Important COVID-19 Related Changes to Human Subject Research

All Springfield College researchers conducting in-person research studies with human subjects must administer to participants both the "Covid-19 Risk Information Sheet" and the "Covid-19 Risks Acknowledgement" form before commencing any data collection. If there are any questions about this, please reach out to Matt Ferrari, Coordinator of Student Research, at mferrari@springfield.edu.

The Springfield College Institutional Review Board

Supported by the Office of Graduate Education, Grants, and Sponsored Research

Purpose

The purpose of the Springfield College Institutional Review Board (SCIRB) is to ensure the protection of human subjects in research studies. 

Who must apply 

All Springfield College personnel (faculty, students under faculty supervision, and administrators) who conduct research studies under Springfield College auspices, utilizing human subjects must apply to the SCIRB.

Chair

James Harnsberger, Ph.D., Associate Vice President for Graduate Education, Grants, and Sponsored Research

Policy statements and applications are available on this site and through the Office of Academic Affairs.

    Contact Information
  • Matthew P. Ferrari, Ph.D.
    Coordinator of Student Research
    Hickory Hall, Room 105

    Email: mferrari@springfield.edu
    Phone: (413) 748-3818

The Purpose of Institutional Review Boards (IRB)

All persons conducting research must maintain the highest ethical standards for human research protections in all human subjects research.

All research adheres to the ethical principles outlined in the Belmont Report (1979):

  • Respect for persons
    • Individuals should be treated as autonomous agents
    • Persons with diminished autonomy are entitled to protection  
  • Beneficence
    • Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being
    • (1) Do no harm (2) maximize possible benefits and minimize possible harms
  • Justice
    • Fairness in distribution (select participants equitably)
    • Who ought to receive the benefits of research and bear its burdens

References:

National Institute of Health

Office for Human Research Protections

Application Process

  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 to the IRB by campus mail (IRB, Academic Affairs, Hickory 105) or electronic submission (scirb@springfieldcollege.edu). Please submit using only 1 method (either hard copy or electronic copy, electronic 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.

Application Components

  1. SCIRB application form
  2. Detailed description of your study (methods section of thesis/dissertation)
  3. Informed consent form (See Requirements) (Consent Form Template)
  4. Data collection instruments
    1. Questionnaires (including any surveys, focus group questions, demographic questionnaires, physical assessment measures, etc.)
  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

Levels of IRB Review

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. 

Informed Consent

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.

Recruitment Materials Overview

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

Additional Resources

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. 

Human Subjects Research Training

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.