Institutional Review Board (IRB)

1. Provide your Faculty Research Advisor and then your Department Chair with your completed IRB Application Form and all supporting documents to read, review, and sign. If you are a Faculty Member, then please please provide the information (and obtain a signature) from your Department Chair.
2. Submit the IRB Application Form and all supporting documents by email to: scirb@springfieldcollege.edu. You may also submit hard copy applications to the IRB office: c/o Matthew Ferrari, LCOM 204D. Please submit using only 1 method (electronic or hard copy). Electronic submission is preferred.
3. The application will be reviewed within 10 business days (2 working weeks).
4. You may receive an email requesting that you make edits and/or provide more information prior to SCIRB approval. You will have 30 days to respond to the email with the information requested. After that time, you will need to reapply.
5. When your application has been approved, you will receive an email with approval letter and may then start your research study. Approvals are granted for a period of one year. If additional time is needed, a continuation application must be submitted  IRB Continuation Form.
6. If you need make any changes to methodology for an approved research project, you must submit a IRB Change of Procedure Form.

1. SCIRB application form
2. Detailed description of your study (methods section of thesis/dissertation)
3. Informed consent form (See form under "Informed Consent Templates and Information" tab)
4. Data collection instruments
   1. Questionnaires (including any surveys, focus group questions, demographic questionnaires, physical assessment measures, etc.)
   2. For all online data collection instruments (e.g. surveys in Qualtrics, Google Forms, Surveymonkey, etc.): The IRB now requires applicants to include in their application materials a live hyperlink to the online data collection instrument(s) that they will be using, with the Informed Consent Form included as it will be administered to participants.
5. Recruitment materials- Any materials that prospective participants will see or hear as part of the recruitment process. Examples include the following:
   • Flyers Flyer Template
   • In-person/phone recruitment script
   • Emails
   • Posting on social media
6. Letters of Support/Permission- Permission is needed from the appropriate authority in order to recruit participants; and when collecting data from locations other than Springfield College. Letters may be needed from:
   1. Community organizations/partners
   2. Professors
   3. Coaches

What Requires IRB Review: Any activity requires IRB review if it meets the federal definition below for research and human subjects.

Human Subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge intended to be disseminated to a scholarly community.
 

What Are the Levels of IRB Review:

Exempt Review: Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46.  All human subjects research must still be submitted to the IRB to determine if it qualifies as “Exempt.” Exempt reviews are conducted by a member of the IRB board, and do not require a convened IRB committee meeting.

Expedited Review: Research can be approved as “expedited” if it is no more than “minimal risk” and fits one of the federally designated expedited review categories as defined by federal regulation 45 CFR 46.  All human subjects research must still be submitted to the IRB to determine if it qualifies as “Exempt.” Exempt reviews are conducted by a member of the IRB board, and do not require a convened IRB committee meeting.

Full Review: Research that presents more than minimal risk to subjects, involves vulnerable populations, or does not qualify for exempt or expedited review, will receive review at a fully convened IRB committee meeting. 

The Springfield College IRB utilizes the Federal Office for Human Research Protections’ decision charts in making determinations about a research proposal’s level of review. 

Qualtrics Instructions

New IRB Application Form

Change of Procedure Form

IRB Continuation Form

Informed Consent is a process in which researchers provide information to participants about the details of a research study before their enrollment in the study. All information in the consent form should be understandable by the participants, thus, it is best practice to use simple, lay language in your consent form. Typically, it is suggested that all language should be at or below an 8th grade reading level. Any medical terminology or academic jargon should be avoided or explained parenthetically.

The following basic elements are required (per federal regulations) for all informed consent forms:

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation (please include a specific time), a description of the procedures to be followed, and identification of procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject. Even if there are no foreseeable risks or discomforts, this still needs to be stated.
• A description of any benefits to the subject or to others which may reasonably be expected from the research. Even if there are no foreseeable benefits, this still needs to be stated.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• A statement describing the measures taken to safeguard the confidentiality of the subject, and to maintain the security of any records identifying the subject during the course of the study. (e.g. no identifying information will be recorded; data will be stored in a secure password protected computer file, etc.)
• For research involving more than minimal risk, statement as to whether there is any compensation and whether medical treatments are available if injury occurs.  If so, specify the extent and nature of the compensation and treatment.
• An explanation of whom to contact for answers to pertinent questions about the research (Include both PI and Faculty Advisor name and contact info.) and whom to contact in the event of a research-related injury to the subject or questions about rights as a participant (Springfield College IRB 413-748-3818).
• A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

For Online Surveys: Keeping data confidential and secure for online survey data collection is different than with in-person surveys, as the risk of a breach of confidentiality always exists in the online environment. So we ask that you add a brief statement on the inherent risks of collecting online survey data. See sample statement below:

Sample statement for online surveys: There is always the possibility of tampering from an outside source when using the internet for collecting information. While the confidentiality of your responses will be protected once the data are downloaded from the internet, there is always a possibility of hacking or other security breaches that could threaten the confidentiality of your responses.

For all online data collection instruments (e.g. surveys in Qualtrics, Google Forms, Surveymonkey, etc.): The IRB now requires applicants to include in their application materials a live hyperlink to the online data collection instrument(s) that they will be using, with the Informed Consent Form included as it will be administered to participants.

In-Person Consent Form Template: This template should be used by researchers who will be administering informed consent to participants in-person. 
Form as PDF

Online Consent Form Template: This template should be used by researchers who will be administering informed consent in an online environment (e.g. online surveys, google forms, etc.)
Form as PDF 

Parent Consent Form Template: This template should be used by researchers who will be administering informed consent to parents of research participants who are minors.
Form as PDF 

Research studies often involve recruiting potential participants using a variety of methods, such as flyers, posters, brochures, media advertisements, recruitment letters/emails and word-of-mouth recruiting.

Recruitment materials must be reviewed by the IRB prior to their use by an investigator in order to make sure that the information is not misleading or coercive to participants.

Include the following in any recruitment material:

• Clearly state that this is a research study
• Purpose of the study
• Eligibility criteria
• Voluntary nature of participation
• What participation will involve (basic procedure and time commitment)
• Benefits to participation, if any
• Contact information (name, number/email) to get in touch if interested

Overview: The IRB recently approved a broad consent protocol for teaching-related research happening in Springfield College Classrooms. The aim of this protocol is to streamline the IRB application and approval process for pedagogical research.

Criteria for Joining: 

• Your study meets the federal definition of exempt educational research (see application form and Normal Educational Practices Guidelines sheet for more information on this).   
• Your study does NOT involve:
  • Children (participants under the age of 18)
  • Adults (age 18 or older) who may not be legally/mentally/cognitively competent to consent
  • Prisoners
  • American Indian/Alaska Native tribes
  • Non-Springfield College personnel engaged in research: a) intervening or interacting with the participants and/or b) having access to participant identifiable private information for research purposes.
  • International Research
  • A study team member with a Disclosable Financial Interest.

Application Process: 

Submit the following materials to: scirb@springfieldcollege.edu

• Completed Application Form with signatures
• Completed Syllabus Information Sheet
• A brief description or overview of the proposed research study (1-2 paragraphs)
• A brief description of methods and procedures (1-2 paragraphs)
• Any relevant data collection instruments

If you have any questions, please contact Matt Ferrari.

CITI Training for Human Subjects Research: The Institutional Review Board does not require Springfield College researchers to complete CITI training, but offers it as an option for anyone intending to conduct human subjects research. See guidelines below for taking CITI’s Social-Behavioral-Educational Researchers course.

Presentations on the IRB Application Process: The Coordinator of Student Research is available to give presentations and workshops for students and faculty on the IRB application process. If you are interested in scheduling something, please contact Matthew Ferrari at mferrari@springfield.edu.

Taking a CITI Training Course: Anyone at Springfield College can take CITI’s “Social-Behavioral-Educational Researchers” course at no cost. The steps for taking the course are:

1. Go to CITI Program website (https://about.citiprogram.org/en/homepage/).
2. Click on the “Register” tab.
3. Under “Select Your Organization Affiliation,” enter “Springfield College.” Click “I Agree” to the terms of service.
4. Continue to “Create Your CITI Username/Password.”
5. Complete registration using your Springfield College email address.
6. Once registered, click on “Institutional Courses” to access the “Social-Behavioral-Educational Researchers” course. It contains seven individual modules.

Additional Course Modules: In addition to the main “Social-Behavioral-Educational Researchers” course, there are several supplemental modules which are also available at no cost to Springfield College researchers. These modules include: “Research with Prisoners,” “Research with Children,” “Research in Public Elementary and Secondary Schools,” “International Research,” and “Internet-Based Research.”

If you have any issues accessing CITI training modules, please contact Matthew Ferrari at mferrari@springfield.edu.

The Code of Federal Regulations (CFR) 45 CFR 46 requires Institutional Review Boards for the Protection of Human Subjects (IRBs) to have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the federal department or agency head of any unanticipated problems involving risks to subjects or others.

Investigator Responsibilities

Investigators must report the following:

• Any adverse event that is unexpected and is related to, or possibly related to, the participation in the research.
• Any unanticipated problem.
• Any breach of confidentiality (which includes lost or stolen confidential information).
• Any significant complaint from the participants that impacts their safety, rights, or welfare, or a complaint that requires a modification to the application.
• Any other event that is unanticipated and indicates that the research study places subjects or others (e.g., other investigators, research assistants, students, the public, family members, or partners of subjects) at an increased risk of harm or otherwise adversely affects the rights, welfare, or safety of subjects or others.
• Protocol deviations.
• Any event that requires prompt reporting to the sponsor.

How to Report

Once the principal investigator (PI) determines that an adverse event meets the IRB's reporting requirements, they must report the adverse events, and related safety information, to the IRB:

• Supporting documents, including a copy of the Informed Consent, should also be attached.
• For serious adverse events, the researcher should provide information on how the serious adverse event relates to the drug, device, intervention of study protocol, and whether a change in the application is needed to minimize risk.
• For reasons of confidentiality, subjects’ names must not be included in the report.
• If the adverse event results in the need to revise the informed consent or other study documents, the PI must submit a study amendment to the IRB.

Reports should be submitted via email to scirb@springfield.edu.

Reporting Schedule

• Reportable events that are life-threatening or that have resulted in death must be reported within 24 hours.
• Reportable events that are not life-threatening or do not result in death should be reported within 10 business days.
• Protocol deviations should be reported within 10 business days.

Review Process Overview

1. The IRB Office will review the report and ask for clarification as needed.
2. The IRB Office will forward the report to the IRB chair. The chair will determine what action, if any, is required. The chair may also ask a subcommittee to review the report, submit it to the next IRB meeting, or schedule an emergency IRB meeting.
3. The IRB Office will assist in communicating with the researcher the results of the review and any necessary next steps. The IRB may suspend or terminate a protocol that has been associated with unexpected serious harm to subjects or others.
4. The IRB Office is responsible for reporting the event to the institutional official (if necessary) and assisting the researcher in reporting to the outside agency according to reporting requirements.

Research Participant Complaint

As a study researcher, you should promptly respond to any study-related concern or complaint you receive or of which you are aware. It is also the responsibility of the researcher to try to resolve the issue in a timely manner. Only significant complaints that impact the participant’s safety, rights, or welfare need to be reported to the IRB. Any complaints that require the researcher to modify the application must also be reported to the IRB. Minor complaints, such as late payment or payment not received, do not need to be reported to the IRB. If you are unsure whether a complaint must be reported to the IRB, please reach out to the IRB Office at scirb@springfield.edu.

Definitions

Unanticipated Problem

An unanticipated problem is any incident, experience, or outcome that meets all of the following criteria:

• Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
• Related or possibly related to a subject’s participation in the research;
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

Adverse Event

An adverse event is any unintended negative experience associated with the study materials or research procedures. Adverse events include both physical and psychological harms; although they most commonly occur in the context of biomedical research, they also can occur in the context of social and behavioral research.

Serious adverse events are adverse events that result in any of the following outcomes:

• Death
• A life-threatening experience
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant disability/incapacity
• A congenital anomaly/birth defect

Protocol Deviation

Protocol deviation is any alteration/modification to the IRB-approved protocol, whether intentional or inadvertent, that is not approved by the IRB prior to its initiation or implementation. Protocol deviations that are substantive and generally affect the subject’s rights, safety, or welfare, or the integrity of the study data, must be reported to the IRB.

Minor protocol deviations, such as over-enrollment of participants and not collecting samples at the exact timeframes indicated in the application, do not need to be reported to the IRB.

References

• The University of Maine: Event Reporting: Unanticipated Problems, Adverse Events and Other Problems
• University of Massachusetts Amherst: Adverse Events Reporting
• Department of Health and Human Services Office for Human Research Protections: Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007)

The following websites may provide additional support, information, and understanding to the process of conducting research:

OHRP Homepage Office for Human Research Protections (OHRP)

This page offers information regarding research with Human Subjects and the protection of Human Research Subjects. Use this page as a starting point in understanding protocol while using Human Research Subjects. 

OHRP Informed Consent Checklist

This page may help guide the design in your Informed Consent and the importance of each piece.

FAQs about Investigator Responsibilities

This page provides answers for questions that often come up when performing research and is a great place to start when defining responsibilities for investigators, advisors, and research assistants. 

Springfield College Graduate Student Research Fund

This is a link to the Graduate Student Research Fund page for Springfield College students. You can find the Application for Student Research funding as well as other pertinent  information regarding the application for research funding.