Grants and Sponsored Research

The mandatory Responsible Conduct of Research training for all faculty, staff and students performing research on campus is now open. Online training will be required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects in the fall of 2009.

These trainings are provided by the Collaborative Institutional Training Initiative (CITI). These modules need only be completed once and you must provide a copy of the certification of completion to the IRB. When finished with the training, be sure to print out the certificate of completion and send to IRB Administrator Bruxanne Hein, Foundation Center Room C308.

Please click on this link CITI Program to register, create your account, and choose your discipline-specific area for training.

All faculty, staff and students performing research must complete the "Responsible Conduct of Research" basic course by November 1, 2009. All other areas of training must be successfully completed by December 31, 2009.

The Institutional Review Board (IRB)

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Coastal Carolina University. The IRB is registered with the Office for Human Research Protection (DHHS) and holds the Federalwide Assurance # FWA00004137 which provides assurances that the University will comply with all applicable federal laws and regulations related to research involving the use of humans as participants. This assurance is valid through July 24, 2011.

The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:

The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.These charts are necessarily generalizations and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.The charts do not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

Frequently Asked Questions on IRB Protocol Review

What is an IRB?

An Institutional Review Board (IRB) is a committee within the University that reviews research proposals that use human subjects as participants in research. The Institutional Review Board reviews medically non-invasive proposals to determine if the research project follows the ethical principles for the protection of human subjects as required by federal and University regulations. The IRB has the authority to approve, disapprove, or require modifications of these projects.

How do I know if my project needs IRB review?

All proposed research that involves the use of human subjects requires review and approval by the IRB prior to the initiation of the research. Human subjects research is research that meets both the definition of research and involves human subjects as defined in the federal regulations. Research means a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.The definition of a human subject is "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.If you have questions about whether your study needs to be reviewed e-mail or call the Office of Grants and Sponsored Research.

How do I submit my research for review by the IRB?

Complete the IRB review protocol form found on the "Forms" page of the CCU website, or from the Grants and Sponsored Research website under "Proposal Forms." Follow the instructions on the form and guidance document. Submit the form and appropriate attachments to the grants office. NOTE: You must submit a final version of all questionnaires, interview protocols, etc. including the informed consent form(s).

If I know my project meets the exempt regulations, do I still have to submit an application for IRB review?

Yes! Only the IRB can determine whether a proposal is eligible for exempt status. EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED.

How long will it take for my proposal to be reviewed?

It depends on the nature of the study and the level of risk to research participants. The times given below are averages for studies that are not given restrictions by the board or require additional information. Studies that are given restrictions or require additional information will take an additional amount of time depending on how fast these restrictions are met or additional information provided.

Exempt Review – 5 to 10 working days.

Expedited Review – two weeks.

Full-Board Review – 5 days following the monthly board meeting.

NOTE: The IRB does not meet during the summer.

How will I know if my project is approved?

Investigators will receive e-mail notification of approval followed by a letter sent by mail.

What do I do with the IRB date-stamped consent information?

Copies of the current, dated documents are the only versions that may be used by investigators when obtaining consent. Investigators should make copies of the stamped version returned to them by the IRB at the time of study approval or reapproval.

What do I do with the signed informed consent documents?

The principal investigator is required by University and federal regulations to maintain records of all correspondence, relating to the use of human subjects in research. Copies of the application,research progress reports, notices of approval and signed Informed Consent Documents must be maintained in the investigator’s records. Copies of these research records must be retained for three years after the close of the study and are subject to inspection by federal authorities and the IRB.

Do I need to complete training on protections of human subjects before starting my work?

Yes. Investigators and all other key personnel are required to complete:

CITI TRAINING

(click on the link to enter the site)

Online training will be required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects by the fall of 2009. These modules need only be completed once and you must provide a copy of the certification of completion to the IRB. When finished with the training, be sure to print out the certificate of completion.

What if I want to make a minor change in the study (add or remove a question from a survey, add a second focus group, or put an advertisement in the newspaper to recruit more participants) do I need to do anything?

All modifications to human subjects research must be reviewed and approved PRIOR TO IMPLEMENTATION. The investigator should request modifications by submitting a request to the Grants & Sponsored Research Office.

What if my funding changes?

Investigators are required to keep the IRB informed about any changes in funding.

Do I need to notify the IRB when my project is finished?

Yes. When your project is completed you will need to submit a final report.

Guidance

Online training from OHRP will be required certification for all CCU faculty, students and staff participating in research and sponsored programs/projects by the fall of 2009. These modules need only be completed once.

Please forward your certification documentation to the Office of Grants and Sponsored Research to keep on file.

Institutional Animal Care and Use Committee

Coastal Carolina University is committed to providing optimal care for its laboratory animals. To this end, the University is in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.Office of Laboratory Animal Welfare (OLAW)

What activities are exempted from review?
NONE! Any activities involving the use of live vertebrates (captive or free-ranging) must be reviewed by the IACUC. Even if all you are doing is watching free-ranging animals through a spotting scope.

I am a graduate student - how do I file an Assurance of Animal Care form?
As a graduate student, you will likely be required to fill out the form; however, please list your supervisor as the PI. He or she must sign the declaration because they are the responsible individual for your training and therefore your research project. If there is another PI (i.e. an agency employee), please contact the IACUC Chair to determine who gets listed as the PI on the Assurance.

I am a Research Associate - do I need to file an Assurance of Animal Care form?
Research Associates and Research Faculty come in a wide array of types. You must file an Assurance of Animal Care form any time you are involved in a project with ties to CCU (for example: funding is channeled through CCU, a CCU student is using the project for his/her thesis research, or you are using CCU animals/animal facilities). In other words, any time you use your CCU affiliation you must file a protocol.. If you are unsure -- please ask!

My project involves the use of animals at another University's animal facility. I have submitted a protocol to that University's IACUC. Does the CCU IACUC need to review this work too?
YES. If you are a CCU employee, student or are working on a project funded through CCU, you must file the CCU Assurance of Animal Care form to this committee. ( The CCU IACUC may request it, but DO NOT JUST TURN IN A FORM FROM A DIFFERENT UNIVERSITY!)

My project involves the use of captive animals housed at a facility that is not registered under the Animal Welfare Act nor has it filed an Assurance of Compliance with PHS Policy on the Humane Care and Use of Laboratory Animals with OLAW, NIH. Can I conduct my research there?
It depends on a few factors! Absolutely no research may be conducted at a facility if they are not in compliance with the Animal Welfare Act (please note that at this time some state run animal facilities holding captive wildlife are not required to be registered under the AWA). Assuming that registration under the Animal Welfare Act is not an issue, then the source of funding might influence your ability to conduct research at certain facilities. A facility MUST have an Assurance on file with OLAW for PHS funded research to be conducted there. You cannot conduct research at this facility if you are supported with PHS funding or funding from any agency that has adopted PHS Policy (i.e. NIH, NSF).

I want to use animals for a lab course. What do I do?
Use of animals in teaching requires IACUC approval. It is our preference that one (1) Assurance of Animal Care form be filled out for each individual course. Therefore, use of animals in many different labs for a single course should be listed on one (1) form. Multiple courses may all be listed on a single form if they use common labs (for example Biol 103, 104, 105 may all use the same mouse metabolism lab). To avoid confusion, be sure to contact the IACUC Chair before trying this.

I am just catching fish and killing them to collect tissues for my study. Do I need to file a protocol?
Yes. The capture and euthanasia of fish are covered activities. You must provide the following minimal information about your work in the appropriate sections of the form: objectives, sample size, scientific methodology, capture technique, and euthanasia technique. What you are collecting (liver for p450 analysis, kidney for heavy metal analysis, liver stable isotopes, stomach content for prey species, etc) addresses the scientific methodology and ultimately the justification to kill fish. However, the specifics of blood and tissue collection techniques are only required if you collect samples PRIOR to killing the animals. You need not describe details of the tissue collection if you humanely euthanize the animal first.

The agency I am submitting a proposal to has requested a letter from the IACUC. What do I do?
The CCU IACUC will issue a signed letter confirming that your protocol has been reviewed and approved. Please provide the name of the individual and/or agency the letter must be addressed to. If you need this letter then YOU must request it!

I am collecting tissues from animals killed by hunters, commercial butchers road-kill etc.. Do I need to file a protocol?
Yes, but you should complete a post-mortem tissue protocol, which is much abbreviated. If you hire a hunter to kill animals for the purpose of scientific collection, then you must justify your work and must file an Assurance of Animal Care form.

I am using chick embryos. Do I need to file my protocol? Only if your research will take the embryo to the stage of hatching. You need not file an Assurance of Animal Care form if the chick embryos are killed prior to hatching.

Are there any reporting requirements?
There has not been any formal reporting requirement in the past; however, we have been asked to institute a reporting process. This is being designed and PIs will be notified shortly. You have always been required to keep your protocol current as to changing activities and to report any modifications made. Also, once a year CCU must submit a report to USDA on our activities involving species covered under the Animal Welfare Act. This means listing species used and providing the number of animals used as categorized by the level of invasiveness or pain induced.

I am doing surgery in the field. Is there a reporting requirement for this?
Yes. In the Animal Welfare Regulations, a field study means any study conducted on free-living wild animals in their natural habitat, which does not involve an invasive procedure, and which does not harm or materially alter the behavior of the animals under study. So, a field study is not subject to the Animal Welfare Regulations if it adheres to the above definition. However, many of our field surgical procedures that involve implantation of telemetry devices are subject to the Animal Welfare Act and these activities must be reported to USDA on an annual basis.

Can the IACUC stop my research project after a protocol has been approved?
Yes. The IACUC can suspend activities if animals under your care experience a high morbidity/mortality rate or if the University receives complaints. The IACUC with the PI reviews the situation and, if required, make modifications to the protocol. OPRR, NIH and USDA must be notified if any suspension of activities occur. Suspension of a protocol to correct unforeseen problems is not a problem for the PI and does not question his/her capability. A PI only runs into problems if they are conducting unapproved protocols or they have been negligent in their animal care.

I do not have an approved protocol but want to get my animals. Can I?
No. Animals may not be purchased from vendors or collected from the wild until you have an approved IACUC protocol. If time is crucial, please contact the IACUC Chair.

I was never told that I needed IACUC approval to use animals!
Surprisingly, some researchers claim ignorance about the animal welfare requirements. To a certain extent this is understandable given the multitude of regulations and guidelines that need to be followed. However, ignorance or misunderstanding of the requirements is no excuse for failing to comply. This, in part, is why a formal training program is now a federally mandated requirement for individuals using animals in research, teaching and testing.

I disagree with some of the current requirements and want to do something about it. Who do I talk to?
You are welcome to submit questions, comments and recommendations about the CCU Animal Care Program to any member of the CCU Institutional Animal Care and Use Committee. However, keep in mind that we are working to ensure that CCU stays in compliance with regulations and guidelines set by federal agencies and professional societies. Whether conducting laboratory based research or field research, you can influence animal welfare requirements more by getting involved in your professional society and providing comments to OLAW, NIH and/or Animal Care, USDA.

Why do I need IACUC permission to do my research if I already have a collecting permit?
The collecting permit, and the like, ensures only that your taking of the animal does not hurt natural populations of that animal. IACUC is charged with ensuring that you take and otherwise use the animal humanely. More specifically, the USDA has recently charged the IACUC with ensuring the three "R's" are met wherever possible. Reduction in the numbers of animals used, Refinement of techniques to minimize pain or distress, or Replacement with non-animal techniques. The IACUC also works to make sure that the experiments proposed do not unnecessarily Replicate other experiments, thereby wasting animal life. If you are working on a vertebrate animal at MLML, or your work impacts vertebrate animals, you need an approved IACUC protocol prior to beginning the work. You also need approval if you are teaching a class that involves vertebrate animals.

How will the IACUC find out I am doing animal research if I don't tell them? What are the consequences of non-compliance?
IACUC must conduct semi-annual inspections of the sites that it is charged with overseeing. At MLML, the Aquarium Room and the Sea Lion facility (SLEWTHS) are inspected at this time. Note that the IACUC itself is also is subject to both internal and external review every six months which includes unannounced inspections of the IACUC records and checks of compliance by the USDA. If the USDA officer finds missing pieces then CCU will be cited for them. MLML too can be cited in this way by the USDA for violations. The point of the IACUC inspection is to avoid and prevent citations. If citations are not corrected by the time noted, facilities can (and have been at CCU) shut down. At this point, federal funding to all researchers within the facility (i.e., MLML as a whole) is also in jeopardy. Federal agencies like NSF and NIH require compliance with IACUC. For these agencies, you have to have an IACUC application in place to even proceed with a grant application. CCU Foundation is now routinely screening all grant applications for any federal funding source and will not allow you to use your money, once awarded, until an approved IACUC protocol is in place. More practically, if you are a graduate student, you may be required to omit any work from your thesis or subsequent publications that was collected prior to IACUC approval, and you can be denied graduation by Graduate Studies if IACUC approval was never granted. Note that if you are a student from a home campus other than CCU, you are still bound by CCU rules because of the source of funds and equipment. Again, this is why we are so actively pursueing the MOUs with the other campuses. Once your CCU IACUC application is approved, you should be sure to route a copy to your home campus IACUC so that your graduation is not hindered in any way by this process.

What if I am getting dead samples from some other source and am not killing the animals myself?
IACUC has a "short form" for this. It is a simple one-page form. If you are collecting dead or stranded animals, or animals that are part of a commercial fishing operation, for example, the form is straight forward. Just provide the sources or locations and copies of any necessary permits. If you are using animals collected by another research institution or individual, you should provide assurance that there is IACUC approval in place at that institution by providing the PI name, protocol number and dates that it is valid at the very least. If the animals come from a study by Fish and Game or some "exempt" agency, you'd just need to explain that to the committee and provide assurances that the animals are/were being killed as humanely as possible. If it is simply the use of animal parts, like an otolith archive, then it should be fairly easy to explain. In general, using animals taken as part of another study is a great way to extend their scientific value, which IACUC fully supports.

Integrity In Scholarship and Scientific Research

Introduction

Integrity in research is the basis for the academic search for knowledge. Persons involved in academic research must guard the truth and protect the public trust that research in an academic environment has long held. Activities which interfere with an honest search for the truth cannot be tolerated in a university setting. All effort must be made to maintain an open and honest search for truth through continual commitment by faculty, staff, and students to scrupulous honesty and integrity in research.

It is clear that scientific and scholarly misconduct cannot be prevented completely by a university policy or federal law; it can only be avoided through each individual's firm commitment to academic ideals and honesty. The importance of such honesty in one's research work should be impressed upon all members of the university community by those responsible for conducting or directing research and scholarship projects. Only in this way can the university community effectively guard the truth and maintain traditions of intellectual honesty.

Policy Statement

In the belief that honesty and integrity are essential to the search for knowledge, it is the policy of Coastal Carolina University that all persons involved in research and scholarship must guard the truth, uphold the highest standards in their research and scholarship, and protect the public trust that the academic environment has long held. Whenever any Coastal faculty member, graduate student, or other research employee is accused of serious misconduct in scientific or scholarly research, the University will conduct an inquiry, make a determination concerning the truth or falsity of the allegations, and take appropriate disciplinary action. The process of inquiry will be expeditious and protect the rights of all those concerned, including the complainant and the accused.

Policies regarding Faculty Misconduct and Greivances can be found in both the Faculty Manual and the University Policies and Procedures Manual. Policies regarding student misconduct can be found in the Student Handbook.

Definition of Research Misconduct

Since the search for knowledge is impeded and subverted by the misrepresentation of facts, openness and honesty are commonly accepted norms within the scientific and scholarly community for proposing, conducting, or reporting research. "Research misconduct" means plagiarism, falsification, fabrication of data, or other forms of deliberate misrepresentation. It does not include honest error or honest differences in interpretations or judgments of data.