Graduate Studies at Minnesota State University, Mankato

Research at Minnesota State University, Mankato

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IRB Manual

The Policies and Procedures Governing the Participation of Human Subjects in Research at Minnesota State University, Mankato

College of Graduate Studies and Research
115 Alumni/Foundation Center
Minnesota State University, Mankato
Mankato, MN 56001
Phone: 507-389-2321
Fax: 507-389-5974

Introduction

This manual prescribes the policies and procedures of Minnesota State University, Mankato (hereafter known as the Institution or the University) for the protection of human subjects in research and related activities conducted at, sponsored or co-sponsored by the Institution. It also serves to implement the Department of Health and Human Services' assurance of compliance with federal and state of Minnesota policies, regulations and laws relating to the protection of human subjects in research.

The policies and procedures described herein apply to all research, development and research-related activities involving human subjects for which the Institution is a responsible participant regardless of the source of funding or whether or not there is funding. In some cases, the regulations at Minnesota State University, Mankato are more stringent than federal guidelines.

Safeguarding the rights and welfare of subjects in research and related activities is primarily the responsibility of this Institution, which receives or is accountable for any funds awarded for the support of the activity. It is also the policy of this Institution that approval by the Institutional Review Board for the Protection of Human Subjects (IRB) be received before a proposal is submitted for funding. In order to meet this institutional responsibility, it is the policy of this University that no research activity involving human subjects shall be undertaken unless the IRB has reviewed and approved such activity except as provided for in Section 3 of this manual. This Institution will submit certification of such review and approval in accordance with any requirements of such action.

The IRB may refer questions regarding the applicability of policies and procedures to legal counsel.

This document constitutes the policies and procedures under which the IRB shall operate.

General Information

Minnesota State University, Mankato is guided by the ethical principles regarding all research involving humans as subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report). In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46) are upheld. Minnesota State University, Mankato has chosen to require that all research under its auspices be conducted in accordance with the requirements of 45 CFR 46, regardless of the source of funding. Additionally, some university requirements are more stringent than those found in the federal regulations.

Underlying the policy of the Institution are the following basic principles embodied in the policy statement contained in part 46 of Title 45. These principles will serve to assist the University in discharging its responsibilities, through its authorized representatives and the Institutional Review Board for the Protection of Human Subjects in Research (IRB), to protect the rights and welfare of human subjects, as well as to assist faculty engaged in relevant research from unknowingly committing unethical acts. The Institution bears full responsibility for the performance of all research involving human subjects covered by this set of policies and procedures.

Research involving human subjects is an important and necessary activity of the University and must be conducted in an ethical manner. Such research has the encouragement of the University when the following principles are fulfilled:

Where appropriate, studies have been conducted first on animals.
Risks are minimized by using the safest procedures consistent with sound research design.
The privacy of the subject is protected and confidentiality of data is maintained.
Before any person is a subject of research, there must be obtained from that person, or a legally authorized representative, informed, voluntary, competent and understanding consent. This involves a full and careful explanation in language that is understandable by laypersons. The consent of the subject must be obtained without duress, deception, or the withholding of information. This means that the purpose of the research, the procedures to be followed, the possible risks involved, and the benefits to result from the activity, are explained to the subject and the subject is informed about informed consent.
The subject should also be told that he/she is free to withdraw from the research at any time without bias or jeopardy or the loss of any services from the University which the subject would otherwise be due.
Modification of the written consent requirement may be allowed when justified, documented, and approved by the IRB. The requirements for informed consent may be modified if the following conditions are met and documented:
1. The research involves no more than minimal risk to the subjects; and
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate the subjects will be provided with additional pertinent information after participation.
1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
  1. Programs under the Social Security Act or other public benefit or service programs; or
  2. Procedures for obtaining benefits or services under those programs; or
  3. Possible changes in or alternatives to those programs or procedures; or
  4. Possible changes in method or levels of payment for benefits or services under those programs; and
  5. The research could not practicably be carried out without the waiver or alteration.
The IRB has the authority to observe or have a third party observe the consent process and the research.
Research involving populations such as children, prisoners, parolees, addicts, persons with AIDS, the mentally or physically infirm, and others in conditions of dependency, helplessness, or deprivation (i.e., vulnerable populations as defined by Minnesota and federal statutes) may require additional precautions and procedures to assure their protection.
Whenever medical, psychological, or physical intervention is used, or whenever the subject's environment is likely to be changed beyond normal limits, the research must be performed in conformity with established standards of health care practice under proper health care supervision.
Subjects may be paid to encourage their participation. Where subjects are drawn from particularly vulnerable groups, however, compensation may under certain circumstances cast doubt upon the voluntariness of their consent. In such circumstances the IRB may either limit or disapprove compensation (e.g., for poor persons or prisoners).
If participation as a subject is part of the academic work of a subject, informed consent procedures must be sufficiently sensitive not to be coercive and clearly not be made a mandatory requirement of the course. Students not wishing to participate should be given a choice of a reasonable alternate academic activity.
Before any research project which uses human subjects can be started and conducted at the Institution (or under its auspices), the project must be submitted for review to the IRB. All research involving human participants will be reviewed by the IRB. Researchers may begin their projects prior to receiving formal, written approval if they have received informal authorization from the IRB Administrator. Classroom activity, laboratory courses or field assignments are normally not classified as research, and typically are not reviewed by the IRB. (Consultation with the IRB Administrator or Chair or Co-Chair is strongly advised). All proposals submitted to federal agencies must have approval of the IRB prior to submission. All proposals must comply with DHHS Policies and Regulations on Protection of Human Subjects and this document.
It shall be the responsibility of the principal investigator to make certain that all current policies and procedures governing the participation of humans as research subjects are adhered to in his/her research. In the event that the researcher is a graduate student, then the supervisory full-time MSU faculty member is considered the principal investigator and consequently the responsible person. All protocols detailing the use of human subjects in research should contain the statement:
"In making this application, I certify that I have read and understand the Policies and Procedures for Projects that Involve Human Subjects, and that I intend to comply with the letter and spirit of the University Policy. Significant changes in the protocol will be submitted to the IRB for written approval prior to these changes being put into practice. Informed consent/assent records of the participants will be kept for at least three (3) years after the completion of the research."
Supplemental to DHHS regulations and applicable law are ethical codes developed and adopted by various professional associations which will assist and guide investigators in various disciplines in protecting the rights of human subjects. They do not supplant or substitute for DHHS regulations or this document.
Students, research assistants or others performing research activities which exceed minimal risk to research subjects, under the supervision of a faculty advisor, which have been approved by the IRB, may be considered "agents" of the University for risk-management purposes.

In such cases the faculty advisor should formally request the services of students/research assistants in a memorandum which outlines their anticipated activities to be performed in the study. A copy of that memorandum must be forwarded to the IRB.
Cooperative research projects which involve more than one institution are those projects covered by this policy. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. An institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. All cooperative research projects, however, must be submitted to the IRB.
Research involving medical devices will be conducted according to the requirements set forth in 21 CFR 812 and 45 CFR 46 of the Code of Federal Regulations.
Research involving investigational drugs will be conducted according to the requirements set forth in 21 CFR 56 and 45 CFR 46 of the Code of Federal Regulations.
Federally funded research may require a Single Project Assurance from the University. Initiation of this process is the responsibility of the investigator.

IRB Membership

Membership Composition
The IRB is a standing committee of Minnesota State University, Mankato. The IRB must be composed of sufficient members with varying backgrounds to assure complete and adequate review of research projects and activities conducted by the Institution. In addition to a balance of research expertise, the IRB shall also include persons able to determine the acceptability of a research proposal with respect to institutional commitments and regulations, applicable law, standards of professional conduct and practice, and community attitudes. The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of the members' backgrounds (including consideration of the racial and cultural backgrounds of members 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.

The IRB is primarily comprised of faculty members from the colleges and departments most concerned with projects involving human subjects. In order to assure diversity of intellectual perspective, the faculty members of the IRB will be selected from more than half the academic colleges in the Institution. A medical doctor will be a member of the IRB whenever possible. The IRB may include a graduate student member chosen at large from the College of Graduate Studies and Research. The Dean of Graduate Studies and Research, and a designated staff assistant, are ex-officio members of the IRB. If the IRB regularly reviews research that involves vulnerable subjects, the IRB shall include one or more individuals who are primarily concerned with the welfare of these subjects.

The IRB may not consist entirely of men or entirely of women, or entirely of members of one profession. The IRB shall include at least one member whose primary concerns are in nonscientific areas (e.g., lawyers, ethicists, members of the clergy). The IRB shall include at least one member who is not otherwise affiliated with the Institution and who is not part of the immediate family of a person who is affiliated with the Institution.

When required, the members shall be identified to DHHS by name, earned degrees (if any), position or occupation, representative capacity, and pertinent experience indicative of members' anticipated contribution to IRB deliberations. In conforming with federal regulations, all permanent changes of membership, replacement or additions, may be reported to Department of Health & Human Services (Office for Prevention from Research Risk, National Institute of Health, DHHS, Bethesda, Maryland 20892).

The IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the University IRB.
Method of Appointment
The administrative authority for the protection of human subjects at Minnesota State University, Mankato has been delegated to the Dean of Graduate Studies and Research.

The members of the University IRB are nominated by the Dean of Graduate Studies and Research in consultation with the Inter-Faculty Organization President and College Deans, and appointed by the University President. The University IRB is a standing committee of the University and is administratively responsible to the Dean of Graduate Studies and Research.

Appointments to the IRB normally are for a period of three (3) years. Terms are staggered to ensure continuity within the group. With appropriate approval, a member may be appointed for more than one term.

The IRB Chair or Co-Chair will normally serve for a period of at least two years, having first served as an IRB member for at least one year.
Meetings, Quorum, Voting and Minutes
The IRB will normally meet monthly or as necessary during the academic year. If an emergency meeting is necessary, a meeting may be called by the IRB Chair or Co-Chair. Level I proposals will be reviewed during the summer.

Meetings are open to all persons who desire to attend. The public, however, may not participate in meetings, nor examine confidential records or documents, etc., used by the IRB.
1. Quorum and Voting
  A quorum of the IRB is defined as a majority of the total active membership, and in order for official Board business to be conducted, a majority must be present. No member of an institutional board shall be involved in either the initial or continuing review of an activity in which he or she has a professional responsibility, except to provide information requested by the IRB and will not vote on any activity in which he or she has a conflicting interest. When the IRB is considering an activity that involves testing a new drug, the FDA regulations require that the quorum of the IRB include at least two members who are licensed to administer drugs and at least one member who is not licensed.
  
  IRB members may become inactive for a period of time when their University duties make participation with the IRB impossible. For a member to become inactive, the member must request moving to inactive status in writing.
2. Minutes
  Provision must be made for taking written Minutes or recordings of the proceedings of all meetings. Such Minutes or recordings must include at least the following information: date, time and place of meeting, members of the IRB present or excused, an accurate description of all actions proposed, and the names of the members who proposed each motion. The Minutes also shall include applications discussed, the action taken, and a listing of Approvals by the Chair or Co-Chair, and IRB Administrator since the previous Minutes. All Minutes will be stored and made available for a period of at least three (3) years.
Leadership
By the last meeting of each academic year, the committee, by majority vote, will nominate to the Dean of Graduate Studies and Research, two IRB members who are MSU faculty as either committee co-chairs or as a chair and a vice-chair. The role of the leaders is to oversee the review process, serve as convenor of the IRB, provide for a consistent, high quality, and timely review process, and to provide verification of the actions of the IRB. The leadership is expected to delegate appropriate tasks to IRB members and to the administrative support. The leadership has the following duties and responsibilities:
1. Serve as convenor for the IRB. This includes scheduling reviews, certifying IRB actions, and certifying approval and disapproval of protocols.
2. Serve as a reviewer and router for protocols that do not require Full Board (Level III) review.
3. Serve as the focal point (along with the IRB Administrator) for interaction of the IRB with the university community.
4. Oversee (along with the IRB Administrator) the development and execution of the educational efforts of the IRB on campus.
5. Monitor (along with the IRB Administrator) changes in federal regulations and institutional policy for the protection of human subjects in research.
6. Make sure that all IRB procedure is appropriately documented. This includes, but is not limited to, reporting of IRB actions to the Dean of Graduate Studies and Research, liaison with the staff support, and liaison with faculty in general.
Replacement of Chair or a Co-Chair Under Extraordinary Conditions
If for any reason either the Chair or Co-Chair should not be able, or is unwilling to complete his/her term of office, notification in writing will be given to the IRB and Dean of Graduate Studies and Research. The IRB will receive the notification in regular or special session and nominate an appropriate replacement. Consultation between the IRB and the Dean of Graduate Studies and Research will occur prior to making nominations. Should both positions become open at the same time, the senior member of the IRB will convene the IRB for elections.

Review Process

General Policy Statement
All research involving the use of human subjects conducted at, or sponsored by, this Institution, including both funded as well as non-funded research, must be reviewed by the University's Institutional Review Board for the Protection of Human Subjects (IRB).
1. Definition of Research for IRB Purposes
  Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.
2. IRB Review Criteria
  In evaluating a research project, the following are basic considerations:
  - Are the risks so outweighed by the potential benefit to the subjects themselves or by the importance of the knowledge to be gained as to warrant a decision to allow them to accept these risks?
  - Are the rights and welfare of the subjects adequately protected? Have steps been taken to protect the subject's personal privacy and the confidentiality of information received from the subject?
  - Has appropriate consent to participate in the study been obtained? Have all the elements of informed consent been included, except where a request for waiver or alteration has been submitted?
  - Do the procedures involve situations that may put the subject at risk?
3. Study Populations
  National Institute of Health (NIH) policy requires that minorities and women be included in relevant research study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that disproportionately affect them. This policy is intended to apply to males and females of all ages, and must be representative of the population at large or that being studied. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided.
4. Classroom Research Assignments
  Both graduate and undergraduate classroom research assignments which are conducted under the supervision of classroom faculty must be submitted to the IRB for approval under the appropriate level of review. Protocols in these studies must identify the research effort as part of a class assignment. The faculty member submitting the classroom research proposal is responsible for the research conducted under the protocol for the study. Approval of such activities is for a period not to exceed more than one calendar year.
  
  Research for master's theses, and independent research studies are not considered classroom research and must comply with the usual IRB review procedures.
Levels of IRB Review
There are three levels of review for research proposals involving human subjects:
1. Level I
  Proposals eligible for Level I review must fall under certain categories of activities involving less than a minimal risk, and not involving special or vulnerable populations, such as children, developmentally disabled, prisoners, and other captive populations.
2. Level II
  Certain proposals which involve minimal or less risk and are not eligible for Level I review may be eligible for Level II review and approval by the IRB Chair or Co-Chair, or other experienced IRB member designated by the Chair or Co-Chair.
3. Level III
  All other proposals must be reviewed by the Full Board.
Applicant's Procedure
The review process begins with identification of those projects or activities which involve human subjects. Determination as to whether any project or activity involves human subjects is a professional responsibility to be discharged initially in accordance with the University Human Subjects Policies and Procedures and ultimately through review by the IRB.

Application forms utilized by the IRB in its review are available to all persons who use human subjects in their research or related activity. Application packets are available at the College of Graduate Studies and Research, or on the institutional Web site. The completed application packet is submitted to the IRB Administrator, College of Graduate Studies and Research, 115 Alumni Foundation Center, Minnesota State University, Mankato, MN 56001. Preliminary review will take place in the order that applications are received.

All proposals must include a faculty member, or continuing professional employee as defined below, as the principal investigator of the research study. Graduate and undergraduate students, for the purposes of the IRB, cannot be the sole investigator.

Upon approval, Level 1 proposals will be provisionally approved by the IRB Adminstrator. Letters will be sent to primary and secondary investigators by the Administrator. Level 2 ad # approvals will be sent out by the IRB Co-Chairs. All approvals are not considered until the IRB approves the monthly log. After the IRB has approved the proposal, any significant changes which are made in the proposal must be submitted to the IRB through the IRB Administrator for the IRB's approval. These approval letters will be kept on file and made available for a period of at least three (3) years after completion of the research.

It is to the advantage of the applicant to submit all materials to the IRB Administrator in the College of Graduate Studies and Research for review by the IRB at least two months in advance of the deadline for submission of the proposal to an agency for non-institutional funding. Time should be allowed for the possibility of changes to be incorporated into the proposal to a funding agency to avoid follow-up reporting after the proposal has been submitted.
Principal Investigators
The principal investigator is ultimately responsible for the protection of human subjects participating in their research. For IRB purposes the following employees can serve as principal investigators:
1. All faculty including adjunct faculty,
2. Other continuing unclassified employees,
3. Members of the following bargaining units:
  1. Health Care Professional Association,
  2. Professional Unit, Supervisor Unit, Managerial.
In all cases there must be sufficient continuity that consent forms and other records are kept and made available for review by the IRB for at least three (3) years after the conclusion of the research.

A student cannot serve as a principal investigator.
Faculty Advisors
1. Academic advisors, faculty research advisors, or faculty members assigning research projects involving human subjects must take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research and assisting in the preparation of applications for human subjects' approval. Advisors shall take an active role in ensuring that the conduct of the research meets the highest ethical standards.
2. Faculty research advisors shall ensure that their advisees:
  1. Minimize the risk to human subjects,
  2. Understand the elements of the consent process,
  3. Develop a readable consent form,
  4. Plan and accomplish appropriate recruitment strategies for identifying subjects,
  5. Establish and maintain strict guidelines for protecting anonymity and confidentiality, and
  6. Conduct their research in accordance with these policies and procedures.
3. The faculty research advisor's signature is required on the IRB application form, providing documentation that these essential aspects of research have been addressed, and that the advisor is ultimately responsible for the protection of human subjects in student research.
Level I Review
1. Process
  For those proposals eligible for Level I review, the principal investigator must first determine if the research meets the guidelines for such review by completing the Level I review checklist.
  
  The completed and signed IRB application is to be forwarded immediately to the IRB Administrator for review, and if appropriate, for approval as a level 1. This decision is then subject to the monthly review of the IRB decision log by the full IRB Committee. The Committee may overturn the Administrator's decision and request a full review by the committee.
  
  Once the principal investigator has received, on letterhead, approval from the IRB Administrator, data collection may begin.
  
  The IRB Administrator will preliminarily approve the proposal if the Administrator determines that the proposal qualifies for Level I status. Administrator approval is preliminary. Final approval is confered only after the IRB Log is approved by the Board. If the IRB Administrator finds that the research activity does not qualify for Level I status, data collection must cease immediately, pending approval by the IRB, and data collected without approval cannot be used for the research study.
  
  IRB Administrator approved Level 1 decisions may be set aside for fuller IRB consideration and evaluation if the Board considers that the Administrator overstepped her or his authority in conferring Level 1 status on a proposal. Any data collection must then halt until the full IRB has reviewed and approved the proposal.
2. Categories Eligible for Level I Review
  Research activities in which the only involvement of human subjects will be in one or more of the following categories are eligible for Level I review unless the subjects constitute a special/vulnerable population as defined in this manual:
  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as:
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
    This category may be applied to research involving children.
    
    [Above (a) is interpreted as studies conducted involving curricula or programs established within educational institutions (or existing groups) which would normally be undertaken by all students (or members) whether or not the research study will be conducted.]
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless:
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects, financial standing, employability, or reputation.
    Surveys on sensitive or personal topics which may cause discomfort to study participants are not eligible for Level I review.
    
    The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. If standardized, educational, or diagnostic testing is used, appropriate professional standards governing the use of testing and test data apply. Standardized, educational, or diagnostic testing will not be approved as a research activity unless appropriate supervision is documented as being available to the researcher.
    
    This category concerns educational tests. These tests are not to be administered by the researcher for the sole purpose of a research study.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior not eligible for Level I status under category b above, is eligible if:
    1. the human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality or the personally identifiable information will be maintained throughout the research and thereafter.
  4. 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.
    Records considered private based on federal and state statute, including medical records and education records, require written release by the study subject or by the custodian of the record. Researchers are cautioned that review of private records involving access to and/or recording of identifiable information are not eligible for Level I review, and requires written consent of the study subject. Existing public records do not require prior consent of subjects to review the records.
    
    Pathological or diagnostic specimens which are considered waste and are destined to be destroyed can be used in research provided that patient identifiers are not linked to the specimen and are not intended to be used in the diagnosis or treatment of a patient. (If either of these conditions apply, consent of the research subject is required and a higher level of review is required). Specimens retrieved as extra during a clinical procedure require review at a higher level and require written consent from the subject.
    
    Inclusion of fetal tissue in the pathological specimens require a higher level IRB review.
  5. Taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed or
    2. if a food is consumed that contains a food ingredient at or below the level for 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.
    This category may be applied to research involving children; however, University policy requires written parental consent to include children in taste testing studies.
  6. Research and demonstration projects which are conducted by or subject to the approval of federal government department or agency heads, and which are designed to study, evaluate, or otherwise examine:
    1. public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternative to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
  Applications for approval under categories b and c require the researcher to supply the IRB with a copy of the questionnaire or survey or interview guide and a cover letter or cover sheet of the questionnaire that informs the respondent of the elements of informed consent. Surveys and interviews of children and other vulnerable populations are not eligible for Level I review.
Level II and Level III Review
1. Process
  1. Initial Review
    The IRB Administrator, IRB Chair or Co-Chair will conduct a preliminary review of each proposal and related documents to determine whether the materials submitted are sufficiently informative and complete to constitute a basis for a fair review by the IRB. The proposal and related documents are to be submitted to the IRB Administrator in typewritten form for initial screening. Proposals meeting the criteria for approval under Level I may be approved by the IRB Administrator. Proposals meeting the criteria for approval under Level II may be approved by the IRB Chair or Co-Chair, or other experienced Board member designated by the Chair or Co-Chair. An inadequate proposal will be returned to the investigator (applicant) to bring it into conformity with IRB requirements.
    
    All IRB approvals, and those with pending status, will be listed in the IRB Log for review and approval by the IRB on a regular basis. All decisions are not considered final until the log is approved. After each log has been approved it will be posted electronically to notify department chairs, deans, faculty, and the campus community. At a convened IRB meeting, any member may request that an activity which has been approved under these procedures be reviewed by the Full Board. A vote of the members shall be taken concerning the request and the majority shall decide the issue.
2. Level II Review
  1. Process
    1. All applications for the Conduct of Research Involving Human Subjects are submitted to the IRB Administrator in the College of Graduate Studies and Research.
    2. The Chair or Co-Chair, or other experienced Board member designated by the Chair or Co-Chair will determine if the proposal is eligible for Level II review. Research that is not eligible for Level II review will require review by the Full Board (Level III). In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after a Level III review.
  2. Categories Eligible for Level II Review
    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 without bringing the protocol to the Full Board:
    1. Minor changes in previously approved research during the period for which approval is authorized, or proposed new research that contains only minor changes from a currently approved protocol.
    2. Collection of hair and nail clippings, in a non-disfiguring manner, deciduous teeth and permanent teeth if patient care indicates a need for extraction.
    3. 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.
    4. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electro-encephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electro-retinography. It does not include exposure to electromagnetic radiation outside the visible range (example, X-rays microwaves).
    5. 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.
    6. Collection of both supra-and subgingival dental plaque and calculus, provided that procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
    7. Voice recordings made for research purposes such as, but not limited to, investigations of speech defects.
    8. Moderate exercise by healthy volunteers.
    9. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
    10. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the research investigator does not manipulate subjects' behavior and the research will not involve stress to subject.
    11. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
    12. Any other category specifically added to this list by DHHS and published in the Federal Register.
3. Level III Review
  1. Research protocols scheduled for review shall be distributed to all members of the IRB prior to the meeting (normally 10 days prior).
  2. When it is determined that consultants or experts will be required to advise the IRB in its review of a protocol, the research protocol shall also be distributed to the consultants or experts prior to the meeting.
  3. All protocols requiring the IRB initial review and continuing review by the full board shall be conducted at convened meetings and at timely intervals (normally at monthly intervals).
  4. A majority of the active membership of the IRB constitutes a quorum and is required in order to convene a meeting for the review of research protocols.
  5. An IRB member whose concerns are primarily in non-scientific areas must be present at the convened meeting before the IRB can conduct its review of research.
  6. For a research protocol to be approved, it must receive the approval of a simple majority of those members present at the convened meeting.
  7. The IRB may not have a member participating in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
  8. In cases where research activities were initially approved under preliminary review procedures and subsequently reviewed by the IRB in session, the decisions reached at the convened meeting shall supersede any decisions made through any other normal review process.
Criteria for IRB Approval
In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:
1. Risks and discomforts to subjects are minimized:
  1. by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk and,
  2. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks and discomforts to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted.
4. Consent to participate in research will be sought from each prospective subject or the subject's legally authorized representative.
5. Consent to participate in research will be appropriately documented.
6. Where appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects.
7. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
Notification of Decision
1. The IRB Administrator or Chair or Co-Chair shall notify the research investigators in writing of the IRB's decisions, conditions and requirements regarding research protocols. The IRB Administrator will consult with the IRB Chair or Co-Chair as to the accuracy of the information communicated to the investigator. Copies of the communications will be made available to the investigator(s), IRB liaison, and faculty advisor.
2. A research protocol that has been approved by a quorum of the IRB, but requires changes suggested by the IRB must be re-approved by the IRB Chair or Co-Chair or the IRB liaison who has been assigned to the project prior to conducting research.
3. The IRB Administrator shall notify the Office of Grants and Sponsored Programs of the decisions for those protocols that have been submitted for external funding.
4. The IRB Administrator or Chair or Co-Chair shall provide to the research investigator reasons for the IRB's decision to disapprove a research protocol and an opportunity for the research investigator to respond.
5. In the event of harm to subjects or if a project is not being conducted in accordance with the Board's requirements and/or conditions, the IRB has the authority to terminate or suspend its approval of the research and to confiscate any data collected.
Continuing Review

Consent Process

Informed Consent
Informed consent is the voluntary agreement obtained from a subject (or his/her legally authorized representative) for the subject's participation in research or related activity, prior to participation in that activity. The consent must permit the individual or legally authorized representative to exercise free power of choice without undue inducement or any element of deceit, fraud, force, duress, or other form of coercion or constraint.
1. Obtaining informed consent:
  1. Research investigators are responsible for obtaining informed consent in accordance with 45 CFR 46.116, and for ensuring that no human subject will be involved in the research prior to the obtaining of the consent.
  2. Consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent except in situations authorized by the IRB.
  3. Unless otherwise authorized by the IRB, research investigators are responsible for ensuring that effective consent shall:
    1. be obtained in writing from the subject or the subject's legally authorized representative;
    2. be in language understandable to the subject or the representative;
    3. be obtained under circumstances that offer the subject or the representative sufficient opportunity to consider whether the subject should or should not participate; and
    4. not include exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the research investigator, the sponsor, the Institution or its agents from liability for negligence.
  4. Research investigators may use a consent form which is either:
    1. A written consent document that embodies the elements of informed consent required by 45 CFR 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the research investigator shall give either the subject or the representative adequate opportunity to read the form before signing it, or
    2. The written summary (verbal script) of what is to be said to the subject.
    3. If a study involves foreseeable risks, a written consent form must be used.
  5. Research investigators are responsible for placement and maintenance of the consent documents signed by human subjects in a repository approved by the IRB. In accordance with federal regulations consent documents must be maintained for three (3) years after completion of the study.
  6. In the case of minors (persons under the legal age), consent includes adequate provisions for written assent of the minor (when able, with appropriate language, usually 7 years or older), or documentation of verbal assent by younger children, and permission of the parents or guardians. Parental or guardian permission may be waived by the IRB provided that an appropriate mechanism for the protection of the minor is substituted or conditions justifying modification of the waiver exist.
  7. Parents and subjects shall have the right to examine certain surveys before participating in them, consent (if they wish) when certain kinds of questions are asked, file complaints under certain circumstances, and receive notice of these rights. The requirements for examination and consent apply if a survey includes a question on any of the following topics as outlined in 34 CFR Part 98:
    1. Political affiliations.
    2. Mental and psychological problems potentially embarrassing to the subject or his or her family.
    3. Sex behavior and attitudes.
    4. Illegal, anti-social, self-incriminating, and demeaning behavior.
    5. Critical appraisals of other individuals with whom the subject has close family relationships.
    6. Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.
    7. Income, other than that required by law to determine eligibility for participation in a program or for receiving assistance under a program.
  8. In the case of questionnaires, return of the questionnaire may be viewed as implying consent which should be indicated in a cover letter.
  9. In surveys there is need to assure the ethical principle that volunteer subjects deserve to know the purpose of the survey and the uses to which their data will be put. The argument that the results would be seriously biased if subjects are informed is not an adequate justification for failing to inform.
  10. Prospective subjects are to be advised at the outset as to the availability or non-availability of medical, psychological treatment, or monetary compensation for physical injuries incurred as a result of participating in research, especially where behavioral or biomedical research presents a risk of physical injury.
  11. Researchers are expected to modify the language used on consent forms and assent forms to match the abilities of special populations (e.g., children, cognitively impaired adults, bedridden elderly, non-English speakers).
  12. In research with developmentally disabled youths and adults and bedridden elderly, assent of the subject is required in addition to the written informed consent of the subject's legal guardian before data collection may begin.
  13. Faculty members assume responsibility for compliance with IRB policies and procedures in all research conducted by students under their supervision. The supervising faculty member's name, e-mail, and telephone must be included on the informed consent forms used by students, as well as on the applications, so that subjects may contact them with questions about the study.
General Requirements for Informed Consent
Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained an effective consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or representative. No consent process, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the Institution or its agents from liability for negligence.
1. Basic elements of consent
  In seeking informed consent the following information shall be provided to each subject:
  1. A statement that the study involves research, an explanation of the purposes of the research and expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  2. A description of any reasonably foreseeable risks or discomforts to the subject;
  3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
  8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
2. Additional elements of consent
  When appropriate, one or more of the following elements of information shall also be provided to each subject:
  1. A statement that a particular treatment or procedure may involve risks to the subject (or the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
  6. The approximate number of subjects involved in the study.
Waiver of General Requirements for Informed Consent
The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
1. The research involves no more than minimal risk to the subjects; and
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects; and
3. the research could not practicably be carried out without the waiver or alteration; and
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  Or
5. the research or demonstration or project could not practicably be carried out without the waiver or alteration, and is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
  1. public benefit of service programs;
  2. procedures for obtaining benefits or services under those programs;
  3. possible changes in or alternatives to those programs or procedures; or
  4. possible changes in methods or levels of payment for benefits or services under those programs; and
The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

Procedures for Special Circumstances

In research projects involving audio or video taping or photographing of subjects, the following guidelines apply:
1. If Consent Forms are utilized, subjects must be advised in the Consent Form that their participation includes the use of audio/video taping. Subjects must be advised when tapes will be erased or destroyed;
2. If Consent Forms are not utilized, an appropriate release must be obtained from the subjects or guardian before taping, photographing or videographing of the interview; this release statement may be included on the tape if results of the interview would otherwise be anonymous;
3. In studies which do not include written consent (i.e., taped interviews in person or over the telephone), the elements of consent as they are explained to the subjects should be included as a preamble to the taped procedure;
4. Before consenting to being taped (audio or video) or photographed, subjects should be informed of the current and planned use of the materials including storage and access by persons other than the researcher. Normally, this information will be contained in the release form;
5. The researcher must make proper arrangements for secure storage of all audio and video tapes and assure that their use complies with the guidelines outlined in the informed consent/release form. Plans may include storage, erasing, or destroying after a given time period.
Any research that uses electrical, electronic or mechanical equipment with which the subject will be in contact may be required to supply the IRB with:
1. Trade Name, Manufacturer, Model Number
2. Schematic diagram, picture or other representation of the equipment including a demonstration or other means of showing the IRB the machine's normal operation;
3. Verification of safety including UL certification or other certification;
4. For old equipment, equipment that has been out of usage, equipment that has been moved, or equipment of local fabrication and/or not available from commercial vendors, the researchers must provide evidence of recent inspection and certification for safety.
In cases where subjects are recruited from other institutions (hospitals, community agencies, physicians, etc.), the first contact with potential subjects should be made by institutional staff who, after outlining the researcher's interest and obtaining the potential subject's permission, will refer the person to the researcher or vice versa. This may also be done by a letter from the researcher which is distributed by the institution. This procedure has been implemented to protect privacy rights of potential subjects.
Researchers engaged in research that is not anonymous to the researcher and that includes the study of subject use or abuse of controlled substances or other possibly self-incriminating responses will be required to state their intent to acquire a Certificate of Confidentiality from NIDA or other appropriate agency before data collection can begin. Certificates must be shared with the IRB before research begins.
A Certificate of Confidentiality is requested to grant protection against compulsory legal process for personally identifiable research information. This authority would protect the privacy of individuals who are the subjects of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.

The protection will be granted sparingly. Research of a sensitive nature should be conducted anonymously whenever possible. When anonymity is not possible, the protection will be granted only when the research is of a sensitive nature where the protection is judged necessary to achieve the research objectives. Research can be considered sensitive if it involves the collection of information on any of the following categories:
1. Information relating to sexual attitudes, preferences, or practices;
2. Information relating to the use of alcohol, drugs, or other addictive products;
3. Information pertaining to illegal conduct;
4. Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;
5. Information that would normally be recorded in a patient's medical record, and the disclosure of which could reasonably lead to social stigmatization or discrimination;
6. Information pertaining to an individual's psychological well-being or mental health;
7. Information in other categories, not listed here, might also be considered sensitive because of cultural or other factors, and protection can be granted in such cases upon appropriate justification and explanation. It applies to all research whether funded or un-funded.
If you believe your research qualifies for this protection or if you have any questions, please call the IRB Administrator at 507-389-2321.
Research with HIV positive or Acquired Immune Deficiency Syndrome (AIDS) patients is subject to additional precautions prescribed by the federal guidelines. This information is maintained by the IRB Administrator and will be shared with all interested researchers. Researchers should allow extra time for review of protocols for studies involving this population.
Vulnerable/special populations include those subjects who, as outlined in state and federal regulations, must be provided extra protection. This includes, but is not limited to minors, prisoners, fetuses/pregnant women, elderly and cognitively impaired persons.
Research with HIV positive or Acquired Immune Deficiency Syndrome (AIDS) patients is subject to additional precautions prescribed by the federal guidelines. This information is maintained by the IRB Administrator and will be shared with all interested researchers. Researchers should allow extra time for review of protocols for studies involving this population.
Vulnerable/special populations include those subjects who, as outlined in state and federal regulations, must be provided extra protection. This includes, but is not limited to minors, prisoners, fetuses/pregnant women, elderly and cognitively impaired persons.
FDA guidelines broaden the scope of different types of "vulnerable subjects" to include: "individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, of a retaliatory response from senior members of the hierarchy or institution in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects may include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency rooms, ethnic minority groups, homeless persons, nomads, refugees, children, and those incapable of giving consent."

Other groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as research subjects. Some groups, such as racial minorities, are not considered vulnerable populations if included in a general population.

Whenever potential subjects are persons of diminished capacity but capable of giving assent, the researcher must obtain their assent in addition to obtaining permission to participate in research from their guardian before involving the individual in a study.
Access to Records: A researcher may have access to institutional records, i.e., hospital, health service agency, etc., if the institution agrees in writing to the accessing and conforms with state guidelines for such access. A copy of the permission letter to access records must be provided to the IRB. The researcher may not obtain names or other identifiers from the records. Data collection shall not begin prior to approval by the IRB.
Research with Human Genomes is subject to precautions prescribed by federal guidelines. This information is maintained by the IRB Administrator and will be shared with all interested researchers. Researchers should allow extra time for review of protocols for studies involving this population.
Modifications to an approved protocol may be requested by memorandum or letter to the IRB but initiation of the modifications must not be undertaken before IRB approval.

Continuing Review

Projects approved for a period of one year or less, require review and approval by the IRB prior to the end of the approval period. The IRB will request more frequent reviews when the element of risk and the nature of the project warrant. At the time of initial approval, the IRB will inform the investigator of the length of approval, and if verification from sources other than the investigators is required as part of the continuing review. The IRB through the IRB Administrator will monitor any and all special requirements to ensure appropriate follow-up.

If the research protocol remains substantively unchanged, the responsible investigator will complete a Continuing Review Form and return it to the IRB prior to the end of the approval period. Completion of the Continuing Review Form serves to assure the IRB that the actual use of human subjects has been conducted in accordance with the approved protocol and conditions. Continuing Review forms are available from the Office of Graduate Studies and Research.

If, in the conduct of research, problems involving risks to human subjects arise which were not foreseen in the approved protocol, the problem must be reported to the IRB through the IRB Administrator at 507-389-2321. In the case of projects funded by federal agencies, the IRB will report such problems to the DHHS (OPRR, the National Institute of Health, DHHS, Bethesda, Maryland 20892) or the appropriate agency.

The IRB has regulatory authority and responsibility to observe, or have observed, any consent process or research activities. Regulations also require that projects be reviewed at least annually to verify that no substantive changes have been made without IRB approval.

Continuing review must be substantive and meaningful. Ordinarily, continuing review will be consistent with the initial review. It is possible that research reviewed under Level I or Level II has changed and additional review may be required.

OPRR interprets "not less than once per year" review to mean review on or before the one year anniversary date of the previous IRB review, even though the research activity may not begin until some time after the IRB had given approval.

The responsibility for continuing review as well as the authority to monitor, terminate or suspend approval of human research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects, rests with the IRB.

Adverse Reaction Report

The guidelines established by the Minnesota State University, Mankato Institutional Review Board require all investigators to immediately report any adverse effects or events to the IRB.

It is the responsibility of all investigators whether students or faculty conducting research on humans at or under the auspices of the Institution to report any situation or condition that leads to harm, injury, or negative effect to a research subject. All reports shall be made as soon as possible in writing to the IRB through its Administrator. The following are two general categories of events or conditions that must be reported:
1. Any injuries or adverse effects to subjects which may occur during the course of the research project.
2. Any possible breach of human subject protection in other research activities conducted at MSU of which the investigator may become aware.
The report must contain the following information:
1. Date of report,
2. IRB log number and title of proposal,
3. Principal investigator of research study (must be faculty),
4. Date of incident/reaction,
5. Cause of incident/reaction,
6. Steps to be taken to avoid incident/reaction in the future,
7. Signature of principal investigator.
If, in the conduct of research, problems involving risks to human subjects arise which were not foreseen in the approved protocol, such incidents must be reported to the IRB through the IRB Administrator. In the case of DHHS projects, the IRB must report such incidents to the DHHS. The IRB Administrator is available for consultation and assistance in reporting either type of adverse outcome at 507-389-2321.

Administrative Functions and Responsibilities

It is the responsibility of the Dean of Graduate Studies and Research to assure that the policies and procedures concerned with projects involving human subjects are carried out in accordance with this manual and with any institutional assurances made by the University.

This Institution will provide both meeting space and sufficient staff to support the IRB's review and record-keeping duties, and training of staff and members.

This Institution assumes full responsibility for IRB policy. The chain of authority for all IRB issues shall be as follows: initial concerns shall first be presented to the IRB Administrator, if unresolved shall proceed to the IRB Chair or Co-Chair, next to the IRB committee, if still unresolved to the Vice-President of Academic Affairs, and finally to the President of the University in whose presence ultimate authority shall reside.

The Dean of the College of Graduate Studies and Research is the IRB Administrator and is the person authorized to sign for the Institution. The Dean may assign all or part of the administrative duties to one or more staff in the Office of Graduate Studies and Research.
The IRB Administrator will make available on the University Web site current policies and procedures. Copies of the Institutional IRB Policies and Procedures and the DHHS materials will be available upon request to faculty, administrators, subjects and any other interested persons. Each time a revision occurs, the revised version of the Institutional IRB Policies and Procedures will be mailed to all deans and to persons designated within the Institution to maintain policy manuals for public inspection.
In addition, the IRB Administrator has the authority and responsibility for promptly reporting to the NIH-OPRR a variety of issues. In conjunction with this requirement, the IRB Administrator must be prepared to receive and act on information received from a variety of sources, such as human subjects, research investigators, the Office of Grants and Sponsored Programs, the IRB, or other institutional staff. For reporting purposes, the IRB Administrator will follow the procedures described below:
1. Non-compliance
  Any non-compliance by research investigators with the requirements of the IRB shall be reported promptly to the IRB Administrator in the College of Graduate Studies and Research for appropriate follow-up who will make a written report to the IRB.
2. Injuries to human subjects
  Information concerning injuries to subjects shall be reported promptly to the IRB Administrator in the College of Graduate Studies and Research for appropriate follow-up and a written report will be submitted by the IRB Administrator to the IRB.
3. Unanticipated problems
  Information concerning unanticipated problems involving risks to subjects or others shall be reported promptly to the IRB Administrator at the College of Graduate Studies and Research. As required by federal regulation, the IRB Administrator is responsible for reporting to the OPRR and submitting a written report to the IRB.
4. Suspension or termination of IRB approval
  Whenever the IRB suspends or terminates approval of research protocols, the IRB Administrator, in consultation with the IRB Chair or Co-Chair, shall include a statement of the reasons for the IRB's action and shall report the action promptly to the research investigator, the Dean of Graduate Studies and Research, the Vice President for Academic Affairs, and if necessary the OPRR.
The IRB Administrator shall prepare and maintain adequate documentation of IRB activities, including the following:
1. Copies of all research proposals reviewed and any supporting documentation that accompanies the proposals; approved sample consent documents; progress reports submitted by research investigators; reports of injuries to subjects; and all other relevant materials.
2. Minutes of IRB meetings which shall be in sufficient detail to show the names of attendees at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining, any required changes; and any dissenting reports and opinions when requested. If a member in attendance has a conflicting interest regarding any project, Minutes shall show that this member did not participate in the review, except to provide information requested by the IRB.
  The Minutes shall include a list of all protocols approved, since the last Minutes through Level I or Level II review procedures. Approval of the Minutes shall constitute Full Board endorsement of those protocols.
3. Records of continuing review activities.
4. Copies of all correspondence between the IRB and the research investigators.
5. Any changes in IRB membership and will report these changes to the OPRR/NIH if required.
6. Written procedures for the IRB.
7. Statements of significant new findings developed during the course of the research which may relate to the subjects' willingness to continue participation and which must be provided to subjects.
The College of Graduate Studies and Research shall provide for the maintenance of records relating to a specific research activity for at least 3 years after termination of the last IRB approval period for the activity.

IRB records shall be accessible for inspection and copying by authorized representatives of DHHS at reasonable times and in a reasonable manner, or shall be copied and forwarded to DHHS when requested by authorized DHHS representatives.

Records for each project will be available for audit at any time. An annual summary report of IRB activities will be developed by the IRB Administrator and presented to the Vice President for Academic Affairs.
Certification Requirements
1. The IRB Administrator is responsible for submitting a certification to the Office of Grants and Sponsored Programs, DHHS and all other funding agencies as appropriate and, upon request, a supplement to an original protocol when:
  1. It is proposed to involve human subjects, and the activity previously had only indefinite plans for the involvement of human subjects, or
  2. It is proposed to involve human subjects, and the activity previously had no plans for the involvement of human subjects, or
  3. It is proposed to change the involvement of human subjects and that involvement is significantly different from that which was initially approved by the IRB.
  In addition, the Institution shall ensure that no human subjects are involved in research projects for which the filing of a supplement is required by DHHS, prior to review and approval of the submitted supplement.
2. All research protocols approved by the IRB which are being submitted for federal funding shall be certified to the federal agency by the IRB Administrator or the IRB Chair or Co-Chair. When the IRB approves a protocol with stipulations that the research investigator make modifications to the protocol, the IRB Administrator shall not certify to the agency until such modifications are made. Each proposal submitted to a federal agency by the IRB Administrator must include:
  1. Certification that the research was reviewed and approved by the IRB, established under a single project or multiple project assurance (the identification numbers of this assurance and the IRB must be included in the certification); or
  2. Notification that the research was approved under 45 CFR 46.
  3. The IRB Administrator shall keep research investigators aware of decisions and administrative processing affecting their respective protocols and shall return all disapproved protocols to the research investigators.
3. Compliance with the Investigational New Drug or Device Certification Requirement
  The IRB Administrator shall comply with the Food and Drug Administration Investigational Drugs or Medical Devices in accordance with 21 CFR 56 and 21 CFR 812. Current FDA Information Sheets are available, upon request, from the IRB Administrator.
Reporting Requirements
The IRB Administrator will report promptly to the IRB, the Office for Protection from Research Risks (OPRR) if appropriate, and any other sponsoring Federal department or agency head;
1. Any injuries to human subjects or other unanticipated problems involving risks to subjects or others;
2. Any serious or continuing non-compliance with the regulations or requirements of the IRB; and
3. Any suspension or termination of IRB approval for research.
Retention of Signed Consent Documents
Project directors/principal investigators will be responsible for maintaining files of signed informed consent statements obtained from individual subjects. These files will be subject to audit. These documents shall be retained for at least three (3) years after termination of the research activities.

Faculty members are responsible for consent forms utilized in graduate research. Necessary arrangements must be made by the faculty to retain the consent forms for the required length of time after the student's research has been completed.
Submission of Progress Reports on the Research
Investigators are responsible for reporting the progress of the research to the IRB Administrator and IRB Board as often as, and in the manner prescribed by the IRB, but no less than once per year.

Continuing review forms should be submitted by the principal investigator approximately 4 weeks prior to annual review.

Classroom activities requiring IRB approval should be approved during the institutional academic term prior to the class.
Submission of report of injury and/or unanticipated problems involving risks
1. Investigators are responsible for promptly reporting, in writing, to the IRB through the IRB Administrator or IRB Chair or Co-Chair any injuries to human subjects, or any unanticipated problems which involve risks to the human research subjects or others.
2. The IRB Administrator or IRB Chair or Co-Chair regularly reports any and all adverse incidents at the IRB meetings which are reflected in the IRB Minutes.
Reporting changes in the research
1. Investigators are responsible for requesting in writing any proposed changes in any approved research activity. Requests for modification(s) are made to the IRB through the IRB Administrator before such changes are implemented.
2. Modifications in research during the period for which IRB approval has already been given shall not be initiated by research investigators without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject. In such occurrence, the IRB is to be notified as soon as possible through the IRB Administrator at 507-389-2321.
Reporting of non-compliance
Investigators, department heads, and faculty advisors are responsible for reporting promptly to the IRB through the Administrator or Chair or Co-Chair any serious or continuing non-compliance with the requirements of these policies and procedures or the determinations of the IRB.
Notifying the IRB concerning Investigational new drugs
The research investigators shall be responsible for notifying the Food and Drug Administration (FDA) and the IRB through the IRB Administrator whenever it is anticipated that an Investigational new drug or device exemption will be required.

Resource Sites

Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report)
Code of Federal Regulations Title 45, Part 46 - Protection of Human Subjects