Institutional Review Board

Certain research activities may be exempt from review by the IRB, if approved by the IRB chairperson and confirmed in writing to the principal investigator(s). The determination as to whether a project is exempt from IRB review cannot be made by the principal investigators themselves. Research may be exempt from review when the only involvement of human subjects falls into one or more of the following categories.

Research that Qualifies for Exemption from Federal Regulations for the Protection of Human Subjects - Code of Federal Regulations, Title 45 CFR 46.101.

45 CFR 46.101 (b)(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.

45 CFR 46.101 (b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

45 CFR 46.101 (b)(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

45 CFR 46.101 (b)(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

45 CFR 46.101 (b)(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; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

45 CFR 46.101 (b)(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Exemptions at 46.101(b)(1) and (b)(3) through (b)(6) are applicable to research studies that use children as subjects. The exemption at 46.101(b)(2) regarding educational tests is also applicable to research involving children as subjects. However, the exemption at 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research involving children as subjects, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed (45 CFR 46.401 (b)).

Exempt studies do not require continued IRB monitoring. However, any revisions made to exempt research must be approved by the IRB before their implementation. The principal investigator may not begin the research study until he/she receives written confirmation that the research meets exemption criteria.

The following research activities do not qualify for exemption:

• Surveys or interviews of children or minors (subjects under the age of 18).
• Research studies that use prisoners, pregnant women, the cognitively or mentally impaired, or other "vulnerable" subjects.
• Recorded audio or taped data that presents potential harm to subjects if revealed.
• Studies in which data, documents, or records are labeled in such a manner that subjects can be identified, directly or indirectly, through identifying links (e.g., codes).
• Research studies that involve more than minimal risk to subjects.
• Surveys or interviews collecting sensitive data such as illegal activities, sexual orientation or behavior, memories of physical abuse, etc., that may be painful or embarrassing to reveal.
• Studies involving deception where an investigator does not disclose the true purpose of the research.
• Observational studies involving sensitive aspects of subjects' behavior or in settings where subjects have a reasonable expectation of privacy.

Some research projects may be eligible for review through an expedited procedure. The IRB may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized (see the policy for Continuing Review). Studies which involve no more than minimal risk to the participants may also be eligible for an expedited review process. Minimal risk means "that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests" (45 CFR 46.102 (i)). Expedited review will be conducted by the IRB chairperson or by one or more IRB members designated by the chairperson to conduct the review. The IRB member(s) conducting the expedited review may approve a research project; however, the reviewer(s) may not disapprove the research. Instead, the reviewer(s) will refer any research protocol which the reviewer(s) would have disapproved to the full committee for review.

IRB Quorum & Voting Procedures

The IRB will observe the following regulations in its voting:

A quorum required to transact business

One half of the total number of IRB members plus one must be present to achieve a quorum.

Diversity requirements of quorum

At least one member whose concerns are non-scientific must be present.

Percent needed to approve, disapprove, or require modification of a study

A motion is made to approve, disapprove, or require modification of a study. In order for the motion to pass it must be agreed upon by a majority of the voting members present (including those who have abstained).

Full voting rights of all members

Each member has one vote. If the member is unable to vote (absent or recused), then one designated alternate member may vote in place of the member.

Proxy votes (written or telephone)

No proxy votes (written or telephone) are allowed.

Prohibition against conflict-of-interest voting

Members who have a conflict of interest may be present to answer questions about the research study but must leave the room before deliberations and voting.

IRB Approval of Research

IRB approval of research will be based on a determination that the potential risks to human subjects are minimal and "reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result" (45 CFR 46.111 (a)(2)). Selection of subjects must be equitable, and oral or written informed consent must be obtained from each subject or the subject's legally authorized representative. In addition, there must be "adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data" (45 CFR 46.111 (a)(7)).

IRB Requirement for Modification of Research

The IRB may require modifications, major or minor, to some part of the proposed study. Major modifications may be required when the IRB believes that it has insufficient information to take action, or when it believes that the research design contains significant risks to human subjects and should be revised to minimize the risks. Examples of minor modifications that might be required include revising the consent form to explain the procedures more clearly or adding a version of a consent form in a language other than English.

Appeals

If an application is denied, the researcher has a right to appeal to the IRB. The researcher should submit a letter to the IRB chairperson requesting another review, and a rationale should be provided. An attempt will be made to resolve the problem(s) identified with the proposal. The IRB is the final authority over whether the proposal is approved.

Continuing Review

The IRB will review ongoing research projects at least once per year. Requirements for continuing review will be provided to the principal investigator in the IRB approval letter. The principal investigator is responsible for submitting a progress report (Application for Continuing Review) and updated informed consent form(s) (when applicable) to the IRB for review and approval. Most research studies require only annual review, but some studies (e.g. those with higher risks) may require more frequent review. The required frequency of review will be determined by the IRB and will be stated in the IRB approval letter.

The IRB will apply the same criteria for approval of continuing review applications (progress reports) as it does for initial applications. The progress report should include the following information: adverse event information, subject complaints, any changes in the protocol, a description of findings of the study, and any presentations or publications of study findings. Any additional information concerning the state of knowledge about the study question (particularly other information that might change the assessment of risks versus benefits) should be presented as part of the progress report.

Based on the information provided in the progress report, the IRB chairperson will determine whether it is eligible for expedited review or whether it must be reviewed by the full committee. Continuing reviews may be expedited if the research initially was:

• Approved by expedited review and no changes in risks have occurred.
• Approved by the full IRB committee but the research is now closed to enrollment of new subjects, all subjects have completed all research-related interventions, the research remains active only for long-term follow-up of subjects, and no changes in risks have occurred.
• Approved by the full IRB committee but now the remaining research activities are limited to data analysis.

The IRB will notify the principal investigator that the research protocol is due to expire at least 30 days prior to the expiration date. It is the responsibility of the principal investigator to ensure that the research protocol does not expire.

The continuation of research after expiration of IRB approval is a violation of the federal regulations. If the IRB has not received and approved continuation of a research study by the study's current expiration date, all study related activities must cease (including enrollment, study interventions, long-term follow-up and data analysis). An email notification of the study expiration will be sent to the principal investigator by the IRB.

Reporting Changes in Research Protocol

Any change in a protocol that affects the subjects must be approved by the IRB prior to implementation. Researchers should submit an "Application for Protocol Modification" to the IRB. If the change in the protocol requires a change in the consent form, the principal investigator must submit a new consent form to the IRB in addition to the "Application for Protocol Modification."

Reporting of Adverse Events

The principal investigator must report any adverse events (unanticipated problems involving risks to subjects or others) to the IRB in a timely manner. Examples of adverse events include the following: problems with study procedures; subject or family complaints regarding recruitment; confidentiality concerns; expressions of fear or emotional upset; and theft or loss of study data. Adverse events should also be reported to the IRB in the progress report at the time of the Continuing Review. The IRB will report adverse events to the following individuals, if applicable: Office for Human Research Protections (OHRP), the Human Subjects Protection Administrator at Holyoke Community College, the Vice President for Administration and Finance (the signatory official for Holyoke Community College's Federalwide Assurance), and the head of any agency supporting the research.

Reporting Research Misconduct or Investigator Noncompliance

Any incident of noncompliance with IRB guidelines or with state or federal laws and regulations should be immediately reported to the Human Subjects Protection Administrator at Holyoke Community College. Any allegation of research misconduct must be reported to the Holyoke Community College Research Integrity Officer. The Holyoke Community College Institutional Review Board Investigator Noncompliance Policy describes procedures to be followed by the College in response to any allegation of investigator noncompliance with federal and state laws or regulations or with IRB policies, procedures, or decisions. The Holyoke Community College Research Misconduct Policy describes the procedures to be followed by the College in connection with any allegation that faculty, staff members, or students may have engaged in research misconduct. The IRB will report the following incidents to OHRP and to any supporting agency as well as to the Human Subjects Protection Administrator at Holyoke Community College and the Vice President for Administration and Finance (the signatory official for Holyoke Community College's Federalwide Assurance):

• Any finding of research misconduct;
• any serious or continuing noncompliance with 45 CFR Part 46 or the requirements of determinations of the IRB; and
• any suspension or termination of IRB approval.

Submitting a Final Report

The principal investigator is required to notify the IRB when his/her study is complete by submitting an "Application for Study Closure." The IRB considers the study to be complete when the primary data analysis is complete and the study question is answered. Any presentations or publications of study findings should be included with the final report.

Research Records

It is the responsibility of the principal investigator to maintain all study-related records. All records relating to research (e.g., signed informed consent forms) must be retained by the principal investigator for three years after completion of the research.

For multi-year projects supported with federal funds, records for the entire project must be kept for three years after the completion of the project. For example, in a four-year project, the first year's records must be kept for seven years. Researchers sponsored by federal agencies should review the specifics of the terms, agreements, and assurances made when the project was funded to determine the record retention requirements for the project.

IRB Records

The IRB will maintain the following records: minutes of meetings, copies of research proposals reviewed and relevant documents (e.g., application forms, informed consent forms, questionnaires), and correspondence with principal investigators. Records will be retained for a minimum of three years. Minutes of IRB meetings will "show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution (45 CFR 46.115 (a)(2))."

Education & Training Requirements for IRB Members & Researchers

IRB members must take an online training course regarding ethical research practices in working with human participants. This website is recommended for the online training.

All investigators and research personnel must complete the online training course in human subjects protection prior to initiating a project. Final IRB approval will be contingent on completion of the human subjects protection course.

Informed Consent

Oral or written consent is required for all research involving direct interaction with subjects. All research conducted in area schools (K - 12) requires written permission of the school district. The Institutional Review Board may require written documentation of informed consent for some research studies. Examples of the types of projects that may require a written informed consent form are:

1. Research which may involve psychological or physical risks to subjects
2. Research involving psychological or physiological intervention
3. Research conducted at schools which involves interaction with students
4. Research involving deception
5. Interviews or surveys on sensitive topics
6. Research on special populations (e.g., minors)

Examples of the types of projects that probably do not require written documentation of informed consent are:

1. Interviews or surveys on non-sensitive topics
2. Anonymous, non-interactive, non-participating observation of public behavior
3. Secondary analysis of existing data
4. Research conducted at schools which involves no interaction with students (e.g., observation of regular classroom activity)
5. Research involving the use of psychological or educational tests such as cognitive, personality, aptitude, and achievement tests
6. Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that subjects cannot be identified
7. Research which does not involve psychological or physiological intervention or deception

When a waiver for a signed consent form is granted by the IRB, potential research subjects should be informed about the research procedures and given an opportunity to decline participation. In addition, the IRB may require the investigator(s) to provide subjects with a written statement (information sheet) regarding the research.

The informed consent form must be explained and signed prior to any procedures being performed on a test subject. The consent form must be written in language understandable to the subject or to the subject's legally authorized representative. A copy of the consent document must be given to the person signing the form. It is the responsibility of the principal investigator to maintain the original signed consent forms on file for three years after the study is completed.

During the course of the study, the consent document should be revised when deficiencies are noted or when additional information will improve the consent process. All revisions must be reviewed and approved by the IRB before a revised consent form may be used to enroll subjects.

Purpose

The purpose of the Holyoke Community College Institutional Review Board (IRB) is to safeguard the rights and welfare of humans who participate in research studies conducted by or with students, faculty, or staff members. The United States Department of Health and Human Services defines a human subject as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information [45 CFR 46.102 (f)]." Research, also defined in 45 CFR 46.102 (d), "means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Holyoke Community College has adopted the policies and procedures as outlined here in compliance with federal regulations and for the purpose of protecting members of its community and the integrity of human subject research.

IRB Composition

The Holyoke Community College IRB will consist of at least five and no more than nine persons "with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution" (45 CFR 46.107). Collectively, the Board will include:

• An individual not affiliated with the college
• The Chief Research Officer or appropriate substitute
• Three faculty members
• A non-scientist
• A scientist
• An individual who is an expert in working with vulnerable subjects (e.g., children, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.

The IRB may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that of the IRB members.

Application Procedure & Forms

The "IRB Application for Research Involving Human Subjects," the "Application for Continuing Review or Study Closure," the "Application for Protocol Modification," and the "Registration of Classroom Research Activities" forms may be found in the IRB Forms section, where you can also find two sample informed consent forms, along with guidelines which specify the type of information that should be included in a consent form or in an information sheet. A sample research project information sheet (to be submitted when a waiver for a signed consent form is granted) is also available. If you have questions or need guidance in the preparation of these materials, please contact a member of the IRB committee.

Application Procedure & Forms

The "IRB Application for Research Involving Human Subjects," the "Application for Continuing Review or Study Closure," the "Application for Protocol Modification," and the "Registration of Classroom Research Activities" forms are available below. This section also provides two sample informed consent forms along with guidelines which specify the type of information that should be included in a consent form or in an information sheet. A sample research project information sheet (to be submitted when a waiver for a signed consent form is granted) is also available. If you have questions or need guidance in the preparation of these materials, please contact one of the committee members.

IRB Application for Research Involving Human Subjects
Application for Continuing Review or Study Closure
Application for Protocol Modification
Registration of Classroom Research Activities

Sample Consent Forms

Sample One
Sample Two

Perpetual Agyemang
B.E.D. Mathematics

Joseph Bruseo
Ph.D., Biology
IRB Chair

Nicole Hendricks
M.P.A. Criminal Justice

Walter Jaworksi
D.V.M., Veterinary & Animal Science/Biology

Patricia Mantia
Ed.D. Health, Fitness & Nutrition

Mary Orisich
M.A., Economics

Michelle Riberdy
B.A. Research Associate

Tracey Trottier
Ph.D., Director of Assessment

Judith Turcotte
M.S. Director of Planning & Assessment