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Policies and Procedures of the Institutional Review Board for the Protection of the Rights of Human Subjects in Research
(September, 1989)

PURPOSE: The Institutional Review Board for the Protection of the Rights of Human Subjects in Research (IRB) has been established to ensure that human subjects participating in research activities at St. Bonaventure University or, under its sponsorship, at another location, are protected from undue risks and deprivation of personal rights or dignity. The IRB has the responsibility to assure protection of individual subjects and the rights of the investigator(s) and the institution. The action of the IRB in approving research will provide the sponsoring investigator(s) with the full legal protection of the University. The policies and procedures of the IRB were formulated according to the Code of Federal Regulation 45, Part 46 as described in the Federal Register, Vol. 46, N.16, January 26, 1981, pages 8366-8392.

MEMBERSHIP: Members, appointed by the Vice President for Academic Affairs, will include both men and women and will have one representative from each of the following: Field of Ethics, Field of Social and Behavioral Sciences, Field of Natural Sciences, The Off-Campus Community, the University Counsel and the Director of Research.

Except for the Director of Research and University Counsel, the normal term of appointment is three (3) years. In order to have continuity, initial members of the IRB will have terms distributed as follows:

2 members - 3 year term

1 member - 4 year term

1 member - 5 year term

AUTHORITY: The IRB has the sole responsibility to review and have authority to approve, require modifications in (to secure approval), or disapprove all research involving human subjects. Research that has been approved by the IRB may be subject to further review and approval or disapproval by the Vice President for

Academic Affairs.

Research involving human subjects that has not been approved by the IRB may not be sanctioned by any other officials of the institution.

The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator(s), appropriate institutional officials, and the Secretary of the Department of Health and Human Services.

DEFINITIONS:

An "adult" human subject is anyone who has passed the age of consent in the state where the research is being conducted. (In New York State fundamental rights can only be waived by persons eighteen (18) years and older; a "minor" is therefore someone less than eighteen (18) years old.)

"Risk" as used in this document means more than minimal risk.

"Review" refers to the ethical evaluations and recommendations of the IRB. The IRB acts at one end of two levels of review, expedited or full.

1. "Exempt Review" is not within the purview of the IRB since it concerns research which involves no risk to subjects (See Appendix A).
2. "Expedited Review" is an abbreviated form of IRB review applied to research which exposes subjects to no more than minimal risk (See Appendix C).
3. "Full Review" is a more thorough review process invoked when research exposes subjects to greater than minimal risk; i.e., procedures which may violate the fundamental rights of subjects (See Section 6.0).
4. "Department" or "HHS" means the Department of Health and Human Services.
5. "Institution" means any public or private entity or agency (including federal, state, and other agencies).
6. "Legally Authorized Representative" means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
7. “Research" means a systematic investigation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute "research" for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some "demonstration" and "service" programs may include research activities.
8. "Human Subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. "Intervention" includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between investigator and subject. "Private Information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
   9. "Minimal Risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
   10. "Certification" means the official notification by the institution to the Department in accordance with the requirements of this part that a research project or activity involving human subjects has been reviewed and approved by the Institutional Review Board (IRB) in accordance with the approved assurance on file at HHS. (Certification is required when the research is funded by the Department and not otherwise exempt.)
   11. "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted.
   12. "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
   13. "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.

   14. "Parent" means a child's biological or adoptive parent.

   15. "Guardian" means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care.

   RESEARCH: Major categories or research activity would normally include the following:

   1. Persons or programs requesting extramural (federal, state, or private) funds for research or training.
   2. Individual faculty members (as well as members of the staff and administration) engaged in research as part of their professional role within the University or as a part of their job assignment.
   3. Graduate students doing research which is of the nature of a thesis and is part of a degree program.
   4. Students (undergraduate and graduate) performing research in the context of a course or other faculty-supervised project (e.g., independent study).
   5. Individuals (including students or persons from outside the University) other than faculty, staff or administration, doing research under the auspices or patronage of the University.

    

GUIDING PRINCIPLES: St. Bonaventure University is an institution rooted in a 700-year Franciscan tradition of academic excellence and respect for human and spiritual values. The continuing presence of Franciscan ideals forms the basis of our respect for human dignity. The desire for the protection of the rights of human subjects in research flows naturally from this mission of the University.

The University also adheres to the codes of ethics as put forth by various research organizations, such as the American Psychological Association and the American Sociological Association.

Throughout the review and disposition of all applications the IRB will be guided by the following principles:

1. No human subject is to be exposed to unreasonable psychological, physical, or social risk to health or well-being.
2. Commensurate with the protection of human subjects, the procedures followed by the Review Board shall respect and protect the academic freedom of faculty members and the well-being of their students in the pursuit of knowledge.
3. Personal privacy and confidentiality of information gathered will be protected in all research.
4. The nature of the research, procedures to be followed, and potential risks to the subjects must be fully and appropriately explained to each subject, or his legally authorized representative. Consent must be obtained in writing if the subjects will be at risk.
5. Where there is possibility of risk to the subject this information may not be withheld nor may undue inducement be offered in order to increase the likelihood of his/her participation.
6. Subjects may be permitted to terminate their involvement with an investigation at any time without fear of penalty or prejudice.
7. The principal investigator is responsible for security expert guidance, where appropriate, when dealing with special populations of subjects or problems in a project.

INSTITUTIONAL REVIEW AND APPROVAL: All research involving human subjects, conducted at St. Bonaventure University or under its sponsorship must be reviewed and approved by the IRB unless it falls under one of the categories which is exempt from these regulations. The decision whether the research falls within one of the exempt categories is the responsibility of the informed investigator. Exceptions to these exemptions include studies involving deception, studies involving children, or populations who are not able to comprehend the study (e.g., mentally ill, mentally impaired, language inadequacies) studies wherein performance, characteristics or traits of the subjects can be identified or traced back to the subject.

If the research is not in an exempt category, the IRB is to provide an independent determination concerning whether requirements are satisfied:

Risks to subjects are minimized: [a] By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and [b] whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted.

1. Informed consent will be sought from each prospective subject or the subject's legally authorized representative.

2.    Informed consent will be appropriately documented.

3. Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subjects.
4. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Decisions of the IRB will be communicated to the Principal Investigator and the Vice President for Academic Affairs.

Investigators have the obligation to request a clarification by the IRB regarding activities or procedures which are seen by the investigator as questionable in terms of their inclusion in the above descriptions and definitions.

INFORMED CONSENT: Except as cited below, no investigator may involve a human subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. Examples of consent forms are found in Appendix B.

The IRB may waive the requirement for the signed consent form for some or all adult subject if:

1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation of consent and the subject's wishes will govern; or
2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

1.    The research involves no more than minimal risk to the subjects;

2.    The waiver or alteration will not adversely affect the rights and welfare of the subjects;

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

4.    Whenever appropriate, the subjects will be provided with additional pertinent information about participation.

OPERATIONS OF THE IRB

Schedule of Meetings: The IRB shall meet to review and discuss all research protocols involving risk to human subjects conducted at the Institution by a student, agent or employee of the Institution and further shall meet at least once each semester for the expressed purpose of reviewing the IRB process and this document. Meetings shall be called by the Chair in accordance with procedures described herein. Appropriate material will be distributed to members at least seven (7) days prior to the meeting.

The Review Process: The decision determining whether the research falls within one of the exempt categories is the responsibility of the informed investigator.

1. Research protocols shall be submitted to the Chair of the IRB, along with appropriate forms, at least thirty (30) days prior to the time IRB action is requested. If the success of the study depends upon its immediate initiation, the IRB Chair will call a special meeting as soon as possible to review the proposal.
2. The IRB Chair shall distribute copies of the protocol, other appropriate information and forms to the IRB members.
3. A meeting of the full IRB will be scheduled no less than seven (7) days and no more than twenty-one (21) days after distribution of the appropriate material to discuss and review the submitted study.
4. The IRB, upon a majority vote of the committee prior to the meeting, may request that the researcher be present when the protocol is being reviewed.

Periodic Continuing Review: With regards to records (continuing review), ongoing research is treated in a manner similar to new research. Once a year from the approval date, forms are submitted for a research program's reapproval and records of the IRB's decision are retained. Any changes in an approved research protocol that affects the subject requires an immediate review by the IRB.

Adverse Reaction Reports and the IRB Response: A researcher doing a study involving greater than minimal risk to subjects that has received IRB approval files an Adverse Reaction Report to the Chair of IRB in a time frame specified by the IRB and upon the completion of the study. This report details how the research complied with the IRB recommendations (or the investigator's procedures) on how to properly handle subjects who are receiving potentially harmful treatment. Within thirty (30) days the IRB submits in writing its acceptance or rejection of the Adverse Reaction Report.

Expedited Review: The IRB will utilize an expedited review procedure in any of the following circumstances:

1.    The research involves no more than minimal risk.

2.    Minor changes in previously approved research during the period in which an approval is authorized.

3.    Categories of research which the Secretary has established as appropriate for expected review and which have been published in the Federal Register as such.

Under the expedited review procedure, the review may be carried out by the IRB Chair or by one or more experienced reviewers designated by the Chair from among members of the IRB. 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 review by the IRB in accordance with non-expedited procedure.

The IRB Chair shall notify the members of the IRB about all protocols that have been approved by the expedited review procedure.

Voting Requirements

1.    All members of the IRB shall be entitled to one (1) vote.

2.    Proxy votes are not permitted.

3.    A quorum, for the conduct of business, shall consist of four (4) of the six (6) members of the IRB and shall include one (1) member whose primary concerns are non-scientific.

4.    An affirmative vote by at least fifty percent (50%) of the members of the IRB present is necessary to approve any study.

5.    Any committee member with a vested interest in any study shall abstain from all voting.

IRB Communications: All communications pertaining to formal IRB policies and decisions in writing. Copies are sent to each IRB member and the affected researcher(s) and the Vice President for Academic Affairs. Likewise all communications from researchers to the IRB are written. They are addressed to the IRB Chair with a copy sent to the Chair of the involved University department. Copies of incoming communications will be made by the IRB Chair and distributed to the members. Note, however, that information communications between IRB members and researchers are encouraged. Such conversations provide information that assist the IRB and the researcher to achieve their mutual goals.

Decisions by the IRB, including [a] requests for additional and clarifying study information and [b] alterations necessary for ultimate approval, shall be forwarded to the researcher and the Vice President for Academic Affairs in writing within seven (7) days.

Appeal for IRB Decisions: An appeal of an IRB disapproval may be requested if the researcher feels that there is sufficient reason for such action. The request for review should include the rationale for the appeal with appropriate documentation and should be sent to the IRB Chair. Upon request to be present, the Chair will invite the investigator to the meeting at which the appeal is being considered.

No protocol may be appealed more than twice without the concurrence of at least five (5) members of the IRB or the recommendation of the Vice President for Academic Affairs.

Amending IRB Polities and Procedures: Policies and procedures of the IRB may be amended by the IRB provided:

1. Proposed amendments are distributed to each member at least one (1) week prior to the meeting at which they are to be presented.
2. At the subsequent meeting, there is an affirmative vote by at least four (4) members of the IRB.
3. Any amendment is approved in advance by the Secretary through such officers and employees of the Department and such experts or consultants engaged for this purpose as the Secretary determined to be appropriate.

Exceptions to Policies and Procedures: Exceptions to accepted procedures and policies for individual cases may be made upon an affirmative vote by five (5) members at a meeting of the IRB.

RECORD MAINTENANCE:

IRB Membership: The list of IRB members and how each meets the criteria for membership is maintained in the office of the IRB Chair. Copies are available upon request.

Procedures and Policies: This manual, which describes current IRB procedures and guidelines, is available upon request. It is periodically sent by the IRB Chair to those individuals and University Departments that are systematically involved with research on human subjects. This manual may be changed in response to new regulations or conditions.

Research Protocol and Consent Procedures: The principal investigator and the IRB Chair maintain all written documents pertaining to the submission, review and, if required, the adverse reaction report for a study for at least three (3) years. Department Chairs are encouraged to maintain copies of all protocols, related correspondence and documents involving members of their Departments.

Minutes of Meetings: A brief written transcript of every meeting of the IRB is prepared by a secretary appointed by the Chairman. This brief transcript includes a list of the members present, substantive issues discussed, and a record of the IRB decisions. Transcripts of meetings are retained by the IRB Chair as long as is required by state and federal statue of limitation law.

IRB Records

1. Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.
2. Minutes of IRB meetings which shall be in sufficient detail to show attendance 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 research; and a written summary of the discussion of controverted issues and their resolution.

3.    Records of continuing review activities.

4.    Copies of all correspondence, between the IRB and the investigators.

5.    A list of IRB members.

6.    Written procedures for the IRB.

7.    Statements of significant new findings provided to subjects.

8. The records required by this regulation shall be retained for at least three (3) years in the office of the Director of Research after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Department at reasonable times and in a reasonable manner.

APPLICATION PROCEDURES: Investigators have the responsibility to familiarize themselves with the principles, definitions and guidelines herein.

Investigators have the responsibility to make the following determinations:
Is my research with human subjects in an exempt category?

If "no," submit Form E (Appendix D) and the appropriate consent form. An IRB review will follow.

If "yes," and there is certainty of no risk, no application to the IRB is necessary.

If uncertain about the category, contact the IRB Chair. All forms are available from the IRB Chair, Office of Graduate Studies.

All forms and other appropriate material should be sent to the IRB Chair, Office of Graduate Studies.

(REVISED: September 25, 1989)

Exempt Categories
Categories that likely involve no risk.

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Research involving survey or interview procedures, except where all of the following conditions exist: (i) Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.

Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and (iii) research dealing with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Expedited Review Categories

Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.

Collection excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.

Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echocardiography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.

Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

Voice recordings made for research purposes such as investigations of speech defects.

Moderate exercise by healthy volunteers.

The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

1. Purpose, duration of subject's participation, and procedures of the research

1. Purpose, duration of subject's participation, and procedures of the

2. Risks and discomforts of the subject.

3. Benefits to subject or others.

4. Alternative procedures.

5. Extent of confidentiality of records.

6. Compensation if injury to subject occurs.

7. Whom to contact for answers about the research, the subject's rights, and

8. Participation of subject must be voluntary and may be discontinued at any

1. Purpose, duration of subject's participation, and procedures of the

2. Risks and discomforts of the subject.

3. Benefits to subject or others.

4. Alternative procedures.

5. Extent of confidentiality of records.

6. Compensation if injury to subject occurs.

7. Whom to contact for answers about the research, the subject's rights, and

8. Participation of minor subject must be volunteered by parent or guardian

1. Purpose, duration of subject's participation, and procedures of the

2. Risks and discomforts of the subject.

3. Benefits to subject or others.

4. Alternative procedures.

5. Extent of confidentiality of records.

6. Compensation if injury to subject occurs.

7. Whom to contact for answers about the research, the subject's rights, and

8. Participation of minor subject must be volunteered by parent or guardian