Research Involving Human Subjects

Research Involving Human Subjects

Policy Statement on Principles and Review

CONTENTS

Page

I.Human Subjects Research at Husson University4

II.Institutional Review Board (IRB) Review4

III.Authority5

IV. Definitions5

V.Guiding Principles6

VI.Responsibilities6

VII.IRB Structure9

VIII.Review Criteria10

IX.Types of Review11

X.Course Related Research13

XI.Students as Research Subjects14

XII.Employees as Research Subjects14

XIII.IRB Continuing Review14

XIV.Suspension or Termination of IRB Approval14

XV.Application for Approval for a Research Project16

(Husson IRB)

CONTENTS (CONTINUED)

Page

Appendix A17

Research Proposal Design18-19

Instructions for Preparing Informed Consent20-22

Research Participants’ Rights24

Sample Indemnification Clause25

Investigator Financial Disclosure Policy26-29

Types of IRB Review30

Financial Disclosure Statement31-32

Emergency Review33

Exempt Status, Form R134-35

Expedited Review, Form R236-38

Full Committee Review, Form R339-40

Statement of Assurance, Form R441

Periodic Review Form42

I.Human Subjects Research at Husson University

This statement of Policy and Procedures Regarding the Use of Human Subjects in Research is designed to assist faculty, staff, and student investigators at Husson University in preparing an application for approval of their research.

Investigators are reminded that research involving human subjects may not begin prior to review and approval of a research protocol by the Husson University Institutional Review Board (IRB) under the aegis of the Husson Science Research Institute (HSRI) or, in the case of federally-funded human subjects research, the Multiple Project Assurance Board of the Eastern Maine Medical Center. In connection with this review, it is the responsibility of the researcher to see that all relevant forms, documents, and supporting materials are filed in a timely manner.

Please contact the Husson University IRB Chair with any questions not addressed by this statement. In keeping with Husson's distinctive mission as a Maine institution of higher education to develop morally responsible individuals, as well as with federal regulations (45 CFR 46), the University is committed to a policy of safeguarding the dignity, rights, and privacy of all human subjects of scientific research, whether such research is federally funded or not.

Husson's commitment to the protection of human subjects is rooted in the conviction that both researcher and subject are human beings of dignity and that each human subject of or participant in biomedical or behavioral research ought thus to be considered as a co adventurer with the investigator in his or her search for knowledge. Consequently, respect and concern for the welfare of each subject should be the investigator's highest priority.

The goal of Husson in research administration is to assist faculty, staff, and student researchers in meeting the highest ethical and professional standards for the use of human subjects in scientific research.

II.Institutional Review Board (IRB) Review

Husson University research (including student research) involving human subjects will require Institutional Review Board (IRB) review. Federally-funded research at Husson College shall be submitted for review to the Eastern Maine Medical Center for review procedures detailed in its Multiple Project Assurance for Compliance with DHHS Regulations for the Protection of Human Subjects. The EMMC Institutional Review Board, like its Husson counterpart, functions under the U.S. Code of Federal Regulations 45 CFR 46 governing research on human subjects.

All applicants are required to secure and complete, Institutional Review Board (IRB) Application Forms and Regulations for Approval to Conduct Research Involving Human Subjects. These are available from the Husson IRB Chair () or at the Husson website at http://www.husson.edu/institutional-review-board. The EMMC packet (used for federally-funded projects) will be provided by the Director or may be directly obtained from:

Ms. Cindy Clukey

IRB Coordinator, Medical Affairs Office

Webber # 1 Eastern Maine Medical Center

489 State Street, Bangor, ME 04401

(207) 973-7906

The above listed office will also provide assistance to researchers in the preparation of required review documentation for federally-funded projects.

III. Authority

The Husson College Dean's Council in close cooperation with the Husson University Office of General Counsel maintains institutional oversight responsibility for all human subjects research conducted at the College and collectively constitute the Campus Review Committee (CRC). Research that has been reviewed and approved by the Husson IRB (or Husson projects under review by EMMC) may be subject to further review and disapproval by The CRC. However, the CRC may not approve research that has been disapproved by the IRB or the EMMC Multiple Project Assurance Board.

IV.Definitions

The following pertinent definitions are established under the United States Code of Federal Regulations:

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.

Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains: a) data through intervention or interaction with the individual; or b) identifiable private information (45 CFR 46.102f).

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Informed Consent means the process through which subjects are made aware of the purpose, risks, and benefits of a specific research investigation, as well as the voluntary nature of participation in the study. See 45 CFR 46.116 for general requirements of informed consent, and see 45 CFR 46.117 for documentation of informed consent.

Unexpected Adverse Experiences means any adverse experience that is neither identified in nature, severity, or frequency of risk in the information provided for IRB review nor mentioned in the consent form.

V.Guiding Principles

The moral principles guiding the IRB review of research proposals involving human subjects are those of the Nuremberg Code, (1949), the World Medical Association's Declaration of Helsinki (1964; 1975; 1983; 1989), and the Belmont Report published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). Three basic principles of overriding importance are mentioned here:

1. Respect for Persons: Human subjects must be treated as autonomous and able to make responsible choices. This principle leads to the requirement of informed voluntary consent.

2. Beneficence: Participants must be protected from harm and their well being must be secured. This principle leads to the requirement that the benefits to subjects or to humanity generally must be judged to outweigh the risks to subjects.

3. Justice: The risks and benefits of research must be distributed fairly without creating differences in treatment among ethnic, racial, religious, sexual, or age defined classes. This principle leads to the requirement that investigators take care not to exploit special classes of persons less able to refuse participation in research (e.g., prisoners, soldiers, mentally incompetent patients, and children).

VI.Responsibilities

Institution

A.Husson University acknowledges that it bears full responsibility for the performance of all research involving human subjects covered by this Assurance, including complying with federal, state, or local laws as they may relate to such research.

B. Clinical research shall be conducted only by scientifically qualified persons and in conformity with applicable law. The principal investigator must have appropriate privileges or employment at Husson.

C.Husson University will require appropriate additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization (see 45 CFR 46 Subpart B), (2) prisoners (see 45 CFR 46 Subpart C), (3) children (see 45 CFR 46 Subpart D), (4) the cognitively impaired, or (5) other potentially vulnerable groups.

D.Husson University acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research covered by this Assurance.

E.Husson University will provide both meeting space and sufficient staff to support the IRB's review record keeping duties.

F.Husson University disallows misconduct in all research and deals forthrightly with all possible misconduct associated with research. The Campus Review Committee (CRC) shall deal with such misconduct.

Responsibilities of the Research Investigator

A.Responsibility for Protecting Rights and Welfare of Human Research Subjects: Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable provisions of this Assurance.

B.Final Determination of Exemption-- Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulations or provisions of this Assurance.

C.Preparation of Application-- Research investigators shall prepare an Application for Approval of a Research Project in substantially the form attached hereto. The application must be accompanied by a protocol giving a complete description of the proposed research. In the protocol, research investigators shall make provisions for the adequate protection of the rights and welfare of prospective research subjects and ensure those pertinent laws and regulations are observed. This requirement is applicable even in cases where the research is determined to be exempt under 45 CFR 46.101(b)(1 6) or 101(i).

D.Submission of Protocol-- Research investigators shall submit the proposed protocol along with any instrument of the study, such as a questionnaire, investigator's brochure, etc. and the informed consent in substantially the form included as part of their application’s appendix. This material and the application must be reviewed and approved by the dean of his/her school prior to submission to the IRB.

E.Prompt Reporting of Proposed Changes--Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects.

F.Submission of Progress Reports--Research investigators are responsible for reporting the progress of approved research to the Husson IRB, as often as and in the manner prescribed by that body on the basis of risks to subjects, but no less than once per year. An oral report may also be required by the IRB.

G.Prompt Reporting of Injuries or Other Unanticipated Problems--Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others.

H.Complying with IRB Decisions--Research investigators shall be responsible for complying with all IRB decisions, conditions, and requirements.

I.Copy of IRB-Approved Signed Informed Consent (Signed by the Subject) to Each Subject-- Research investigators are responsible for providing a copy of the IRB-approved signed informed consent document (signed by the subject) to each subject at the time of consent, unless the IRB has specifically waived this requirement. The consent form must be designed to be at an appropriate reading level to the participants in the study. All signed consent documents are to be retained in a manner approved by the Chair, IRB.

J.Obtaining Informed Consent--Research investigators shall be 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.

K.Documentation of Informed Consent-- Research investigators shall be responsible for documenting informed consent in accordance with 45 CFR 46.117.

L.Retention of Signed Consent Documents--Research investigators shall be responsible for placing the consent documents signed by human research subjects in the IRB’s project record file. These documents shall be retained for at least 3 years after the final review by the IRB.

M. Attending IRB Meetings--To facilitate the review of research and the protection of the rights and welfare of human subjects, research investigators are encouraged to attend IRB meetings when invited by the IRB.

Responsibilities of the IRB

A.Determination of Human Subject Involvement--The Husson University IRB shall make a determination whether research shall involve human subjects as defined in 45 CFR 46.102(f).

B.Preliminary Determination of Exemption Eligibility-- The IRB shall make the preliminary determination whether research that does involve human subjects is exempted from coverage under 45 CFR 46.101(b)(1-6) or 101(i).

C.Evaluation of Scientific Merit and Review of Ethical Considerations-- The IRB shall be responsible for reviewing research protocols for evaluation of scientific merit and review of ethical considerations.

Responsibilities of the Chair of the IRB

A.Institutional Determinations--The Chair of the IRB shall review the preliminary determinations of the research investigator, the IRB, and make final institutional determination whether research protocols qualify for exemption from coverage under 45 CFR 46.101(b)(1 6) or 101(i).

B.The Chair of the IRB shall forward all nonexempt research protocols to the IRB for review. The IRB shall determine whether Husson College shall support or sponsor such research.

C.The Chair of the IRB shall keep the research investigators aware of decisions and administrative processing affecting their respective protocols and shall return all disapproved protocols to the research investigators.

D.The Chair of the IRB shall be responsible for reporting to the Deans Council:

1. Any changes in the IRB membership

1. In the case of research governed by 45 CFR 46

a.injuries or any other unanticipated problems involving risks to the subject or others

b.any serious or continuing noncompliance with the regulations or requirements of the IRB, by the research investigators

c.any changes in the proposed research or proposed human subject involvement

d.any IRB suspension or termination of approved research.

VII. IRB Structure

Establishment of the Institutional Review Board

The Deans Council of Husson University, in consultation with the Faculty Forum President, shall appoint the chair and the members of the IRB.

IRB Membership Requirements

A. The IRB shall be comprised of members from diverse backgrounds to promote complete and adequate review of research activities covered by this assurance and have the professional competence necessary to review the specific research activities that will be assigned to it.

B. The IRB shall be sufficiently qualified through the experience and expertise of its members and the diversity of the members' backgrounds (including consideration of the racial, gender 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.

C. When research is reviewed involving a category of vulnerable subjects (e.g., pregnant women, prisoners, children, or handicapped or mentally disabled persons), the IRB shall include in its reviewing body one or more individuals who have as a primary concern the welfare of these subjects.

D. The IRB shall include both male and female members.

E.The IRB shall include members representing a variety of professions.

F. The IRB shall include at least one member whose primary expertise shall be in a non-scientific area, and at least one member whose primary expertise shall be in a scientific area.

G. The IRB shall include at least one member who is not otherwise affiliated with the institution and who is not a part of the immediate family of a person affiliated with the institution.

IRB Records

The IRB at Husson University shall be maintained in the office of the Chair of the IRB:

A. Copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals; approved consent documents; assurances; progress reports submitted by research investigators; and reports of injuries to subjects.

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; the basis for requiring changes in or disapproving the research; a written summary of the discussion of controversial issues and their resolution; and dissenting reports and opinions. 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. These minutes shall be sent to the Director, the CRC, and the President of Husson University.

1. Records of continuing review activities.

1. Copies of all correspondence between the IRB, the research investigators and others.

E. A list of IRB members, as required by 45 CFR 46.103(b)(3).

F. Written procedures for the IRB as required by 45 CFR 46.103(b)(4).

G.Statements of significant new findings provided to subjects, as required under 45 CFR 46.116(b)(5).

VIII. Review Criteria

Proposals are normally reviewed by an IRB for conformity to the aforementioned principles in both the design and implementation of the research project itself. Since the IRB is concerned above all with the protection of the well being, dignity, and rights of each human subject of research, the following questions will be among those normally asked of each research protocol.

1. whether and how adequately human subjects are protected from exposure to more than minimal risk of harm, whether physical or psychological (under exempt and expedited review categories only);

1. whether in research where human subjects are exposed to greater than minimal risk the benefits of the research outweighs the burdens imposed on human subjects, be they physical or psychological;

1. whether and how adequately human subjects' participation in the research is informed and voluntary;

1. whether and how adequately the privacy rights of each human subject

are protected;

1. whether and how adequately vulnerable population groups (children, pregnant women, prison inmates, incompetent adults, frail elderly, soldiers, etc.) are protected from harm, whether physical or psychological;

1. whether and how adequately the proposed research fairly distributes both risks and benefits between ethnic, racial, religious, sexual, and/or age defined classes.

IX. Types of Review

All research involving human subjects falls under one of three categories:

Exempt Review - research of minimal or no risk;

Expedited Review - research involving no more than minimal risk

Full Board Review - research involving more than minimal risk to the subject, or research involving children or other vulnerable populations; requires review by the full Husson IRB (or the EMMC Multiple Project Assurance Board in the case of federally-sponsored projects).