Institutional Review Board (IRB)

Important: In response to the update of the 2018 Common Rule, on January 21, 2019, the Revised Common Rule regulations (also called the 2018 Common Rule) that apply to human research became effective.

Please note: 

There was a temporary freeze imposed on new IRB study submissions received in the Office for Research Compliance between January 18 – 22, 2019.

All new IRB projects submitted BEFORE January 18, 2019 will be subject to the 2018 – Pre-Common Rule regulations. 

Any study that is approved after January 21, 2019 will be subject to the new requirements unless it is Food and Drug Administration (FDA)-regulated or funded by the Department of Justice (DOJ). At this time, the FDA has not yet revised their regulations, and the DOJ has not signed onto the 2018 Common Rule.

This is not an IRB policy change but rather an IRB regulatory change.

What the Revised Common Rule Regulations Mean for Your Research:

1. An expanded definition of “research” which will definitively exclude some activities from requiring IRB oversight.
2. The removal of the “continuing review” (or renewal) requirement for expedited studies; some exceptions will be applied. UA projects will require an Annual Report to be submitted.
3. Changes in the “exemption” categories which will expand what is considered exempt.
4. The inclusion of data sets and biospecimens in the definition of “human subjects,” with additional guidance on appropriately reviewing studies including data sets or biospecimens.
5. A focus on readability of informed consent forms.

Please email rscompliance@research.ua.edu if you have specific questions about the upcoming changes.

In an effort to improve the software application process for users, effective February 1, 2019, all IRB submissions must be submitted using the EP2 version of the e-Protocol system.

Investigators who have previously submitted paper submission(s) or project(s) in the EP1 system must create and submit the project as “new” in the EP2 system and must reference the legacy number with the project’s title. Example: (14-OR-999) Monitoring the Use of Smartphones during Meals. Please note, the term “new” is only used to reconcile the project(s) from their previous version to the EP2 system. (Suggestion from the ORC is to copy and paste the entries from the previous version to the EP2 version). If the investigator chooses to close the IRB project, the ORC will accept the final report/closure form from the EP1 system or a paper copy.

The EP2 version of the e-Protocol system may be accessed via the myBama portal using your UA credentials. Once logged in, please select the Research tab and then the Research Systems tab. You may then select e-Protocol for IRB and proceed to complete the application.

If you have questions or need assistance with the transition to the EP2 system, please call the ORC at 205-348-8461.

Authorization on Use or Disclosure of Health Information

Assistant or Graduate Teaching Assistant Employed on Grants, Contracts, and Other Sponsored Projects

Decision- Making Capacity Assessment

Human Research Determination Checklist (DHHS and FDA)

Investigator Statement of Financial Interest

IRB Checklist for Reviewers and Investigators

IRB Member Disclosure of COI

IRB Members’ Pledge of Confidentiality of IRB Deliberations and Protocol Content

Notification to IRB of Emergency Use of a Test Article

PI Statement of Conflict of Interest

Question/Suggestion for HRPP/IRB

Report of Attempt to Exert Undue Influence

Report of Complaint or Concern About a Research Study

Report of Study Problem

Signature Assurance Sheet

Survey for Participants in UA-Sponsored Research Study

Research Staff Satisfaction with Study Conduct

Translator’s Declaration

Class Assignments & IRB Approval

In support of its teaching mission, the University of Alabama encourages novel and innovative classroom activities. Some faculty design class assignments that involve questionnaires, interviews, or other interactions with individuals, such as those commonly used in research methods courses. In these cases, faculty should consider if such assignments should be reviewed by Institutional Review Boards (IRBs) to ensure the protection of human subjects.

For these projects, it is best practice to check with the IRB for a determination regarding whether IRB review is necessary.

Guidelines for Classroom-Based Research

In order to determine if classroom assignment-based research does not require IRB approval the following conditions must be met:

1. The risk level of the project is minimal (no more than would be encountered in routine daily activities).
2. Unless a student is qualified to do so, there may be no studies that involve interaction with vulnerable subjects (e.g., pregnant women, children, prisoners, or cognitively impaired persons). Observational study of protected vulnerable populations can be done with the appropriate protections in place.
3. No identifiers are collected.
4. The project is limited to surveys/questionnaires/interview procedures, observation of public behavior, or standard educational exercises directly related to the topic(s) being studied.
5. Surveys/questionnaires/interviews, if used, may contain sensitive personal questions (e.g., questions about alcohol/drug use, sexual behavior/attitudes, criminal activity, medical history, grades/test scores) or other personal information only if surveys are completely anonymous.
6. No University faculty, staff or student is receiving monetary compensation or any type of support from an external company/organization/agency for collecting, analyzing or reporting the results of this project.
7. The project is not conducted on the VA premises and does not use the VA resources, and is not otherwise subject to oversight by a federal regulatory body.
8. Subjects are recruited in a voluntary manner.
9. The data are not archived or saved in any way to be used in the future.
10. It is understood that the end result of the research may be presented in the classroom to peers but may not be used for any publication or public presentation outside of the immediate classroom.

IRB Approval for Class Projects

Student class assignments that are intended to collect information systematically with the intent to develop or contribute to generalizable knowledge (e.g., publish or disseminate data) meet the federal regulatory definition of “research.”  These class assignments fall under the jurisdiction of the IRB and require IRB application, approval and oversight.  Instructors wishing to use such assignments must apply to the appropriate IRB for review and approval of these assignments before they begin.

Faculty Obligation and Class Assignments

Some faculty design class assignments that involve questionnaires, interviews, or other interactions with individuals, such as those commonly used in research methods courses. In these cases, faculty should consider if such assignments should be reviewed by IRBs to ensure the protection of human subjects.

Most student class assignments pose little or no risk to students or others.  However, faculty should take special care to ensure that students realize the potential for harm and take all possible steps to eliminate the risks to students or individuals outside the class involved in the assignment.  These risks may include: physical harm, or potential psychological, social, economic, or legal harm, especially when data is collected about sexual activity, use of alcohol or illegal drugs, or involvement in illegal activities.  Such risks can be exacerbated when the individuals outside the classroom are minors, pregnant women, prisoners, or people who are otherwise vulnerable, such as cognitively impaired persons.

It is best practice to check with the IRB for a determination regarding whether IRB review is necessary for class projects.

The guidance documents have been updated and will be posted soon – please check with our office for the most updated version!

A Pediatric Research “Assent Matrix”
Alabama Law on Children, Minors, Consent, and Other Research-Related Topics
Copyrighted Instruments and IRB Applications
Department of Defense Regulations for Human Subjects Research
Department of Energy Regulations for Human Subjects Research
Developing a Data and Safety Monitoring Plan (DSMP) or a Data Safety Monitoring Board (DSMB)
Environmental Protection Agency Requirements for Human Subjects Research
Evaluating Sound Study Design
Examples of Assent Forms
Family Educational Rights and Privacy Act (FERPA)
General Responsibilities of Investigators
Information on Oral History Projects
Informed Consent
International Research
IRB Advertising Guidelines
IRB Application Guide
IRB Determinations and Motions
Investigators and Legally Authorized Representatives
Legislation on School-Based Surveys and Passive Consent: No Child Left Behind (Public Law 107-110)
Mandatory Reporting Laws Affecting Research Conducted in Alabama
Meaning of Departmental Signature on Signature Assurance Sheet
Minor Changes to Approved Protocols
Model Telephone Consent
Protection of Human Subjects in HIV/AIDS-Related Research
Public Datasets Approved for Secondary Analysis Without IRB Review
Regulatory Requirements for Investigators Who Hold INDs or IDEs
Reportable Events
Research and You: Know Your Rights (English and Spanish)
Student Researchers at UA
Student Research Participants
Template: Informed Consent
Template for Study Presentation for Web Surveys
The Meaning of Anonymous, Confidential, and De-Identified and Implications for Data Sharing or Re-Use
Use of Deception/Concealment in Research
Writing Understandable Consent Forms

01-21-19: The 2018 Common Rule regulations that apply to human research will go into effect.

12-10-15: The Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule (45 CFR 46: Federal Policy for the Protection of Human Subjects) has been extended.  The new comment period deadline is January 6, 2015.  Please see the note below for additional information regarding the submission of comments to OHRP regarding the NPRM.

11-9-15: Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule (45 CFR 46: Federal Policy for the Protection of Human Subjects)

The Department of Health and Human Services (DHHS) Announces Proposal to Improve Rules Protecting Human Research Subjects

The U.S. Department of Health and Human Services, along with fifteen other Federal Departments and Agencies, has announced proposed revisions to the regulations for protection of human subjects in research. On September 8, 2015, a Notice of Proposed Rulemaking (NPRM) was published in the Federal Register to revise the Common Rule. The NPRM seeks comment on proposed changes.  Comments regarding the NPRM may be submitted to the Office for Human Research Protections (OHRP) until December 7, 2015 electronically, by mail, or by hand/courier.  Instructions for submitting comments can be located on the OHRP webpage at the following link: http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html

7-17-15: Change in State Law regarding Age of Consent/Majority

In May 2015, Governor Robert Bentley signed into law Act 2015-167, which lowered the age of consent to participate in research (“age of majority”) to 18 years old for IRB-approved research conducted by a federally accredited college or university. Therefore, parental permission is no longer required for 18-year-olds who may now provide their own consent to participate in IRB-approved research conducted at UA.

The UA IRB has updated its relevant policies, guidance, and forms. The revised IRB documents must be used for all IRB submissions (new, modification, and continuing review/renewal) received within the Office for Research Compliance beginning July 17, 2015.

Please click here for additional information.

9-16-2014: NEW – Access to CITI Training via myBama Login Portal 

University of Alabama faculty, staff, and students can now access the CITI Program’s Human Subjects Research Training through their existing myBama accounts.  Access to CITI via myBama is ONLY for individuals with valid myBama accounts. UA users should log into the myBama CITI Login Portal using their myBama user name and password (NOTE: a separate CITI login is no longer required).  All other non-UA investigators should go to www.citiprogram.org to access the training.  Training must be completed/updated every three (3) years.

09-03-2014: NEW GUIDANCE DOCUMENT:  “U.S. Environmental Protection Agency Requirements for Human Subjects Research” has been added to the list of Guidance Documents.  The topic “Environmental Protection Agency” and the document have also been added to the FIND IT FAST grid.

07-28-2014: The UA guidance document on Department of Defense Regulations for Human Subjects Research has been updated.  The following changes have been made to the document at this time:

• Additional protections for military research participants to minimize undue influence
• Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D
• Waiver of consent is prohibited for classified research and “experimental subjects”
• If obtaining consent from the LAR of an experimental subject, the IRB must determine that the research will benefit the subject.
• Additional safeguards for international research to minimize risks, host country approval, investigator permission, and international collaborators
• Additional requirements for reporting of non-compliance or suspension/termination of DoD-sponsored research
• Formal agreement between organizations is required for multi-site research

07-28-2014: Investigators working on FDA regulated studies should note the following additional FDA requirements for informed consent:

• As of March 7, 2012, the FDA requires the following language in all consent forms for drug or device clinical trials that are initiated on or after that date:  “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U. S. Law. This website will not include information that can identify you.  At most, the website will include a summary of the results. You can search this website at any time.”
• The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in circumstances where the research meets criteria for “emergency research”.
• The FDA permits waiver of documentation of informed consent if certain criteria are met.

Does your project need IRB approval?

1. Is your project considered research?
For IRB purposes, research is defined as “a systematic investigation, including research development, testing and  evaluation,       designed to develop or contribute to generalizable knowledge”.

2.  Does it involve human participants?
A human participant is a living individual about whom or from whom an investigator obtains data through intervention or interaction with the individual or through records containing identifiable private information.

If you answer “yes” to both of these questions, you need to have the IRB approve your project before you begin conducting any research. Click here to find out whether your proposal might qualify for expedited review.

The policies have been updated and will be posted soon – please check with our office for the most updated version!

Allegations and Findings of Noncompliance
Appropriate and Equitable Selection of Subjects
Authority and Independence of the IRB in Protecting Human Research Participants
Closure of Approved Protocols
Conflict of Interest for IRB Members, Chairs, and Consultants
Conformity of Investigational or Unlicensed Test Articles (Devices) to Federal Regulations
Conformity of Investigational or Unlicensed Test Articles (Drugs, Biologics) to Federal Regulations
Continuing Review of Approved IRB Protocols
Creation, Revision, Review, and Dissemination of Policies for Human Research Protection Program
Data and Safety Monitoring in Proposed Research
Documentation of IRB Discussions and Decisions (IRB Minutes)
Educational Opportunities for the Community
Emergency Use of a Test Article
Expedited Review
Faculty Use of Students as Research Participants or Paid or Unpaid Assistants in their Research
Federalwide Assurance (FWA) for Protection of Human Subjects

Financial Conflict of Interest
Full Board Review of Protocols
Human Research Determination
Human Research Participant Protection Plan
Identifying and Minimizing Risks to Human Research Participants
Improving Qualifications and Expertise of IRB Members, Investigators, and Office for Research Staff
Institutional Commitment to Protection of Human Subjects by the IRB
Investigator and Staff Response to Participants’ Questions, Complaints, and Concerns
Investigator Assessment of Participant Comprehension
Investigator Input into the HRPP/IRB Review Process
Investigator Responsibility for Informed Consent Process and Documentation
IRB and Investigator Responsibilities for Applications Involving Declared or Undeclared Investigator Conflicts of Interest
IRB Application for Modifying Approved Protocols
IRB Record Keeping and Management
Monitoring of Previously Approved Research for Cause: Suspension and Termination
Obtaining Additional Expertise or Expert Consultation for IRB Reviews
Participant and Community Questions, Suggestions, Complaints, and Concerns about Research Studies
Protection of Children in Research
Protection of Human Research Participants’ Privacy and Confidentiality
Protection of Pregnant Women, Fetuses, and Neonates
Protection of the Cognitively Impaired
Qualifications and Responsibilities of Investigators
Reportable Events: Protocol Deviations, Unanticipated Problems, and Adverse Events
Research Involving Prisoners
Research Involving the Internet
Research Using a Limited Data Set
Research Using a Restricted Access Data Set
Research Using Publicly Available Datasets
Research Utilizing Records, Chart Reviews, and Case Studies/Reports
Review and Oversight of Research Conducted at Multiple Sites
Review for Exemption
Routine Post-Approval Monitoring of Protocols (PAM)
Sponsored Projects Agreements for Human Subjects Research and Human Research Protections
Student Research Pools
Subject Recruitment and Compensation
University Expectations for Persons Involved with HRPP
University of Alabama Policy on Conflict of Interest/Financial Disclosures in Research and Other Sponsored Programs
Waivers, Alterations, and Exceptions to Informed Consent or its Written Documentation

Office for Human Research Protections (OHRP)

• The OHRP is a division of the U.S. Department of Health and Human Services.  The homepage contains news, information, and links relevant to the IRB policies and procedures, including an IRB member guidebook.
• Code of Federal Regulations, Protection of Human Subjects

Food and Drug Administration (FDA)

• The FDA’s home page contains news and information regarding the FDA, as well as links to human research participant protection information.
• FDA’s Guidance on Protection of Human Subjects.  The FDA’s information sheets regarding the projection of human participants for IRBs and investigators; includes a guide on informed consent.

Under federal regulations, any research activity involving a human participant cannot commence until all persons involved in the research are appropriately trained. All investigators who submit protocols are required to have IRB training regardless of whether the project is funded or unfunded. This educational requirement includes not only training for the principal investigator but also training for co-investigators, students and any personnel on the project who will be collecting data, intervening with the human participant or who has access to identifiable data. This requirement comes as a condition of UA’s IRB registration and Federalwide Assurance (FWA) through the U.S. Department of Health and Human Services. Training must be completed every three years. The Office of Research Compliance will notify investigators of when their training expires.

The training requirement may be fulfilled by completing the appropriate Collaborative Institutional Training Initiative (CITI) Program training module for either medical or non-medical research. CITI training is valid for three (3) years.

University of Alabama faculty, staff, and students can access the CITI Program’s Human Subjects Research Training through their existing myBama accounts. Access to CITI via myBama is ONLY for individuals with valid myBama accounts. UA users should log into the myBama CITI Login Portal using their myBama username and password (NOTE: a separate CITI login is no longer required individuals with myBama accounts)

All other non-UA investigators should go to www.citiprogram.org to access the training.

Select the appropriate training course:

“Medical Research Investigators

                        or

“Non-Medical Investigators”

from the UA curriculum list within the CITI Program.

Training must be completed/updated every three (3) years.

Please note the trainings listed below will not substitute for the CITI Program’s Human Subjects Research Training:

• The NIH Office of Extramural Research training will no longer be accepted nor will it substitute for the CITI Program’s Human Subjects Research Training
• The Responsible Conduct of Research (RCR) Training will not substitute for the basic human subjects training course

The Health Insurance Portability and Accountability Act (HIPAA) Training

• UA HIPAA Training
• CITI Health Information Privacy and Security (HIPS) http://www.citiprogram.org

The IRB & You – How to Submit an IRB Application

Please click the link below to register for the IRB training session.

https://ualms.docebosaas.com/learn/course/internal/view/classroom/13276/the-irb-you-how-to-submit-an-irb-application