Types of Review

IBR Flow Chart

All human subject research projects that do not qualify for exemption is considered non-exempt research. Non-exempt research protocols are reviewed by the full membership of the board. 

Your complete application must include the following components:

1. CITI training (Social and Behavioral Research Module, Basic Course/Refresher) completion certificate for all researchers listed in the application, including the faculty supervising the student research.
2. Application Form (Save the file as “Your Name_Application” in one file.)
3. Appendices (Appendices should be saved as “Your Name_Appendices” in one file. We do not accept a zip file).

If your study meets one of the following criteria, it can be reviewed as an exempt study. This means that your application will only be reviewed by the IRB chair and not the full committee. Be sure to mark which exemption category your study falls under on the application form.

Based on 45 CFR 46.401(b), the below exemption category applies to research with children as follows:
● The use of educational tests is exempt, but survey or interview procedures are not exempt
● Observations of public behavior is exempt only when the investigator does not participate in the observed activities

Category 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(i) research on regular and special education instructional strategies; OR
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, observation of public behavior, IF:

(i) the information obtained is recorded in such a manner that subjects CANNOT be identified, directly or through identifiers linked to the subjects; OR

(ii) any disclosure of the subject's responses outside of the research could NOT reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.

*This exemption does not apply to children except for research involving observation of public behavior when the investigator does not interact with the children. Workplace meetings and activities, as well as classroom activities, are not considered "public behavior".

Category 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under Category 2, IF:

(i) the subjects are elected or appointed public officials or candidates for public office; OR

(ii) federal statute requires confidentiality of identifiable information to be maintained permanently. *In most cases, managers and staff in public agencies are not "public officials".

Category 4 (Fill out a Secondary Data Analysis Form instead of this Non-Exempt/Exempt Form)

Research involving collection or study of existing data, documents, records, or specimens, IF:

(i) these sources are publicly available; OR

(ii) the information is recorded by the researcher in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Category 5

Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

(i) public benefit or service programs;

(ii) procedures for obtaining benefits or services under those programs; OR

(iii) possible changes in or alternatives to those programs; OR

(iv) changes in methods of payment for benefits under those programs.

Category 6

Taste and food quality evaluation and consumer acceptance studies, IF: (i) wholesome foods without additives are consumed, OR (ii) a food is consumed that contains a food ingredient at or below the level and for a use found to be safe by the Food and Drug Administration (FDA) or approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service (FSIS) of the US Department of Agriculture (USDA); OR (iii) a food is consumed that contains an agricultural chemical or environmental contaminant at or below the level found to be safe by the FDA or approved by the EPA or the FSIS of the USDA.

Policy

Research activities within a course may be shared with the campus community without the IRB review if ALL of the following Course Exemption Criteria are met.

• The data or the results of analysis are NOT disseminated outside of the campus. For example, publishing in ProQuest is considered outside of campus.
• The study is conducted anonymously, and the reporting of the data maintains the confidentiality of direct and indirect personal identifiers (i.e., anonymity in reporting the data).
• The study does not involve children, prisoners, or institutionalized persons.
• The study does not purposively collect data from the following vulnerable populations:
• Pregnant women
• Individuals with terminal illness, cognitive impairments, or mental or physical disabilities  
• The data collection site does not require IRB approval.
• The study does not trigger emotional or physical distress (see IRB application form for the complete list of examples), such as
  • Any probing for personal or sensitive information in surveys or interviews that might be experienced as an invasion of privacy (such as self-disclosure of personal information)
  • Presenting materials to participants that they might consider sensitive, offensive, threatening, or degrading
  • Distress resulting from the topic of the study (such as surviving political violence or natural disaster)
  • Deception (lying to the participants—includes both withholding and misinforming)

Faculty Responsibility

Instructors who wish to provide students with the opportunity to share the results of the data gathering activities within courses with the campus community are required to meet the following requirements:

• Complete the CITI training (Social and Behavioral Research Module, Basic Refresher or other module appropriate for the type of study in the field).
• Attend a workshop sponsored by the IRB and be listed as an IRB Fastrack certified research personnel. It is one-time attendance, and the workshop serves the following purposes:
  • Make an appropriate decision for each student project, whether it needs IRB review or not. Consult IRB if there are any questions about whether course exemption criteria are met.
  • Acknowledge and accept the responsibility for protecting the rights and welfare of human participants by signing the agreement to be a research personnel on the IRB protocol.
  • When there are substantive changes in the regulatory requirements governing research activities with human participants, the IRB may require the Fastrack certified research personnel to retake the training refresher.
• Stay informed about the ethical standards and regulatory requirements governing research activities with human participants.
• Make adequate time to consult with the students on their research activities to ensure compliance with the internal IRB policies, regulations and state law.
• Notify the IRB of unanticipated inadvertent or adverse effects within 10 days of learning them.

SMC IRB’s policy on research that examines teacher practice and pedagogy models and adopts the guidelines at Columbia University Teachers College.     

It is important to remember that asking your own students to participate in your research is inherently coercive because they likely feel compelled to participate or perceive some intangible benefit to participation. Therefore, the IRB generally advises against approaching your own students to ask for their participation in your research unless the research is about your own teaching practice or pedagogy informed by the student learning of the course material.

There are some commonly experienced difficulties in preparing an IRB protocol for this type of research. Your rights and responsibilities as a classroom teacher are much broader than those of a researcher. As a teacher, you may be free to assign homework and activities, try a pedagogical intervention, observe and record classroom dynamic and discussion, etc. As a researcher, collection and recording of student activities for your research need to follow the design and procedures approved by the IRB. While research on teaching practice and pedagogy may appear to be self-study and in some ways auto-ethnographic, this type of research typically draws a conclusion about pedagogical efficacy and curriculum effectiveness upon student work as evidence of learning. When evidence and data are taken from human participants to make a claim about teaching practice patterns or curriculum structures that demonstrate effectiveness, your research becomes the IRB’s concern.  

If you are conducting research that involves your own student’s coursework, your research project may be approved under exemption category #4 (Secondary Analysis of Data). Category 4 exemption may apply to studies that meet the following conditions:

1. The course work (e.g., assignments, exams, quizzes) or activity observation (e.g., class discussion) is one that I am free to assign in my role as the instructor of record;
2. The entire class can engage in the course work and activity, even if I only want to analyze data from a smaller subset of my students;
3. The course work or activity does not require participation outside the classroom or outside normal class hours (except for homework assignments);
4. The research does not involve a survey, interview, or focus group to obtain student personal account on teaching practice or pedagogy and/or topics outside of the teaching practice;
5. Data can be de‐identified in any report or publication.

For the research that meets the above criteria for Category 4 exemption, you do not need to obtain child assent/consent or parent/guardian permission forms, but you must send an information letter to parents of minors and include the letter in the appendix to the IRB application material.

You may be required to complete an IRB review process for the school district or educational organization where your research will be conducted. If this is the case, you will need to obtain the approval from that process before you begin your research.

If your research involves interviewing or surveying your own students who are minors (e.g., K-12 in-service teachers), it needs to be reviewed as a non-exempt study.

If your research involves interviewing or surveying your own adult students (e.g., faculty in college classrooms), it needs to be reviewed as Category 1 exemption.

The Code of Federal Regulations (CFR) defines scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) as the collection and use of information that focus directly on the specific individuals about whom the information is collected. However, IRB at different institutions apply their own protocols to research activities in these fields in order to protect participants/interviewees.

1. If you are interviewing people with cognitive disabilities or mental illness that make their decision to participate in the interview or to understand their rights as participants difficult, your study must be reviewed by the IRB.
2. If you are interviewing children, it is very unlikely your study is oral history.
3. If you are putting participants in potential psychological, physical, or legal risks, you should consult the IRB member.

The Oral History Association provides the principles and best practices for oral history. A few things to consider include:

• Interviewees' rights if and when they feel uncomfortable answering your questions or feel unsafe by disclosing some information during the interviews
• Agreement for any type of recording and treatment of the recorded material
• Clarity regarding how much of the personal identification the interviewees are willing to share
• Researchers' safety, liability, and responsibility

The most distinctive difference is whether the researcher is trying to illuminate a particular past through narratives (oral history) or to generalize the findings to the population (social science). The table below provides some examples for this distinction.

If you are unsure whether your project is oral history or social science, please ask our oral history expert consultant, Dr. Gretchen Lamke-Santangelo (History, SOLA).