Institutional Review Board

Who Must Submit Information to the IRB?

Faculty Members, Staff Members or Other Employees

Faculty members, staff members, or other employees planning to conduct research involving living human subjects or private information previously obtained about individuals will complete the St. Norbert College Application for IRB Review.

Faculty Members Teaching Courses in which Students Undertake Investigations

Faculty members teaching courses in which a single shared investigation involving living human subjects or private information previously obtained about individuals is conducted by all students (e.g., students contribute questions to a single common survey, cooperate in administering the survey, share in analyzing the data, and each report a portion of the results) will complete the St. Norbert College Application for IRB Review and submit it to the IRB. The instructor must have current training in human subject protection. If a comparable project is conducted each time the course is offered, the instructor may request renewal of IRB authorization once the initial application is approved. Faculty members will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate courses.

Students enrolled in regularly offered courses conducting, either individually or in small groups, investigations involving living human subjects or private information previously obtained about individuals will complete the St. Norbert College Application for IRB Review and submit it to their instructor. The instructor will evaluate the application, complete the SNC Instructor Evaluation of Student Course-Related Research and forward a copy of the evaluation to the IRB. The instructor may accept the application, reject the application, or refer the application to the IRB. The instructor must have current training in human subject protection. If the instructor chooses to refer the application to the IRB the student(s) must submit the application along with a copy of the instructor’s evaluation. These students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

Independent Student Investigations

Students conducting independent investigations involving living human subjects or private information previously obtained about individuals, whether for academic credit (e.g., directed research, senior thesis, graduate thesis, etc.) or supported by funding from the College (e.g., grant from Student-Faculty Development Endowment Fund), will complete the St. Norbert College Application for IRB Review and submit it to the IRB along with a letter from the supervising faculty or staff member. In that letter, supervisors will acknowledge their responsibility for overseeing the investigation and report the date of their most recent training in human subject protection. Students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

Rationale for IRB Oversight of Student Investigations

We have chosen to include IRB review of student class-related and independent investigations, even though they may not formally constitute research, because we believe human participants deserve protection whether or not the data they provide are a part of a “systematic investigation designed to develop or contribute to knowledge in a particular discipline.” Imagine an investigation of students' thoughts of suicide. We believe investigators should approach such an investigation with appropriate sensitivity and safeguards for confidentiality whether the investigators are students completing a project for a course or a faculty member conducting a systematic investigation designed to develop or contribute to knowledge in her or his particular discipline.

All research involving living human subjects or private information previously obtained about individuals is subject to IRB review.

Some research may, according to federal regulations (Sec. 45 CFR 46.101b), be exempt from review by the entire board. It may be reviewed and approved by the chairperson of the board.

Other research posing no more than minimal risk may, according to federal regulations (Sec. 45 CFR 46.110), receive expedited review. This research may be reviewed and approved by the chairperson after consulting at least one other member of the board.

All other research will be reviewed by the entire board at a properly scheduled meeting.

Unless otherwise required by the head of a federal department or agency, research activities in which the only involvement of human subjects will be in one of more of the following categories are likely to be classified as exempt from review by the entire IRB and as such will require only minimal documentation.

1. 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.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the participants; and

b. Any disclosure of the human subjects’ responses outside the research could reasonably place the participants at risk for criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation.

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section if:

a. The human subjects are elected or appointed public school officials or candidates for public office; or b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

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

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:

a. public benefit or service programs b. procedures for obtaining benefits or services under those programs; c. possible changes in or alternatives to those programs or procedures; or d. possible changes in methods or levels of payment for benefits or services under those programs. (Sec. 45 CFR 46.101)

Applications and related materials should be submitted as attachments to email messages. Address these messages to: irb@snc.edu.

File names for applications and related materials should be descriptive and include the primary investigator's last name, for example: “smith IRB application.doc,” “smith consent statement.doc,” “smith questionnaire.doc.”

Applications may be submitted at any time.

Exempt and Expedited Review

Investigations that are exempt from review by the full IRB will be reviewed and approved by the chairperson of the IRB, or an appropriate designee. Please allow at least one week for review.

Investigations that qualify for expedited review will be reviewed by the chairperson of the IRB and at least one additional member, or by appropriate designees. Please allow at least two weeks for review.

Review by Full IRB

When an investigation requires review by the full IRB, the board will generally convene within 3 weeks of receiving a completed application.

Investigators will be notified of the decision by the full IRB within two weeks after the application has been reviewed.

The IRB may review some or all of the research submitted by using an expedited review procedure, if the research involves no more than minimal risk. The IRB may also use the expedited procedure to review minor changes in previously approved research within one year after initial approval has been authorized. Under an expedited review procedure, the review may be carried out by the IRB chairperson, by one or more experienced IRB reviewers, or by persons with specialized knowledge in a particular discipline who are designated by the chairperson. In reviewing the research, the reviewers may exercise all of the authority of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the full review procedure.

Review Procedure When Full Review is Warranted

Upon receipt of the Submission of Proposed Research for IRB Approval form, the chairperson of the IRB reviews the materials to ensure that the form was properly completed, that the necessary description of the research is provided, and that the applicant has current training in human subject protection. Copies of the application are then distributed to members of the IRB.

Upon request of the IRB, the investigator may be asked to provide additional information or to appear in person before the committee to present a full explanation of risks and protection for the human subjects. Any investigator may ask to appear before the IRB to describe the proposed research.

In cases where it is deemed necessary by the board, consultants to the IRB may be asked to comment on a proposed research activity.

A necessary quorum for the IRB to consider a proposal is a majority of the total membership. No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

The IRB will decide by a majority of the members present:

• to approve the proposal.to approve the proposal with restrictions or conditions.
• to approve the proposal with restrictions or conditions.
• to defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB.
• to disapprove the proposal.

Minutes will be taken at all IRB meetings.

The chairperson will inform the principal investigator in writing of the decision of the IRB.

• If the IRB recommends changes, the IRB chairperson or designated member will communicate these in writing to the investigator.The IRB chairperson or designee will be responsible for review and approval of the investigator's submitted changes.
• The IRB chairperson or designee will be responsible for review and approval of the investigator's submitted changes.If the investigator deems it necessary to make further changes, these can be submitted to the chairperson or a designee for review and approval.
• If the investigator deems it necessary to make further changes, these can be submitted to the chairperson or a designee for review and approval.If there are changes in the study which the chairperson or designee feels may change the level of risk to human subjects, the investigator will be requested in writing to submit the proposal to the full board for further review.
• If there are changes in the study which the chairperson or designee feels may change the level of risk to human subjects, the investigator will be requested in writing to submit the proposal to the full board for further review.Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard only when the proposal has been revised and/or provides additional information.
• Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard only when the proposal has been revised and/or provides additional information.

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to participants. A list of the reasons for any suspension or termination will be provided to the investigator, appropriate department heads and dean of the college.

It is incumbent on any faculty, staff, administrators and students engaged in research involving human subjects to familiarize themselves with federal guidelines governing human subjects research. Any faculty, staff, administrator or student undertaking research involving human subjects is expected to submit the St. Norbert College Application for IRB Review prior to beginning their research. Failure to submit research for IRB approval constitutes a serious breach of professional standards. In the event of a legal challenge, the college will not defend research which has not been approved by the Institutional Review Board.

In order to approve research covered by federal regulations, the IRB shall determine that all of the following requirements are satisfied:

1. Researchers possess appropriate knowledge of human subject protection.Risks to participants are minimized.
2. Risks to participants are minimized.
3. Risks 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.
4. Selection of participants is equitable.
5. Informed consent will be sought from each prospective participant or the participant’s legal representative and will be appropriately documented, in accordance with, and to the extent required by federal regulations.
6. Adequate safeguards are implemented to insure the safety of the participants during the data collection.
7. Participants’ right to privacy and confidentiality is protected.
8. Where some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economical or educationally disadvantaged persons, appropriate additional safeguards have been included in the study to protect the rights and welfare of these participants.
9. Projects that will be conducted in a cooperating institution or organization must include a letter of acceptance from the sponsoring individual or body of that institution or organization.

The IRB shall have the authority to approve, require modification in (to secure approval) or disapprove all research activity covered by this policy. The institution may reverse an approval given by the IRB, but it cannot overrule a negative decision by the IRB.

Required education in protecting human research participants

In order to be eligible to submit applications for IRB review at St. Norbert College, all faculty and staff researchers, those who supervise student researchers, and student researchers themselves, must demonstrate their understanding of the fundamental principles underlying and current regulations guiding the ethical conduct of research involving human participants.

Agencies that fund research, including federal agencies, require investigators to demonstrate that they understand the principles and regulations related to protecting human subjects. For example, since 2000, the National Institutes of Health have required education in the protection of human research participants for all investigators and key personnel submitting applications for grants or proposals for contracts, or receiving new or non-competing awards.

Such requirement are often extended to all research involving human participants at colleges and universities, whether funded or not, by institutional policies governing such research.

There are several reasons for such requirements.

Researchers will be better able to plan and conduct research that upholds the values of respect, beneficence and justice and to prepare applications that meet the criteria for approval if they have a basic understanding of relevant fundamental principles and current applicable applications that meet the criteria for approval if they have a basic understanding of relevant fundamental principles and current applicable regulations.

The IRB will be more confident in approving a research application if it has evidence that the researcher possesses that basic understanding of fundamental principles and current regulations.

At St. Norbert College, the required human participants research ethics tutorial is one developed by the National Institutes of Health (NIH) Office of Extramural Research, and is titled, Protecting Human Research Participants.

The tutorial includes five educational modules:

• History
• Codes and Regulations
• Respect for Persons
• Beneficence
• Justice

Case studies (applied scenarios) and brief quizzes accompany each module. A certificate is issued once all modules are completed successfully.

Users may complete one module on one occasion and return at a later time to complete another module. Users may work through a module, quiz and scenario as often as need to successfully complete the module.

Once all the modules have been successfully completed, a certificate of completion will be provided. One copy of this certificate should be sent via email to the IRB; a copy of the certificate of completion should also be kept on file by the applicant.

Researchers and those who supervise student researchers will renew their certificate every five years.

Student researchers will renew their certificate ever two years.

To access and complete the required NIH Protecting Human Research Participants tutorial, please visit the Protecting Human Research Participants website.

Consent to participate in research must be obtained from every potential participant who is a mentally and physically able adult. Consent must be obtained prior to the conduct of any research activates.

Elements of Conformed Consent

In clear and non-technical language which is appropriate to the participant, participants must be informed of:

1. The fact that the study is research.
2. The purposes of the research.
3. The expected duration of the subject's participation.
4. The procedures to be followed.
5. Any reasonably foreseeable risks or discomforts.
6. Any benefits to the participant or to others that may reasonably be expected from the research.
7. Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
8. The extent, if any, to which confidentiality of data and privacy of participants will be maintained
9. For research involving more than minimal risk, whether any compensation and whether any medical treatments are available if injury occurs.
10. Whom to contact for answers to pertinent questions about the research, participants' rights and research-related injury to the participant.
11. The fact that participation is voluntary and that the participant may withdraw his or her consent at any time without penalty or loss of benefits.

Procedures for Obtaining Informed Consent

Written Consent: The participant or a legal representative signs a written consent document, which explains all of the elements of informed consent.

Oral Consent: The participant or a legal representative signs a document indicating the participant had the all of the elements of informed consent explained orally and that s/he understands this description and s/he agrees to participate in the activity described In addition, an auditor-witness to the oral presentation must be present and must sign the consent form as “witness.” A written script of the oral presentation must be approved by the IRB and will be retained as a part of the IRB records.

Surveys/Anonymous Questionnaires: Surveys and questionnaires are “anonymous” only when the individual’s identity is unknown to the investigator. Requirements of informed consent can be fulfilled by instructions or a cover letter that explains (as applicable) the project, purpose and duration of participation time; how to contact the investigator for more information; a statement that assures anonymity; indication that voluntarily returning the questionnaire constitutes consent to participate.

Audio or Video Taping

A research project that proposes use of audio or video taping must include a separate consent form that states what type of medium will be used to record the participant. This form must also state how the audiotape or videotape will be secured after the research project has concluded.

Exceptions

There may be cases in which the use of either of these procedures for obtaining informed consent may be considered inappropriate by the investigator because they would adversely affect the experimental design or procurement of valid results. Accordingly, modifications to the above informed consent procedures can be recommended to the IRB.

However, all modifications must be approved prior to implementation of the proposed research this approval must be recorded in the board's minutes. No such modification will be approved unless, and until, the IRB or designee determines:

1. That the risk to any human subject is, in fact, minimal, justifying a less full disclosure in the informed consent procedures than would normally be required; or
2. That the use of either consent procedure would, in fact, invalidate objectives of considerable immediate consequence, and that the use of any reasonable alternative means for attaining these objectives would be less advantageous to the participant.

Consistent with federal regulations, the St. Norbert College Institutional Review Board shall consist of at least seven members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. As a college-wide committee, the IRB will be appointed by the college president. Five members will be drawn from among active researchers representing all three academic divisions, the student life division, and the assessment committee. At least one of these appointments should include a scientist with experience conducting non-exempt research. A member at-large will represent the interests of the campus community not directly engaged in human subjects research. Efforts will be made to ensure that at least one of these six is an ethicist (i.e. someone who is knowledgeable about research method, who has a substantial understanding of the broader implications of human subjects research, and who is predisposed to ask questions related to equity, privacy, confidentiality, and risk to human subjects). A seventh member will be appointed who is not otherwise affiliated with the college. Members of the IRB will be expected to have or develop (e.g. through on-line training, review of key documents) the expertise necessary to evaluate the proposals they receive.

The IRB shall be sufficiently qualified through the experience, expertise and diversity of its members, including consideration of race, gender and cultural backgrounds 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 as well as investigators. IRB members will serve a three-year term with rotation. IRB membership may, when necessary be supplemented on a temporary basis, by individuals with specialized expertise.

The chair of the IRB will be appointed by the president in consultation with the dean of the college. Ordinarily, the IRB chair will serve a one-year term as part of her/his three-year appointment to the IRB. The chair will receive and review all submissions and, if appropriate, confirm approval for research that requires minimal or limited review. The IRB Chair may consult with experts to answer questions at any time. The chair will call meetings of the full IRB whenever a full IRB review is warranted. The chair will conduct minimal and limited reviews based on the application. The IRB will meet at least once each academic year to hear the chair’s report on submissions received and actions taken, to suggest changes in procedure as appropriate, and to construct a report to the AAC and faculty. Minutes of IRB meetings will be posted on its web site and the IRB member representing the Assessment Committee will make regular reports to the Assessment Committee. Suggested changes in IRB procedures will be forwarded to the AAC for action.

Faculty members teaching courses in which a single shared investigation involving living human subjects or private information previously obtained about individuals is conducted by all students (e.g., students contribute questions to a single common survey, cooperate in administering the survey, share in analyzing the data, and each report a portion of the results) will complete the St. Norbert College Application for IRB Review and submit it to the IRB. The instructor must have current training in human subject protection. If a comparable project is conducted each time the course is offered, the instructor may request renewal of IRB authorization once the initial application is approved. Faculty members will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate courses.

Students enrolled in regularly offered courses conducting, either individually or in small groups, investigations involving living human subjects or private information previously obtained about individuals will complete the St. Norbert College Application for IRB Review and submit it to their instructor. The instructor will evaluate the application, complete the SNC Instructor Evaluation of Student Course-Related Research, and submit a copy of the evaluation to the IRB. The instructor may accept the application, reject the application, or refer the application to the IRB. The instructor must have current training in human subject protection. If the instructor chooses to refer the application to the IRB the student(s) must submit the application along with a copy of the instructor’s evaluation. These students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

Students conducting independent investigations involving living human subjects or private information previously obtained about individuals, whether for academic credit (e.g., directed research, senior thesis, graduate thesis, etc.) or supported by funding from the college (e.g., grant from Student-Faculty Development Endowment Fund), will complete the St. Norbert College Application for IRB Review and submit it to the IRB along with a letter from the supervising faculty or staff member. In that letter supervisors will acknowledge their responsibility for overseeing the investigation and report the date of their most recent training in human subject protection. Students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

Rationale for IRB Oversight of Student Investigations

We have chosen to include IRB review of student class-related and independent investigations, even though they may not formally constitute research, because we believe human participants deserve protection whether or not the data they provide are a part of a “systematic investigation designed to develop or contribute to knowledge in a particular discipline.” Imagine an investigation of students' thoughts of suicide. We believe investigators should approach such an investigation with appropriate sensitivity and safeguards for confidentiality whether the investigators are students completing a project for a course or a faculty member conducting a systematic investigation designed to develop or contribute to knowledge in her or his particular discipline.

You may be enrolled in a course in which all students work together on a single investigation.

Faculty members teaching courses in which a single shared investigation involving living human subjects or private information previously obtained about individuals is conducted by all students (e.g., students contribute questions to a single common survey, cooperate in administering the survey, share in analyzing the data, and each report a portion of the results) will complete the St. Norbert College Application for IRB Review and submit it to the IRB. The instructor must have current training in human subject protection. If a comparable project is conducted each time the course is offered, the instructor may request renewal of IRB authorization once the initial application is approved. Faculty members will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate courses.

You may be enrolled in a course in which students, either individually or in small groups, conduct an investigation.

Students enrolled in regularly offered courses conducting, either individually or in small groups, investigations involving living human subjects or private information previously obtained about individuals will complete the St. Norbert College Application for IRB Review and submit it to their instructor. The instructor will evaluate the application and complete the SNC Instructor Evaluation of Student Course-Related Research. The instructor may accept the application, reject the application or refer the application to the IRB. The instructor must have current training in human subject protection. If the instructor chooses to refer the application to the IRB the student(s) must submit the application along with a copy of the instructor’s evaluation. These students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

You may undertake an independent investigation.

Students conducting independent investigations involving living human subjects or private information previously obtained about individuals, whether for academic credit (e.g., directed research, senior thesis, graduate thesis, etc.) or supported by funding from the college (e.g., grant from Student-Faculty Development Endowment Fund), will complete the St. Norbert College Application for IRB Review and submit it to the IRB along with a letter from the supervising faculty or staff member. In that letter supervisors will acknowledge their responsibility for overseeing the investigation and report the date of their most recent training in human subject protection. Students will apply even though the investigation may not formally constitute research (“systematic investigation designed to develop or contribute to knowledge in a particular discipline”). This requirement applies to undergraduate and graduate students.

Rationale for IRB Oversight of Student Investigations

We have chosen to include IRB review of student class-related and independent investigations, even though they may not formally constitute research, because we believe human participants deserve protection whether or not the data they provide are a part of a “systematic investigation designed to develop or contribute to knowledge in a particular discipline.” Imagine an investigation of students’ thoughts of suicide. We believe investigators should approach such an investigation with appropriate sensitivity and safeguards for confidentiality whether the investigators are students completing a project for a course or a faculty member conducting a systematic investigation designed to develop or contribute to knowledge in her or his particular discipline.

• Academy of Management
• American Anthropological Association
• American Educational Research Association
• American Historical Association
• American Political Science Association
• American Psychological Association
• American Sociological Association