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  1. 1. Faculty/Staff Guidelines

 

 

Faculty/Staff Guidelines


The University follows the ethical principles regarding human subject research as set forth in The Nuremberg Code and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, "Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (also known as the Belmont Report). The University acknowledges and accepts its responsibilities for protecting the rights and welfare of human subjects of research.

Responsibilities of Researchers

Researchers have the primary responsibility for assuring the day-to-day protection of the rights and welfare of human subjects. Specifically, the researchers are responsible for:

  1. Obtaining and demonstrating certification of ethics training.
  2. Research design.
  3. Adhering to ethical codes; applicable federal, state, and local laws and regulations; and the applicable policies and procedures of the University, the sponsoring agency, and cooperating institutions, if any.
  4. Training and supervising staff and students assisting in the research.
  5. Obtaining legally effective, informed consent from subjects.
  6. Fully disclosing the research protocol and potential risks to human subjects and complying with the requirements of the IRB to minimize risk to the research subjects.
  7. Retaining required records.
  8. Obtaining the prior approval of the IRB to initiate the research or to change approved research protocols involving human subjects.
  9. Reporting promptly to the IRB any adverse events involving research subjects that are, or reasonably may be thought to be, related to the research activity.

 


UA Fort Smith IRB Policy (Revised February 2012)

 

IRB Policy on Course Projects

University of Arkansas – Fort Smith

2011

Class projects are generally conducted for education purposes and not as research. The purpose of these course projects is to train students and provide them with a closer view of educational, social, or psychological processes, and an opportunity to practice various research methods. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Some will require submission of an IRB application or a determination that IRB approval is not required. Instructors are strongly encouraged to contact the IRB for guidance about ways to handle topics concerning privacy, confidentiality, informed consent, and ethics when class projects are part of a course requirement.

Assignments that are part of a course requirement and meet the stated conditions may be exempt from individual review by the Institutional Review Board (IRB). Instructors seeking approval of course projects are required to demonstrate certification through National Institutes of Health (NIH) Office of Extramural Research found at Protecting Human Research Participants (http://phrp.nihtraining.com).

The course instructor who has received approval from IRB (by completing and submitting the Request for Course Approval of Research Projects) to make research assignments for the course is responsible for communicating the ethics of human subjects research to the students. Course instructor and students will:

1. Plan appropriate strategies for subject recruitment.

2. Identify and minimize potential risks to the subjects.

3. Assess the risk-benefit ratio of the assignment.

4. Understand elements of an informed consent.

5. Develop consent forms as appropriate.

6. Declare and maintain strict guidelines for confidentiality.

7. Submit to IRB for approval as appropriate.Page | 3

Conditions that do not require individual IRB review and approval (only course approval) are:

A. Surveys, interviews, questionnaires, and public observations are exempt if the following conditions are met:

1. The assignment is a class assignment for learning purposes only and not designed to develop or contribute to generalizable knowledge.

2. Results of the research are not made public outside the classroom, not published in paper or electronic format, and destroyed after submission for grade.*

3. Research procedures are no more than minimal risk.

a. If the subject is of a sensitive nature, i.e. rape, incest, etc. the research is NOT exempt and requires IRB approval.

4. Vulnerable populations are not included, (i.e. children under 18, prisoners, persons with cognitive impairment, pregnant women).

5. Data collected cannot be linked back to the subjects.

6. Audiotaping or videotaping are allowed under the following conditions:

a. Faculty are required to oversee process and ensure permission is granted by the subject before taping is done.

b. Faculty are to submit course syllabi with course application to IRB. Syllabi must state that all data gathered as part of a course project remains the property of the University and will be forfeited to the course faculty at the end of the project.

c. Faculty are to ensure the taped information is destroyed at the end of the project

unless application has been approved by University IRB to continue project.

B. Analysis of secondary data for which there is no identity key.

*The researcher is cautioned that without IRB approval the findings cannot be published. IRB approval cannot be granted after the data collection has begun. It is best to seek IRB approval in the event of future desire to publish the outcomes.

 

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Student researchers have the same submission options as any investigator. They may submit as Principal Investigator with a faculty advisor as co-signer. A student may be included on an existing project that has already been approved by IRB. Below are cases with appropriate processing requirements.

 

 

Research Action Class projects involving secondary analysis of data, records, or specimens that publicly available, de-identified, or are otherwise

impossible to be linked to personal identities.

No IRB action is required

Class projects involving secondary data analyses that are assigned and conducted as education exercises, and that use datasets that include private information and code linked to identifiers,

but the students do not have access to the identifiers.

No IRB action is required

Research that involves direct interaction but

where the purpose is training and educational exercise and not research. The information is not generalizable knowledge.

No IRB action is required.

Research that involves direct interaction or secondary analyses of identifiable data and is

undertaken as research such presented, stored, and/or used by the students as research data.

IRB approval required. For a class project, a single IRB application may be submitted by the course instructor as primary investigator listing all students who will be involved. The PI must have research ethics certification.

 

Student Research

 

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Viewing 1 of 1 comments: view all
You might want to have a conversation with your IRB chair. From the information you provided, it sounds like you might not have to submit an IRB application. However, please let the IRB chair know your intention is to publish your work; many publications ask about IRB approval.
Posted 12:07, 18 Jul 2012
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