8.+The+IRB

=Institutional Review Boards=

Jenaee McWhirter-Wingfield, Kayleigh Sheppard, and Emily Shown Please see attached document for appropriate formatting



The Institutional Review Board (IRB) is a carefully selected group of persons that work together to ensure all individuals asked to participate in any kind of research study have their rights and well beings protected. Established in 1981 as a provision to the National Research Act (Public Law 93-348) passed by Congress in 1974, the act had initially given the Department of Health, Education, and Welfare (HEW) the task to institute federal regulations with policies on the protection of human subjects in research studies. In 1981, the Department of Health and Human Services (formerly HEW) approved Title 45, Code of Federal Regulations, Part 46, Protection of Human Subjects (45 CFR Part 46), which required all federally funded research to follow specific guidelines when working with human subjects. One of these guidelines specifically called for the use of an institutional review board. The IRB may also be referred to as an ethical review board, a research advisory committee, or human subjects’ committee (Cottrell & McKenzie, 2005).
 * What is an Institutional Review Board?**

To ensure the Institutional Review Board is able to complete comprehensive and sufficient evaluations of research studies, federal guidelines state that the board must have a minimum of five members of different backgrounds. These members must be comprised of individuals of diverse representation that have adequate experience and expertise, and those with sufficient knowledge regarding the commitments, regulations, and standards set forth by institutions and law. In addition to this, there needs to be at least one individual on the board who has no affiliation (personal, professional, or familial) with the institution conducting the study. There may be times when the IRB invites another person onto the board who can contribute their knowledge of expertise in an area not already established amongst members of the board. It is not uncommon for a board to have ten to twenty or more members in order to fulfill all the necessary requirements of representation amongst its members (Cottrell & McKenzie, 2005).
 * Who usually comprises such a Board?**

The main task of the Institutional Review Board is to ensure that human subjects’ rights are protected within experimental methods. Members of the IRB meet up approximately once a month to review submissions of research proposals; this is known as the full committee review and the project must receive a majority vote in order to be granted approval. The IRB can approve, disapprove, or request modifications to proposals. Experimental designs can be approved outside of full committee meetings if they meet certain criteria such as posing minimal risk to participants of the study. At any point in time during the research process if changes are to be made to the experiment they also require IRB approval. These can be big changes to protocols or small details like what is displayed on flyers advertising for participants (“Widener University,” n.d.).
 * What are the general tasks of an IRB?**

The IRB’s greatest concerns are highly based on protecting participants’ mental and physical health during research. IRB’s want to ensure that participants are well aware of what they will be engaging in, while also ensuring that there aren’t any barriers preventing them from making the choice to participate or decline. For example, the IRB places limitations on the consent of minors and mentally disabled individuals in order to protect them from unknowingly making harmful decisions (Cottrell & McKenzie, 2005, pg. 32). The IRB is highly based upon acknowledging and identifying potential risk to participants. The text provides a box that lists the criteria for IRB approval for research and the minimizing of potential risks is prioritized (Cottrell & McKenzie, 2005, pg. 104). This criteria is very important in order to ensure that the benefits outweigh the potential risks.
 * What are their greatest concerns?**

References Cottrell, R., & McKenzie, J. (2005). Health promotion and education research methods: Using the five chapter thesis/dissertation model (2nd ed.). Sudbury, Mass.: Jones and Bartlett.

Widener University (n.d.). Institutional Review Board (IRB) Office. Retrieved from: https://prod.campuscruiser.com/q?pg=offices_welcome&tg=OfficeWelcome&cmd=switch&cx=22.97- 51.3073&tabId=OfficeWelcome_ODJdrYz5Member

A Step-by-Step Guide to Completing a Widener Institutional Review Board Proposal
Megan Ulrich & Shane'a Thomas Please see attached document for appropriate formatting



//Before starting the process of submitting an Institutional Review Board (IRB) proposal, it is important to familiarize yourself with Widener's IRB Office website which provides helpful links and forms for completing your submission. The website can be found at the following:// ** https://prod.campuscruiser.com/q?pg=offices_welcome&tg=OfficeWelcome&cmd=switch&cx=22.97-51.3073&tabId=OfficeWelcome **


 * First, understand the Parts of the Application and then determine if this is an Initial Submission or a Resubmission of your proposal and follow the appropriate steps. **

A. **The Application**: can be found and downloaded at the above link. Look for the 'IRB Application Materials & Forms' section B. **Brief Summary of the Experimental Protocol**: Use the checklist below to make sure you covered each required part. If you have any questions on the particulars of each section, please use the 'IRB Application Completion Instructions' document on the website. - Purpose - Background and Review of the Literature - Participants & Recruitment Procedures - Data Collection Instruments & Materials - Methodology - Ethical Issues - Compensation - Potential Significance of the Study - References - Appendices & Attachments - Conflict of Interest and/or Disclosure Statement
 * __Parts of the Application__**

C. **Consent Form and Informational Letters:** To determine what you may need, you can seek advice from members of the IRB Board. This Part includes completing and submitting:
 * Consent Form //(See 'Consent Form Template on pg. 12-15 of the 'IRB Application Completion Instructions' document)//
 * Informational Letters
 * Assent Form

D. **Child Assent/ Permission Form:** This is a consent document that is written at the appropriate reading level of the participant(s). //(See pg. 16-17 of the 'IRB Application Completion Instructions' document for more details and an Child Assent Template)//

1. For initial submission, from the initial website page, click on the Application Submission Procedure tab. 2. Read IRB Application Completion Instructions listed on the right hand side of the page (New Application Materials section). 3. After completion, download the IRB Application instructions listed within in the same section. 4. After the IRB Application is fully completed, forward an electronic copy to irb@mail.widener.edu, and two paper copies of application materials need to be sent to Marilyn Lehman, located in Old Main, 1st Floor, in Room 10. 5. For timely submission, the completed application must be in the Office of the Provost no later than two weeks prior to the scheduled IRB committee meeting. 6. For first time submission, please allow at least two weeks following the IRB committee meeting date. All applications which are incomplete, or need to be resubmitted for correction will not be reviewed until the next meeting (Please see next section for Resubmission instructions).
 * __Initial Submission__**

1. In order to resubmit a previous application to the IRB committee due to incompletion or rejection, first reprint your revised version, showing the revised changes through modifying the font or applying Microsoft Word’s track changes feature (available through the Review tab at the top of the software program).
 * __Resubmission__**

2. With bullets and/or an outline, respond to each recommendation made by the committee

3. Resubmit revised application (two paper copies) to Marilyn Lehman, located in Old Main, 1st Floor, in Room 10, along with an electronic copy to irb@mail.widener.edu.

4. For first time resubmissions, allow two weeks for review by the IRB committee.

References Widener University (n.d.). //Institutional Review Board (IRB) Office//. Retrieved from: https://prod.campuscruiser.com/PageServlet?pg=offices_welcome&tg=OfficeWelcome&cx=22.97-51.3073