8. An Overview of the Institutional Review Board (IRB) and Memorandum of Understanding (MOU) Processes
Learning Objectives
By the end of this chapter, you will be able to:
- Explain the purpose of an Institutional Review Board (IRB).
- Describe the importance of Memorandums of Understanding (MOUs) for effective program implementation and collaboration.
- Create an MOU for your specific or intended capstone project.
Overview
This chapter will begin with a brief introduction to the role and responsibilities of Institutional Review Boards (IRBs). The purpose of Memorandums of Understanding (MOUs) and the components of a well-developed MOU are provided. While not all capstone projects will require IRB approval prior to implementation, all capstone projects will require a n MOU. For this reason, it is important to reach out to your capstone instructors and mentor to ensure you are following the correct protocol for your capstone project.
Introduction
An IRB is a panel of professionals and lay people who are tasked with the safety of research conducted in community and clinical settings. Typically, IRBs exist within academic institutions, hospitals, and some community settings. The role of the IRB is to act as a protecting body for research-based capstone projects. Prior to conducting any kind of intervention, you must contact your capstone instructors and mentor to determine if your capstone project will require IRB approval prior to implementation. If required, it is important to contact the IRB and follow all proper procedures to secure approval prior to the implementation of your capstone project (Doll, 2010). Furthermore, to ensure a successful capstone project, it is important that all stakeholders involved in the capstone project are familiar with one another’s roles, responsibilities, and expectations. A common method for documenting partnerships is the use of a n MOU. Simply, an MOU is an agreement between two parties outlining how each will work together. Creating and obtaining a signed MOU for your capstone project, from all parties, should be completed prior to IRB approval and/or project implementation.
What is an Institutional Review Board (IRB)?
Under U. S. Food and Drug Administration (FDA) regulations, an Institutional Review Board (IRB) is an appropriately constituted group that has been formally designated to review and monitor research involving biomedical and other research involving human subjects. An IRB has the authority to approve, require modifications (to secure approval), or disapprove research. Therefore, IRBs serve an important role in the protection of the rights and welfare of human subjects (Office of the U.S. Food and Drug Administration [FDA], 1998).
IRB Size
According to federal regulations, the minimum number of people required for an IRB is five. The number of IRB members is contingent on the size of the institution and the IRB workload. Many schools and universities have multiple IRBs that specialize in particular types of research. For this reason, it is important for you to gather information about your institution’s IRB and speak with your capstone instructors and mentor to determine if your capstone project will or will not require IRB approval.
IRB Composition
As stated above, an IRB must consist of a minimum of five members with varied backgrounds to facilitate diversity in its composition. Additionally, if federally funded research is being performed, an IRB should be composed of members with specific characteristics (Refer to Table 7.1: IRB Member Characteristics for Federally Funded Research-Based Capstone Projects)
Table 7.1: IRB Member Requirements for Federally Funded Research-based Capstone Projects
| Scientific Area | At least one member must work in science (for example, Biology, Psychology, or Chemistry) |
| Nonscientific Area | At least one member must work in a non-science area (for example, History, English, Philosophy-or-a Lawyer, Clergyman, or Ethicist) |
| External to the Institution | One member must come from outside the institution and not be affiliated with the institution |
| Diversity of Representation | An effort must be made to achieve diversity of representation, particularly if members of “vulnerable populations” are often study subjects (for example, children, prisoners, and individuals with intellectual disabilities) |
| Diversity of Gender | The IRB should have, at least, male and female representation |
| Diversity of Profession | The IRB should not have representation from just one profession |
Source: American Psychological Association [APA]. (2019, October). Getting started: The Institutional Review Board College Planning Guide. American Psychological Association. Retrieved September 11, 2022, from https://www.apa.org/ed/precollege/undergrad/ptacc/irb-college-guide/getting-started
The IRBs have the authority to approve, require modifications to, or disapprove any research activities according to both federal regulations and school policies. For these reasons, it is important to become familiar with your School and/or Institutions general approval criteria that provide the decision framework within which an IRB operates (Touro University, n.d.). It is vital that you speak with your capstone instructors and mentor to determine if your capstone project will require IRB approval before implementation. Additionally, it is important for you to review your institution’s IRB application system, so you have all information and supporting documents, such as a memorandum of understanding (MOU), as appendices prior to submitting. (Refer to Appendix 8.A: Sample IRB Application).
Memorandums of Understanding
Documentation of partnerships demonstrates a commitment and should be a component of your capstone project to demonstrate community/stakeholder collaboration. A common method of documenting evidence of partnership is the use of an MOU. An MOU is not a contract; rather, it is a written agreement between two entities outlining how each will work together during the capstone process. An MOU usually includes the following components:
- Names of the partners involved
- A brief history of the partnership (if applicable)
- A brief description of how the partners will work together
- The proposed activities of the partnership
- Signatures from representatives of all parties
MOUs provide formal documentation of each partner’s responsibilities and the structure of the collaboration. MOUs are commonly used in settings where contracts for services may not be necessary or applicable (Doll, 2010). (Refer to Appendix 7.B: Sample MOU).
Conclusion
An IRB is a panel of professionals and laypeople who examine the safety of research being conducted in clinical and community settings (Office of the U.S. Food and Drug Administration [FDA], 1998).
A memorandum of understanding is an agreement between two or more parties outlined in a formal document. The MOU can be seen as the starting point for the implementation of your capstone experience as it defines the scope and purpose of your project. Prior to conducting any sort of research-based capstone project, you will need to contact your capstone instructors and mentors to determine if IRB approval is necessary for you to move forward with your capstone project.
Case Study: MOU and IRB Application
Case Study: Selecting a Theoretical Framework
It has been determined that Glynn will require IRB approval from her educational institution prior to implementing the Health Literacy Universal Precautions Workshop at their partner skilled nursing facility (SNF). For this reason, Glynn is reviewing her educational institution’s IRB application and meeting with their mentor and capstone instructor(s) for further guidance with this process. Glynn will also contact the IRB directly with any questions. In preparing her IRB application, Glynn created an MOU. Once this MOU is signed by all parties, it will be kept in her capstone project file and will include a copy of it as an Appendix to her IRB application.
Glynn’s MOU:
This MOU was placed on the facility’s letterhead
Date
To Whom it May Concern,
This letter is to serve as permission for Glynn Smith to complete an evidence-based capstone project at Greenwich Woods Health Center, 1165 King Street, Greenwich, CT. 06831.
Specifically, Glynn Smith will be permitted to implement an evidence-based occupational therapy intervention with members of the Occupational Therapy Department at Greenwich Hills, who choose to volunteer. The evidence-based occupational therapy intervention will use elements of the Health Literacy Universal Precautions Toolkit to improve occupational therapists’ working knowledge of health literacy and their self-perceived ability to identify, assess, and provide client-centered interventions for patients who may be low-health literate in order to improve outcomes. The project will begin in August 2017 and will run through October 2017. The intervention will take place in the Occupational Therapy Department of Greenwich Hills with Glynn Smith, 1x per week, for approximately 45 minutes, during lunchtime, in a lunch-and-learn format.
I understand the purpose of this evidence-based capstone project is to determine if a health literacy workshop for occupational therapists incorporating elements of the Universal Precautions Toolkit can improve their working knowledge of health literacy, and increase their self-perceived ability to identify, assess, and implement client-centered interventions for patients identified as low health literate in order to improve outcomes.
Sincerely,
(Signature here)
John Doe, OTR/L
Director of Rehabilitation
Greenwich Woods Health Center
Signature of Glynn Smith: _____________________________Date:________________________
(A copy of this letter was kept on file by Glynn and provided to John Doe, Director of Rehab at Greenwich Woods Health Center).
Appendix 8.A: Sample IRB Application
TOURO UNIVERSITY
INSTITUTIONAL REVIEW BOARD APPLICATION
Please complete and return this form to: HSIRB@touro.edu (for proposals to the Health Sciences IRB) or IRB1@touro.edu (for proposals to IRB #1).
Exempt Proposal Information
Date Submitted to IRB:
IRB No. (for office use only)
School: Touro University, School of Health Sciences
Department/Program: Occupational Therapy
Principal Investigator: Faculty Advisor: (For TU Student Projects only)
Name: Name:
Title: Title:
Touro University Email: Touro University Email:
Phone #: Phone #:
Are you a:
Full-time Touro University Faculty Member or Student?
If the Faculty Advisor is not a Full-time Touro University Faculty Member, a Touro University Full-time Faculty Member must have overall responsibility for the project and serve as the primary institutional point of contact. This person must be identified below:
Responsible Faculty Member:
Name:
Title:
Touro University email:
Phone #:
Project Title:
Co-Principle (Co-PI) or Co-Investigator (Co-I)
| Co-PI
Co-I |
Name: | Touro University Email: |
| School/Department: | Phone #: | |
| Co-PI
Co-I |
Name: | Touro University Email: |
| School/Department: | Phone #: | |
| Co-PI
Co-I |
Name: | Touro University Email: |
| School/Department: | Phone #: | |
| Co-PI
Co-I |
Name: | Touro University Email: |
| School/Department: | Phone #: |
- SPONSORED PROJECT: If this study is being conducted under an externally sponsored project, please identify the sponsor(s); the proposal and/or award number(s); and the proposed or actual period(s) of performance associated with the project. If this study is being conducted under an intramural grant program, please provide the equivalent information.
- HUMAN SUBJECTS PROTECTIONS MANDATORY TRAINING CERTIFICATION: Please check the applicable statement(s) below regarding human subjects protection training certification. [Note: IRB requirements for training can be found at: Mandatory Training in the Protection of Human Subjects
____ All employees, or students, or consultants who will directly interact with human subjects participating in, or who have access to identifiable subject data collected for, this research project have completed the required human subjects training and their certificates are attached.
____ I/WE anticipate that at a later date there may be new employees, students, or consultants who will interact with human subjects participating in, or who will have access to identifiable subject data collected for, this study. If this occurs, I/WE understand that these individuals must complete the required human subjects training and their certificates must be filed with the IRB prior to their involvement in the study. When copies of those certifications are submitted to the IRB, I/WE understand I/WE must identify the IRB Exempt Proposal Number with which the certifications are associated.
- CONFLICT OF INTEREST: Do any of the individuals working with subjects or identifiable data as part of this project have an actual or potential conflict of interest?
[ ] Yes [ ] No
If you have checked “Yes”, please identify the individual(s). All individuals identified as having actual or potential conflicts of interest must contact the Touro University Office of Institutional Compliance (OIC) for appropriate guidance and/or action. IRB determination on this Request will be contingent upon OIC adjudication of any actual or potential conflict of interest.
- EXEMPTION CATEGORY FOR PROPOSED RESEARCH PROJECT:
Before completing this section, please carefully read the Exemption Categories (and exclusions) in the Exempt Review Proposal Guidance and Instructions. If you are uncertain whether the proposed project meets any of the exemption criteria, please consult with your IRB Chair prior to submission of this form.
NOTE: The Common Rule restricts applicability of Exempt Research to certain potential subject populations for whom additional protections are required.
Prisoners: The exemptions cannot be applied to any research involving prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners.
Children: Categories (2)(i) and (ii): These exemption criteria may only apply to projects with children as potential participants if the projects involve educational tests or the observation of public behavior when the investigator does not participate in the activities being observed. Category (2)(iii) and Category (3): These criteria may not be applied to projects with children as potential participants.
PI Exemption Claim: Based upon my reading of the full exemption category descriptions contained in the federal regulations, I believe the (summary) exemption category checked below best describes my proposed research project.
(1) Research conducted in a commonly accepted educational setting. Involves normal educational practices, no adverse impact on student opportunity to learn, and no adverse impact on instructional providers.
(2) Research involving educational tests, surveys or interviews, or observation of public behavior (including visual or auditory recording), if: (i) subjects cannot be readily identified; (ii) disclosure outside the research will not generate risk; (iii) subjects can be readily identified from the recording, and a limited IRB review will be made to determine there are adequate provisions to protect the privacy of the subjects and the confidentiality of the data.
(3) Research involving benign behavioral interventions only with adult subjects who have agreed to participate. Moreover, the data will either be: (i) not subject identifiable nor put subjects at risk—or, in the case of identifiable data being collected, a limited IRB review will be made to determine there are adequate provisions to protect the privacy of the subjects and the confidentiality of the data; or, (ii) brief and harmless, and exclude medical interventions; or, (iii) in the case of research involving the deception of subjects, collected only after subjects authorize use of deception.
(4) Secondary research using identifiable private information or identifiable biospecimens, if: (i) the information or biospecimens are publicly available; (ii) the data will not be recorded as identifiable and will not be re-identifiable; (iii) the identifiable health information used is regulated for purposes of “health care operations”; (iv) the research is conducted by or on behalf of the Federal government using government generated or collected data obtained for non-research studies.
(5) Research that is supported by (i.e., funded by) or subject to the approval of a federal agency and is designed to study, evaluate, or improve public benefit or service programs.
(6) A taste and food quality evaluation and consumer acceptance study.
(7) and (8) NOT APPLICABLE—ThesIs exemption categories only apply to research for which Broad Consent is required and the IRBs have not currently approved the use of Broad Consent at Touro University
- ATTACHMENTS REQUIRED FOR IRB REVIEW: In order for the IRB to determine if an exemption claim is valid, the following items must be appended to this Request form in the order set forth below.
Please submit all pertinent documents in Word.doc/docx format, using Arial 11 or 12 point font with single line spacing; documents that cannot be submitted as a Word.doc/docx (e.g., published questionnaires or originally signed site approval letters) may be submitted in Adobe pdf format.
A summary statement that addresses the following key information (and, although concise, provides sufficient detail to aid in the IRB review process):
- The nature and structure of the research. Be sure to include clear descriptions of any issues regarding anonymity or confidentiality (including the means of recording and storing all information to ensure its anonymity), as well as any potential benefits/risks to subjects by virtue of their participation.
Benefits/Risk Ratio:
The benefits of participation in this study include increasing participants’ knowledge in health literacy, increasing participants’ confidence in their ability to identify and provide services to low-health literate patients, and enhancing their clinical skills. Participation in this health literacy workshop may help participants prepare for health care professional licensing exams. Through increased knowledge of and confidence with health literacy and health literacy universal precautions, participants may demonstrate the ability to promote health literacy in clinical and academic settings. This study benefits society by providing participants with an evidence-based, client-centered approach to clinical care, which can result in improved health
- The method of solicitation of subjects that is planned, including the method and exact communication to be used when recruiting potential participants (letters, flyers, etc.).
- A description of the participant pool. Indicate if the potential participants are members of one of the designated “special populations” who are required to be provided additional protections (children; prisoners; and pregnant women, fetuses, and neonates), or who are considered to be particularly vulnerable to coercion or undue influence (children; prisoners; individuals with impaired decision-making capacity; and economically or educationally disadvantaged persons).
- A description of any compensation that might be offered to subjects.
- The estimated period of time for project data collection; and the estimated period of time for the project from commencement to completion, including time for analysis of data.
- A description of the consent process and a copy of any consent documents to be used. If the project will involve any deception regarding the nature or purpose of the research, a consent document must be included that reflects (1) each subject’s understanding that his/her participation may involve his/her being unaware of or misled about the nature or purpose of the research and (2) his/her authorization of using such deception.
- Copies of any instruments/questionnaires that will be used with subjects, along with any other appropriate information about those instruments (e.g., whether the instruments are validated and published; previously used, etc.).
- For secondary research projects, a description of the identifiable private information (including identifiable biospecimens).
- In the case of collaborative studies where Touro University is the lead institution, a copy of the Exempt approval from the IRB of the collaborating institution covers the human subjects research to be undertaken at that institution. Other relevant information may also need to be submitted depending upon the discussion held between the Touro University Principal Investigator and the IRB Chair or Vice Chair.
- PRINCIPAL INVESTIGATOR/FACULTY ADVISOR ASSURANCE:
- As Principal Investigator, Co-Principal Investigator, Co-Investigator, or Faculty Advisor, I /WE certify that to the best of MY/OUR knowledge the information contained in all materials submitted to the IRB as part of this “Request for Exempt Review” are complete and accurate.
- I/WE agree to conduct the study as described and to comply with IRB and Touro University policies for conducting ethical research.
- Once Exempt status is confirmed by the IRB, I/WE understand the approving IRB must be notified of any proposed changes to this research project that may have an impact on Exempt status. Such changes include but are not limited to changes in procedures or collaborating investigators, or changes requested by a sponsor in the case of sponsored funded research. No changes may proceed prior to IRB adjudication of the issue.
- I/WE understand that any unexpected, adverse, or otherwise significant events in the course of this study will be reported promptly to the IRB.
PLEASE SIGN OR INSERT E-SIGNATURE(S) BELOW
| Principal Investigator’s Signature | Date | |
| Principal Investigator’s Name (Print) | ||
| If the project involves Co-Principal Investigators/Co-Investigators, please have each person complete and sign the following section, duplicating the format for each individual. | ||
| Co-Principal Investigator’s/Co-Investigator’s (circle status) Signature | Date | |
| Co-Principal Investigator’s/Co-Investigator’s Name (Print)
|
|
|
| Co-Principal Investigator’s/Co-Investigator’s (circle status)
Signature: Date: |
||
| Co-Principal Investigator’s/Co-Investigator’s Name (Print): | ||
| Co-Principal Investigator’s/Co-Investigator’s (circle status)
Signature: Date: |
||
| Co-Principal Investigator’s/Co-Investigator’s Name (Print):
|
References
Source: Touro University. (n.d.). General criteria for IRB approval of Human Subjects Research proposals. Retrieved September 25, 2022, from https://www.touro.edu/departments/tcny-research/human-subjects-research/hrsp-revised-common-rules/general-criteria-for-irb-approval-of–hsrp/
Appendix 8.B: Sample MOU (Please note that this MOU is fictional and for example purposes only)
This document constitutes a Memorandum of Understanding between Jane Smith, Touro University OTD candidate, and the Community Response Team regarding the Suicide Prevention Plan.
Jane Smith has established a partnership with the Community Response Team and a historical partnership with the community for more than 14 years. For purpose of the Prevention Plan, Jane Smith indicates a willingness to work with the Community Response Team to address the critical issue of suicide prevention in the community.
Roles and Responsibilities
Jane Smith agrees to implement the following:
- Develop and implement an evidence-based and culturally relevant stress management program for the prevention of suicide
- Develop sensory rooms and a traveling sensory workshop for the purpose of stress management as a tool for suicide prevention in the local schools
- Conduct stress management workshops four times per year in the community
- Engage in planning and development as needed in partnership with the Community Response Team
- Provide training to Community Response Team staff and school staff in the stress management program for sustainability
Planning and Development Contact Person
- Jane Smith, OTR/L, Touro University, OTD candidate
- Touro staff/faculty PRN
Resources Provided by Jane Smith:
- The expertise of Jane Smith, who has an established relationship with the Community Response Team, and who has received training in collaboration with Touro University in the areas of program development and implementation
I hereby agree to fulfill my sections of this project, and I agree to abide by the terms and conditions contained in this MOU between Jane Smith, Touro University, OTD Candidate and the Community Response Team.
Signature: _________________________________ Date: _________________
Jane Smith
Signature: ______________________________________ Date:__________________
Representative from Community Response Team
