Faculty Senate Bill 12-A-6 begins here
Policy Regarding the Role of the Office of Research and Grant Development
The Office of Research and Grant Development is an academic service dedicated to enriching the professional development of faculty and equivalent- level staff by providing those individuals with opportunities for research and/or public service. In turn, those activities augment the instructional processes of the University.
By monitoring the current research and development interests of public agencies, private philanthropic organizations, and business, the office provides faculty with an important repository of information which can aid them in their efforts to keep abreast of new trends in virtually any field of study.
The office provides faculty with a central location from which they can seek colleagues from around the campus and the state whose specialized knowledge or talent is needed for a complex research study. Research and Grant Development will assist faculty when they seek to identify and contact professional associations. The knowledge and skills of the office director also serve as a valuable asset.
The office provides three types of services: technical assistance, information management, and skill/knowledge development. Technical assistance is given in the proposal preparation phase, the proposal submission phase, and the project administration phase. Information management includes searching for or identifying potential fundors, monitoring external events, and communicating that information to the University community. The development of skills and knowledge related to the process of grantsmanship takes place in one-on-one sessions with interested parties, formal events such as workshops, and linkage with individuals whose talents, pooled with the proposal's author(s), might enhance the proposal's chances of acceptance. The Office of Research and Grant Development Procedures and Guidance manual can be viewed at: http://www.semo.edu/grants/manual.htm.
Updated August 15, 1997
Updated October 5, 2005
Updated by Change Form May 28, 2008
Faculty Senate Bill 11-A-31 begins here
The Grants and Research Funding Committee of the Faculty Senate was organized to encourage
faculty involvement in research, scholarship, and creative projects.
Amended by Faculty Senate Bill 11-A-31 November 2, 2011
Reviewed by President November 2011
Approved by Board of Regents December 15, 2011
Faculty Senate Bill 11-A-32 begins here
Detailed guidelines and application procedures for these faculty development grants
are periodically revised and published in a separate booklet by the Grants and Research
Funding Committee. Please see http://www.semo.edu/facultysenate/committees/grantsandresearch_16438.htm
Amended by Faculty Senate Bill 11-A-32 November 2, 2011
Reviewed by President November 2011
Posted for 15 Day Review November 2011
The purpose of this policy is to protect the rights and benefits of Southeast Missouri State University, the people of Missouri, and the inventor, discoverer, or author in matters pertaining to patents and copyrights. Within this purpose it should be recognized that the objectives of the University do not encompass the invention or development of a product or process for commercial use. Patentable inventions, processes, etc., will instead be a by-product of the usual intellectual endeavors of the faculty and staff of the University.
Any invention or discovery made by an employee of the University or resulting from research carried on under the direction of an employee in which the University may have an interest shall be promptly reported by such discoverer to the Grants and Research Funding Committee. The committee shall review related data and information and make recommendations concerning financial terms and problems concerned with the development and administration of such inventions and discoveries and patents secured thereon. The committee shall make recommendations to the President concerning the disposition and terms of administration of such inventions and discoveries.
Faculty Senate Bill 83-A-04 begins here.
Except in cases where other arrangements have been specifically agreed to in writing, it shall be the policy of Southeast Missouri State University to permit University employees and students to retain in full all copyright and patent privileges resulting from their usual intellectual endeavors. In cases where University support or sponsorship has been provided, the recovery of institutional costs shall:
Residual profits shall be defined herein as total profits generated by a copyrighted or patented product or process minus all costs borne by the individual or group owning those products' or processes' copyright or patent privileges.
In all cases where University support or sponsorship has not been provided, the cost of administering or procuring copyright or patent privileges will not be borne by the University unless agreed to in writing by the Board of Regents. University support or sponsorship will be defined herein as:
In all cases where University support or sponsorship has been provided and institutional costs have been recovered, all monies resulting from the recovery of institutional costs shall be returned to the funding unit of the University from which support or sponsorship was provided.
Southeast Missouri State University and its Board of Regents disclaim and expressly deny any liability or responsibility for patent infringement or negligence on the part of any person or entity who may elect to obtain a patent or copyright under the provisions of this policy. Approved by Faculty Senate, Bill 83-A-04 - April, 1983 Approved by Board of Regents - May, 1983
Through its membership in AASCU, the University is able to use the services of the Research Corporation to assist faculty in obtaining a patent. The Research Corporation will evaluate the patent potential of an invention based on receipt of a Disclosure Submission and Invention Administration Agreement. Neither the faculty member nor the institution bears any direct cost for the evaluation, nor if the invention is accepted, for the cost of filing. The Research Corporation will assume responsibility for marketing the product. Gross receipts are shared with the faculty member (subject to the University Patent Policy) receiving 57.5% of the gross income. Specific details may be obtained from the Office of Research and Grants.
Faculty Senate Bill 88-A-11 begins here.
Subject to (other provisions of the law). . ., the owner of copyright under this title has the exclusive rights to do and to authorize any of the following:
Notwithstanding the provisions of (the previous section). . ., the fair use of a copyrighted work, including such use by reproduction in copies of phonorecords or by any other means specified by that section, for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research is not an infringement of copyright.
In determining whether the use made of a work in any particular case is a fair use, the factors to be considered shall include
Approved by Faculty Senate, Bill 88-A-11 - November 9, 1988 Approved by Board of Regents - December 1988
Additional Information Regarding Copyrights
Faculty wishing more information about copyrights under federal law should
consult Title 17 of the U.S. Code, especially Sections 106 and 107, portions of
which are duplicated below:
Faculty Senate Bill 88-A-11 begins here.
Exclusive Rights in Copyrighted Works
Subject to (other provisions of the law). . ., the owner of copyright under this title has the exclusive rights to do and to authorize any of the following:
Please refer to section on PHOTOCOPYING COPYRIGHTED MATERIALS FOR TEACHING AND RESEARCH
Faculty Senate Bill 12-A-14 begins here
Science rests on a foundation of mutual trust. To an extraordinary degree, that trust is thoroughly justified. However, scientists are subject to all human frailties and temptations, including at times the temptation to engage in scientific misconduct. Though such misconduct is rare, once misconduct is detected, it must be dealt with quickly and forcefully in order to sustain the atmosphere of trust necessary for science. Not only must individual scientists behave in a trustworthy manner, scientists must also take collective responsibility for detecting, judging, and controlling scientific misconduct. This is not an easy task for an enterprise founded on integrity; trust must not be replaced with suspiciousness. However, when there is ample reason to suspect misconduct, that information should be brought to the attention of individuals responsible for assuring that scientists connected with their institution are behaving responsibly. To that end, Southeast Missouri State University has established a policy on scientific misconduct, has designated an officer responsible for receiving allegations of scientific misconduct, and has created a process for resolving such allegations.
A crucial element of any fair and effective policy on scientific misconduct is a process that will distinguish instances of genuine and serious misconduct from insignificant deviations from acceptable practices. The policy proposed in this document will allow such distinctions to be made in a manner that minimizes disruptiveness and protects the conscientious, honest scientist from false, trivial or mistaken accusations.
Misconduct includes fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data.
An information-gathering and initial fact-finding to determine whether an allegation of misconduct warrants an investigation.
A formal examination and evaluation of all relevant facts to determine if an instance of misconduct has taken place. If misconduct is confirmed, the investigation should determine the seriousness of the offense and the extent of any adverse effects resulting from the misconduct.
Guiding Principles of This Policy
Approved by Faculty Senate, Bill 90-A-05 - April 4, 1990 Approved by Board of Regents - May 4, 1990 Reenacted with slight amendment by Faculty Senate Bill 12-A-14 approved by the Faculty Senate April 4, 2012 and by the Board of Regents May 12, 2012
Faculty Senate Bill 12-A-15 begins here
These procedures shall apply to faculty, administrative and professional staff, and graduate students. The University process for handling allegations of scientific misconduct involves three stages: inquiry, investigation, and resolution. All parties involved in the process shall be entitled to consultation with legal counsel (at his/her own expense) in all meetings relating to the alleged misconduct.
Southeast Missouri State University has a responsibility to pursue an allegation of scientific misconduct fully and to resolve questions regarding the integrity of research. In the inquiry and any investigation which may follow, the University will attempt to focus on the substance of the issues and be vigilant so that personal conflicts between colleagues do not obscure the facts.
In order to address all allegations of scientific misconduct expeditiously, Southeast Missouri State University designates the Dean of the Graduate School as the administrator to whom allegations are to be reported. If he/she has a conflict of interests with a case, the allegation will be pursued by the Provost in accordance with the procedures described in this policy document.
The Dean of the Graduate School will pursue all allegations to resolution. He/she will consult in confidence with any individual who comes forward with an allegation of scientific misconduct. If the Dean of the Graduate School determines that the concern should be addressed through this policy, the subsequent inquiry and investigation procedures will be discussed with the complainant. If the complainant chooses not to make a formal allegation but the Dean of the Graduate School believes there is sufficient cause to warrant an inquiry, the matter will be pursued. In such a case, there is no complainant for the purposes of this document.
Even if the respondent leaves the institution before the case is resolved, Southeast Missouri State University has a responsibility to continue the examination of the allegations and reach a conclusion. Further, Southeast Missouri State University will cooperate with the processes of other involved institutions to resolve such questions.
Whenever an allegation of misconduct is filed, the Dean of the Graduate School will initiate an inquiry--the first step of the review process. In the inquiry stage, factual information is gathered and expeditiously reviewed to determine if an investigation of the charge is warranted. An inquiry is not a formal hearing; it is designed to separate allegations deserving of further investigation from frivolous, unjustified, or clearly mistaken allegations.
The inquiry process may be handled with or without a formal committee. Regardless of the approach chosen, it is the responsibility of the Dean of the Graduate School to ensure that the inquiry is conducted in a fair and just manner. The Dean of the Graduate School shall informally review any allegation of misconduct and confer on the merit of the allegation and need to form an inquiry committee with a dean of one of the colleges not represented by the complainant or respondent. The Dean of the Graduate School will determine whether the allegation should be addressed through this policy. If individuals are chosen to assist in the inquiry process, they should have no real or apparent conflicts of interests with the case in question, be unbiased, and have an appropriate background for judging the issues being raised. If the alleged scientific misconduct is a failure to comply with regulations regarding the use of human subjects or laboratory animals in research, members of the inquiry committee may be selected by the Dean of the Graduate School from the appropriate University compliance committee(s) for human and/or animal subjects.
Upon initiation of an inquiry, the Dean of the Graduate School will notify the respondent in writing within a reasonable period of time of the charges and the process that will follow. If the committee method is to be used, the committee members will be appointed and convened.
Whether a case can be reviewed effectively without the involvement of the complainant depends upon the nature of the allegation and the evidence available. Cases that depend specifically upon the observations or statements of the complainant cannot proceed without the open involvement of the individual; other cases that can rely on documentary evidence may permit the complainant to remain anonymous. During the inquiry, confidentiality is essential in order to protect the rights of all parties involved.
The respondent will be given copies of written documents (if any) that support the allegations. To ensure the safety of any written documents associated with the allegation, committee members will be asked to review a copy of such documents within the office of the Dean of the Graduate School.
When the inquiry is initiated, the respondent will be reminded of the obligation to cooperate in providing the material necessary to conduct the inquiry. Uncooperative behavior may result in immediate implementation of a formal investigation and other appropriate institutional sanctions. The respondent will be invited to present a written response to the allegations, and this response will become a part of the case file maintained by the Office of the Dean of the Graduate School.
Due to the sensitive nature of an alleged case of scientific misconduct, the University will strive to resolve each case expeditiously. The inquiry phase will normally be completed and a written report of the findings filed for the institution's own record within thirty days of written notification to the respondent. A thirty-day period meets the federal regulatory requirements. If the committee anticipates that the established deadline cannot be met, a report, citing the reasons for the delay and progress to date, will be filed with the Dean of the Graduate School, and the respondent and appropriately involved individuals will be informed by the thirty-fourth day.
Findings of the Inquiry
The completion of an inquiry is marked by a determination of whether or not an investigation is warranted. There will be written documentation to summarize the process and conclusion of the inquiry. The complainant and respondent will be informed by the Dean of the Graduate School of the outcome of the inquiry. Allegations found to require investigation will be forwarded to the investigative body discussed below. At this point, any agency sponsoring the research will be notified of a pending investigation.
If an allegation is found to be unjustified but has been submitted in good faith, no further formal action other than informing all involved parties will be taken. The proceedings of the inquiry, including the identity of the respondent, will be held in strict confidence to protect the parties involved.
If confidentiality is breached, the University will take reasonable steps to minimize the damage to reputations that may result from inaccurate reports. If an allegation is found to be unjustified and to have been maliciously motivated, disciplinary actions will be taken against anyone under University jurisdiction so involved.
Southeast Missouri State University will seek to protect the complainant against retaliation. Less senior people are particularly vulnerable. Individuals under the University's jurisdiction found engaging in acts of retaliation will be disciplined in accordance with appropriate institutional policies.
An investigation will be initiated only after an inquiry issues a finding that an investigation is warranted. The investigation's purpose is to explore further the allegations and determine whether there has been scientific misconduct. In the course of an investigation, additional information may emerge that justifies broadening the scope of the investigation beyond the initial allegations. The respondent will be informed in writing when significant new directions of investigation are undertaken. The investigation will focus on accusations of misconduct as defined previously and examine the factual materials of each case. The investigation will look carefully at the substance of the charges and examine all relevant evidence.
The investigating body will be a five-person ad hoc committee appointed by the Dean of the Graduate School to handle the investigation. Members of the investigative committee should be chosen from within the University. Appropriate individuals outside the University may be selected if sufficient qualified members cannot be found from within the institution. Those investigating the allegations will be selected in full awareness of the closeness of their professional or personal affiliation with the complainant or the respondent. Any prospective member who has a conflict of interests in a case will not be permitted to be involved in that case. It is important, however, that the committee members have appropriate research expertise to assure a sound knowledge base from which to work.
Upon receipt of the inquiry finding that an investigation is warranted, the Dean of the Graduate School will initiate the investigation promptly. The complainant and respondent will be notified in writing of the investigation; the written summary of the inquiry stage will be included with this notification. All involved parties are obligated to cooperate with the proceedings in securing additional data related to the case. All necessary information will be provided to the respondent in a timely manner to facilitate the preparation of a response. The respondent will have the opportunity to address the charges and evidence in detail in consultation with legal counsel if he/she wishes.
In the interim, the University will, if necessary, act to protect the health and safety of research subjects, patients, and students. Administrative action could range from complete suspension to slight restrictions in the research activities of the respondent. Interim administrative action will be taken in full awareness of how it might affect other individuals and the ongoing research within the institution.
The written record for the investigative stage will be handled in the same manner as for the inquiry stage, i.e., one copy of the record will be given to the respondent. A second copy, maintained by the Office of the Dean of the Graduate School, will be available for inspection by the committee.
All significant developments during the investigation, as well as the final findings of the committee, will be reported to any sponsor of the research. When the investigation is concluded, all entities initially notified of the investigation will be informed of its final outcome.
The University will attempt to complete an investigation within 120 days. If the deadline cannot be met, an interim report will be submitted by the committee to the Dean of the Graduate School with a request for an extension.
The findings of the investigative committee will be submitted in writing to the Dean of the Graduate School. The respondent will receive the full report of the investigation.
In the event of a finding of scientific misconduct, Southeast Missouri State University will provide the respondent with an appeal opportunity. The grounds should be based either on the failure of the University to follow appropriate procedures or the presence of new evidence.
An appeal based on procedural violations should be made in writing to the Dean of the Graduate School. The appeal should be filed within 30 days of notification to the respondent of the committee's findings and include a list of specific violations. A proper reaction to the appeal should be made in writing by the Provost within two weeks of the filing of the appeal.
An appeal based on new evidence should be made in writing to the Dean of the Graduate School. The appeal should be filed within 30 days of the committee's findings and include a description of the new evidence and its relevancy to the case. A written reaction should be sent to the respondent from the Dean of the Graduate School within two weeks of the filing of the appeal. The decision of the appeal is final. The reaching of such a decision; or the failure of the respondent to submit an appeal within the stated 30 days; is considered to exhaust the appeal process.
When the investigation finds no support for allegations of scientific misconduct, all federal agencies, sponsors, or other entities initially informed of the investigation will be notified by the Dean of the Graduate School. The findings of the investigation will be sealed and retained in a confidential and secure file within the Office of the Graduate Studies.
If the allegations of misconduct were found to have been maliciously motivated, the appropriate administrative official (e.g., college dean or Provost) will be notified so appropriate disciplinary action can be taken against the responsible University employee. If the allegations, however incorrect, were found to have been made in good faith, no disciplinary measures will be taken, and efforts will be made to prevent retaliatory actions.
Notification - All federal agencies, sponsors, or other entities initially informed of the investigation will be notified of the findings of misconduct once the appeal process has been exhausted.
Consideration will also be given to formal notification of other involved parties after the appeal process has been exhausted. The following list of such parties is illustrative but not complete.
Disciplinary Action - University disciplinary action will be in proportion to the
misconduct. Possible actions could include termination of employment. The Dean of
the Graduate School, in consultation with the respondent's college dean, shall recommend
appropriate disciplinary action to the Provost.
Approved by Faculty Senate, Bill 90-A-05 - April 4, 1990 Approved by Board of Regents - May 4, 1990 Reenacted with slight amendment by Faculty Senate Bill 12-A-15 approved by the Faculty Senate April 4, 2012 and by the President April 23, 2012, Posted for 15 Day Review April 2011
Faculty Senate Bill 13-A-17 begins here
Southeast Missouri State University recognizes its role in society to further human knowledge, to advance the sum of such knowledge through teaching and research, and to protect the rights and welfare of human subjects involved in research. Similarly, the University acknowledges the rights of the faculty, staff and administrators to utilize appropriate educational methods and research techniques in their classes, in instructionally related activities and in Student Services programming and activities.
Human subjects are involved in many areas of research in which there is potential risk to the individual, such as experimental research utilizing drugs, vaccines, and radioactive materials. Less obvious are classroom or Student Services programming-related research activities in which risks to human subjects may be significant.
To facilitate compliance with this policy, review committees will be established at the academic college level, the student services division level, and the University level.
The University Committee on Research Involving Human Subjects is best qualified to ensure that human subjects will receive adequate protective measures, that faculty, staff and administrative privileges to pursue the advancement of knowledge are guaranteed, and that restrictive policies which might discourage research, innovative teaching and programming are eliminated. This committee is the official review body for the University and functions as the Institutional Review Board as set forth in federal legislation. Its function is to conduct initial and continuing review of those research proposals which use human subjects and to determine that such proposals are in accordance with existing federal regulations. The committee operates under and reports directly to the Office of the Provost.
Members of the committee shall possess varying backgrounds so that their review of research proposals will assure that the rights and welfare of human subjects are adequately safeguarded. The committee must be sufficiently qualified through the expertise and diversity of its membership to ensure respect for its advice and counsel. When necessary, the committee will solicit opinions from individuals having recognized expertise in a specific area. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
Decisions concerning human subjects in research are not made unilaterally by the committee. Through a deliberative process, it is the responsibility of the department chairperson, the College Review Committee (CRC), the college dean of the research investigator conducting the study, and the University Committee to ensure that the rights of human subjects are protected. For projects originating from Student Services personnel, the Student Services Review Committee (SSRC) will act as the CRC, and the Dean of Students will assume the review functions delegated to the college dean in this document.
As used in this document, research is defined as a trial or special observation, usually made under conditions determined by the investigator, which aims to test a hypothesis or to discover some unknown principle, effect, or relationship. Activities which use experiments, tests, and observations designed to elicit non-public information are types of research. Research does not include the conducting of classroom experiments or demonstrations or programming used for an educational purpose. Routine course and program development, including evaluation of the effectiveness of such development and the assessment of established courses or programs, is not research as defined and does not require review. (See next section for details of requirements for or exemptions from review.)
Determining the degree of risk in research involves making a series of judgments because certain risks are inherent in life itself. For certain types of research projects (especially medical), the risk is quite obvious. Somewhat different are those research procedures in which the subjects perform strenuous physical exertion or undergo varying degrees of public embarrassment and humiliation. These experiences may constitute a psychological threat to the subject, thereby posing another type of risk.
In reviewing research proposals involving human subjects, the reviewing body will place the research activity into one of two categories:
Category 1 - those research activities in which the subjects involved have no more than the risks associated with their customary everyday activities or risks associated with the performance of routine physical or psychological examinations or tests by qualified individuals.
Category 2 - those research activities in which the risk to subjects is greater than that encountered when performing customary activities under ordinary conditions.
As used in this document, human subjects are part of the investigator-subject relationship in a research activity which has the discovery of new knowledge as its primary objective. Of course, there are several types of human subjects, including adults, minors, residents of institutions, etc. Donors of organs, tissues, etc., are also considered to be subjects.
As used in this document, the definition of human subjects excludes the normal professional-client relationship which has the welfare of the client as the sole objective. Examples of such relationships are those in which the client is receiving aid or services consistent with accepted and established practice (e.g., physician and patient).
It is incumbent upon the investigator to make sure that all human subjects are treated with respect and dignity, not just by the principal investigator, but by the research associates as well. The principal investigator should make it clear to the subjects that they are free to discontinue their participation in the research at any time without prejudice to the subject.
In those research projects that have potential risk to the subject, the investigator must make every effort to minimize the risks or discomfort related to the subject's participation. For example, if the research activity exposes the subject to considerable physical risk, the investigator must consider whether the subject's response should be monitored by a physician during the testing.
The investigator whose research plans place subjects at risk has the responsibility for justifying that risk. Such a justification will indicate that a thorough search of the literature has been made to ascertain that either the experiment has already been performed with animal subjects or good reasons exist for not utilizing animal subjects; that similar research has not already provided an adequate answer to the research question; and that the design of the study is adequate to yield worthwhile data on the topic under investigation.
The investigator is responsible for the research procedures during the investigation and must be sensitive to individual differences which may predispose certain individuals to experience harmful psychological or physical consequences by participating in the study. Realizing this, the researcher must exercise care to exclude such individuals from the research sample. Should unanticipated harmful effects develop during the research, the investigator shall take immediate steps to correct the situation. For those studies having the potential to produce undesirable effects which may be manifested later, the investigator's responsibility is to plan appropriate follow-up procedures.
The responsibilities of the investigator include scheduling a debriefing session with the subjects following the conclusion of the research. The methodological procedures associated with the study may have caused certain subjects to experience anxiety, embarrassment, and loss of self-esteem. The experimenter should determine whether the subjects have suffered such effects. If they have, the investigator must take positive steps to counteract the effects the study produced. Debriefing procedures to be used must also be described to reviewers. The reviewers must then decide whether the subject's rights and welfare are adequately protected.
The investigator should make every effort to see that the subjects are rewarded or recognized for their participation. Such benefits could be material (money or gifts), educational (added information or knowledge), some other self-enhancing gains (e.g., improved health and well-being), or the award of a certificate of participation. Any payment intended for the subjects should not be so large as to constitute an excessive inducement to participate. The investigator's description of the research submitted to the committee shall include plans to reward or recognize the subjects.
The content of this policy and the procedures that follow it incorporate material from the April 18, 1979 “Belmont Report” of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Academic Affairs Revised April 1993
Reenacted with slight amendment by Faculty Senate Bill 13-A-17 approved by the Faculty Senate March 13, 2013, Reviewed by President April 5, 2013 and by the Board of Regents April 10, 2013
Faculty Senate BIll 13-A-18 begins here.
During the preparation of the research proposal, the research investigator has the responsibility to seek advice from the department chairperson, college dean, Dean of Students and/or Human Subjects Committee Chairperson regarding potential implications for the rights of human subjects. If human subjects are not involved, the investigator may proceed with the study without consulting the committee.
Any research activity conducted by the faculty, staff, or students involving human subjects will be reviewed by the college dean or Dean of Students, by the CRC or SSRC, by the University Committee, or by both the CRC or SSRC and the University Committee. However, some proposals are exempt from full review.
Interview, survey, and observation of public behavior procedures are not exempt and must be reviewed when
Responses are recorded in such a manner that the human subjects can be identified,
directly or through identifiers linked to the subjects,
The subject's responses, if they became known outside the research, could reasonably place the subject at risk, or expose the subject to criminal or civil liability, or be damaging to the subject's financial standing or employability,
The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol,
The subjects are minor children. All research using interview and survey procedures
that include children as the subjects must be reviewed.
(For educational/classroom study exemption, see Definition of Terms, Research, in policy section)
Projects involving human subjects but considered exempt from full review by the investigator may be initially submitted to the college dean or Dean of Students and the chairperson of the College or Student Services Review Committee who will act for the College or Student Services Committee. The material submitted will include a brief outline of the project, including survey instruments, interview protocols and/or methods to protect the identity of subjects when secondary data, etc., are used and the rationale for considering the project exempt from full review. If the college dean or Dean of Students and the chairperson of the College or Student Services Review Committee concur that the project is exempt, the Dean or Dean of Students will inform the investigator, and she/he may proceed with the study. At that time, the investigator will submit a copy to the University Committee Chairperson for retrospective review. If either the college dean or Dean of Students or the chairperson of the College or Student Services Review Committee thinks the project is not exempt, the project must be subjected to the normal review process. In the event that the college dean, Dean of Students and/or chairperson of the College or Student Services Committee are among the proposers, the project must be submitted to the entire College or Student Services Committee and to the University Chairperson for retrospective review.
If the project is not exempt from full review, the proposal normally must be submitted to the College or Student Services Review Committee. If funds external to the University are sought and the granting agency requires approval at the University Committee level, the investigator may submit the research proposal directly to the University Committee for review.
The following materials and information will be submitted by the proposer for research requiring full review:
A brief outline of the project; if applicable, survey instruments, interview protocols, and a description of methods to protect the identity of subjects when secondary data are used; a description of what risks to subjects can be reasonably expected; methods for obtaining informed consent; and methods for ensuring the subjects' rights of privacy and confidentiality of data.
If a designation of Category 1 is expected, the proposer may submit rationale to support risks no greater than customary everyday activities or risks associated with routine physical or psychological examinations and indicate the level of qualifications of investigators to undertake the study. If a designation of Category 2 is expected, the proposer should submit an explanation describing the need for the level of risk, what is being done to minimize risk, and qualifications of the investigators to carry out the research.
Investigators are encouraged to include only information pertinent to the safety of human subjects.
The CRC or SSRC will determine whether the human subjects to be studied in the investigation are in Category 1 or in Category 2 and will verify that procedures for human subject protection will meet University and federal guidelines. The decision of the CRC or SSRC, together with the research proposal, is then sent to the college dean or Dean of Students. When the dean or Dean of Students agrees with the CRC or SSRC that the research involving human subjects is in Category 1 and that the guidelines for protection of human subjects have been met, the dean or Dean of Students will inform the investigator that she/he may proceed with the study, and the dean or Dean of Students will send to the University Committee a copy of the researcher's proposal, together with a report of action taken by the CRC or SSRC and the dean or Dean of Students' statement of approval. In these instances, the University Committee has the responsibility for a retrospective review. All proposals subject to retrospective review by the University Committee will be examined for appropriate safeguarding of human subjects. If adequate safeguarding is not evident, the University Committee Chair will notify the appropriate dean or Dean of Students and the CRC or SSRC Chair, and the research will cease until agreement among all parties is reached.
When the dean or Dean of Students agrees with the CRC or SSRC that the research involving human subjects is in Category 2 or when the dean or Dean of Students and the CRC or SSRC do not agree on the category, the dean or Dean of Students will inform the investigator that the proposal must be submitted to the University Committee for review. When the category is in question or for proposals submitted directly to the University Committee, the University Committee will decide whether the research is Category 1 or Category 2. Following review of the proposal, recommendations of the committee are sent to the Provost. (See section "Responsibilities of the Committee: Notification of Committee Action" for details.)
The following statements are presented as guidelines for research projects involving human subjects. The investigator should consult these guides when planning the research project. The committee also will utilize these statements during its evaluation of research proposals submitted by faculty, staff, and students of the University.
The investigator must be qualified in the field in which the research is conducted. If during the research the investigator finds himself/herself in areas beyond his/her level of competency, appropriate consultation must be obtained.
Research involving human subjects normally is not permitted without the voluntary consent of the human subject or the consent of his/her authorized representative if the subject lacks the capacity to consent. The investigator should provide the subject with all appropriate information, whether positive or negative, which is likely to influence the subject's decision to participate. No coercion, explicit or implicit, may be used to obtain or maintain cooperation. To assure that the subject's decision is truly free, the investigator must exercise particular care in certain circumstances. Examples include relationships involving a measure of control over the potential subject, e.g., teacher/student, employer/employee, and in institutions such as prisons and hospitals.
Certain research studies utilize subjects (e.g., minors, intellectually disabled, etc.) that require special consideration. Competent adults must give their own informed consent. If the research involves incompetent adults, it is the investigator's responsibility to make certain that consent for participation is obtained from authorized representatives in accordance with applicable statutes and regulations. Assent must be obtained from competent children. "Children" are individuals below the legal age of consent. Age, maturity, and psychological state are to be considered when determining competency of the child/children.
Assent means a child's affirmative agreement to participate in research. Failure to object should not be construed as consent. Informed consent must also be obtained from one of the child's parents or guardians. For research which involves greater than minimal risk and no prospect of direct benefit to the child, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has legal custody of the child. This requirement may be waived for research designed for conditions for a subject population for which parental or guardian consent is not a reasonable requirement to protect the subjects (e.g., abused or neglected children).
When the research involves minimal risk to the subject (Category 1), there is no single method required to assure that the subject consents to participation. Whether the subject's consent is obtained orally or is implicit in voluntary participation in a well-advertised activity or is secured via a written document, it must be "informed consent." The term "informed consent" implies that the individual has exercised free power of choice without the presence of excessive inducement or any element of deceit, fraud, duress, force, or other form of restraint or coercion. While not mandatory, written documentation is strongly recommended.
A dilemma arises in some research because fully informing the subjects would invalidate the experiment. If it is necessary to withhold information from the subject, the investigator must carefully inform the reviewers of what information will be withheld and must clearly justify the withholding of information. Nondisclosure of information to subjects must not be used simply to assure their participation in the research.
Investigators whose proposed research activity is in Category 2 are obligated to obtain legally effective informed consent. The basic elements of information necessary to such consent include:
An explanation of appropriate complaint procedures.
A written document is preferred for obtaining the consent of subjects involved in research activity in Category 2. If consent is obtained orally, the investigator must provide some documentation of consent for the records.
However consent is obtained, the method used must be described and justified in the material sent to the committee for review. Such materials might include, for example, a summary of oral explanations to be given to the participants when obtaining their informed consent. Also, to be submitted to the committee is an explanation of how the investigator plans to monitor the risks and safeguard the subject during the course of the investigation.
Note 1: The method of obtaining consent must not include any exculpatory language through which the subject waives, or appears to waive, any of her/his legal rights, including any release of the University or its agents from liability or negligence. Obtaining a signed consent form is not a release. Rather, it is simply an evidence of disclosure to the subject of essential information necessary to obtain informed consent.
Note 2: Special procedures are required for obtaining and documenting informed consent of subjects placed at risk in activities supported by many external sources of funds.
It is the investigator's responsibility to protect the rights of subjects against invasions of their privacy. The investigator must exercise care in obtaining and handling sensitive material and has ethical obligations to treat in confidence all private or personal information related to the subjects. The investigator should explain to those subjects providing information of a private or personal nature how such information will be used. Whenever feasible, such information from subjects should be obtained anonymously. If this is not possible, the data should be coded and the code separated from the data and kept in a secure place. Finally, the investigator should make certain such data are destroyed when the research is concluded.
The investigator must specify in the description of the project submitted to the committee for review her/his plans to ensure the confidentiality of the data and anonymity of the subjects. The following points can serve as a checklist to ensure that adequate protection will be provided:
It is also the responsibility of the principal investigator to advise all subjects, either in writing or orally, of their right to file a complaint with the University Committee. Each subject shall be given the name, address, and telephone number of the appropriate person to contact to register a complaint regarding her/his participation in the research. The participant or her/his legal representative should direct the complaint to the chairperson of the committee, with a copy to the Provost/Provost's representative.
The University Committee has the responsibility for investigating all complaints. After its investigation, the committee will report its findings to the Provost. Normally, these findings will indicate one of the following: (a) that the complaint is invalid, (b) that the complaint is valid and that the principal investigator must submit an amended statement of procedure for consideration by the committee, (c) that the complaint is valid and that committee approval of the research project is withdrawn. In all cases, the Provost notifies both the principal investigator and the complainant (if identified) of the findings of the investigation and of the action to be taken.
Each college, school, and Kent Library shall maintain a College Review Committee (CRC), composed of one (or, at the discretion of the unit, two) representative(s) from each department within the unit, such representatives being elected by the full-time faculty in each department. The CRC may develop internal working procedures not inconsistent with the Faculty Handbook or those of the University Committee.
The Dean of Students shall appoint and maintain a Student Services Review Committee (SSRC) consisting of no fewer than five members. These members shall be broadly representative of the personnel and administrative responsibilities of the division. The SSRC may develop internal working procedures not inconsistent with the Faculty Handbook or those of the University Committee.
The University Committee may develop internal working procedures not inconsistent with the Faculty Handbook.
Qualifications for Committee Membership
The Committee shall not consist entirely of persons who are officers, employees, or agents of or otherwise associated with the institution apart from their membership on the committee.
No member of the committee shall be involved in either the initial or continuing review of an activity in which he/she has a conflicting interest, except to provide information requested by the committee. Composition and Selection of the Committee The committee shall not consist entirely of members of a single professional group. The committee shall not consist entirely of men or entirely of women. The Provost shall appoint the membership of the committee as follows:
|1. Three members from the professions outside the University,|
|2. One member from each college, school, and Kent Library (from two nominees submitted by each college council),|
|3. One at-large representative (from two nominees submitted by the Faculty Senate),|
|4. One representative from the Graduate Faculty,|
|5. One representative of the college deans,|
|6. One representative from Student Services,|
|7. The Dean of the School of Graduate Studies or his/her designee, and|
|8. One representative of the Provost.|
Members of the committee shall be identified to appropriate agencies by name; earned degrees, if any; position or occupation; representative capacity; and by other pertinent indications of experience, such as board certification, licenses, etc., sufficient to describe each member's chief anticipated contributions to committee deliberations. Any employment or other relationship between each member and the institution shall be identified, i.e., full-time employee, part-time employee, member of governing panel or board, paid consultant, unpaid consultant. Changes in committee membership shall be reported in such form and at such times as may be required by law.
Terms of Committee Members
The terms of membership for the Committee members shall be three years, staggered to ensure an orderly rotation of members. Members may not exceed two consecutive three-year terms, but may be reappointed following a one-year hiatus. The Dean of the School of Graduate Studies shall not be subject to any term limit. The Provost's representative, and the designee of the Dean of the School of Graduate Studies (if used) shall not be subject to a limit on terms served. They may be reappointed at the end of their term, and they may be replaced within their term or at the end of their term by the appointing or designating authority.
The quorum of the committee shall be defined as a majority of the total membership. Approval by a majority of the members meeting in quorum shall constitute approval of the proposal.
A research proposal which has received the endorsement of the department chairperson, College Review Committee or Student Services Review Committee, and the dean or Dean of Students requires a majority of the total committee membership for rejection.
Duties of Committee Chairperson
The Provost shall appoint the chairperson of the committee within a reasonable time following the annual appointment of new members to the committee. Duties of the committee chairperson include developing and publicizing an annual schedule of regular committee meetings, and he/she is responsible for the prompt communication of committee findings to appropriate parties. Furthermore, the chairperson is responsible for communicating annually with deans and the Dean of Students and College and Student Services Research Committees regarding criteria for research involving human subjects.
Notification of Committee Action
Following its initial review of a research proposal, the committee shall report the action taken to the Provost or designee. Recommendations by the committee are subject to further consideration by the Provost and by the President. Normally, the report of committee actions sent to the Provost or his/her designee will (a) recommend approval, or (b) indicate any special requirements to be met and the conditions under which approval would be recommended, or (c) reject the proposal, in which case the reasons for rejection are stated. With concurrence of the Provost, the chairperson of the committee sends a notification of committee restrictions to the principal investigator. Investigators dissatisfied with findings of the committee may appeal to the Provost. A subsequent reconsideration of a research proposal may, at the discretion of the Provost, involve attendance of the principal investigator and/or consultants selected by the committee and by the investigator. Unfavorable recommendations and restrictions cannot be removed except by the committee. Procedural changes in a project can be implemented only after these changes are reviewed and approved by the committee. When reviews are completed and approval granted by the committee, the chairperson completes a certification of review and forwards a copy to the Provost, who agrees or disagrees and informs the principal investigator.
It is the responsibility of the Provost to insist that restrictions and recommendations made by the committee are fully implemented. Any disregard of committee restrictions and recommendations by a principal investigator shall be reported immediately to the Provost, who takes steps for remedial action.
Academic Affairs Revised April 1993 Reenacted with slight amendment by Faculty Senate Bill 13-A-18 approved by the Faculty Senate March 13, 2013 and by the President April 11, 2013, Posted for 15 day review on April 11, 2013