Institutional Review Boards (IRBs) are required by the federal government to protect the rights and welfare of human subjects participating in research activities.  An IRB ensures that physical, psychological, and social risks to research participants are minimized, and that the risks associated with the research are commensurate with the importance of the research and/or the knowledge to be gained.  Consistent with the ethical principles of the Belmont Report, the IRB also ensures that research subjects receive accurate, complete, and comprehensible information about the nature of the research and any associated risks, as well as their rights as research subjects.  In addition, the IRB reviews human research activities to ensure that the College and investigators are compliant with the ethical standards and the regulations governing human subject research.  These regulations are summarized in the Code of Federal Regulations (45 CFR 46)from the U. S. Department of health and Human Services and from the Food and Drug Administration (21 CFR 50; 21 CFR 56)

The IRB reviews all projects that meet two criteria:  (1) The project must be “research,” and (2) the project must include “human subjects.”  The federal regulations provide definitions for each of these terms, which are the definitions that we use.

Research is defined as “. . . a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102d).  For example, a case report on a single individual may not meet this definition because it is unlikely that one could generalize from that single case.  On the other hand, an open-ended interview that includes a number of probing questions to ensure that all interviewees address the same topics would be considered to be systematic and would meet the definition of research—so long as several individuals were interviewed so that the resulting information was generalizable.

A Human Subject is defined as “. . . a living individual about whom an investigator conducting research obtains (1) data through intervention of interaction with the individual, or (2) identifiable private information (45 CFR 46.102.f).  Thus, individuals are considered a human subject if the researcher interviews them, surveys them, formally observes and takes notes on their behavior, or asks them to complete an experiment, or if the researcher obtains private information about them (e.g., medical or educational information obtained from reviewing their confidential records).

IRB oversight is required when a project meets the criteria for both research and human subject participation.  A project that only analyzes data from publicly available databases would not require IRB oversight because there is no interaction with the individuals whose data are being studied and the information being studied is not private (it is publicly available).

Unless they are part of a project described below that is considered research by the IRB, the following activities are not considered research by the IRB and therefore are not subject to IRB oversight:

·       Scholarly and journalistic activities (e.g., oral histories, journalism, biography, literary criticism, legal research, and historical scholarship) designed to provide an accurate and evidence-based portrayal of individuals and not to protect them from public attention

·       Surveillance of public health activities, including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health

·       Collection and analysis of information, biospecimens, and records for a criminal justice agency or criminal investigation

·       Operational activities in support of intelligence, national security, defense, or homeland security

Many classroom or course projects that are designed solely to instruct students about research methods and data collection procedures would not require IRB oversight because they would not result in generalizable knowledge.  Nonetheless, these projects should be supervised by a faculty member to ensure that they do not intrude on human rights.  If a course related project involves more than routine pedagogical procedures employed on a regular basis, involves more than minimal risk to participants, and/or involves participants outside the college and formal permission is required from the research site, the project may need to be submitted to the IRB for review.

A faculty member or student who is writing an article for a campus newspaper would not be considered to be engaged in research but instead would be subject to the ethics of journalism since journalistic activity is not intended to contribute to generalizable knowledge.  If the article is intended to publish findings from a project designed to contribute to generalizable knowledge, however, then the activity constitutes research and should be reviewed by the IRB prior to beginning the project.

Projects that involve data gathering that is only to be used for internal purposes by an instructor, department, organization, or institution (e.g. for quality control, routine course or program development, or student or employee evaluations) do not need to be submitted to the IRB for review.

The following activities, if they involve human subjects and meet the definition of research, would require IRB review:

· A project to be used as a thesis or other form of capstone project;

· A project intended for publication or presentation, if the college is to be listed as the researcher’s affiliated institution;

· Pilot testing of materials to be used for a formal research project. 

Special considerations:  There are circumstances where IRB oversight may be required, even if these projects do not neatly fit the specific definition of “research.”

If the findings of a project are to be disseminated in any public forum (either a public presentation that is not part of a course or required program evaluation or a publication that is not part of a course or required program evaluation), the research proposal must be submitted to the IRB for review before the study may be conducted. This means that if a researcher thinks there is any possibility of sharing her/his findings beyond a course or program requirement, the researcher must submit a proposal to the IRB for approval.  If a researcher engages in a project that initially did not involve an intent to publish or present finding but at a later date, decides to pursue formal publication or presentation of the work, the project should be submitted to the IRB for review when such a decision is made.  In this case, the IRB will determine whether the project data may be used for publication/presentation purposes or if it may only be used for its originally intended purpose.

If the research is to be conducted with human subjects who are members of a protected population, the project must be submitted to the IRB for full board review.  Under federal regulations, Protected populations include children, minors under 18 years of age, and prisoners.  Others who may be considered protected are cognitively impaired persons; traumatized persons; comatose persons; terminally or seriously ill persons; elderly/aged persons; minorities; and students or employees who may potentially feel coerced into participation in a study.

The primary investigator for a research project is required to:

• Protect the rights and preserve the safety and welfare of prospective and participating subjects;
• Submit appropriate CITI Program completion certificates for all individuals involved with the research, including those who interact with participants and/or assist in the processing or analysis of the data collected.  She/he should follow all IRB policies and procedures  and discuss any questions with members of the IRB regarding proposed research activities;
• Ensure that applicable laws, regulations, procedures, and guidelines are observed by all researchers or staff members involved in the project; Take proper measures to assure where appropriate that research activities involving human subjects are incompliance with the applicable federal and state regulations related to environmental risks as administered by the College’s Chemical Hygiene Officer;
• Submit an adequately prepared IRB Form to the IRB for each research project involving human subjects;
• Ensure that IRB approval has been granted before commencement of the research;
• Ensure that all parameters of the approved research protocol are followed in conducting the study;
• Promptly notify the IRB and any appropriate research sponsor of any injury or difficulty (physical, psychological, social) suffered by a participant because of her/his participation in the research activity;
• Obtain prior IRB approval before making any changes in the study or extending the study beyond its initial term of approval;
• Make provisions to keep adequate records, documents, and executed informed consent forms related to IRB approved research for at least three years following the completion of the project or activity;
• Take proper measures to ensure confidentiality and security of all information obtained from the subjects.

Application for Exempt Research Status (Form A):

Research involving the least risk to participants (i.e., less than minimal risk):  Generally includes research using publicly available databases; unobtrusive observations of public behavior; the use of educational or diagnostic tests; the use of surveys or interview procedures (when participants are over 18 years of age); research on instructional techniques in commonly accepted educational settings; and secondary research studies for which consent is not required.  Exempt from review signifies that once your study has been approved, the study will not be subject to continuing oversight from the IRB. To receive exempt status, the researcher must submit a complete application; this includes a completed Form A, a detailed Research Outline, consent form, written recruitment materials, and other relevant materials for your research participants (such as a copy of the completed survey). Further information on the provisions of exempt review is provided on the FAQ page of this website and on the Form A document under the IRB Forms tab.

Application for Expedited Review (Form B):

Research involving no more than minimal risk: Generally includes research involving participants in studies of physical or psychological responses or collection of samples of tissues or body fluids. Additional information on the provisions of expedited review is provided on the Form B document under the IRB Forms tab.

Application for Full Board Review (Form C): 

Research involving greater than minimal risk, whether physical or psychological:  All research involving participants who are considered members of vulnerable, or protected, populations must go through full board review.  Research of a sensitive nature that requires particular attention to protecting the anonymity or confidentiality of responses may also require full board review.

All investigators have both an ethical and legal responsibility to obtain voluntary consent to participate in a study from each research participant. For studies that do not fall into one of the exempt categories, this process is facilitated by using a written “consent form” [see samples provided on Website] which must be reviewed by the potential research subject and then signed by her or him.  No research activity can begin until the subject’s written informed consent is obtained.  In the event that the research participant is under 18 or falls into a “protected population” category [See FAQ 2.2], permission must be obtained from the individual’s parent or guardian.  Additionally, when appropriate, investigators must obtain verbal assent from those under 18 at the time the research takes place.

Informed Consent Checklist. According to federal regulations, a consent form must include the following elements (Note: This listing has been edited to address minimal risk student projects):

• A statement that the study involves research (the term “research study” must be included in this description).
• An explanation of the purposes of the research.
• A clear description of the procedures that will be followed.
• The approximate amount of time required for participation.
• A description of any other obligations expected.
• A description of any reasonably foreseeable risks or discomforts to the subject. The possibility of a breach of confidentiality is a risk and must be included. No study is without risks, so it is more appropriate to say that risks are “minimal” rather than that there are “no risks” in a study.
• A description of any benefits the subject might expect. If there are none, that should be stated.
• A description of how the confidentiality of research records will be maintained.
• Contact information for an individual who can answer questions about the research (usually, this is the primary investigator and a faculty mentor or sponsor, if applicable), as well as the email address for the IRB co-chairs if the subject has questions about her/his rights as a research participant.
• A statement that participation is voluntary, that refusal to participate will not result in any penalty of loss of benefits to which the subject is entitled, and the fact that the subject can discontinue participation at any time without penalty. 
• If there is a possibility that the subject may be charged for some or all of the procedures (unusual in student research), that the investigator may terminate the subject from participation during the study, or that significant new findings which emerge during the study may affect the subject’s willingness to participate, these issues should also be addressed in the consent form.

​Please see Section 46.116​ of the Office for Human Research Protections (OHRP) Policy and Guidance document for additional elements that may be required for informed consent. One additional element that is commonly requested by the IRB is the approximate number of subjects involved in the study. This is especially important when the researcher intends to recruit only a few subjects or will break the subjects down into sub-groups that contain only a few members.

Documentation of Informed Consent. Documentation of informed consent may be obtained in one of the following ways:

1. A written consent document that contains the elements of informed consent required by federal regulations and outlined above. The investigator should give the subject or representative adequate opportunity to read it before it is signed. If necessary, this form may be read to the subject or the subject's legally authorized representative. ​

2. A short form written consent document, stating that the elements of informed consent required by federal regulations and outlined above have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. In addition, the IRB must approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person that obtains consent (e.g., the researcher) shall also sign a copy of the summary. A copy of both the summary and the short form shall be given to the subject or the representative.

The IRB may waive the requirement for the research to obtain a signed consent form if one of the following conditions is met:

1. The only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. In this case, each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.
2. The research presents no more than minimal risk to subjects and involves no procedures for which written consent would normally be required outside of the research context.

​In order to have the signed consent form waived, the researcher must provide the IRB with a clear rationale based on one of the above conditions. In addition, the researcher must provide each potential subject with a written informed consent document that contains all of the required elements listed above. The subject must acknowledge that she/he has received and read the informed consent document, understands it, and consents to participate in the study (e.g., by checking a consent box on an online or written survey).

For additional information regarding federal regulations, please see the informed consent checklist and documentation of informed consent​ on the web site of the Office for Human Research Protections (OHRP) of the U.S. Department of Human Health & Services.

This may be allowed if the research involves children under 18 years of age in an educational setting, the research involves no more than minimal risk, and the modification to normal informed consent procedures will not adversely affect the rights and welfare of the participants. In this case, the researcher may request that the Board consider approving a consent procedure for any student as long as their parent or guardian did not return a permission form which stated that their child was not permitted to participate in the study. That is, unless a parent or guardian puts in writing that their child is not permitted to participate, the researcher may have participants under the age of 18 if the Board determines that it is appropriate. The Board would require that the researcher follow the usual processes of seeking permission from all parents or guardians using an approved permission form and providing students with an opportunity to give assent (or not) when presented with participation in the study.

Participants may begin to be recruited and data collection may begin when the researcher has received the official IRB approval in writing.

IRB approval must be obtained before making any changes in approved research, even if the study has already been approved, unless the change is immediately necessary in order to eliminate a hazard to a participant.  The IRB should be notified immediately in the event of a serious hazard to a subject requiring change in the previously approved procedures.

Minor changes that do not increase risk or discomfort of participants may be authorized by expedited review by the IRB Chairpersons.  Substantial changes may require full review and formal approval from the IRB.  Approval of changes does not extend the study beyond the original expiration date of approval.

Researchers that have been granted exempt status (Form A) must also submit all changes to the IRB for approval to ensure that the changes do not affect the exempt status of the project.

Some examples of changes include: increasing the number of subjects initially targeted, changing the research site, using a different method to recruit subjects, becoming funded or sponsored if initially unfunded, altering an intervention or treatment, changing amounts of substances administered if a chemical or pharmaceutical study.

If you want or need to make a change to your study, please submit a Request to Change an Approved Study form to the IRB co-chairs at [email protected].

For more information, see the U.S. Department of Health & Human Services' Code of Federal Regulations, Subpart A, Sec. 46.110 IRB Records, part (b), item 2.

In the case of investigations that were approved using a Form C and that are to last longer than twelve months, the researcher must file an Application for Continuing Approval at the end of each twelve-month period. If substantial changes in the research protocol are to be made, the IRB must be notified in writing and approval sought for these changes before such changes may be implemented (please use the Request to Change an Approved Study form). If the study has advanced to the stage to where only data analysis is being conducted, however (i.e., data collection and all interaction with human subjects has concluded), the research does not need to submit an Application for Continuing Approval.

In the case of grant applications for which continuing applications must be submitted yearly, the continuing application must be submitted to the IRB to conform with continuing review policy.

In order to avoid any disruption in research activities, the Application for Continuing Approval must be submitted to the IRB co-chairs (at [email protected]) no later than one month prior to the expiration date of the project.

When discussing the protection of human subjects, applicants often use the terms “privacy,” “anonymity,” and  “confidentiality” interchangeably, but these terms really do have different meanings in the context of conducting research. For example, “privacy” refers to individuals’ right to control access to themselves.  This includes both access to an individual’s personal information and access to an individual’s body (e.g., if using biological specimens).  Federal regulations (45 CFR 46 102.f) define private information as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).”

“Confidentiality” refers to how private information provided by individuals will be protected by the researcher from release.  Describing how the confidentiality of potentially private research information will be maintained is an important component of the informed consent process.  While confidentiality is not formally defined in the federal research regulations, the regulations make it clear that researchers have an obligation to inform participants (1) how their data will be used, (2) who will have access to it, (3) what procedures will be in place to ensure that unauthorized individuals will not have access to this information, and (4) of any limitations to these confidentiality procedures.

“Anonymity” means that a participant’s name is not known to the researcher at all.  If the researcher knows a participant’s name, then the most the researcher can claim is that s/he will maintain confidentiality of participants’ identities and potentially private data collected from the participants.

Federal regulations require that all research records be “…retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.” See the U.S. Department of Health & Human Services’ Code of Federal Regulations, Subpart A, Sec. 46.115 IRBRecords, part (b).

In order to comply with federal regulations, all signed consent forms and research data shall be retained for three years after completion of the research. If the researcher remains at the institution for the entire three-year period, he/she may indicate in the application the manner in which the records will be securely stored. If the researcher leaves the institution, he/she must indicate what person or office will hold these records for the three-year period. Records will normally be retained in the unit where they are produced. Research records must be retained on the Le Moyne College campus, or in facilities under the auspices of Le Moyne College, such as on a Le Moyne College server.

Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations. See the Code of Federal Regulations 45 CFR 46.101(b).

The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight.  Please note, however, that for each change that is proposed or occurs during the execution of the research activity, the investigator will need to consult with IRB to determine if the change affects the eligibility of the research activity to continue as exempt from IRB review and approval.

Exempt status does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

In order to have a research project recognized as exempt, researchers must submit a Form A, along with other study-related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.) to the IRB. The IRB co-chairs will evaluate the materials and notify researchers if their project qualifies for exempt status. Applications that are incomplete, or that do not contain sufficient information so as to allow the IRB to make a determination, will be returned with a request for revisions.

Yes. In accordance with the recommendations of the Office for Human Research Protections of the U.S. Department of Health and Human Services, Le Moyne College policy does not allow investigators to self-exempt their human participant research projects due to the potential for a conflict of interest (see the OHRP FAQs). Determining if a project is exempt from continuing IRB oversight is handled by the Le Moyne College IRB co-chairs.​

Upon completion of all Form C approved research projects, a Project Closure Form must be submitted to the Institutional Review Board. Researchers who were granted exempt status (Form A) or who have a project that was approved via expedited review (Form B) do not need to notify the IRB when their project has ended. The Project Closure Form can be found under the Forms link and may be submitted to the IRB co-chairs at [email protected].​

Researchers intending to conduct studies in a normal educational setting with children under 18 years of age may submit a Form A application (Research Exempt from Continuing IRB Oversight) if it involves educational tests, observation of public behavior, or normal educational practices that are not likely to adversely affect students’ opportunity to learn or the assessment of educators. Research with children may not be exempted when it involves interviews with children, surveys of children, or observation in which the researcher participates in the activities observed.

All persons affiliated with Le Moyne College (faculty, administration, staff, and students) who are engaging in research with human subjects (as defined above) may submit proposals to the IRB for review.  This includes:

• Persons or programs requesting extramural (federal, state, or private) funds for research or training;
• Individual faculty members as well members of the staff and administration engaged in research as part of their professional role within the college or as part of their job assignment;
• Students doing research as a thesis or capstone degree requirement;
• Students performing research as part of an independent study or within the Honors program.

Note: No student applications to the IRB will be reviewed unless sponsored by a faculty member who works closely with the student and oversees the research activity 

Individuals from institutions other than Le Moyne College who wish to conduct research involving participants from Le Moyne College may also apply to the Le Moyne IRB.  In such cases, these researchers must submit an application to the Le Moyne IRB even if they have already received approval from another institution’s IRB. No data collection may begin involving Le Moyne participants without first receiving Le Moyne IRB approval.  In those instances where individuals from an institution other than Le Moyne College wish to conduct research on its campus, a faculty member, staff person or administrator of the College must sponsor the application to the Le Moyne IRB.