What is the Le Moyne College Institutional Review Board (IRB)?
Any institutions such as colleges where faculty, students or staff conduct research using human subjects are bound by federal law to have an IRB committee, review and approve such research prior to the collection of any data. This federal law (National Research Act (P.L. 93-348) was enacted after abuses of human subjects in biomedical experiments were revealed. This law was enacted to prevent any further abuses of human subjects in a research study. Specifically the Federal regulations states " each institution or agency which conducts or which proposes to conduct or authorize human research shall establish a human research review committee…No human research shall be conducted or authorized by such institution or agency unless…such committee has reviewed and approved the proposed human research project…." The Le Moyne College IRB (Institutional Review Board) exists to meet this federal regulation and to insure that research done at Le Moyne College meets the high standards of ethical compliance expected given our mission and status as a Jesuit institution
Who serves on the IRB?
There are four faculty members from the four academic areas, one member
appointed from outside the college community, one Le Moyne student who
is at least a junior and one member of the student life professional
staff and a chairperson.
What is the definition of a human subject?
A human subject is any living human individual about whom or from whom
an investigator conducting research seeks to obtain data through intervention
or interaction with that individual and/or seeks for research purposes
to identify private information about that individual.
What are some critical questions I should consider as a researcher?
Who is being studied? Am I going to use human subjects in
my research? - Can any of my human subjects be considered members
of vulnerable groups, such as children or emotionally handicapped
individuals?
What is being studied? Will my research project be investigating
matters that are especially sensitive for the subjects?
Why is my research project being conducted? What will be
done with its data? Will my research be published or presented publicly?
How will I conduct the study? Will I be using any potentially
upsetting or harmful techniques?
How does the IRB Process work?
All research on human subjects requires IRB approval prior to the commencement of the data collection. Many research projects on human subjects require formal review from the IRB as a whole. However, many proposals need be reviewed only by the IRB chair. Still others require no formal analysis from either the IRB as a whole or from the chair. Therefore, the IRB process begins when a researcher requests from the IRB a full formal review, an expedited review, or an exemption from formal review. Whether the researcher asks for a full or expedited review or for an exemption depends on the type of population from which the researcher proposes to draw human subjects, and the degree of risk to which the subjects are to be exposed.
What is the definition of an exempted review?
Exempted research consists of one of the following categories
" Research conducted as part of academic coursework involving instructional
strategies, techniques, curricula, or classroom management methods
" Research involving the use of educational tests
" Research involving survey and interview procedures
" Research involving observation of public behavior
" Research involving the collection of existing data, documents
or records
Further this research must specify that no human subjects may:
" Be identified directly or through identifiers linked to the subjects
or researcher
" Be identified in such a way that subjects could be reasonably
be placed at risk of criminal or civil liability or incur damage to
their financial standing or employability; or
" Be identified in such a way which deals with sensitive aspects
of the subject's own behavior such as illegal conduct, drug use, sexual
behavior, or use of alcohol.
What are the key elements of exempted research?
" Surveys, questionnaires, innocuous topics
" Involve human subjects who over 18 years of age
" Involve human subjects who are not identified
" There is minimum risk to the human subjects
Do I still have to apply to IRB for approval if I am doing exempted
research?
Yes. You must submit formal notification to the IRB chair that you intend
to conduct research that you consider to be exempt from formal review.
The IRB chair will then decide if your research project is indeed exempt.
If the IRB chair decides that your project is not exempt, the chair
will ask that you apply for either an expedited or full formal review.
What do I submit for exempted research?
" Form A - signed by faculty advisor if the applicant is a student
" Description of research as outlined in Research Outline Attachment
(Form RO)
" Copy of survey, questionnaire questions
" Adult Informed Consent form
" Permission of agency ( if applicable)
" Submission Checklist A (for Education majors only)
What should I expect after submission of exempted research?
Once your all forms are sent to the chair of the IRB, the research will
be reviewed to see if it can be considered exempted. If it can be considered
exempted and if all of the forms are submitted, then you will receive
written notification in the mail. If the research can not be considered
exempted or if some of the forms are missing, your packet will be returned
to your faculty sponsor if you are a student. If you are a faculty or
staff member the packet will be returned directly to you.
What is the definition of expedited research?
Expedited research at Le Moyne usually consists of one of the following
categories:
" Voice recordings
" Moderate exercise by healthy volunteers
" Studies of existing data, documents, records, pathological specimens
or diagnostic specimens from individuals who can be identified.
" Studies of perception, cognition, game theory or test development
where no manipulation of subjects occurs and subjects are not stressed
or exposed to more than minimal risks of minimal harms.
What are the key elements of expedited research?
" Research involves no more than minimal risk to human subjects
" Human subjects are over 18 years of age
" Does not qualify as exempt research
Do I still have to apply to IRB for approval if I am doing expedited
research?
Yes, you must notify the chair of the IRB that you intend to do expedited
research? This must be done prior to beginning your research. Usually
expedited research does not need to be reviewed by the full committee
What do I submit for expedited research?
" Form B - signed by faculty advisor if the applicant is a student
" Description of research as outlined in Research Outline Attachment
(Form RO)
" Copy of survey, questionnaire questions (if applicable)
" Adult Informed Consent form
" Permission of agency ( if applicable)
" Submission Checklist B (for Education majors only)
What should I expect after submission of expedited research?
Once your all forms are sent to the chair of the IRB, the research will
be reviewed to see if it can be considered expedited. If it can be considered
expedited and if all of the forms are submitted, then you will receive
written notification in the mail. If the research can not be considered
expedited or if some of the forms are missing, your packet will be returned
to your faculty sponsor if you are a student. If you are a faculty or
staff member the packet will be returned directly to you. In come cases,
the expedited research will need to be reviewed by the full IRB committee.
What is the definition of full review research?
Full research involves more than minimal risk of harm and or any research
that deals with minors under the age of 18, no matter what the risk
level.
What are the key elements of full review research?
" Human subject are at greater than minimal risk of harm
o Examples - taking internally or externally applied substance, deceiving
subjects
" Human subjects are younger than 18 years of age
What do I submit for full review research?
" Requirements of submission - Eight Copies of the following:
" Form C - signed by faculty advisor if applicant is a student
" Copy of survey, questionnaire questions ( if applicable)
" Description of research as outlined in Research Outline Attachment
(Form RO)
" Parent Informed Consent form or Adult Informed Consent form
" Permission of agency ( if applicable)
" Submission Checklist C (For Education majors only)
How much time must I give the IRB committee to complete their review
prior to beginning my research?
For exempted and expedited reviews, you should allow at least two weeks.
For full review you need to submit all form at least 10 calendar days
prior to IRB scheduled meetings. Meeting dates of the IRB are posted
on the website.
How long does this full review process take after submission of
forms to the IRB and how will I know the status of my proposal?
If the application is incomplete, it will be returned. If the application
is complete and the IRB approves the proposal, you will receive notification
of the IRB's evaluation in the mail within the week following review.
If the IRB has questions or concerns about the proposal, you will be
contacted either through email or your faculty sponsor. Once the IRB's
questions or concerns have been addressed to the satisfaction of the
IRB, you will receive approval. Normally, the chair of the IRB will
determine whether issues raised by the IRB have been satisfactorily
resolved; you will not have to wait for another committee meeting to
receive approval.
When can I start collecting data?
You cannot start collecting data until your proposal either has
been formally approved by the IRB or IRB chair, or has been determined
by the IRB chair to be exempt from formal review.
What if I'm involved with a research study based at another institution.
Does this require IRB notification and approval?
Yes it does.
How do I get more information or discuss questions not addressed
here?
You may contact the chair listed on the website