秘密研究所

Institutional Review Boards were created as a result of instances of research misconduct throughout history. These instances caused serious harm to human subjects and has had a lasting effect within communities being recruited to participate in research studies. Some of the most infamous were the Nazi war crimes during World War II, the Willowbrook hepatitis study and the Tuskegee Syphilis study. These events have resulted in the publishing of ethical research foundations to be followed such as:

• The Declaration of Helsinki

In 1974, the National Research Act was passed in the United States which brought about the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission, responsible for creating the Belmont Report, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. These principles are as follows:

• Respect for persons establishes that all individuals should be treated as autonomous agents and those with diminished autonomy are entitled to protection.
• Beneficence is the concept that researchers should do no harm as well as maximize possible benefits and minimize possible harms.
• Justice is the fair distribution of the risks and benefits. No one group of individuals should bear the burden of research without benefiting.

This document summarizes key points and principles set forth in each of these foundational documents.

IRBs follow a list of Exempt and Expedited review categories, set by federal regulations. All study activities must fit into one or more of these categories to be eligible for their respective levels of review. A full list of these IRB review categories can be found here.

Examples of Exempt Categories
Category 1:
Example 1 - A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, investigators will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
Example 2 鈥� Comparing two curricula that are currently being implemented in a school. Investigators will observe classrooms and interview instructors about their experience implementing the materials (but not about specific students).

Category 2:
Example 1 鈥� Anonymous surveys regarding workplace satisfaction
Example 2 鈥� Interviews of college students about their plans after graduation
Example 3 鈥� Focus groups with expectant mothers regarding perceptions of parenting education

Category 3:
Example 1 鈥� Solving puzzles under various noise conditions taking 2 hours
Example 2 鈥� Asking subjects to play an online game that takes 30 minutes to complete

Category 4:
Example 1 鈥� Patient medical chart reviews
Example 2 鈥� Secondary analysis of coded survey results

Category 5:
*Exempt category 5 only applies to research on public benefit programs such as Social Security, Medicare and Medicaid, etc. and is rarely used at universities.

Category 6:
Example 1 鈥� A taste-test on different varieties of fruit to determine consumer preference when the fruits do not have any additives and subjects are asked to indicate which they prefer
Example 2 鈥� Taste-testing of various beef products from cattle that have been given feed

Examples of Expedited Categories
Category 1:
Example 1 鈥� Comparing how different over-the-counter bandages affect wound healing
Example 2 鈥� Analysis of how well standard doses of over-the-counter NAIDs relieve headache pain in adults

Category 2:
Example 1 鈥� Analysis of glucose levels in healthy adults using a finger stick glucometer
Example 2 鈥� Analysis of human blood interactions with various types of synthetic biomaterials

Category 3:
Example 1 鈥� Collection of buccal swabs to analyze enzyme function
Example 2 鈥� Collection of saliva samples to test for markers of environmental sensitivity using genotyping techniques

Category 4:
Example 1 鈥� Analyzing brain activity through Electroencephalogram (EEG) while viewing different media
Example 2 鈥� Magnetic Resonance Imaging (MRI) scans used for recording brain signals from the motor cortex

Category 5:
Example 1 鈥� Patient registry trials
Example 2 鈥� Analysis of previously collected specimens that contain identifiable information

Category 6:
Example 1 鈥� Any project involving the collection of audio/video recordings of minors
Example 2 鈥� Audio/video recordings of vulnerable populations

Category 7:
Example 1 鈥� Focus groups or interviews of a sensitive topic or that include minors as participants

The review process begins once your project is submitted to the IRB office. All IRBNet submissions are routed to the USA IRB Administrator who assigns each project a local reference number and conducts a pre-review. This pre-review includes ensuring all required documentation is included and adequately completed, all training has been provided, all required signatures have been obtained, etc.

During the pre-review stage, the IRB Administrator also determines the level of review. The level of review (Exempt, Limited, Expedited or Full Board) is determined based on the study鈥檚 level of risk. The risk level of a study is based off of the concept of minimal risk, which is defined as 鈥渢he probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests鈥�.

Exempt studies are considered less than minimal risk such as anonymous surveys, retrospective chart reviews, benign interventions, etc. Exempt studies are reviewed and approved by the IRB Administrator or IRB staff.
Limited Review studies are a subset within the Exempt realm. The difference between the two is that the identity of the participant is readily ascertained by investigators within Limited Review studies. This includes, but is not limited to, audio or video recorded interviews, focus groups, or longitudinal surveys where personally identifiable information is retained. All Limited Review studies are reviewed by our EBR committee within a convened setting.
Expedited studies are considered minimal risk and include noninvasive biological specimen collection, the collection of data via physical sensors, interviews of sensitive topics, etc. Expedited studies under the purview of the EBR committee are reviewed in a convened setting; Expedited studies under the purview of the Biomedical committee are reviewed by a single IRB member.
Full Board studies are those that are greater (but not significantly greater) than minimal risk such as experimental drug or device studies, blood draws over a certain parameter, studies that require anesthesia or sedation, etc. All Full Board studies are reviewed by a full IRB committee in a convened setting.

Once the level of review is determined, the study/project is routed through the appropriate channel.

Visual representation of the full review process.

Educational and Behavioral Research IRB

The Educational and Behavioral (EBR) IRB committee is responsible for reviewing all social, educational, behavioral and exercise science research conducted at USA. This includes survey or interview research, educational initiatives, exercise interventions/testing and non-invasive physical measurements.

At the 秘密研究所, all Limited Review and Expedited status studies under the purview of the EBR committee are reviewed in a convened setting.

The EBR committee meets every 3 weeks. Submission deadlines for these convened meetings can be found on the IRB Calendar.

Biomedical Research IRB

The Biomedical IRB committee is responsible for reviewing all biomedical research conducted at USA. This includes all FDA regulated research, medically invasive procedures, retrospective and prospective medical chart reviews, and the collection/storage of biological specimens.

The Biomedical IRB committee meets every second Tuesday of the month. Submission deadlines for these convened meetings can be found on the IRB Calendar.

Projects requiring review by a single committee member or the full board are voted on for an approval determination. The following are voting options granted to committee members and their respective meanings:

• Approve 鈥� The study is approved as is and can begin once the investigator receives written documentation of IRB approval.
• Modifications Required 鈥� The study requires minor changes or clarifications. Revisions are reviewed by IRB administrative staff and, once satisfactory, the research may proceed once the investigator receives their letter of IRB approval.
• Information Required 鈥� The study requires more than minor changes or clarifications. Revisions are reviewed by the primary and/or secondary reviewer and, once satisfactory, the research may proceed once the investigator received their letter of approval.
• Defer 鈥� Substantial changes are necessary before approval can be granted. The investigator鈥檚 response, along with and revised materials, must be reviewed at the next convened IRB meeting.
• Suspension/Termination 鈥� This determination may be made due to an adverse event, noncompliance, or other danger to human subjects. The IRB Chair or the convened IRB may suspend a study at any time. Once a study has been suspended, the convened IRB reviews the study and either requires changes to the protocol, allows the study to restart, or terminates the study. While the IRB Chair may suspend a study, only the convened IRB can make the decision to terminate a study.
• Disapprove 鈥� The study requires major changes that are not likely to be feasible without a complete reassessment of the protocol by the investigator and/or sponsor. Disapproval is only permissible through a majority vote at a convened meeting of the IRB.

The timeline between submitting your project and receiving approval from the IRB has many variables including how well put-together your initial submission is, the number of currently pending submissions, how quickly the PI/study team is able to respond to revision requests, the timing of when a project requiring committee review is submitted, etc.

For studies requiring Limited, Expedited (EBR), or Full Board review, we highly encourage planning your IRBNet submission around the respective IRB committee鈥檚 submission deadlines and meeting dates listed on the IRB Calendar.

Exempt studies with zero required modifications are typically reviewed and approved within 1-2 weeks after submission. This timeline is extended should your study require modifications such as missing or inconsistent documentation, electronic signatures, etc.

Expedited studies under the purview of the Biomedical committee are typically reviewed and approved within 2-3 weeks after submission. This timeline is extended should your study require modifications before and/or after being sent to a single committee member for their review. All committee members are granted 5 business days to complete Expedited reviews.

Studies that require revisions (Modifications Required or Information Required) are heavily dependent on how timely these revisions are received by the IRB Office. If your study received a:

• Modifications Required letter, your submitted revisions are reviewed by the IRB Administrator. If all revisions are satisfactory, the new timeline for approval is within an additional week. If additional revisions are required, this timeline is extended.
• Information Required letter, your submitted revisions are sent back to the primary reviewer for their additional review. If all revisions are satisfactory, the new timeline for approval is within an additional 5 business days. If additional revisions are required, this timeline is extended.

All Doctor of Nursing Program (DNP) students are required to complete a quality improvement (QI) project during the course of the DNP program. While QI projects do not meet the federal definition of human subjects research, the USA IRB and the DNP Program has partnered over many years to establish an educational pathway for DNP students to exercise creating and submitting their projects within IRBNet.

To learn what materials are required for DNP project submissions, please see our IRBNet Submission and Review site.

To learn what training is required for DNP students, please see our Training site.

Investigators may partner with two or more institutions to conduct human subjects research or be involved in multi-site research studies. To enhance and streamline the IRB review process when such collaborations occur, regulations allow institutions to 鈥渆nter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort鈥� ().

If a non-USA owned IRB is chosen as the reviewing IRB, it is called an 鈥淓xternal IRB," as it is external to our organization. The following are different types of external IRB models:

• Central IRB: A reviewing IRB provides the ethical review for all sites participating in more than one multi-site study. The relying sites are usually in a network, consortium, or particular program such as the National Cancer Institute Adult Cooperative Groups and Children鈥檚 Oncology Group.
• Single Independent or Commercial IRB: The IRB is independent, established for commercial purposes, developing products and services to support the research industry. Pharmaceutical companies conducting multi-site studies may rely on 鈥楽ingle Independent (Commercial) IRBs to coordinate IRB review services (e.g., WCG).
• Single IRB, or sIRB: A reviewing IRB, selected on a study-by-study basis by partner institutions, provides the ethical review for all relying sites participating in that multi-site study (two or more sites).

The USA IRB authorizes the use of a designated external IRB through an administrative review.  The external IRB agrees to take the responsibility of IRB oversight and perform IRB functions in compliance with applicable federal and state regulations for new research studies conducted at USA.  The USA IRB conducts an Administrative, or ceded, review of studies requesting use of external IRB oversight.

Whichever IRB is utilized as the reviewing IRB is referred to as the IRB of Record for that particular study. It is vital that research teams know who the IRB of Record is for their studies, as IRBs may have differing policies and reporting procedures. Additionally, the IRB of Record is responsible for the continuing review of the research study. 

• National Cancer Institute Central IRB - NCI CIRB
  秘密研究所 investigators intending to conduct any clinical trial reviewed and approved by the NCI CIRB must utilize the CIRB as the IRB of record for the study.  When planning to initiate a NCI sponsored cooperative group trial, consult the to see if the trial is listed on the menu of CIRB approved trials.  
  
  See IRB SOP 1102 for USA's NCI CIRB Policy and Procedures.
  For information on how to perform NCI CIRB submissions, please click here.
  
  
  
• WCG IRB
  WCG IRB is an independent, commercial IRB that USA investigators may utilize for specified studies when conducting multi-site research facilitated by an outside sponsor. 
  
  See IRB SOP 1101 for criteria of studies eligible for review by WCG.
  For information on how to perform WCG submissions, please click here.
  
  
• Other External IRB
  

  USA Investigators may rely on an outside Institution's IRB or another commercial IRB when conducting multi-site research.

Before the research using an outside IRB can begin, USA IRB must enter into a Reliance Agreement (also referred to as an Authorization Agreement) with the external IRB.  A reliance agreement is a formal, written document that provides a mechanism for institutions partnering in research to rely on one IRB to be responsible for multi-site IRB review.

The Reliance Agreement will clearly establish the roles and responsibilities of the Reviewing IRB and the Relying IRB. The Reviewing IRB takes on IRB oversight responsibilities associated with the study throughout its duration. Relying IRBs provide key local context information about state law, study team member training and qualifications, and any applicable conflict of interests. At this time, the 秘密研究所 will only serve as the Relying IRB.

Reliance Agreements are coordinated through online portals, such as SMART IRB, among others. These portals do not serve IRB functions, but rather act as a platform to connect various IRBs. Study teams should be familiar with who is serving as the Reviewing IRB (the IRB of Record), as well as how to locate their policies and procedures.

Note: The USA IRB does not require reliance agreements for studies with Exempt status. These arrangements are only necessary for all non-Exempt research studies where the USA IRB will rely on an external IRB. 

If your study requires a Reliance Agreement, The Office of Research Compliance and Assurance will need to facilitate review and completion. Please contact dlayton@southalabama.edu

To request review by an external IRB, the USA investigator / research site must first receive an acknowledgement letter from the USA IRB via . For instructions on how to get started with IRBNet, see our IRBNet guidance page.

Initial Submission

1. Once you are in IRBNet, create a new project. Package 1 should include the following:
   • USA IRB Application Part A (Wizard)
   • 'External Review Request' Form
   • Study Protocol
   • Informed consent with applicable USA boilerplate language included
2. All Key Personnel listed on IRB Application Part A must have completed the required applicable human subject training.
3. The Principal Investigator must electronically sign Package 1
4. An acknowledgement letter will be published in Package 1
   • Do not submit to any external IRB without receipt of USA IRB acknowledgement letter

Post-Approval Submissions

Although the USA IRB has ceded study review to the IRB of Record, there are some items that require submission to the USA IRB through IRBNet post study approval. These include:

1. Annual Check-in
   • Note, this is not the same as a continuing review and may occur at a different time than the continuing review required by the IRB of Record. The study team should pay attention to the renewal date listed on the USA IRB Acknowledgement letter and reminders sent from IRBNet. The 'Renewal - Annual Check-In' form should be submitted through IRBNet.
     
     
2. Reportable events including:
   • Change in PI/Key personnel
   • Change in funding
   • Change in study title
   • Updated local recruitment/advertising materials
   • Subject complaints
   • Conflict of Interest updates
   • Breaches of confidentiality/ HIPAA privacy or security violations
   • Protocol deviations that may represent a systematic problem requiring local evaluation by USA IRB to determine that sufficient local resources are available for safe conduct of the study
   • Study holds/suspensions from the IRB of Record or Sponsor that are not built into the study design
   • Study terminations from the IRB of Record or Sponsor
   • Any death of a participant outside of death as a result of natural disease progression
     
     
3. Study Closure
   • Once all subjects at the site have finished their final visits and follow up and there will be no further interaction with Human Subjects, the 'Closure Form' should be submitted through IRBNet.