The IRB will observe the following regulations in its voting:
(1) A quorum required to transact business
One half of the total number of IRB members plus one must be present to achieve a quorum.
(2) Diversity requirements of quorum
At least one member whose concerns are non-scientific must be present.
(3) 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).
(4) 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.
(5) Proxy votes (written or telephone)
No proxy votes (written or telephone) are allowed.
(6) 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 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)).
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.
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.
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:
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.
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."
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.
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):
(a) any finding of research misconduct;
(b) any serious or continuing noncompliance with 45 CFR Part 46 or the requirements of determinations of the IRB; and
(c) any suspension or termination of IRB approval.
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.
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.
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))."
IRB members must take an online training course regarding ethical research practices in working with human participants. The following 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.
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.