Research Ethics & Compliance

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.

• Human Research Determination Checklist (DHHS and FDA)

If you answer “yes” to both of these questions, you need to have the IRB approve your project before you begin conducting any research.

Before You Submit

Determine Who May Serve as Principal Investigator

Every research study requires a Principal Investigator (PI). This person takes full responsibility for the conduct of the study including the eligibility and training of the research staff.

Identify the Study Team

Determine whether any member of the team has a financial interest. Investigators must submit a disclosure of financial interests other than those included on an external activity request.

• Investigator Statement of Financial Interest

Complete Training

Under federal regulations, any research activity involving a human participant cannot begin until all persons involved in the research are appropriately trained. 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. Training must be complete before protocols are submitted, regardless of whether the project is funded or unfunded.

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. University of Alabama faculty, staff, and students can access the CITI Program’s Human Subjects Research Training through their existing myBama accounts. UA users should log into the myBama CITI Login Portal using their myBama username and password. All other non-UA investigators should go to www.citiprogram.org to access the training.

Please note the training 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.

Gather Support Documents

Support documents may include:

• CONSENT DOCUMENTS
  • Informed Consent Template : Consent forms will need to include a brief summary that explains the research to potential participants in an easy-to-understand and clear manner. It is now mandated that consent forms be concise while also giving the full context of a study, including its risks and benefits, so potential participants have all the information they need to make an informed decision. Consent forms will also need to include information regarding the potential for future use of de-identified data and biospecimens.
  • Writing Understandable Consent Forms (link to doc)
  • Model Telephone Consent
  • Template for Study Presentations for Web Surveys
  • Use of Deception/Concealment in Research
  • Decision – Making Capacity Assessment
  • Signature Assurance Sheet:The Principal Investigator (PI) and one other person (Dean, Associate Dean, Chair, Supervising Professor, or departmental designee) must sign and submit before application can be reviewed by IRB.
    • Meaning of Departmental Signature On The Signature Assurance Sheet (link doc)

• Copies of all instruments to be used must be submitted as appendices to the application. Copyrighted Instruments and IRB Applications

• RECRUITMENT & ADVERTISING STRATEGIES
  • The IRB must review all means of recruiting subjects to participate in a research study, including advertisements prior to publication.
  • IRB Advertising Guidelines (Link doc)

• DATA TRANSFER AND USE AGREEMENT – see ORTA page to be cohesive
  • Developing a Data and Safety Monitoring Plan (DSMP) or a Data Safety Monitoring Board (DSMB)
  • The Meaning of Anonymous, Confidential, and De-Identified and Implications for Data Sharing or Re-Use

• SPECIAL DOCUMENTS FOR INTERNATIONAL STUDIES
  • Translator’s Declaration: This form should completed by the identified translator of any project related documents including but not limited to the IRB approved Informed Consent Form, or recruitment materials such as advertisements. This form is to be included along with the translated documents for all projects proposing to recruit and enroll individuals who may have limited English proficiency.

• SPECIALTY PROJECTS
  • Information on Oral History Projects
  • Protection of Human Subjects in HIV/AIDS-Related Research

The e-Protocol system may be accessed via the myBama portal using your UA credentials.

Once logged in, select the following tabs: Research > Research Systems > eProtocol for IRB & IACUC > IRB > eProtocol (left top corner) > Investigator > Create Protocol

Proceed to follow prompts to complete and submit the application.

Your project will then be processed by our office. An IRB analyst will contact you if additional information is needed.

Learn more and get hands-on experience with our virtual training sessions: The IRB & You – How to Submit an IRB Application.

Review Type

1. Exempt

• Research that involves no more than minimal risk and meets criteria specified by federal regulations may qualify for exemption.  Exempt is a category and still requires an application to the IRB.  Please note that only the IRB can determine whether human subjects research is exempt.

• The exempt determination process begins by submitting an initial application via the e-Protocol system. 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.  You can identify the application type as exempt by selecting “Study Eligible for Exempt Review” within the General Checklist section of the application. 

• For a study to be eligible for exemption, all research activities must fit in one or more of the six categories listed below. Please note the University of Alabama does not review research protocols for exemption under regulatory categories #7 or #8 at this time.

Meeting Schedule: Research projects that fall in this category are reviewed on a rolling basis.

2. EXPEDITED

Expedited review refers to certain types of research considered to involve minimal risk to participants.
Meeting Schedule: Research projects that fall in this category are reviewed on a rolling basis.

3. FULL BOARD REVIEW (MEDICAL AND NON-MEDICAL)

The University of Alabama has two Institutional Review Boards: a Medical and Non-Medical IRB. The same protocol e-protocol applications are used by both committees.  Both committees review and approve human subjects research in accordance with the Department of Health and Human Services (DHHS) regulations (45 CFR 46).

Most of the research reviewed by the UA full boards falls within the broad categories of medical or social and behavioral research. While it is difficult to draw a clear line between these two broad categories, consideration is given to the research field, characteristics of the subjects, the research procedures or interventions being employed, and the nature of the research risks when determining the appropriate board for review.

The two boards meet on different days to review full board protocol applications and their respective calendars and submission deadlines are provided within the sections below.

• MEDICAL IRB FULL BOARD
  • Research involving physical or physiological methods of evaluation that involve primarily physical risks or that are physically invasive are reviewed by the medical IRB.  The medical IRB typically reviews research involving physical activity, investigational medical devices, venipuncture, x-rays, or the collection of blood samples, or physiological statistics. 
  • Authorization on Use or Disclosure of Health Information
  • Notification to IRB of Emergency Use of a Test Article
  • Regulatory Requirements for Investigators Who Hold INDs or IDEs

Medical IRB Full Board: Meeting Dates & Submission Deadlines

• NON-MEDICAL IRB FULL BOARD

Non-Medical IRB Full Board: Meeting Dates & Submission Deadlines

Potential Responses Include

Investigators will receive letters from IRB reporting the board’s decision about their applications and describing needed revisions or rationales
for decisions.

• IRB Determinations and Motions

Ongoing Projects

Principal investigators are responsible for ensuring that all subject participation and other research activity occurs only within IRB approval periods. Therefore, they must submit applications for continuing review and modifications of the protocols to the IRB in time to allow continuous approval.

Modifications

Principal investigators are responsible for requesting and reporting modifications, unanticipated events, adverse events, the nature of any new literature that may affect participant risk or benefit to the IRB, and the nature and resolution of participant questions or complaints when requesting continuing review in order to facilitate substantial and meaningful review.

Proposed modifications must be submitted. The e-Protocol system may be accessed via the myBama portal using your UA credentials. Once logged in, select the following tabs: Research > Research Systems > eProtocol for IRB & IACUC > IRB > eProtocol (left top corner) > Investigator > Approved Protocols > select protocol number of project for action to be performed (ex. 20-01-7272) > select desired action (continuing review, amendment, final report, adverse event, etc.)  > Proceed to follow prompts to complete and submit the application. Your project will then be processed by our office. An IRB analyst will communicate to you if additional information is needed.

• Minor Changes to Approved Protocols

Complaint/Concern or Study Problem

Projects that require an Amendment (Modification), Continuing Review (Renewal), Final Report (Closure Form), Serious Adverse Event Form

• Report of Attempt to Exert Undue Influence
• Report of Complaint or Concern About a Research Study
• Report of Study Problem
• Reportable Events

Closing the Study

Investigators (including students) are responsible for notifying the IRB that an approved protocol has been completed and completing the Request for Study Closure (Investigator) Form. If students fail to close their studies, their supervising professors must do so for them.

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.

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.

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

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

• The risk level of the project is minimal (no more than would be encountered in routine daily activities).
• 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.
• No identifiers are collected.
• 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.
• 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.
• 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.
• 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.
• Subjects are recruited in a voluntary manner.
• The data are not archived or saved in any way to be used in the future.
• 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.

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.

What You Should Know Before Deciding to Participate in a Research Study

If you would like to volunteer in a research study, please review the Participant Brochure and FAQs to help you decide whether to take part.

• Research and You: Know Your Rights (English and Espanol)
• Student Research Participants

The following resources are helpful in understanding research, your rights as a participant, and what you should consider before joining a study.

• Finding a Clinical Trial: Search for a trial by disease or geographic location at clinicaltrials.gov.
• Office for Human Research Protections (OHRP)
  • Becoming a Research Volunteer: It’s Your Decision
• Food and Drug Administration (FDA)
  • Clinical Trials: What Patients Need to Know

WHAT IS PERMISSION?

Permission is the agreement of parent(s) or guardian(s) for their child or ward to participate in a research study.

• A Pediatric Research “Assent Matrix”
• Examples of Assent Forms
• Investigators and Legally Authorized Representatives

WHAT IS THE NO CHILD LEFT BEHIND (NCLB) ACT?

The No Child Left behind Act (NCLB) of 2001 was signed into law on January 8, 2002, by President Bush. The Act represents the President’s education reform plan and contains the most sweeping changes to the Elementary and Secondary Education Act (ESEA) since it was enacted in 1965. NCLB changes the federal government’s role in K-12 education by focusing on school success as measured by student achievement. The Act also contains the President’s four basic education reform principles:

• stronger accountability for results
• increased flexibility and local control
• expanded options for parents
• an emphasis on teaching methods that have been proven to work.

Fact Sheet: No Child Left Behind Act

WHAT IS THE AGE OF MAJORITY IN ALABAMA?

The UA IRB policy for recognizing 19 as the age of majority is based on the Code of Alabama (Section 26-1-1) which defines the age of majority as nineteen years of age.

WHO IS A “CHILD” IN ALABAMA?

Under Alabama law, a child is a person under age 19, unless that person is married or otherwise emancipated (independent of parental control). Many UA freshmen are legally children.

• Alabama Law on Children, Minors, Consent, and Other Research-Related Topics

• National Education Association (NEA)
• Family Educational Rights and Privacy Act (FERPA)
• The National Institute of Environmental Health Sciences (NIEHS) Kids Page
• Kids 4 Research has information on animal research studies for students, teachers, and parents.
• Clinical Trials for Children and Teens

More Information on Parental Permission for School-Based Studies

Summary of the federal legislation about school-based research studies

ClinicalTrials.gov Guidance and General Information

ClinicalTrials.gov is a public database developed by the National Library of Medicine (NLM) that offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. The information available on ClinicalTrials.gov includes registration and results reporting information. ClinicalTrials.gov background information can be found on ClinicalTrials.gov.

This information is intended to help University of Alabama Investigators understand the requirements for clinical trials registration, their responsibilities for clinical trials registration, and how to register clinical trials on ClinicalTrials.gov.

To set up a ClinicalTrials.gov account or for any questions, please contact Tanta Myles, Director of Research Compliance and UA PRS Administrator, at cmyles@ua.edu.

Study Requirements For Registration And Results Reporting

Registration And Results Reporting Of A Clinical Trial Is REQUIRED If Your Study Meets One or More of the Following Conditions:

1. FDA Regulated Applicable Clinical Trial.
   • Includes Clinical studies with no external sources of funding (“unfunded” studies).
2. Funded (fully or partially) by National Institutes of Health or National Cancer Institute.
3. Qualifying Clinical Trial which will render claims for items and services from the Centers for Medicare and Medicaid Services (CMS)
   • The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.1 
4. Sponsor Requirements. Many sponsors have their own trial registration and results reporting requirements.

ClinicalTrials.gov Investigator Responsibilities

1. Register
2. Annual, Protocol and Study Status Updates
3. Results reporting

ClinicalTrials.gov Policies & Regulations

• FDAAA 801 Requirements: Food and Drug Administration Amendments Act
• CMS Medicare Clinical Trial Policies
• Final Rule: Clinical Trials Registration and Results Information Submission 2016
• NIH Clinical Trials