Frequently Asked Questions

Exempt Protocols: 1 week
Amendments: Approximately 2 weeks
Expedited Protocols: Approximately 2-3 weeks
Full Board Protocols: Must be submitted at least 2 weeks prior to the meeting. Click here to access the IRB submission and meeting date schedule.

The IRB Office processes the submitted protocol, inputs information into the database, and assigns the protocol a unique IRB number. The protocol is assessed by the IRB office for determination of the level of review. The protocol is then routed through the appropriate review process. The IRB has available a flowchart on the IRB process which details the entire review process from beginning to end.

Your study will require a Full-board review if it involves vulnerable subjects such as children, pregnant women, persons with disabilities, prisoners, and those who are institutionalized. It may also require Full-board review if the research procedures are particularly risky and have notable potential to harm a subject. Your protocol may also require a Full-board review where disclosure of the participant's identity might result in negative legal, financial, economic or social consequences. It is best to candidly describe your research design and procedures and allow the IRB to assess the level of review required.

There are four major areas of concern that are evaluated in determining whether participants' rights and welfare are protected. They are 1) the design of the research, 2) the balance of harm and benefit, 3) the process of informed consent, and 4) the selection of subjects. The research design is considered for several reasons. For example, if a research project is poorly designed, no valuable information is likely to be gained. Thus, such a protocol cannot justify risks or inconveniences to the subject. This is part of conducting the risk-benefit analysis. Another issue is that some individuals think of "informed consent" as a document containing details of the research that is signed by the subject. In the development of your research, think of informed consent as a process. Informed consent means that the subjects truly understand what they are agreeing to and all of the risks and benefits inherent in the activity.

Data collection instruments may be coded (i.e., insert number on paper), and the code linked to a mailing list. As the survey instruments are returned the coded number can be traced back to the mailing list. By matching the code to the mailing list, the researcher will have a record of replies received while retaining anonymity. The mailing list should be destroyed following data collection.

Non-affiliated researchers must seek approval from their institutional IRB first. Next, depending on the nature of the research, the USA IRB can do several things: 1) Defer to the primary institution's IRB; 2) Require the non-affiliated researcher to complete a USA IRB application and apply for approval according to USA's standard operating procedures. If it is determined that the project requires an approval at USA, the researcher will need to find an on-campus faculty member in the appropriate discipline to endorse the project and to act as a liaison/contact for the project. USA IRB will accept documented evidence of IRB training from other institutions.

If a class project is done with the intent to share information within a classroom, IRB review is not required, because the federal regulations define "research" as a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. However, if you plan to publish your data in any way (e.g. abstract, article, poster) or plan on sharing your data outside of a classroom setting, then you should contact the IRB.

Yes, the Office of Research Compliance or IRB staff is available to discuss the importance of protecting human subjects/participants and the procedures with any group on campus.

USA's Federalwide assurance proof of approval and IRB registration can be founding by clicking here.

Federalwide Assurance Number is FWA00001602
Expiration date: 11/20/2011. This applies to all human subjects activities, regardless of the funding source.

IRB Registration Number
IRB00000286 - U of South Alabama Coll of Med

Yes, unless the cell line has been characterized to be free of human pathogens. The letter of interpretation from OSHA can be accessed by clicking here.

Yes, human blood, body fluids, tissue or waste specimen, human cell lines and non-human primate cell lines need an IBC application and are handled at the BSL-2 level. In some cases, the use of bloodborne pathogens may also need IRB approval. For further information about the use of human subject or blood, and tissue from human subjects, please contact the Office of Research Compliance and Assurance (ORCA). Additionally, if a cell line that the PI creates and is a species that may harbor a zoonotic agent then an IBC application is needed.

If it is a non-human/non primate line from a public-commercial company (e.g. one that certifies reasonably healthy lines), a protocol may not be necessary. If it is a cell line that the PI creates and is of a species that "could" harbor a zoonotic agent then an IBC protocol would be needed.

If the hazardous materials are to be shipped, then a certain amount of training is involved depending on what it is. There are two categories requiring differing levels of instruction, the most stringent of which requires actual certification. It all depends on the risk associated with the substance that you are shipping. USA has both trainings available and tools to help you decide what category the hazardous substance fits in to. Training materials and tools can be accessed by clicking here.

The fit tests are to be done annually for BSL-3 work and anytime there are changes in the fit of the respirator, e.g. large weight gain or loss, facial injury/surgery. The appropriate respirator will be selected for you, fit tested on you by a member of Safety and Environmental Compliance (SEC) to ensure proper fit and seal, and you will be trained on the proper use and maintenance.

There is a form for the researcher to complete with the information specific to their lab. That information is used to fill in the signs using a software program and print them out. Sign holders for the lab door signs can also be provided. Other templates are available as well. e.g. the Satellite Accumulation Area signs. Contact Safety and Environmental Compliance at 460-7070.

IBC registrations are through our online protocol management system, IRBNet.  The P.I. will need to complete the protocol application form and the IACUC/IBC Application Form (wizard). Both of these forms can be found and submitted as a new project in IRBNet. Every three years the PI will receive a notice asking if the study has changed, remained the same, or needs to be cancelled and the laboratory will be inspected once a year by the IBC. At any time, amendments can be submitted.

The Occupational Safety and Health Administration (OSHA) requires individuals working with bloodborne pathogens must undergo bio-safety training on a yearly basis. As per our institutional policy, any PI with an approved registration from the IBC must undergo that same training yearly. This also includes any associates that are listed in the protocol. Training is located online at CITI Program. Reminders will be sent when it is time to renew.

An export is an actual shipment or transmission of any commodity (equipment or hardware) out of the United States, or the release of technology (technical data or information) about controlled commodities, or software (commercial or custom-made) to a foreign national out of or within the United States.

• Prevent Terrorism
• Curtail export of technologies that assist the military potential of adversaries
• Compliance with Trade Agreements
• Prevent development of nuclear, chemical and biological weapons

Does the activity involve:

• A foreign company whether the activity is conducted in the US or abroad?
• A foreign national
• A contract with a restriction on the participation of foreign nationals or other restrictions?
• A contract with a publication restriction or an associated NDA or proprietary rights agreement?
• Taking equipment overseas?
• Foreign nationals (faculty, postdocs, students, visiting scholars, collaborators, etc) using equipment on USA campus?

It is very likely that you already own items that are one the Commerce Control List (CCL). Computers, smart phones, MP3 players, GPS navigation systems, every day software (Window operating systems),etc all have components included in the descriptions on the CCL. Almost all are covered under a "mass market" exemption, but it shows how diligent universities have to be with the equipment contained labs and the data being collected. The potential to come across something "controlled" is unlikely.

A deemed export is the transfer, release, or disclosure to foreign persons in the United States of technical data about controlled commodities. A transfer of "technology" or "technical data" to the foreign person is "deemed" to be an export to the home country of the foreign person. In non-government speak: If you are talking to someone from a foreign country, you are considered to be exporting the information contained in your discuss to where ever they are from. i.e. If you are having lunch at Panera Bread with a friend from Germany, your conversation is "exporting" information to Germany.

There are several exclusions, but two are particularly relevant to academic research: the fundamental research exclusion and the public domain exclusion. These exclusions can become void, if researchers make side agreements that contain publication restrictions or restriction on who may participate in the research. Specifically,

• Public Domain
  • publication in periodicals, books, print, electronic, or other media available for general distribution (including websites that provide free uncontrolled access) or to a community of persons interested in the subject matter, such as those in a scientific or engineering discipline;
  • readily available at libraries open to the public or at university libraries;
  • patents and published patent applications available at any patent office; and
  • release at an open conference, meeting, seminar, trade show, or other open gathering held in the U.S. (ITAR) or anywhere (EAR).
• Education
  • exclusion for "educational information" released by instruction in catalog courses and associated teaching laboratories. So, in general, no need for a license to share information as part of a regular course being taught at USA.
• Fundamental Research Exclusion (FRE)
  • Fundamental research is defined as basic and applied research in science and engineering conducted at an accredited U.S. institution of higher education where the resulting information is ordinarily published and shared broadly within the scientific community.

IF IT MEETS THIS CRITERIA, THEN EXPORT CONTROLS DON'T APPLY

University research will not be deemed to qualify as fundamental research if:

• The university accepts any restrictions on the publication of the information resulting from the research
• Research is federally funded and specific access and dissemination controls regarding the resulting information have been accepted by the university or the researcher.

• Discussing non-public domain technology with foreign companies and foreign nationals without have an export review done.
• Taking controlled technology oversees without having an export review done
• Taking foreign nationals on lab tours without first discussing with the Office of Research Compliance and Assurance

Possibly. Microsoft provides information on their website at http://www.microsoft.com/en-us/exporting/exporting-information (each for "export control") that lists their different hardware and software products along with the DoC ECCN (export classification number) and the status of this item relative to requirement of a license for export.

The Institutional Animal Care and Use Committee (IACUC) oversee the responsible use of animals in University research and instructional activities, including field research. The IACUC reviews protocols, reviews the animal care and use program, and monitors University animal facilities to ensure compliance with institutional and federal standards and regulatory requirements.

The IACUC meets on the third Thursday of every month. Meeting dates and submission deadlines can be found on the IACUC website.

You will need to complete the specified training requirements, as well as, enroll in the Occupational Health Program (OHP) before you are able to work with animals. The training requirements can be found on the IACUC website, or by clicking here.

Anyone who works with animals must complete training and OHP. An OHP waiver may be requested in circumstances where the named PI of the protocol does not plan to handle the animal in the conduct of the planned animal research activity. These requests require approval by the University's veterinarian.

Your training is only good for three years. The CITI on-line training program will send you e-mail messages asking you to update your training, sixty days before it expires. OHP participation is initiated prior to any animal work being conducted and then updated every three years. Except for those employees who handle non-human primates or ABSL-3 workers who require annual updates.

USA uses an online protocol management program called IRBNet to submit protocols.   The P.I. will need to complete the protocol application form and the IACUC/IBC Application Form (wizard). Both of these forms can be found and submitted as a new project in IRBNet. Every three years the PI will be required to submit a new protocol to the IACUC. At any time, amendments can be submitted.

USA requires IACUC approval for work with live vertebrates. The IACUC must review ALL projects involving the use of ANY vertebrate animals for ANY purpose (including, but not limited to, biomedical and behavioral research, teaching, testing, field work and exhibition projects) to ensure compliance with USA policies and federal regulations. Even studies which involve no direct contact with vertebrate animals but which affect animals through influencing or changing their habitat (e.g. observing the result of outside stimulus on bird calls, observation of fish or wildlife after modifying their habitat or interrupting their daily routine) must be submitted for the Committee's consideration prior to initiation

Procedures are classified according to the level of potential pain or distress that the animal may experience. If more than slight or momentary pain and distress could be caused by the procedure, then relief must be provided (pain class D). If relief cannot be provided (pain class E), there must be scientific justification for the withholding of relief, the justification must be included in the animal use protocol, and it must be approved by the IACUC. Additional information can be found in the USDA Animal Care Resource Guide, Policy #11, Painful Procedures.

Multiple Major Survival Surgery: A major survival surgery penetrates and exposes the body cavity or produces substantial impairment of physical or physiologic functions (such as laparotomy, thoracotomy, craniotomy, joint replacement and limb amputation). Scientific justification is required in the animal use protocol, if more than one major survival surgery is to be performed on an animal during the course of the protocol experiment.

The generation of custom antibodies is considered an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for a grantee must have or obtain an assurance, or be included as a component of the grantee's assurance. In addition, the applicant must provide the date (verification) of project-specific IACUC approval for the production of the antibodies.

The three year limit on animal protocols is explicitly stated in the Federal regulations. We cannot grant extensions after the three year expiration date; you must file a new protocol.

If the animals are specifically raised for you, then you need a protocol. If you are obtaining animals or tissue that was already dead then you do not need an IACUC protocol. However, the IACUC requires you to submit a brief memo, if obtaining commercially purchased (i.e. grocery store, slaughterhouse, Carolina Biological, etc) animal tissue. The memo needs to be received by the IACUC office before the animal tissue is purchased. The information to be disclosed is available here.

You should contact either the IACUC Office or the Department of Comparative Medicine's veterinarian as soon as possible. The University veterinarian or the IACUC chairperson will determine whether an amendment or a new protocol is required.

By federal law and University policy, Investigators are required to notify the committee of any changes made to an active protocol. Typical modifications may include addition/removal of personnel, numbers and species of animals, modifications to the experimental methods or procedures, special requirements for animal husbandry and housing, etc.

Please refer to "Guidelines for the Use of Fishes in Research" made available by the American Fisheries Society.

What if my research involves reptiles and/or amphibians?
Please refer to "Guidelines for Use of Live Amphibians and Reptiles in Field and Laboratory Research, 2nd edition".

When protocols are approved, the number of animals to be used in the studies covered by that protocol is also approved. The Department of Comparative Medicine (DCM) tracks the number of animals used and assesses charges for their care based on the protocol to which they are assigned. Neglecting to transfer animals from one protocol to another may risk exceeding quota for on-going studies. Moreover, DCM needs to know in which studies the animals are involved to be able to provide appropriate veterinary care if needed. Animals can be readily transferred from one of your protocols to another by contacting DCM.

AAALAC Accreditation Letter
For use when funding agencies request a copy of the most recent USA AAALAC accreditation letter. You can view/download accreditation letter by clicking here.

Animal Welfare Assurance Number is A3288-01
Most recent renewal date: 12/14/2015. Expiration date: 12/31/2019. This applies to all animal activities, regardless of the funding source.

The University policy for Responding to Allegations on Research Misconduct describes the procedures followed when an allegation is made. Additionally, where Public Health Service (PHS) funding is involved, Federal Regulations at 42 CFR 50 apply. Other agencies, such as the National Science Foundation, also have research misconduct policies.

The University of South Alabama has adopted the definition of misconduct as stated by the Office of Science and Technology Policy (OSTP): Research misconduct is defined as fabrication, falsification, plagiarism in proposing, performing, or reviewing research, or in reporting research results. Research misconduct does not include honest error or differences of opinion. This definition applies to all research activities regardless of funding source.

The University will undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations of scientific misconduct.

At any time, an employee may have discussions and consultations about concerns of possible research misconduct with their immediate supervisor, college/school dean or institute director, Research Integrity Officer or other University administrative officials. The identity of confidential sources will be protected to the extent consistent with the needs of an inquiry or investigation.

While anonymous allegations will be accepted, it is often difficult, if not impossible to investigate a matter without the source of the allegations becoming obvious. For this reason, among others, anonymity cannot be assured. Often, if anonymity is required, an ongoing investigation gets to a point where it cannot proceed and must be abandoned because more information is needed but cannot be obtained. An anonymous source cannot be informed of the status or outcome of an investigation.

The Ethics & Compliance Hotline can be accessed as follows:

• Web: http://secure.ethicspoint.com/domain/media/en/gui/60474/index.html
• Phone: (844) 666-3599
• Click here for USA's Ethics and Compliance Hotline Policy

The Office of Internal Audit maintains the Ethics and Compliance Hotline and associated policy. Click here to access the Ethics and Compliance information. 

If the allegations appear to have merit and there is evidence of wrongdoing, the Deciding Official (VP for Research) will appoint an ad hoc committee composed of three persons. The Deciding Official will select the ad hoc committee members on the basis of scientific expertise that is pertinent to the matter.

Depending on the severity of the misconduct, sanctions will vary. Recommendations for sanctions are made by the Standards in the Conduct of Research Committee and referred to the appropriate University officials.

The acronym RCR stands for the Responsible Conduct of Research.

RCR includes most professional activities that are part and parcel of a research career and that are coming under increasing regulatory scrutiny. As defined by federal agencies, RCR encompasses the following nine areas: research misconduct, human participants, research involving animals, data acquisition, management, sharing, and ownership, mentor/trainee responsibilities, publication practices and responsible authorship, peer review, collaborative science, and conflicts of interests.

NSF for awards made for proposals submitted after 1/4/2010. For NIH designated grants. See : http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-019.html

To comply with the Congressional mandate under the America COMPETES Act (applies to NSF awards), NIH policies for training grants and career development awards, and to demonstrate USA's commitment to providing the highest quality education for all students and scholars. Instruction in the Responsible Conduct of Research is fundamental in the preparation of our future scientists and engineers.

The America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Act of 2007 or America COMPETES Act was enacted to ensure our nation's competitive position in the world through improvements in math and science education and a strong commitment to research.

Because USA is committed to providing the highest quality education for all students and scholars and believes that instruction in the Responsible Conduct of Research is essential to encouraging and producing the best scientists and researchers for the future.

Yes, certification by each subcontractor is required.

The Office of Sponsored Programs certifies that USA has implemented an RCR training plan when signing grant applications submitted to NSF. The PI will be responsible for informing new hires of the requirements.
The Office of Research Compliance and Assurance (ORCA) will have to access to data available from the approved RCR training options and NSF funded research personnel. ORCA will review the data on a quarterly basis for compliance and notify PIs of non-compliance. ORCA will make this data available upon request from NSF or individual faculty member.

It is online at the Research Compliance and Assurance website. This plan meets requirements of the NSF COMPETES Act, Section 7009.Certification Requirements

Yes

Yes. Therefore, they must complete the appropriate training curriculum as defined in the RCR Training for Students policy document.

The online CITI training certification is transferable for components that are shared among institutions. If additional training is required, which is dependent on level of education, other requirements specific to USA are not transferable. Regardless of other RCR training, new trainees will need to take approved courses or the online training offered through USA. Training from other institutions will not be accepted.

The USA RCR training plan is being tailored to meet the needs of the individuals and the career stage of those who participate in research. We believe a graduated, tiered approach is the best solution to meet these needs.

No, the Postdoctoral Mentoring requirement is a separate initiative requiring the submission of a mentoring plan that is described in a supplemental document specific to each proposal submission. The plan is considered during the merit review process. Guidelines for addressing mentoring plans within grant applications are available on the Research Compliance and Assurance website.

Online training needs to be completed within 90 days of hire. Interactive training for graduate students or postdoctoral researchers is required during the first year of conducting research. At this time, USA has not defined a training expiration period.

Login to register a user account at the following site: http://about.citiprogram.org/

Yes, CITI provides a certificate upon completion. Those records are also sent to ORCA. The PI should expect to be contacted quarterly as to the names of those individuals newly hired. ORCA will then verify those individuals have completed training by access the completion records.

The responsible Principal Investigator will be notified by ORCA and a corrective action plan will be required.

The Principal Investigator/Supervisor is responsible for notification of training requirements.

Documentation of the online CITI training should be maintained by the student and the PI. If the activity is sponsored research, then documentation should be maintained for a minimum of three years. The Office of Research Compliance and Assurance will be responsible for monitoring compliance with the institutional plan. For NSF sponsored research activities, the Office of Grants Administration requires RCR training documentation as part of the close-out process.