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Institutional Review Board
Policies and Procedures


Table of Contents

  1. Institutional Review and Approval
  2. Definition
  3. IRB Membership
  4. Scope of IRB Review
  5. Operation of the IRB
  6. Student Research
  7. Course Related Research
  8. Informed Consent
  9. Responsibilities of Investigators
  10. Implementation and Operation of the IRB
  11. Enforcement of the IRB Policies and Procedures
  12. Authorization

I. Institutional Review and Approval

All research conducted at Le Moyne College, or under its sponsorship at another location involving human subjects which is not explicitly determined to be exempt (see below), must be reviewed and approved by the Institutional Review Board for the Protection of Human Subjects (hereinafter referred to as the IRB). Review is also required for research carried out under the sponsorship of an institution other than Le Moyne College, even if the research has already been approved by the IRB at the sponsoring institution or elsewhere.

These policies covering all human subjects' research at Le Moyne College result from:

  1. The College's self-imposed commitment, based on its fundamental mission and values, to equally safeguard the rights and welfare of human participants in all instances of research under its sponsorship and to serve as their protector on behalf of the community of persons of which the College is a part.
  2. The desire of the College to comply with federal regulations concerning the establishment of such a board. (See Title 45, Part 46 of the Code of Federal Regulations - CFR.)
  3. The recognition that professional journals and other media of professional communication increasingly require that published reports based on human subject research have IRB approval.
  4. The need for the College to reasonably manage institutional risk.
The IRB, whose goal is the safeguarding of the rights and welfare of individual research participants, is to provide an independent determination concerning whether research participants are placed at minimal risk (defined below) or greater than minimal risk; and, if greater than minimal risk is involved, to assure that:
  1. The risks to the subject are substantively outweighed by the sum of the benefits to the subject and the importance of the knowledge to be gained, so as to warrant a decision to allow a subject, who has been properly informed of the potential risk (see discussion of informed consent below), to accept such risk.
  2. Legally effective informed consent will be obtained by adequate and appropriate means.
  3. The conduct of the activity will be reviewed at timely intervals.

Research covered by this policy that has been approved by the IRB may be subject to further review by the officials of the College. (For example, in the case of application for external funding see Le Moyne College Policies and Procedures for External Funding.) However, those officials may not approve the research if it has not been approved by the IRB or if written assurances have not been provided that it will be submitted for review at the next scheduled IRB meeting.

II. Definition

Activities within the scope of the IRB's responsibilities include research, development, and related activities which would normally be construed as biological, behavioral, or psychological investigations involving human subjects. Included are studies involving not only adults and children, but also investigations of prenatal life and the deceased. Studies or procedures utilizing organs, tissues, or bodily fluids of a human being are also included, as are the use of graphic, written, or recorded information about individuals even when this information has been collected by other institutions or investigators.

For the purpose of the IRB review, Le Moyne College stipulates the following definitions:

Research - Research is any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute "research" for the IRB, whether or not they are considered research in other contexts. Excluded from this definition are activities whose sole purpose is instructional; also excluded are activities whose purpose is related to routine course or program development. However, when such research activities involve subjects drawn from outside of the course, the instructor should follow the procedures outlined below for exemption from review, expedited review, and formal review.

Research activity would normally include the following:

  1. Persons or programs requesting extramural (federal, state, or private) funds for research or training.
  2. Individual faculty members as well as 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.
  3. Students doing research which is of the nature of a thesis and is part of a degree program.
  4. Students performing research as part of an independent study or the Honors program.
  5. Individuals (including students or persons from outside the College) other than faculty, staff, or administration, conducting research at Le Moyne College.

Minimal Risk - Minimal risk exists when the probability of 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. (See 45 CFR 46.102 [i].) (Investigators have the obligation to request a clarification by the IRB when there are any questions regarding whether planned activities or procedures involve only minimal risk.)

IRB Approval - Approval means that the IRB has reviewed the research and that the research may be conducted at Le Moyne within the policies and procedures outlined in this document and within the constraints of other institutional and federal requirements. IRB approval does not necessarily imply approbation for the research itself.

III. IRB Membership

The IRB will be constituted with eight members, to be appointed as follows:

(1) The Academic Vice President will appoint the Chairperson of the IRB from within faculty or administrative ranks of the College.
(2) The Academic Vice President will appoint to the IRB a qualified person from outside the College community who is not part of the immediate family of a person affiliated with the College.
(3, 4, 5, 6) The President of the Faculty Senate, in formal consultation with the Committee on Faculty Research and Development, will appoint four faculty members to the Committee, one from each of the four academic areas of the College (Humanities, Social Sciences, Business & Management, Natural and Quantitative Sciences).
(7) Upon the recommendation of departmental chairs and the Vice President for Student Life, the Academic Dean will appoint a student to the IRB. The student must:
  1. have at least 3rd year status
  2. have completed his or her core curriculum ethics requirement (PHL 301-303)
  3. have completed the major research design course within his or her major
(8) Upon the recommendation of the Vice President for Student Life, the Academic Vice President will appoint a member of Student Life's professional staff who has at least a masters degree and experience in the conduct of research involving human subjects. The IRB shall be sufficiently qualified through the experience, expertise, and diversity of its members, including their racial, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. Every nondiscriminatory effort will be made to ensure that the IRB does not consist entirely of men or entirely of women.

IRB members are ordinarily appointed to two-year terms and may be reappointed for two additional terms when their initial term expires. Because it is important that there be continuity in the work of the IRB during the summer months when many faculty prepare research proposals and initiate research projects, the term of IRB members will run from January 1 through December 31. Half of the initial appointees to the IRB shall be appointed for one-year terms so that in the years that follow the establishment of the IRB a maximum of only half of the IRB membership will be replaced in any given year.

If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women or mentally disabled persons, consideration shall be given in the appointment process to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote on the IRB.

Procedures followed by the IRB for review and approval of research involving human subjects are described in detail on the following pages of this document.

IV. Scope of IRB Review

A. Research Exempt from Review

Investigators conducting human subject research exempt from IRB review shall give notice to the IRB chairperson of such research on Form A: Notice of Exempt Research, which will require a statement that the research is in one of the following categories:
  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  3. Taste and food quality evaluation and consumer acceptance studies (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
  4. Research and demonstration projects which are conducted by, or subject to the approval of, department of agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
  5. Research involving the unobtrusive observation (including observation by participants) of public behavior, except where any of the following conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; (ii) the observations recorded about the individual, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; (iii) the research deals with sensitive aspects of the subject's own behavior, such as legal conduct, drug use, sexual behavior, or use of alcohol.
  6. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) survey or interview procedures, except where any of the following conditions exist: (i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; (ii) the subjects responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol; (iv) the survey or interview involves children or respondents requiring supervision, e.g. mentally retarded adults. All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

B. Expedited Review

The IRB may review some research through an expedited review procedure, if the research involves no more than minimal risk. This procedure is initiated by the filing of an Application for Expedited Review, Form B, and the review may be carried out by the IRB Chairperson or by one or more experienced reviewers designated by the Chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authority of the IRB except the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the full formal review procedure set forth below. The Chairperson shall inform all IRB members of research proposals approved under the expedited review procedures.

Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed by the IRB through the expedited review procedure. (Please note that instances (1) through (4) are more relevant to Le Moyne College):

  1. Voice recordings made for research purposes such as investigations of speech defects.
  2. Moderate exercise by healthy volunteers.
  3. The study of existing data, documents, records, pathological specimens, or diagnostic specimens, if the individual from whom the data were collected were identifiable.
  4. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
  5. Collection of: hair and nail clippings in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
  6. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
  7. Recording of data collected from subjects 18 years of age or older in the course of non-invasive procedures routinely employed by professionally certified/licensed individuals in the clinical practice of medicine, psychology and social work. This includes the use of physical practice sensors that are applied either to the surface of the body or at a distance and do not involve input or matter or significant amounts of energy into the subject or an invasion of the subjects' privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electro-encephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (i.e. x-rays, microwaves).
  8. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
  9. Collection of both supra- and sublingual dental plaque and calculus, provided the procedure is not more invasive than routing prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

C. Full Formal Review

Application for full formal review may be made to the IRB through the submission of a completed "IRB Form C: Application for Review of Research," a Research Description (described below) and an informed consent form (see Section VIII), unless the investigator believes the proposed research meets the criteria for exemption from formal review or expedited review. A copy of Form C can be downloaded from the IRB website. A new application for review is required for each research project that differs significantly in terms of procedures or subject populations from a previously approved application.

The ultimate determination of whether subjects are at greater than minimal risk and therefore require full formal review can be made only by the IRB. If, however, the investigator believes subjects will be placed at more than minimal risk (as defined above), then the IRB must approve the Research Description and the required informed consent form to be used. The IRB must approve both the form and the procedure by which consent for any study involving children (under 18 years of age) and other vulnerable populations, no matter what the condition of risk. The procedures necessary for a proper informed consent are described below. Examples of approved informed consent forms for adult subjects and parents of minor subjects are available at the IRB website. When reviewing research proposals, the IRB is primarily interested in safeguarding the rights and well-being of the human subject and in assessing the ethical implications of the proposed procedures.

When reviewing research descriptions, the IRB may pass judgment on "research design", but only to the extent that such design affects the rights or well-being of human subjects. In analyzing the risk/benefit ratio of a research activity, both the stated goals and the scientific merit of the research will be considered. If the IRB's analysis reveals serious flaws in the research design that influence the risk/benefit ratio of the proposed research activity, the IRB Chairperson or an experienced member of the IRB will consult with the investigator with the goal of clarifying the concern and resolving it. For those reasons, it is essential that the research be described to the IRB in a manner that allows adequate review of all these aspects of the research.

The IRB recommends that research descriptions adhere to the following outline [also available as form RO]. (In the interest of expeditious review and the IRB Chairperson and other experienced members of the IRB will be happy to informally review drafts of proposals from investigators who have not previously submitted proposals for IRB review prior to full formal review.)

  1. Rationale and Aims - This includes a concise statement of the background, or rationale, for the study, stressing its significance to the area of inquiry. What are the specific goals of the study? What, in particular, is expected to the found or learned from this study?
  2. Procedure - A clear and full disclosure of the methods and procedures including necessary debriefing used to conduct a study is absolutely necessary to secure adequate review of a research proposal. Any protocol submitted for review that is of insufficient clarity or lacking in the reporting of details necessary for a fair and complete review will be returned to the investigator without review and with a request for revision.
  3. Subject Population - Describe the subject population, stating specifically any reason for using a special population such as children, the mentally retarded, or other groups whose ability to give a proper informed consent is questionable.
  4. Potential Risks - Describe carefully the potential risks (physical, psychological, social, legal, or other) and assess the likelihood and seriousness of such risks. If methods are used which create certain risks, explain why these methods were used and not others. What alternative methods are available.
  5. Consent Procedures - Outline the procedures for obtaining informed consent, including how and where informed consent will be obtained. When more than minimal risk is involved, a copy of the informed consent form to be used must accompany the application.
  6. Safeguarding Against Risk - Describe particular procedures (e.g. proper screening of risk prone individuals, availability of psychological or medical aid, methods for detecting illness, etc.) which will be taken to safeguard the welfare of the subjects.
  7. Benefits and Risks - Assess the potential benefits of the investigation for the subject and for society in general. Summarize your view of the risk/benefit ratio for this particular investigation.

V. Operation of the IRB

A. Meetings

The IRB Chairperson will schedule monthly meetings throughout the academic year and convene them if proposals requiring review have been submitted. It is also the responsibility of the IRB Chair to schedule one mid-summer meeting to review proposals and to assure that the IRB personnel are available throughout the summer to review minor changes in research protocols involving the protection of human subjects. Further, it is expected that the IRB Chair will make reasonable efforts to schedule IRB meetings to accommodate the cycle of "calls for research proposals and review" established by the Faculty Senate Research and Development Committee.[1] Any Le Moyne investigator who anticipates submitting a proposal for funding to an external organization that requires IRB approval should provide substantial prior notice (at least two weeks) of this fact to the IRB Chairperson so that an IRB meeting may be scheduled with sufficient time to allow the investigator to meet the granting organization's deadlines.

In special circumstances, the IRB may conduct business via telephone, secure computer-based conferencing or mail. The times of all IRB meetings are to be announced to all faculty and administrative offices of the College. Changes in time and/or date of the meetings will be communicated to all concerned.

B. Who May Submit a Proposal for Review

A review and approval of research activities will be made by the IRB only for studies sponsored or supervised by members of the faculty, staff, or administration of Le Moyne College. 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 IRB.

C. Student Research

Students attending Le Moyne College are bound by the same procedures and policies as the faculty, staff, and administration. Moreover, no applications to the IRB from a student will be reviewed unless sponsored by a faculty member, staff person or administrator familiar with the student and the proposed activity. Specific guidelines for the review and approval of student research are presented below.

D. Deadline for Submission of Applications

All applications to the IRB must be submitted at least 10 calendar days prior to the date of the IRB meeting. Investigators whose applications are received too late to permit proper review may expect that their proposals will be deferred until the next regularly scheduled IRB meeting. Individuals unable to comply with this deadline should contact the Chairperson of the IRB.

E. Review and Approval

Specific review and approval procedures of the IRB are as follows:
  1. All researchers must submit 10 copies of the Form C Application to the Chairperson of the IRB. Upon receipt of 10 copies, the Chairperson of the IRB checks to insure that the properly completed accompanying forms are present and that the necessary description of the research is provided. Copies are then distributed to members of the IRB.
  2. Upon the request of the IRB, the investigator may be asked to provide additional information or to meet with the committee to provide additional information or to meet with the committee to present a more complete explanation of risks and protection for the human subjects. Any investigator may ask to appear before the Board to describe the proposed research.
  3. In cases where it is deemed necessary by the IRB, consultants to the IRB may be asked to comment on a proposed research activity.
  4. A necessary quorum for the IRB to consider a proposal is a majority of the total membership, including at least one member whose primary concerns are in non-scientific areas. No IRB may have a member participate in the board's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
  5. The IRB will decide by a majority of the members present:
    1. to approve the proposal
    2. to approve the proposal with restrictions or conditions
    3. to defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB
    4. to disapprove the proposal
  6. Minutes will be taken at all IRB meetings.
  7. Records, including minutes of meetings, applications and their supporting materials, consultants' reports, IRB correspondence and other official materials related to the work of the IRB will be retained by the IRB for a period of three years after the review of projects rejected by the IRB or the completion of projects that have received IRB approval.
  8. The IRB Chairperson will inform the principle investigator in writing of the decision of the Board within seven (7) calendar days of full formal review:
    1. If changes are recommended by the board, the IRB Chairperson or designated members will communicate these in writing to the investigator.
    2. The IRB chairperson or designated member will be responsible for review and approval of the investigator's submitted changes.
    3. If the investigator deems it necessary to make further changes, these can be submitted to the Chairperson or designated IRB member for review and approval.
    4. If there are changes in the study which the Chairperson or designated board member feels may change the level of risk to human subjects, the investigator will be requested in writing to submit the proposal to the full board for further review.
    5. If the IRB decision is to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
  9. Adverse decisions may be appealed by requesting review of the proposal. Appeals will be heard only when the proposal has been revised and/or additional information has been provided.
  10. The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to subjects. A list of the reasons for any suspension or termination will be provided to the investigator, all appropriate department heads, deans, and the Vice President for Institutional Advancement and the Vice President for Finance and planning in the case of sponsored research.
  11. It is the responsibility of investigators who have received IRB approval to provide reports to the IRB of any "exceptional occurrences" that may influence the IRB's initial determination that the research merited IRB approval.

F. Continuing Review

Only in the case of investigations that entail more than minimal risk to the subjects and that are to last longer than twelve months, the investigator must file a short Application for Continuing Approval at the end of each twelve-month period. This Application will be provided to the Investigator by the IRB in a timely manner.

If substantial changes in the protocol are to be made, the IRB must be notified in writing and approval sought for these changes. 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.

VI. Student Research

A student intending to do research involving human subjects as a part of an individual project (i.e. undergraduate honors thesis, independent research) should discuss the project with his or her major advisor.
  1. If it is decided that the project is not exempt from review and involves no more than minimal risk, the student and advisor must together complete IRB Form B requesting expedited review and submit this application to the IRB.
  2. If it is decided that the project may involve more than minimal risk, then the student and the advisor shall together prepare a description of the project in the manner described above and shall submit ten copies of this description to the IRB together with:
    1. Ten (10) copies of the research description.
    2. Ten (10) copies of IRB Form C.
    3. Ten (10) copies of the informed consent form.

VII. Course Related Research

Course related research, beyond that specified above, does not fall under the purview of IRB policies except when:
  1. The research is not a routine procedure that is employed on a regular basis in the course.
  2. The research involves more than minimal risk.
  3. The research involves subjects outside the College.
In cases 1 and 3, either IRB Form A and a complete description of the research or IRB Form B (if expedited review of desired) must be submitted to the IRB. In case 2, IRB Form C (with a copy of the appropriate consent form) and a complete description of the project must be submitted directly to the IRB. Approval given to course related research projects, i.e. those projects routinely carried out by students as part of their research methods training, shall remain in effect for three years unless significant changes have occurred that may influence the IRB's initial assessment. In this case, it is the responsibility of the instructor to communicate this information concerning the change(s) to the IRB in a timely manner.

VIII. Informed Consent

In all research activities that are not exempt and that have not received expedited review (i.e. research that has been determined to pose greater than minimal risk), the informed consent of each of the participants must be obtained by the investigator; or, in the case of those not able to give consent (e.g. children, mentally retarded), consent must ordinarily be obtained from their guardians or legal representatives. A copy of the document giving informed consent should ordinarily be given to the person giving consent. The IRB must approve all consent documents and copies of such are to be kept on file by the IRB. Any exception to the use of these provisions must be obtained from the IRB explicitly. The informed consent document should inform subjects, in clear and non-technical language of:

  1. The fact that the study is research.
  2. The purposes of the research.
  3. The expected duration of the subject's participation.
  4. The procedures to be followed, and an identification of those which are experimental.
  5. Any reasonably foreseeable risks or discomforts.
  6. The benefits to the subject or to others which may reasonably be expected from the research.
  7. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
  8. The extent, if any, to which confidentiality of data and privacy of subjects will be maintained.
  9. For research involving more than minimal risk, whether any compensation and whether any medical or other treatments are available if injury occurs.
  10. Whom to contact for answers to pertinent questions about the research, subjects' rights, and research related injury to the subject.
  11. The fact that participation is voluntary and that the subject may withdraw his or her consent at any time without penalty or loss of benefits.
There are two procedures which may be used to obtain informed consent:
  1. The subject or subject's legal representative signs a written consent document, which embodies the eleven elements above. [See examples of adult informed consent forms and parent or guardian informed consent forms.]
  2. The subject or legal representative signs a document indicating that the subject had the above eleven elements explained to him or her orally and that he or she understands that this oral description and he or she agrees to participate in the activity described. In this case, however, an auditor-witness to the oral presentation must be present. A written summary of the oral presentation must be submitted to and approved by the IRB. A copy of this presentation is to be retained by the IRB.
There may be cases in which the use of either of these procedures for obtaining informed consent may be considered inappropriate by the investigator because it would adversely affect the research design or procurement of valid results. Accordingly, modifications to the above informed consent procedures can be recommended to the IRB. The IRB may approve an informed consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that all of the following conditions exist:
  1. The research involves no more than minimal risk to the subjects.
  2. The waiver or alteration will not adversely affect the right and welfare of the subject(s).
  3. The research could not practicably be carried out without the waiver or alteration.
  4. Whenever appropriate, the subject(s) will be provided with additional pertinent information after participation.
Modifications must be approved prior to implementation of the proposed research. This approval must be recorded in the board's minutes.

IX. Responsibilities of Investigators

Investigators are responsible to:
  1. Familiarize themselves with these guidelines and to discuss with members of the IRB any questions regarding proposed research activities.
  2. Submit either an adequately prepared IRB Form A or Form B or Form C to the IRB for each research project involving human subjects.
  3. Notify the IRB and the departmental chairperson of any injury - physical, psychological, or social - suffered by a subject because of his or her participation in a research activity.
  4. Submit an Application for Continuing IRB Approval if the research is judged by the IRB to involve more than minimal risk and extends beyond a twelve-month period.
  5. 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.
  6. Take proper measures to insure confidentiality and security of all information obtained from the subjects.
  7. Take proper measures to assure where appropriate that research activities involving human subjects are in compliance with the applicable federal and state regulations related to environmental risks as administered by the College's Chemical Hygiene Officer.

X. Implementation and Operation of the IRB

It is the responsibility of the Academic Vice President to:

  1. Implement these policies and procedures.
  2. Provide the administrative and clerical support necessary for the proper functioning of the IRB.
  3. Provide a secure repository for the records of the IRB and required by these policies and procedures.

XI. Enforcement of the IRB Policies and Procedures

Other than denying or withdrawing IRB approval for a research project, the IRB has no authority to impose sanctions. If the IRB determines that an infraction of its policies has occurred and no resolution of the matter can be reached informally by the IRB acting through its chair with the researcher, the IRB will forward a report of its finding that an infraction of the IRB policy has occurred to the departmental chair or other College administrator most directly responsible for the supervision of the researcher suspected of policy infraction. The administrator will act upon this report by following existing procedures pertaining to the administrator's unit of the college.

XII. Authorization

These policies and procedures are approved by the President of Le Moyne College.


[1]The IRB drafting committee recommends to the Research and Development Committee (R & D) that procedures be developed to assure that funding for proposals approved by R & D involving human subjects that require IRB approval will not be released until this approval has been obtained by the researcher.



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