Study! Have You Created a StudyFinder Listing Yet?

The ReSPECT Registry: A Recruitment Resource for Investigators

Benefits and Disadvantages of Mass Media as a Recruitment Tool
 

 

Screening Subjects

 

Either You're In or You're Out! Screening Research Subjects - October, 2006 Issue
 

 

Subject Eligibility (inclusion and exclusion criteria)

 

Fitting Round Subjects into Round Holes The Importance of Eligibility Criteria -November 2010 Issue
 

 

Scientific Review of  
   Research
Sample Size
Data Analysis

 

Data Analysis and the IRB: A Guide for BUMC Investigators - March 2006
 
You Should Count on It: Statistical Considerations When Planning Research Studies - September 2012 Issue

Aiming for the Right Sample Size - February 2009 Issue

A Statistician Reflects on Fraud in Clinical Research - June 2007 Issue

Strategies to Help Ensure Validity of Web-based Research Samples - February 2012 Issue

Scientific Review and the IRB
 

 

Research Risks 

Research Benefits

 

Clinical Research: A Risky Business

A Closer Look at Risk -Benefit Analysis - November 2008 Issue
 

 

Therapeutic
Misconception

 

Therapeutic Misconception: Crouching Research, Hidden Meaning - December 2009 Issue
 

 

Informed Consent

  • Obtaining consent
  • Waiver of informed consent

 

  • Translating consents

 

 

  • Content of consent forms
  • Consenting Non-English and Low Literate Populations
  • Consenting Decisionally Impaired

 

 

Consenting Subjects - Looking for Answers - January 2006

If the Subject Can't Consent, Then What?

Clinical Research Without Informed Consent: How Can it be Legal? How Can it be Ethical?

The Language of Consent: Using the Short Form Process when Consenting non-English Speaking Subjects in Research - September 2008 Issue

Translated Consent Forms – When Do You Need to Use One

A Clear and Present Purpose - May 2010 Issue

Are You Consent Compliant? - March 2011 Issue

Releasing Research Results to Subjects - October 2008 Issue

Problems of Informed Consent and Low Literate Populations - June, 2006 Issue

Tracking Individual Consent Histories for Participants in Research - April 2012 Issue

Waiving Elements of Consent Consenting Decisionally Impaired Subjects
 

 

Data and Safety Monitoring

 

 

Reporting Adverse Events 

 

Unanticipated Problems

 

Planning for Data and Safety Monitoring in Clinical Research Studies:

Developing Your Study-Specific DSMP - November, 2006 Issue

 

Minding your Bs and Ps: The Purpose of the Data Safety Monitoring Board and its Role in the Overall Data Safety Monitoring Plan - January 2009 Issue

Reporting Unanticipated Problems to the IRB
(Formerly SAE Reporting) - October 2007 Issue

Unanticipated Problems and Adverse Events:
Investigator Responsibilities - November 2007 Issue

Developing a Corrective Action Plan - May 2011 Issue

What's “Independent”?
 

 

Confidentiality Protections

Privacy and HIPAA

 

The Certificate of Confidentiality - April, 2007 Issue

Privacy and Confidentiality Requirements in the Use and Disclosure of Information for Research - March 2013 Issue

HIPAA Algorithm
 

 

Vulnerable Subjects

  • Children
  • Pregnant Women
  • Prisoners

 

Do the Usual Rules Apply? Special Considerations When Conducting Research With Children - March 2012 Issue

Research in Children: What Level of Risk is Acceptable?

Beyond the Pregnancy Test: When Can Pregnant Women Participate in Research? - May 2007 Issue

Arrested Enrollment: What Happens When Research Subjects are Incarcerated? - January 2008 Issue
 

 

Repositories

 

Research Repositories (Part I) - Understanding Recipient Research Proposals - April 2013 Issue

Research Repositories (Part II) - IRB Review of Repositories - May 2013 Issue

Research Repositories (Part III) - Data Use Agreements and Materials Transfer Agreements - June 2013 Issue

BANISHING BANKING BEWILDERMENT: Considerations for Banking Tissue Samples and Data - January 2011 Issue
 

 

Conducting the Research

Research Forms

 

 

 

Closing Research

Final Reports

 

ANATOMY OF THE RESEARCH RECORD - December, 2006 Issue

Case Report Forms - Critical to the Success of your Research Study - March 2008 Issue

Source Documents, Case Report Forms (CRFs) and ALCOA

When the Participation of a Research Subject is Discontinued - April 2009 Issue

The Final Frontier: IRB Final Reports - January 2010 Issue

You Just Can’t Take It With You! - May 2012 Issue
 

 

Summary

Developing an IRB application is challenging. The information that needs to be provided to the IRB varies greatly depending on the research study.  There are many resources available to BUMC investigators to assist them in writing their IRB protocols.  This article provides a summary of many of those resources from previous Feature Articles in the Clinical Research Times. Investigators are also encouraged to consult with the BUMC Clinical Research Resources Office if they have questions when preparing their INSPIR applications, especially for questions related to IRB review pathways.


Quiz

This Quiz applies to the current recertification period from July 1, 2013 to June 30, 2015. We recommend that you take this quiz now so you can stay up-to-date.

Click here, close this window, and login to My Account if you are
a BUMC researcher and would like to take the quiz now.

Close Window