Institutional Review Board: Expedited Review
Susan Kahlenberg, Department Coordinator
The following resources are for students intending to submit applications to conduct research with human subjects, whether in person or online.
Muhlenberg College’s Institutional Review Board (IRB) internet site provides information and resources guiding students on how to complete a successful IRB application. MC majors completing research projects with human subjects typically submit expedited review applications (see Appendix B). These applications are submitted to the MC Departmental Coordinator, with the expectation that the faculty sponsor offers mentorship and preliminary review of the application. If MC majors are planning research projects with vulnerable populations (i.e., minors, pregnant women, prisoners), these go through full review (see Appendix A), rather than departmental. The MC Department Coordinator’s role is to ensure all research with human subjects--online or in person--comply with federal regulations and sustain records on all projects involving human subjects on behalf of the department. It’s imperative that MC majors see the IRB website and the MC coordinator as resources.
What constitutes academic research?
Federal regulations define research as “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” As discussed in Media Theory and Methods, systematic investigations require a research plan with ideas about what scholars want to learn about communication phenomena according to agreed upon practices, structures, processes, and protocols. Hence, each ‘method’ whether qualitative or quantitative are organized around notions pertaining to the role of the researcher, the purpose of the research, the nature of data collected, interactions with human subjects, and so forth.
Why do you need to submit an IRB application to work with human subjects?
Any institution that receives federal funding is required to have an IRB composed of faculty, students and external reviewers. As noted on the IRB website “Muhlenberg College is committed to protecting the safety, welfare, rights and privacy of all persons who participate as subjects in research projects conducted under its auspices by faculty, staff, and students. It is also committed to ensuring that the subjects of such research are fully aware of their rights and the projections available to them.” Further, the MC Department’s learning goals align with the IRB’s priorities to think systematically about media and communication and the salience of the relationship between media and social justice imperatives. MC courses position students to pursue research that improves human and social conditions and these research projects by design must be conducted ethically to ensure no harm comes to participants. More pragmatically, research-scholars must strive to contribute high quality research to the field. You may recall in a library instruction session that the ‘peer review’ process is one means of assuring this, with researchers determining the validity, significance, and originality of the study, including its ethical practices with human subjects. When you submit your research to a scientific journal, it tends to be reviewed by scholars who are experts in the same field and method. Research involving human subjects without IRB approval does not meet this threshold and will not be considered nor published.
The Belmont Report guides many aspects of how to approach your research plans to ensure ethical treatment of human subjects according to three principles: respect, beneficence, and justice. For the purpose of an expedited departmental review, students prepare IRB applications with their faculty sponsor being attentive to guidelines outlined in the Belmont Report, especially in preparation of the informed consent form.
Do all research projects require IRB approval?
MC majors have MC faculty support to ascertain whether their research study requires IRB approval. First, federal regulations stipulate that research does not need IRB review if it does not involve human subjects. Second, there are some research studies that involve human subjects that do not meet the definition of research and would, therefore, be exempt or excluded from IRB review. In our field, this includes some scholarly and journalistic activities (for example, oral history, journalism, biography, literary criticism, legal research, historical scholarship, documentaries). Third, if you are unsure, check with the MC Department Coordinator and/or faculty sponsor.
What are the required components of the IRB Application Process?
- Completion of the Application Form. The MC Department uses the same form required by the college as noted in Appendix B.
- Informed Consent Form, to be distributed and signed by, and then collected from all research participants.
What is informed consent?
Informed consent is a process that begins with human subject recruitment and continues throughout the duration of the project, including the human subject’s involvement in the research directly and any unplanned changes to the research plan.
Informed consent provides human subjects with all pertinent information needed to understand their involvement in the research project, including a basic description of the project, potential risks and benefits, compensation, protection of identity, and contact information. For example, the study design must have a clearly defined explanation of how the researcher is collecting and reporting identifying data to ensure there is no potential harm. This includes re-identification of data (e.g., pseudonyms, removal of all direct identifiers), data storage protocol (e.g., unauthorized access, data mining), and the nature of data collection (i.e., confidentiality versus anonymity). The following template is provided by the Muhlenberg College IRB for researchers to create their own informed consent.
What format should be used for informed consent?
MC majors can use any format, such as a letter, table, or bullet point listing. However, there are some essential qualities within the informed consent. It must be written in language that is understandable to the intended human subject (e.g., adult, child) and make clear their involvement is voluntary, benefits/risks, and how their identity will be protected. Without signed informed consent, the human subject cannot participate in the research project and MC majors must follow the protocol ascribed in their application materials; any changes to the research plan must be approved by MC Departmental Coordinator as there may be a need to re-inform human subjects.
How long does it take to receive approval of an IRB application?
This depends on the nature of the research project, but typically a week if an IRB application is in good order (including Appendix B and informed consent).
The MC Department Coordinator prioritizes applications with the understanding that research is conducted in a tight time frame within a traditional semester, but there is required compliance with federal guidelines which can lengthen the process. It is typical for IRB applications to be returned for additional information, and this back-and-forth process can be timely so students should expect this in advance. Students are encouraged to create a timeline for their research projects that includes IRB review. The MC Department considers the IRB application process to be a learning opportunity and the faculty sponsor/MC Department Coordinator should be included together on all email communications; this way all parties are informed and our experience has been that this shortens the approval timeline.
What types of reasons contribute to returned applications? Most of the time, applications are returned to MC majors for revision due to insufficient information. Areas that students often need to flush out further include human subject recruitment strategies, elucidation of benefits/risks to participation in the research project, and gaps in the informed consent. Again, make sure the informed consent is understandable to your targeted human subject sample (e.g., avoid jargon and technical terms).
What contact information should be provided on the informed consent form? There are two contacts required on the informed consent form: the MC Departmental Coordinator ( faculty name, email address, phone number, and college address), and the student investigator. MC majors are strongly encouraged to provide your college contact information, not personal email or home addresses.
Who is the faculty sponsor?
The faculty sponsor is always the MC faculty member who you are ‘collaborating with’ on the research project. This can be the director of the honors program, your course instructor who is evaluating your research project, and/or the faculty advisor for your independent study.
What is appropriate compensation for participation in a research project?
It is typical for students to receive some type of compensation for their involvement in a research project, such as extra credit in a course, snacks, or a small monetary gift card. There may be departmental funds available to pay for gift cards; check with your faculty sponsor. Oftentimes, MC faculty are willing to help with student recruitment efforts in addition to offering extra credit for participation in a research project. Be prepared to provide ‘proof of participation’ upon faculty request.
Are there any recommended resources? Students are encouraged to review materials from Media Theory and Methods, such as a book chapter on ethics (IRBarticle). In the future, we will provide examples of informed consents submitted by faculty and students.