Southeast Missouri State University

Bill 12-A-17 - Revising the "Research" Description of Faculty Professional Responsibilities by Establishing Several "Procedure" Sections regarding Research Involving Human Subjects (Failed)

FACULTY SENATE SOUTHEAST MISSOURI STATE UNIVERSITY

FACULTY SENATE BILL 12-A-17

Approved by the Faculty Senate
April 4, 2012

REVISING THE "RESEARCH" DESCRIPTION OF FACULTY PROFESSIONAL RESPONSIBILITIES BY ESTABLISHING SEVERAL "PROCEDURES" SECTIONS REGARDING RESEARCH INVOLVING HUMAN SUBJECTS

BE IT RESOLVED THAT: subject to the passage and approval of both this bill and its companion bill establishing a corresponding "policy" section, Chapter 3, Section D7 of the Faculty Handbook be amended by making the following changes to the existing content, thereby establishing a "procedures" section (to follow the companion "policy" section in the Handbook):

so that the resulting Section D 7 of Chapter 3 read as follows:

Procedures for the Review of Research Proposals Involving Human Subjects

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.

These include

1. Secondary use of existing data documents and pathological or diagnostic specimens if the subjects are not identifiable.
2 Use of publicly available data, regardless of whether the subjects are identifiable.
3 Non-intervening observations of public behavior. The exemption includes research involving observations of public behavior of children where the investigator(s) does not participate in the activities being observed.

Interviews and surveys of adults (with exceptions noted below).

Interview, survey, and observation of public behavior procedures are not exempt and must be reviewed when

1. Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects,

AND

2. 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,

OR

3. The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol,

OR

4. 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.)

Procedures Regarding Responsibilities of the Principal Investigator

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.

Procedures Regarding Informed Consent

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, the mentally retarded, 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:
1. A fair explanation of the procedures to be followed and their purposes, including identification of any procedures which are experimental;
2. A description of any attendant discomforts and risks reasonably to be expected;
3. A description of any benefits reasonably to be expected;
4. A disclosure of any appropriate alternative procedures that might be advantageous for the subject;
5. An offer to answer any inquiries concerning the procedure;
6. An instruction that the individual is free to withdraw his or her consent and to discontinue participation in the project or activity at any time without prejudice to the subject;

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.

Procedures for Confidentiality of Data Regarding Human Subjects

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:
1. The instruments for procuring data should be carefully constructed to ensure that only personal information absolutely essential to the study is acquired.
2. Personal information checklists which permit identification of the subject should be stored in files accessible only to authorized personnel.
3. Data containing personal information should be changed into coded form as soon as feasible. This means removal of the name and any other information which would reveal the subject's identity.
4. Adequate procedures for the disposal of data must be included in the research plans.
5. The identity of subjects must not be released without their express permission.

Certain research studies utilize data involving identifiable subjects that were collected previously for a different purpose. In such instances, the investigator must (a) re-evaluate the risk to the subjects, (b) determine whether the new use is within the scope of the original consent, and (c) provide for the anonymity of subjects in the intended study.

Procedures Regarding Complaints

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.

Procedures Regarding the Committee

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 thirteen members to the committee as follows:
1. Three members from the professions outside the University,
2. One member from each college/and the School of Polytechnic Studies (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, and
7. The Dean of the Graduate School or his/her designee.

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 Dean of the Graduate School at the University shall be a permanent member of the Committee. The terms of membership for the other twelve initial appointees shall be for one, two, and three years to ensure an orderly rotation of members. Beginning with the second year, four appointments will be made annually, and each of these will be for a three-year term. Members may not exceed two consecutive three-year terms, but may be reappointed following a one-year hiatus.

Quorum Requirements

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.

Provision for Modification of Procedures

The operational policy of the Committee on Research Involving Human Subjects shall be subject to a continuing review that will be cognizant of changes in regulations of appropriate agencies. Recommendations for changes also may be initiated by individuals who are not members of the committee. A proposed change and the rationale for the change must first be reviewed at the college or division level before being forwarded to the committee. Proposed changes coming to the committee from the various college councils or the Student Services Division shall be studied to determine whether they are feasible. If a proposed change seems desirable to the committee, the proposal shall be sent via the Provost to all the college councils and the Student Services Division for their consideration and input. Proposed changes originating in the committee also will be sent via the Provost to the various college councils and the Student Services Division for study.

A proposed change that is supported by the committee and a majority of the college councils (with the vote of the Student Services Division being equal to a college council vote) shall be sent by the committee to the Provost and shall be accompanied by a rationale for change. If the proposed change is unacceptable to the Provost, it shall be returned to the committee for further study. If the change is approved by the Provost, it shall be forwarded to the President for his/her approval. Following approval by the President, a statement of the change shall be disseminated on campus and forwarded to appropriate agencies for their information and/or negotiation. Proposed changes in existing policy shall become effective when they have been approved by the committee and the President and notification of the changes has been sent to appropriate agencies.

Academic Affairs Revised April 1993
Reenacted with slight amendment by Faculty Senate Bill 12-A-XX approved by the Faculty Senate XXXX and by the Board of Regents XXXX

***

Action Date
Introduced to Senate 2/29/12
Second Senate Meeting 3/21/12
Faculty Senate Vote 4/4/12
President's Review
15 Day Review
Posted to Faculty Handbook
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