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Minnesota State University, Mankato
Minnesota State University, Mankato

IRB Manual

Page address: http://grad.mnsu.edu/irb/manual.html

Minnesota State University, Mankato IRB Manual

Table of Contents

Introduction

General Information

IRB Membership

Review Process

Reliance Agreements

Consent Process

Procedures for Special Circumstances

Continuing Review

Adverse Reaction Report

Administrative Functions and Responsibilities

Certification Requirements

Reporting Requirements

Additional Resources

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 participants 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' (DHHS) assurance of compliance with federal and state of Minnesota policies, regulations and laws relating to the protection of human participants in research. For the purposes of this document, research is broadly defined as a systematic investigation designed to develop or contribute to generalizable knowledge.

The policies and procedures described herein apply to all research and research-related activities involving human participants 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 participants 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 participants shall be undertaken unless the IRB has reviewed and approved such activity except as provided for in Section I, Subpart D of this manual. This Institution will make available documentation of these review processes as necessary in accordance with federal policies.

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 participants 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 45 CFR 46. 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 participants, as well as to assist faculty engaged in relevant research from unknowingly committing unethical acts. The Institution bears full responsibility for the oversight of all research involving human participants covered by this set of policies and procedures.

Research involving human participants 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:

I.            Where appropriate, studies have been conducted first on animals.

II.            Risks are minimized by using the safest procedures consistent with sound research design.

III.            The privacy of the participant is protected and confidentiality of data is maintained.

IV.            Before any person participates in research, that person, or a legally authorized representative, must be given the opportunity to fully comprehend the consent process and give informed, voluntary, competent consent. This involves a full and careful explanation in language that is understandable by laypersons. The consent of the participant 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 participant and the participant is informed about informed consent.

V.            The participant should also be told that she or he 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 participant would otherwise be due.

VI.            Consistent with 45 CFR 46, 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:

A.    The research involves no more than minimal risk to the participants; and

B.      The waiver or alteration will not adversely affect the rights and welfare of the participants; and

C.    The research could not practicably be carried out without the waiver or alteration; and

D.     Whenever appropriate the participants will be provided with additional pertinent information after participation.

E.      The research 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:

                                                   i.      Programs under the Social Security Act or other public benefit or service programs; or

                                                 ii.      Procedures for obtaining benefits or services under those programs; or

                                                iii.      Possible changes in or alternatives to those programs or procedures; or

                                              iv.      Possible changes in method or levels of payment for benefits or services under those programs; and

                                                v.      The research could not practicably be carried out without the waiver or alteration.

VII.            The IRB has the authority to observe or have a third party observe the consent process and the research.

VIII.            Research involving populations such as children, prisoners, parolees, addicts, persons with AIDS, persons with diminished mental capacity, and others in conditions of dependency, helplessness, or deprivation (including vulnerable populations as defined by Minnesota and federal statutes) may require additional precautions and procedures to assure their protection.

IX.            Whenever medical, psychological, or physical intervention is used, or whenever the participant's environment is likely to be changed beyond normal limits, the research must be performed in conformity with established standards of healthcare practice under proper healthcare supervision.

X.            Where participants 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).

XI.            If students are asked to participate in research as part of a course, informed consent procedures must be sufficiently sensitive not to be coercive and explicitly stated in a way that makes clear how students will be protected from feeling coerced into participation. Student should be clearly informed that research participation is not a mandatory requirement of the course. If credit is awarded for research participation, students not wishing to participate or who do not follow through with research participation must be given a choice of a reasonable alternate academic activity that is comparable in time, effort, and credits earned. Penalizing those who do not follow through violates 45 CFR 46.

XII.            Before any research project which uses human participants can be started and conducted under the auspices of the Institution, 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 upon receiving formal, written approval from the IRB Coordinator. 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 Coordinator or Chair or Co-Chair is strongly advised). All proposals submitted to federal agencies may require approval of the IRB prior to submission per granting agency guidelines. All proposals must comply with DHHS Policies and Regulations on Protection of Human Subjects and this document.

XIII.            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 MSU faculty member is considered the principal investigator and consequently the responsible person (i.e., students who also are faculty cannot be principal investigator on research required for completion of their degree). All applications detailing the use of human participants 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. Changes in the application will be submitted to the IRB for approval prior to these changes being put into practice. Informed consent/assent records signed by the participants will be kept by the Principal Investigator in a secure location at Minnesota State University, Mankato for at least three years after the completion of data collection."

XIV.            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 participants. They do not supplant or substitute for DHHS regulations or this document.

XV.            Students, research assistants or others performing IRB approved research activities which exceed minimal risk to research participants, under the supervision of a faculty advisor 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 and may need to be reviewed by other University administrators.

XVI.            Cooperative research projects which involve more than one institution are covered by these policies. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human participants. The University may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make other arrangements for avoiding duplication of effort. All cooperative research projects, however, must be submitted to the IRB.

XVII.            Research involving medical devices will be conducted according to the requirements set forth in 21 CFR 812 and 45 CFR 46.

XVIII.            Research involving investigational drugs will be conducted according to the requirements set forth in 21 CFR 56 and 45 CFR 46.

XIX.            Federally funded research may require a Single Project Assurance from the University. Initiation of this process is the responsibility of the investigator.

XX.            Any possible breach of human participant protection in research activities conducted at the University of which investigators may become aware should be reported immediately to the IRB Administrator.

IRB Membership

I.            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 participants.

The IRB is primarily comprised of faculty members from the colleges and departments most concerned with projects involving human participants. 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 graduate student members chosen at large from the College of Graduate Studies and Research. The Associate Vice President of Research and Dean of Graduate Studies, and IRB Coordinator, are ex-officio members of the IRB. If the IRB regularly reviews research that involves particular classes of vulnerable participants, the IRB shall include one or more individuals who are primarily concerned with the welfare of these participants.

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, professionals from the arts and humanities). 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 to 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.

II.            Method of Appointment

The administrative authority for the protection of human participants at Minnesota State University, Mankato has been delegated to the Associate Vice President of Research and Dean of Graduate Studies.

The members of the University IRB are nominated by the Associate Vice President of Research and Dean of Graduate Studies and appointed by the University President. The University IRB is a standing committee of the University and is administratively responsible to the Associate Vice President of Research and Dean of Graduate Studies.

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.

 

III.        Removal of IRB Members

An IRB may recommend to the Administrator that a person be removed as a member for cause, by specifying the reasons in writing, and providing a copy to the member.  The Administrator will review the recommendation with the Chair or Co-Chairs and Coordinator and come to a decision. If the decision is to remove a member from the Board, the Administrator will provide the member with a letter outlining the decision and reason(s) for the decision.  The decision will be based on the member’s failure to complete her/his responsibilities as an IRB member.

Membership Responsibilities

·         To review all assigned research protocols in the timeframe requested or advise the coordinator within 24 hours of being notified of the review assignment that review is not possible

·         To prepare for and attend all Committee meetings and to notify IRB coordinator in advance if there is a need to be absent from a scheduled meeting

·         To complete required human subjects protection training

·         To maintain confidentiality regarding reviewed protocols

·         To participate in Committee discussion of protocols

·         To participate actively in continuing education to assure continued excellence in the research review process

IV.            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. Proposals may 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.

A.    Quorum and Voting

A quorum of the IRB is defined as a simple majority of the total active membership, and in order for official Board business to be conducted, a quorum 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.

B.      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 Coordinator since the previous Minutes. All Minutes will be stored for a period of at least three (3) years and made available upon request.

V.            Leadership

Leadership of the IRB consists of an IRB Coordinator, and two co-chairs. The IRB Coordinator is appointed by the Associate Vice President of Research and Dean of Graduate Studies as the Dean's designee. By the last meeting of an IRB co-chair's expiring term, the committee, by majority vote, will nominate to the Associate Vice President of Research and Dean of Graduate Studies, one IRB member who is MSU faculty as co-chair. The role of the leaders is to oversee the review process, serve as convener 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:

A.    Serve as convener for the IRB. This includes scheduling reviews, certifying IRB actions, and certifying approval and disapproval of applications.

B.      Serve as a reviewer and router for applications that do not require Full Board (Level III) review.

C.    Serve as the focal point (along with the IRB Administrator) for interaction of the IRB with the university community.

D.     Oversee (along with the IRB Administrator) the development and execution of the educational efforts of the IRB on campus.

E.      Monitor (along with the IRB Administrator) changes in federal regulations and institutional policy for the protection of human subjects in research.

F.       Make sure that all IRB procedures are appropriately documented. This includes, but is not limited to, reporting of IRB actions to the Associate Vice President of Research and Dean of Graduate Studies, liaison with the staff support, and liaison with faculty in general.

VI.            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 her or his term of office, notification in writing will be given to the IRB and Associate Vice President of Research and Dean of Graduate Studies. The IRB will receive the notification in a regular or special session and nominate an appropriate replacement. Consultation between the IRB and the Associate Vice President of Research and Dean of Graduate Studies 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

I.            General Policy Statement

All research involving the use of human participants 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).

A.    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.

B.      IRB Review Criteria

                                                               i.      In evaluating a research project, the following are basic considerations:

                                                             ii.      Do the procedures involve situations that may put the participant at risk?

                                                            iii.      Are the risks so outweighed by the potential benefit to the participants or by the importance of the knowledge to be gained as to warrant a decision to allow them to accept these risks?

                                                          iv.      Are the rights and welfare of the participants adequately protected? Have steps been taken to protect the participant's personal privacy and the confidentiality of information received from the participant?

                                                            v.      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?

C.    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 people 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.

D.     Classroom Research Assignments

A project is only research for IRB purposes if it is meant to generate generalizable knowledge. Accordingly, graduate and undergraduate course research assignments that are conducted under the supervision of course faculty and not shared outside of the course do not need to be submitted to the IRB for approval.

Research for master's theses, doctoral dissertations, research that will be publicly presented, and independent research studies are not considered course research and must comply with the usual IRB review procedures.

II.            Levels of IRB Review

There are three levels of review for research proposals involving human participants:

A.    Level I

Proposals eligible for Level I review must fall under certain categories of activities outlined in 45 CFR 46 involving minimal risk, and not involving special or vulnerable populations, such as children, adults with cognitive impairments, prisoners, and other captive populations. Research with children conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods may be eligible for Level I review.

B.      Level II

Certain proposals that involve minimal risk and are not eligible for Level I review may be eligible for Level II review and approval by the IRB Coordinator, Chair, or Co-Chair, or other experienced IRB member designated by the Chair, Co-Chair, or Coordinator.

C.    Level III

Consistent with §46.108, proposals involving more than minimal risk must be reviewed at convened meetings at which a quorum present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a simple majority of those members present at the meeting.

III.            Application Procedure

The review process begins with identification of those projects or activities which involve human participants. Applicants should use the DHHS decision tree to determine if a project is human participant research. Ultimate verification as to whether any project or activity is human participants research is the responsibility of the IRB.

Application forms utilized by the IRB are available at www.irbnet.org. The completed application packet is submitted at www.irbnet.org. 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 cannot be the principal investigator.

Primary investigators will be notified through the IRBNet system when their proposals are approved. Any changes to approved proposals must be submitted to the IRB for approval. Approvals will be kept on file and made available for at least three (3) years after the application is closed.

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 well 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.

IV.            Principal Investigators

Principal investigators are ultimately responsible for the protection of humans participating in their research. For IRB purposes the following employees can serve as principal investigators:

A.    All faculty, excluding adjunct faculty,

B.      Other continuing unclassified employees,

C.    MSU employees who are members of the following bargaining units:

                                                               i.      Health Care Professional Association,

                                                             ii.      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 data collection. If the PI leaves the employment of MSU prior to the 3 years, measures should be taken to store the consent forms in the former department, and the IRB should be informed of the new location. If storage within the department is not feasible, then the PI should (a) make sure the consent forms are labeled with the IRB log number, (b) hand carry the consent forms to the Graduate Office, and (c) request that the Graduate Office take responsibility for storing the consent forms for the remaining portion of the 3 years.

V.            Principal Investigators Working with Student Co-Investigators

A.    Principal investigators who have student co-investigators must take an active part in preparing student co-investigators for the role of researcher, instructing them in the ethical conduct of research and sharing responsibility for the preparation of applications for IRB approval. Primary investigators shall take an active role in ensuring that the conduct of the research meets the highest ethical standards.

B.      Principal investigators shall ensure that their student co-investigators:

                                                               i.      Minimize the risk to human participants,

                                                             ii.      Understand the elements of the consent process,

                                                            iii.      Develop a readable consent form,

                                                          iv.      Plan and accomplish appropriate recruitment strategies for identifying participants,

                                                            v.      Establish and maintain strict guidelines for protecting anonymity and confidentiality, and

                                                          vi.      Conduct their research in accordance with these policies and procedures.

C.    The principal investigator's electronic signature is required when submitting the IRB application form, providing documentation that the principal investigator verifies that the application is accurately completed and consistent with all IRB policies and procedures. The principal investigator is ethically responsible for the protection of human participants in student research.

VI.            Level I Review

A.    Process

The completed and signed IRB application is reviewed by the IRB Coordinator to determine the appropriate level of review. The IRB Coordinator will review the proposal if the Coordinator determines that the proposal qualifies for Level I status. This decision is subject to the monthly review by the full IRB Committee. The Committee may request placement as Level II or Level III, as appropriate. Once the principal investigator has received, on letterhead from IRBNet, approval from the IRB Coordinator, data collection may begin.

B.      Categories Eligible for Level I Review

Research activities in which the only involvement of human participants in one or more of the following categories are eligible for Level I review unless the participants constitute a special/vulnerable population as defined in this manual:

                                                               i.      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 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.

                                                             ii.      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 participants can be identified, directly or through identifiers linked to the participants; and

2.      any disclosure of the human participants' responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participants', financial standing, employability, or reputation.

Surveys on sensitive or personal topics which may reasonably be foreseen to 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 if necessary 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.

                                                            iii.      Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior is eligible for Level I status if:

1.      the human participants are elected or appointed public officials or candidates for public office; or

2.      federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained indefinitely.

                                                          iv.      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 participants cannot be identified, directly or through identifiers linked to the participants.

Records considered private based on federal and state statute, including medical records and education records, require written release by the study participant 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 participant. Existing public records do not require prior consent of participants 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 participant 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 participant.

Inclusion of fetal tissue in the pathological specimens requires a higher level IRB review.

                                                            v.      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.

                                                          vi.      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 ii and iii 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.

VII.            Level II and Level III Review

A.    Initial Review Process

The IRB Coordinator, 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. Proposals meeting the criteria for approval under Level I may be approved by the IRB Coordinator. Proposals meeting the criteria for approval under Level II may be approved by the IRB Chair or Co-Chair, or other experienced Board member. An inadequate proposal will be returned to the investigator (applicant) to bring it into conformity with IRB requirements.

All IRB approvals will be listed in the IRB Log for review and approval of the log by the IRB on a regular basis. 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.

B.      Level II Review

                                                               i.      Process

All applications for the Conduct of Research Involving Human Subjects are submitted to the IRB Coordinator.

The Coordinator 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.

                                                             ii.      Categories Eligible for Level II Review

Research activities involving minimal risk and in which the only involvement of human participants will be in one or more of the following categories (carried out through standard methods) may be reviewed by the IRB without bringing the application 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 application.

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, or amniotic fluid at the time of rupture of the membrane prior to or during labor.

4.      Recording of data from participants 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 participant or an invasion of the participant'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 participants 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.  In accordance with federal policy, research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

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.

C.    Level III Review

                                                               i.      Research application scheduled for review shall be made available through IRBNet to all members of the IRB prior to the meeting (normally 10 days prior).

                                                             ii.      When the IRB Coordinator determines that consultants or experts will be required to advise the IRB in its review, the research application shall also be distributed to the consultants or experts prior to the meeting.

                                                            iii.      All applications requiring full IRB review shall be conducted at convened meetings and at timely intervals (normally at monthly intervals).

                                                          iv.      A simple majority of the active membership of the IRB constitutes a quorum and is required to convene a meeting for the review of research applications.

                                                            v.      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.

                                                          vi.      For a research application to be approved, it must receive the approval of a simple majority of those members present at the convened meeting.

                                                         vii.      The IRB may not have a member participating in the review of any application in which the member has a conflicting interest, except to provide information requested by the IRB.

                                                       viii.      The decisions reached at the convened meeting shall supersede any decisions made through any other normal review process.

                                                           ix.      After review of a Level III proposal, the Board may stipulate that the Coordinator and one other Board Member may review any resubmission and, on the Board’s behalf, decide if the resubmission will be approved.  If the resubmission is not approved, the revised documents will be brought to the next Board meeting for review. The two reviewers will provide the Board with advice on what requested modifications were not made or what additional modifications need to be requested.

VIII.            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:

A.    Risks and discomforts to participants are minimized:

                                                               i.      by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk and,

                                                             ii.      whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

B.      Risks and discomforts to participants are reasonable in relation to anticipated benefits, if any, to participants, 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 participants 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.

C.    Selection of participants 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.

D.     Consent to participate in research will be sought from each prospective participant or the participant's legally authorized representative.

E.      Consent to participate in research will be appropriately documented.

F.       Where appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of participants.

G.    Where appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data.

IX.            Notification of Decision

A.    The IRB Coordinator, Chair, or Co-Chair shall notify the research investigators in writing of the IRB's decisions and required modifications regarding research applications. The IRB Coordinator may consult with the IRB Chair or Co-Chair as to the accuracy of the information communicated to the investigator. Copies of the decision letters will be made available to the investigator(s).

B.      The IRB Coordinator, Chair or, Co-Chair shall provide to the research investigator reasons for the IRB's decision to disapprove a research application and an opportunity for the research investigator to respond.

C.    In the event of harm to participants or if a project is not being conducted in accordance with the Board's requirements and/or conditions, the IRB Administrator has the authority to terminate or suspend its approval of the research and to confiscate any data collected.

X.            Continuing Review

Level II and III projects extending beyond a period of one year less a day require annual review and approval by the IRB.

Reliance Agreements

For a description of reliance agreements, see http://www.niaid.nih.gov/LabsAndResources/resources/toolkit/Pages/faq.aspx  .

The MSU investigator is required to load all documents submitted to the Reviewing IRB into IRBNet for example the application, the consent form as approved by the Reviewing IRB, the approval letter from the Reviewing IRB, etc. The documents must contain specific information regarding the research that will be conducted by the MSU investigator. For example, how will recruitment occur at MSU? In addition, there must be a consent form appropriate for use at MSU. To ensure that the Reviewing IRB includes all MSU-required elements of consent in the consent form, The MSU IRB has provided a Consent Form Check List for the MSU investigator and the Reviewing IRB - http://grad.mnsu.edu/irb/Approved_Consent_Form_Checklist.docx

The MSU IRB Coordinator will review Level I and II submissions and inform the Administrator if the Reliance Agreement should be approved. Level III submissions will require full board review. Once the Reliance Agreement is in place, the MSU IRB researcher will load a copy of the document to the IRBNet site for the research outline in the Reliance Agreement.

Although the MSU IRB does not provide any oversight when an external IRB is the Reviewing IRB, the MSU IRB remains responsible for the research activities that take place at MSU. The MSU IRB requires that all revisions to approved research and continuing reviews be updated to IRBNet to ensure that the research approval hasn't lapsed and the most current approved documents are being used.

Consent Process

I.            Informed Consent

Informed consent is the voluntary agreement obtained from a participant (or his/her legally authorized representative) prior to participation. 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.

A.    Obtaining informed consent:

                                                               i.      Research investigators are responsible for obtaining informed consent in accordance with 45 CFR 46.116, and for ensuring that no human participant will be involved in the research prior to obtaining consent.

                                                             ii.      Consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the participant or the participant's legally authorized representative at the time of consent except in situations authorized by the IRB in accordance with 45 CF 46. The requirement of a signed informed consent may be waived if the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether she or he wants documentation linking her or him with the research, and the participant's wishes will govern. Alternatively, the requirement of a signed informed consent may be waived if the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

                                                            iii.      Unless otherwise authorized by the IRB, research investigators are responsible for ensuring that effective consent shall:

1.      be obtained in writing from the participant or the participant's legally authorized representative;

2.      be in language understandable to the participant or the representative;

3.      be obtained under circumstances that offer the participant or the representative sufficient opportunity to consider whether the participant should or should not participate; and

4.      not include exculpatory language through which the participant or the representative is made to waive or appear to waive any of the participant's legal rights, or releases or appears to release the research investigators, external sponsors, the Institution or its agents from liability for negligence.

                                                          iv.      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 participant or the participant's legally authorized representative, or

2.      The written summary (verbal script) of what is to be said to the participant.

3.      If a study involves more than minimal risk, a written consent form must be used.

                                                            v.      Consistent with FDA policy, participants generally must consent to any screening procedures as well as to participation in the study. The PI may choose to use two separate forms or one form encompassing both elements. Participants must be informed that they may be withdrawn if they do not meet inclusion criteria. Exceptions to obtaining consent prior to screening may be made, e.g., if the screening is done through contact that the participant initiates and that it does not involve extensive or intrusive questions. During the screening process identifying information should not be recorded until after the participant signs an informed consent form or if there is an IRB-approved waiver of the requirement to obtain signed consent.

                                                          vi.      Research investigators are responsible for secure storage of the signed consent documents in a location approved by the IRB. In accordance with federal regulations consent documents must be maintained for three (3) years after completion of data collection.

                                                         vii.      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 consent may be waived by the IRB provided that 1) the research involves no more than minimal risk 2) an appropriate mechanism for the protection of the minor is provided and 3) conditions justifying modification of the waiver exist.

                                                       viii.      In the case of questionnaires, return of the questionnaire may be viewed as implying consent which should be indicated in a cover letter.

                                                           ix.      There is need to assure the ethical principle that participants deserve to know the purpose of the research and the uses to which their data will be put. The argument that the results would be seriously biased if participants are informed is not an adequate justification for failing to inform. In instances where the research is not practicable without deception, there is no more than minimal risk, and the benefits of the research outweigh the risks of deception, the IRB may waive the requirement of this information being given before consent as long as the information is provided as soon as possible after participation and participants are allowed to withdrawal their data.

                                                             x.      Prospective participants 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.

                                                           xi.      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, non-English speakers).

                                                          xii.      In research with participants with cognitive impairments, assent of the participant is required in addition to the written informed consent of the participant's legal guardian before data collection may begin.

                                                        xiii.      Although 45 CFR part 46 is the procedural standard that must be complied with for all research involving human participants, special attention should be given to local customs and to local cultural and religious norms in drafting written consent documents or proposing alternative consent formats when conducting international research. If it would be appropriate for the IRB to waive some or all requirements for written consent based on cultural norms or conditions (e.g., societies where no written language is used, societies where signatures represent the surrender of spirit or soul), research proposals should include a thorough explanation of such conditions. Additionally, applications for international research projects that include such alternative procedural standards must provide protections at least equivalent to those of 45 CFR 46 and proof of approval by the local equivalent of an IRB before they are presented to the university IRB. Where there is no equivalent regulatory authority, investigators must include approval from local experts or community leaders.

                                                       xiv.      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 and e-mail or telephone must be included on the informed consent forms used by students, as well as on the applications, so that participants may contact them with questions about the study.

II.            General Requirements for Informed Consent

Basic elements of consent

A.    In seeking informed consent the following information shall be provided to each participant:

                                                               i.      A statement that the study involves research, an explanation of the purposes of the research and expected duration of participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

                                                             ii.      A description of any reasonably foreseeable risks or discomforts to the participant;

                                                            iii.      A description of any benefits to the participant or to others which may reasonably be expected from the research;

                                                          iv.      A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;

                                                            v.      A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;

                                                          vi.      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;

                                                         vii.      An explanation of whom to contact for answers to pertinent questions about the research and research participant's rights, and whom to contact in the event of a research-related injury to the participant; and

                                                       viii.      A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled and the participant may discontinue at any time without penalty or loss of benefits to which the participant is otherwise entitled.

B.      Additional elements of consent

When appropriate, one or more of the following elements of information shall also be provided to each participant:

                                                               i.      A statement that a particular treatment or procedure may involve risks to the participant (or the embryo or fetus, if the participant is or may become pregnant) which are currently unforeseeable;

                                                             ii.      Anticipated circumstances under which participation may be terminated by the investigator without regard to the participant's consent;

                                                            iii.      Any additional costs to the participant that may result from participation in the research;

                                                          iv.      The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant;

                                                            v.      A statement that significant new findings developed during the course of the research which may relate to the participant's willingness to continue participation will be provided to the participant; and

                                                          vi.      The approximate number of participants involved in the study.

III.            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:

A.    The research involves no more than minimal risk to the participants; and

B.      the waiver or alteration will not adversely affect the rights and welfare of the participants; and

C.    the research could not practicably be carried out without the waiver or alteration; and

D.     whenever appropriate, the participants will be provided with additional pertinent information after participation.

Or

E.      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:

                                                               i.      public benefit of service programs;

                                                             ii.      procedures for obtaining benefits or services under those programs;

                                                            iii.      possible changes in or alternatives to those programs or procedures; or

                                                          iv.      possible changes in methods or levels of payment for benefits or services under those programs; and

                                                            v.      The research could not practicably be carried out without the waiver or alteration.

IV.            Preemption

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.

V.            Exception

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

I.            Electronic Recording

In research projects involving audio or video recording or photographing of participants, the following guidelines apply:

A.    If signed Consent Forms are utilized, participants must be advised in the Consent Form that their participation includes the use of audio/video recording. Participants must be advised when recordings will be erased or destroyed;

B.      If signed Consent Forms are not utilized, an appropriate signed release must be obtained from the participants or guardian (if applicable) before recording or photographing of the interview. This release statement may be included on the recording if results of the interview would otherwise be anonymous;

C.    In studies which do not include signed written consent (i.e., recorded interviews in person or over the telephone), the elements of consent as they are explained to the participants should be included as a preamble to the recorded procedure;

D.     Before consenting to being recorded (audio or video) or photographed, participants 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 consent or release form;

E.      The researcher must make proper arrangements for secure storage of all recordings and assure that their use complies with the guidelines outlined in the informed consent/release form. Plans must include storage, erasing, or destroying after a given time period.

II.            Equipment Description

Any research that uses electrical, electronic or mechanical equipment with which the participant will be in physical contact may be required to supply the IRB with:

A.    Trade Name, Manufacturer, Model Number

B.      Schematic diagram, picture or other representation of the equipment including a demonstration or other means of showing the IRB the machine's normal operation;

C.    Verification of safety including UL certification or other certification;

D.     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.

III.            Contacting of Participants

In cases where participants are recruited from other institutions (hospitals, community agencies, physicians, etc.), the first contact with potential participants should be made by institutional staff who, after outlining the researcher's interest and obtaining the potential participant's permission, will refer the person to the researcher or vice versa. This may also be done by a letter or email from the researcher which is distributed by the institution. This procedure has been implemented to protect privacy rights of potential participants.

IV.            Certificate of Confidentiality

Researchers engaged in research that is not anonymous to the researcher and that includes the study of participant 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 participants 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:

A.    Information relating to sexual attitudes, preferences, or practices;

B.      Information relating to the use of alcohol, drugs, or other addictive products;

C.    Information pertaining to illegal conduct;

D.     Information that if released could reasonably be damaging to an individual's financial standing, employability, or reputation within the community;

E.      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;

F.       Information pertaining to an individual's psychological well-being or mental health;

G.    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 requires this protection or if you have any questions, please contact the National Institutes of Health (NIH).

V.            HIV/AIDS

Research with people who are HIV positive or have Acquired Immune Deficiency Syndrome (AIDS) is subject to additional precautions prescribed by the federal guidelines. This information can be obtained from the National Institutes of Health (NIH). Researchers should allow extra time for review of applications for studies involving this population.

VI.            Vulnerable Populations

Vulnerable/special populations include those participants 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 participants. Some groups, such as racial minorities, are not considered vulnerable populations if included in a general population.

Whenever potential participants are persons of diminished capacity but capable of giving assent, the researcher must obtain their assent in addition to obtaining consent to participate in research from their guardian before involving them in a study.

VII.            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 to 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.

VIII.            Human Genomes

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 applications for studies involving this population.

IX.            Revisions to Approved Applications

Changes to an approved application may be requested by submission of the revision form through the IRBNet system, but initiation of the changed procedure must not be undertaken before IRB approval.

Continuing Review

Projects that will continue for a period of more than one year 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 Coordinator will monitor any and all special requirements to ensure appropriate follow-up.

If the research application 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 Continuation form serves to assure the IRB that the actual use of human participants has been conducted in accordance with the approved application and conditions. Continuing Review forms are available at www.irbnet.org.

If, in the conduct of research, problems involving risks to human participants arise which were not foreseen in the approved application, the problem must be reported to the IRB through the IRB Administrator at 507-389-1242. 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 II has changed and additional review may be required.

OPRR interprets "not less than once per year" review to mean review within a 30 day window before the one year anniversary date of the previous IRB review , even though the research activity may not begin until after the IRB had given approval.  For example, if an IRB conducts initial review of a research project and approves it without conditions on October 1, 2016 for one year, the IRB may conduct its first continuing review anytime between September 1 and October 1, 2016, and re-approve the research for another one-year period that expires on October 1, 2017.

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 participants, 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. 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 507-389-1242.

I.            Reporting

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 participant. All reports shall be made as soon as possible in writing to the IRB through its Administrator. Any injuries or adverse effects to participants which may occur as a result of participation in the research project must be reported:

II.            Required Information

The report must contain the following information:

A.    Date of report,

B.      IRB log number and title of proposal,

C.    Principal Investigator of research study (must be faculty),

D.     Date of incident/reaction,

E.      Cause of incident/reaction,

F.       Steps to be taken to avoid incident/reaction in the future,

G.    Signature of principal investigator.

Administrative Functions and Responsibilities

It is the responsibility of the  Associate Vice President of Research and Dean of Graduate Studiesto assure that the policies and procedures concerned with projects involving human participants 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 Coordinator, Chair, or Co-Chair, if unresolved shall proceed to the IRB committee, next to IRB Administrator, and if still unresolved to the Vice-President of Academic and Student Affairs, and finally to the President of the University.

I.            The Associate Vice President of Research and Dean of the College of Graduate Studies 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.

II.            The IRB Administrator will make available on the University Web site current policies and procedures. Current copies of the Institutional IRB Policies and Procedures and the DHHS materials will be available upon request to faculty, administrators, participants and any other interested persons. Each time a revision occurs, all deans and persons designated within the Institution to maintain policy manuals for public inspection will be notified.

III.            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 participants, research investigators, the Office of Grants and Sponsored Programs, the IRB, or other institutional staff. For reporting purposes, the procedures described below are to be followed:

A.    Non-compliance

B.      Any non-compliance by research investigators with the requirements of the IRB shall be reported promptly to the IRB Administrator for appropriate follow-up. The IRB Administrator then will make a report to the IRB.

C.    Injuries to human participants

D.     Information concerning injuries to participants shall be reported promptly to the IRB Administrator for appropriate follow-up. The IRB Administrator then will make a report to the IRB.

E.      Unanticipated problems

F.       Information concerning unanticipated problems involving risks to participants or others shall be reported promptly to the IRB Administrator. As required by federal regulation, the IRB Administrator is responsible for reporting to the OPRR and submitting a report to the IRB.

G.    Suspension or termination of IRB approval

H.     Whenever the IRB suspends or terminates approval of research applications, the IRB Administrator, in consultation with the IRB Coordinator, 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 Vice President for Academic and Student Affairs, and if necessary the OPRR.

IV.            The IRB Administrator or designee shall prepare and maintain adequate documentation of IRB activities, including the following:

A.    Copies of all research applications reviewed and any supporting documentation that accompanies the applications; approved sample consent documents; progress reports submitted by research investigators; reports of injuries to participants; and all other relevant materials.

B.      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.

C.    The Minutes shall include a list of all applications approved since the last Minutes through Level I or Level II review procedures. Approval of the Minutes shall constitute Full Board endorsement of those applications.

D.     Records of continuing review activities.

E.      Copies of all correspondence between the IRB and the research investigators.

F.       Any changes in IRB membership and will report these changes to the OPRR/NIH if required.

G.    Written procedures for the IRB.

H.     Statements of significant new findings developed during the course of the research which may relate to the participants' willingness to continue participation and which must be provided to participants.

V.            The College of Graduate Studies and Research shall provide for the maintenance of IRB records relating to a specific research activity for at least 3 years after termination of the last IRB approval period for the activity.

VI.            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.

VII.            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 or designee and presented to the Vice President for Academic and Student Affairs.

Certification Requirements

I.            The IRB Administrator is responsible for submitting a certification to the Office of Research and Sponsored Programs, DHHS and all other funding agencies as appropriate and, upon request, a supplement to an original applications when:

A.    It is proposed to involve human participants, and the activity previously had no or only indefinite plans for the involvement of human participants, or

B.      It is proposed to change the involvement of human participants and that involvement is significantly different from that which was initially approved by the IRB.

C.    In addition, the Institution shall ensure that no human participants 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.

II.            All research applications 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 Coordinator, Chair, or Co-Chair. When the IRB approves an application with stipulations that the research investigator make modifications to the application, the IRB Administrator or designee shall not certify to the agency until such modifications are made. Each proposal submitted to a federal agency must include:

A.    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

B.      Notification that the research was approved under 45 CFR 46.

C.    The IRB Administrator or designee shall keep research investigators aware of decisions and administrative processing affecting their respective applications and shall return all disapproved applications to the research investigators.

III.            Compliance with the Investigational New Drug or Device Certification Requirement:

The IRB Administrator shall comply with the Food and Drug Administration (FDA) Investigational Drugs or Medical Devices in accordance with 21 CFR 56 and 21 CFR 812. Current FDA Information Sheets are available from the FDA.

Reporting Requirements

I.            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:

A.    Any injuries to human participants or other unanticipated problems involving risks to participants or others;

B.      Any serious or continuing non-compliance with the regulations or requirements of the IRB; and

C.    Any suspension or termination of IRB approval for research.

II.            Notifying the IRB Concerning Investigational New Drugs. Investigator Certification Requirements

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.

Additional Resources

Current IRB Members

[PDF] Application for the Conduct of Research Involving Human Subjects (511 KiB)

[PDF] Continuation Form (24 KiB)

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