Institutional Research & Assessment

1. The institution engages in ongoing, comprehensive, and integrated research-based planning and evaluation processes that (a) focus on institutional quality and effectiveness and (b) incorporate a systematic review of institutional goals and outcomes consistent with its mission. (Institutional Planning) *Core Requirement* 
2. The institution has a Quality Enhancement Plan that (a) has a topic identified through its ongoing, comprehensive planning and evaluation processes; (b) has broad-based support of institutional constituencies; (c) focuses on improving specific student learning outcomes and/or student success, (d) commits resources to initiate, implement and complete the QEP, and (e) includes a plan to assess achievement. (Quality Enhancement Plan) 
3. The institution identifies expected outcomes of its administrative support services and demonstrates the extent to which the outcomes are achieved. (Administrative effectiveness) 

2. The institution identifies expected outcomes, assesses the extent to which it achieves these outcomes, and provides evidence of seeking improvement based on the analysis of the results in the areas below: 

a.  student learning outcomes for each of its educational programs. (Student outcomes: educational programs) 
b. student learning outcomes for collegiate-level general education competencies of its undergraduate programs. (Student outcomes: general education) 
c. academic and student services that support student success. (Student outcomes: academic and student services) 

IRB Policies, Complaint Procedures, and Other Event Reporting Policies

Reporting of Concerns or Complaints for Human Subjects Research

Anyone with a concern about any aspect of research involving human subjects at Austin College or who wants to report a violation of these Policies and Procedures may contact the Institutional Official (the Vice President for Academic Affairs or the College President), the IRB Chair, or any IRB member. Concerns may also be emailed to IRBChair@austincollege.edu or submitted using the report form on the IRB Forms below.

No adverse action will be taken against anyone making a good-faith report. No college employee, committee member, student, or another person shall be discriminated against or be subject to any reprisal for reporting, in good faith, concerns or violations of regulations or standards under Title 45 Code of Federal Regulations Part 46 or Title 21 Code of Federal Regulations, Parts 50, 56, 312 or 812. Persons with no formal relationship with the Austin College are also encouraged to an Institutional Official, the IRB Chair or an IRB committee member with and concerns, also without fear of reprisal or future discrimination.

Noncompliance with Austin College IRB Guidelines or Committee Decisions

Any research project involving human subjects that is carried out without IRB approval constitutes noncompliance. The IRB cannot approve any project if the student or faculty investigator has begun data collection prior to receipt of the IRB approval. Projects cannot be retroactively approved.

Investigators may not begin a project until they receive official approval of their project from the IRB. No actions involving engagement of participants or potential participants (including recruitment or prescreening of participants) may begin until the investigator receives final approval of the project from the IRB Committee.

For IRB approved research projects, any significant protocol deviation by an investigator or protocol change without prior IRB approval also constitutes noncompliance. A IRB Modification Extension Renewal Form that includes relevant supporting materials needed to evaluate proposed changes must submitted to and approved by the IRB Committee before the investigator can implement any changes to a project.

In the case of student projects, the faculty supervisor is responsible for providing oversight to ensure that the student complies with IRB Committee guidelines and follows ethical guidelines for all activities involving human subjects.

All incidences of noncompliance shall be promptly reported to the Institutional Official. For sponsored projects or significant violations noncompliance may also be reported to the Secretary of the Department of Health and Human Services or the sponsoring agency. Actions resulting from noncompliance may range from additional humans subjects education requirements or increased oversight to suspension or termination of research activities.

Data Breach

A data security breach (e.g., a stolen laptop, misplaced thumb drive, unauthorized access of a data file by internal or external entities) almost always constitutes an unanticipated problem.

Unanticipated Problems

Definition: An unanticipated problem is any event, experience, issue, instance, situation, problem, or outcome that meets all 3 of the following criteria:

1. Is unexpected in terms of the nature, severity, or frequency given the research procedures that are described in the IRB application/protocol-related documents AND in the characteristics of the population under study.
2. Is related or possibly related to participation in research. This means that there is a reasonable possibility that the incident may have been caused by the procedures or activities involved in the research study.
3. The incident suggests that the research places the subject or others at greater risk of harm (physical, psychological, economic, social, etc.) than was previously known or recognized OR results in actual harm of the subject or others. An unanticipated problem usually will require a change in policy or procedure, consideration of substantive changes to the protocol/consent materials, or other immediate corrective actions in order to reduce the risk or eliminate immediate hazard.

Reporting of Unanticipated Problems, Protocol Violations/Noncompliance, or a Data Breach

If an unanticipated problem, protocol violation/noncompliance, or data breach should occur during the conduct of any study under the jurisdiction of the IRB, the primary or faculty investigator should notify the IRB within 10 days from the time the PI/Study team receive knowledge of the event and complete the report form. The Austin College has a single reporting for reporting Unanticipated Problems, Protocol Violations/Noncompliance, or a Data Breach. For student projects the supervising faculty member should work with the student to complete the report. The faculty member should be the person who notifies the IRB and submits the reporting form and any other relevant documentation.

Unanticipated Problems: Per federal regulations the IRB must report unanticipated problem to OHRP and other sponsoring agency (if applicable). Per IRB policy these reports are copied to institutional officials involved in research oversight.  The primary or faculty investigator will also receive a copy of this letter.

Protocol Violations/Noncompliance: For addressing protocol related violations the committee will have to determine if this also constitutes an unanticipated problem. Minor violations that the IRB determines to involve no risk or not more than minimal risk to participants will be addresses with the researchers and will be reported to Institutional Officials in the IRB committee’s end of year report. Any problem that is deemed to present more than minimal risk will be reported to Institutional Officials within 10 of the IRB committee review of the event.

Data Breach: Since data breaches will typically meet the definition of an unanticipated problem or involve more than minimal risk to participants they will be reported to Institutional Officials within 1o days. When a data breach occurs, the PI should immediately contact the Austin College IT director and in the case of stolen equipment or illegal access of a database contact campus police.

For a data security breach that involves protected health information under HIPAA or FERPA protected educational records the IRB will notify the Institutional official within 10 days.

Student Projects

All student-initiated research must have a faculty sponsor. The faculty sponsor is responsible for reading and editing the IRB application and all related materials before submitted the application to the IRB. All IRB applications must be submitted by a faculty member, students may not submit applications directly to the IRB. In the case that a student is to work on a faculty’s project that already has IRB approval, the faculty investigator shall submit an amendment to the IRB to name the student as a co-investigator. Note this only applies to students who are collaborating as an investigator. Student research assistants who work on projects to complete specific, delegated tasks do not need to be added as an investigator.

Record Maintenance

The faculty principal investigator or the faculty supervisor shall maintain all documents pertaining to each research project. Project documents and any signed consent forms must be kept for a minimum of three (3) years following termination of the study and be made available for internal reviews or external audits as necessary.

HHS regulations at 45 CFR 46.115(b) require that IRB records be retained for at least 3 years, and records relating to research which is conducted be retained for at least 3 years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of HHS at reasonable times and in a reasonable manner.

Conflict of Interest Policy for Researchers

Faculty and staff should have a conflict of interest form on file with the business office. The Austin College policy on Conflict of Interest can be found on the intranet.

For grant or other funded projects Austin College prohibits real or apparent conflicts of interest related to award and prohibit acceptance of gratuities, favors, or anything of monetary value from collaborators, contractors, or parties to sub-agreements.

Disclosures

Before a project begins investigators must disclose: anything that could be considered a significant financial interest or that could reasonably appear to be affected by research (this includes influencing the outcomes of the research or receiving undisclosed personal benefits from research).

One a project begins investigators must disclose if a significant financial interest is acquired to the IRB, institutional official, and funding agency. Such disclosures should happen within 30 days of a significant financial interest arising during the project.

Researchers are also expected to follow the disclosure policies of the granting agency and to following agency reporting guidelines.

Nepotism

Whenever PI faces decision potentially benefiting family, partner or business which employs family or partner using sponsored research funds, PI must report the situation to the institutional official before proceeding.

Purchasing

PI must disclose proposed purchase of goods or services from entity in which s/he or an immediate family member has financial interest.  PI must submit a completed employee-vendor disclosure form (see business office). The purchase should not be completed until the institutional official and the business office have reviewed and approved the purchase.

Conflict of Interest Management Plan

Where relationships are deemed appropriate by the institutional official and the business office, but the potential for a conflict of interest exists a conflict of interest management plan should be developed and implemented.

See the NSF conflict of interest guidelines.

Duration of Approval

All Full Board and Expedited studies must be periodically reviewed again at least annually. There are times when the risks associated with a particular project are such that continuing review should take place more frequently than annually.  In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval (e.g., 3 or 6 months) or after a specified number of participants (e.g., after each participant or after 3 participants) are enrolled. The PI’s report must describe the observed effects of the research activities and/or how the participant(s) responded to the research interventions.  Such a determination will be recorded in the IRB files (e.g., minutes), along with whether the reports will be reviewed by the full board or primary reviewer.

Appealing an IRB Decision

If the IRB makes a decision that an investigator believes to be unfair, unsubstantiated, or unduly restrictive on his/her proposed research, the investigator should first discuss the matter with the IRB Chair. The investigator should be prepared to present reasons that he/she believes that the proposed research is in compliance with College policy and federal regulations for the protection of human participants.

If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision, in writing, to the IRB. In developing his/her appeal, the investigator is encouraged to seek the advice or opinion of an objective, qualified consultants to support the claim that the proposed research is in compliance with human participants policy and regulations.

The investigator must appear before the IRB to present his/her appeal and any supportive material or documentation obtained through consultation. Based upon this appeal, the IRB will issue a final determination on the proposed research. The Institutional official CAN overrule the IRB to disapprove a project, but CANNOT overrule the IRB to approve a project. Only the IRB can approve a project.

Negative decisions by the IRB may be appealed to the vice president for academic affairs on the grounds of a failure by the IRB to carry out a thorough and complete review in accordance with its stated procedures or on the grounds of a possible violation of the academic freedom of the investigator. Final appeal rests with the President.

Informed consent guidelines (adapted from CFR 45 Part 46.116)

Informed consent is more than just a form; it is the basis of a dialogue between the researcher and research subject(s). Except under special conditions specified below (Waiving the informed consent requirements), researchers are required to obtain written informed consent from all adult participants.

Researchers are required to provide prospective adult participants with sufficient information and opportunity to consider that information. Every consent form should obtain a statement of the participants’ rights. Basic elements of consent forms are summarized below.

When the participants are under 18 years of age, parental (or guardian) consent must be obtained. Parents and guardians may sign a consent form giving permission for their child(ren) to participate in a series of projects conducted over a period of an academic year. Parent consent letters should provide information about the purpose of the research as well as information about the procedure itself from the child’s point of view. As with research involving adult participants, this letter should indicate how confidentiality would be maintained.

Researchers may request a waiver of parental consent for students who are under the age of 18, but who are also matriculated students at Austin College. The request and rationale for such a waiver should be clearly stated on the IRB application form.

It is understood that although parental consent is obtained, child participants are free to decline invitations to participate without any penalty. Child participants should be given an age appropriate explanation about the procedures used and what to expect by way of participation. Children should be asked if they want to participate. Mere failure to object on the child participant’s part should not, in the absence of an affirmative response, be interpreted as assent. In the proposal, the researcher should indicate how assent would be obtained and documented. A copy of the ascent form/statement should be included in materials submitted to the IRB for review.

Basic elements of informed consent

1. A statement that the study involves research, a readily understood explanation of the purpose(s) of the research, the expected duration of the subject’s participation, a brief description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject. These may include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
3. A description of any benefits to the subject or to others that may reasonably be expected from the research (if no direct benefit, this should be stated).
4. A statement concerning costs or compensation to the subject, if any.
5. An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject. Possible contacts include: the Primary Researcher, the Departmental Coordinator of Human Subjects Research, or the IRB Chairperson. Student researchers must include contact information for their faculty sponsor. Phone numbers and emails should be provided.
6. Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained.
7. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Compensation is separate from benefits and a distinction should be made here. If participants will not received compensation under certain conditions then an explanation of those conditions should be provided. Add link to paper on compensation.
8. Signature of subject indicating agreement to participate and date of signature.

NOTE: If there are multiple parts to your study, make sure the participants has the opportunities to agree or not to each of those separate pieces (rather than a blanket statement where they agree to everything)

Waiving the informed consent requirements (adapted from CFR 45 Part 46.116 C and D)

Federal guidelines allow that there are some situations where a written consent form may not be required or where the above elements may be modified: (1) if the principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research; (2) if the consent document is the only record linking the subject with the research; (3) if the research involves no more than minimal risk to the subjects and involves procedures that do not require written consent when they are performed outside of a research setting; or (4) the research could not be carried out in any other practical way.

If there is no written consent form, an oral presentation of the research should be provided to the subjects by the researcher, with documentation that such a presentation was made to the subjects. In this instance, researchers should maintain a written summary of the oral presentation and some record that consent was provided by the participant.

Researchers who believe their proposal may qualify for a waiver of informed consent should refer to CFR 45 Part 46.116 C and D and then consult with the IRB Chairperson.

IRB Forms are listed below as Word documents:

• IRB Application for a New Project
• IRB Modification Extension Renewal
• IRB Reviewers Checklist
• IRB UP Protocol Violation or Data Breach Report 

Links to IRB and Human Subjects Resources

• Belmont Report
• HHS Office for Human Research Protection
• Code of Federal Regulations: Title 45, Part 46—Protection of Human Subjects—To What Does This Policy Apply? (46.101)
• American Sociological Association Code of Ethics
• American Psychological Association Ethics Code
• American Anthropological Association Ethics and Methods
• Office of Human Subjects Research National Institutes of Health
• Human Subjects National Science Foundation
• US Department of Health and Human Services Guidelines for International Research
• Starting an Institutional Review Board at a PUI (CUR Quarterly, December 2001)

Terry Hoops, chair – Social Sciences

Members

Lisa Emery, Off campus member
Kirk Everist, Humanities
Eugenia Harris, Ex-Officio
Peter Marks, At Large
Wayne Meyer, Science
Mark Monroe, At Large
Ivette Vargas-O’Bryan, Humanities
David Whelan, At Large

Signatory Official: Steven P. O’Day, President

Human Protections Administrator: Dr. Steve Goldsmith, Dean of Sciences