Procedures & Responsibilities

The IRB is guided by the ethical principles regarding all research involving human participants as subjects, as set forth in the Belmont Report, regardless of whether or not the research is subject to federal regulation involving human subjects. The IRB is responsible for determining whether research complies with the letter and spirit of these human research participant protections as well as the three principles defined in the Belmont Report: respect for persons, beneficence, and justice.

The IRB is charged with the responsibility to review all research, whether externally sponsored or not, conducted at the University and/or by University faculty, staff, or students, for conformity to Federal Regulations and all other applicable laws and regulations. To that end, CCSU’s IRB is dedicated to ensuring that the University’s use of human participants in research conforms to federal and state laws and regulations designed to ensure that the rights of participants are fully protected.

The IRB consists of members of the campus and non-campus community. The IRB Administrative Team consists of the IRB Administrator and the IRB Chair(s) and is responsible for the oversight of all IRB activities. The IRB and its Administrative Team serve the campus research community under the direction of the Vice President of Academic Affairs and Associate Vice President of Academic Affairs. The IRB is charged with reviewing and approving submissions, requiring modifications, or disapproving protocols for all research activities conducted at CCSU. The IRB must notify investigators in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity.

The IRB is required to review all human subjects research activities for which: the research is conducted by or under the direction of any employee, student, or agent of CCSU; the conduct of the research involves CCSU resources (property, facility, or funding, including extramural funds administered by CCSU); the research is conducted by an agent of CCSU using any CCSU property or facility; the research involves the use of CCSU's non-public information or records; or the research involves the recruitment of, identification of, or contact with prospective human research participants on the CCSU campus.

Both Principal Investigators (PIs) and Lead Investigators (LI) are responsible for ensuring their submissions are complete and accurate and for allowing sufficient time in their overall research design of their protocol to be reviewed and approved before beginning data collection (as according to the procedures outlined in the Review Process section of this document).

PIs must promptly report any incidences of unanticipated problems or adverse events to the IRB. The IRB Administrative Team must forward to the Associate Vice President of Academic Affairs any report (from either the investigator or an informed source associated with the research) of unanticipated problems involving risk to participants or others or serious or continuing noncompliance with IRB requirements.

In consultation with the Vice President of Academic Affairs and Associate Vice President of Academic Affairs, if appropriate, a designated University official will also forward the information to the relevant agencies, regulatory bodies, and/or the Office for Human Research Protections and, as necessary, include the information in the annual report of research activities submitted by CCSU to the Department of Health and Human Services Office of Research Integrity.

To maintain a review process that is responsive to the concerns of all involved, the IRB committee members reflect diverse experience and expertise as well as diversity in academic research interests, professional backgrounds, demographics, and awareness of and sensitivity to community attitudes.

IRB members are appointed by the Associate Vice President of Academic Affairs, who also provides administrative oversight. The IRB committee is comprised of faculty members and staff representing a variety of academic and professional fields, includes at least one non-scientist, and includes at least one non-University affiliated member. The IRB may, at its discretion, invite individuals with competence in special areas or advocates of vulnerable populations to assist in the review of projects which require expertise beyond or in addition to that of the committee.

Members of the IRB Administrative Team are authorized by the Vice President of Academic Affairs to act on behalf of CCSU for exempted projects and expedited review. These members may enlist the assistance of an experienced IRB member to review research that meets the criteria for expedited review.

No member of the IRB may participate in the initial or continuing review of any research protocol for which that member has a conflict of interest, except to provide information requested by the IRB.

To help determine if a project meets the federal definition of human subjects' research, please refer to "Does my research require IRB review?" as found on the IRB website.

For review purposes, research activities involving human subjects are divided into three categories:

1. Exempt – This classification applies to research as described in the IRB document, "IRB Exemption Categories." Upon receipt of the Initial Protocol Submission Form, the IRB Administrative Team will review the submission to determine if the research is exempt or will proceed to expedited review or review by the convened IRB. The federal guidelines recommend that most research involving protected populations (such as prisoners, individuals with impaired decision-making capacity, or economically or disadvantaged persons, and some research involving children) be reviewed by a convened IRB.
2. Expedited Review – This type of review is used for research protocols which involve no more than minimal risk to human subjects. Minimal risk means that the probability of harm or discomfort resulting from participating in the research would be no greater than that routinely encountered in daily life. The IRB Administrative Team determines whether a submission can be reviewed through expedited status. Expedited review is conducted by an IRB Chair and may include a member of the IRB designated by the reviewing Chairperson. Occasionally, more complex protocols involving no greater than minimal risk may be sent to the convened IRB for input
3. Full Review – This type of review is used for research protocols that may involve more than minimal risk to human subjects. These research protocols will be reviewed at a convened IRB meeting. Submissions must be received at least two weeks prior to a scheduled meeting to be put on the IRB agenda for review. PIs are encouraged to attend when they have a protocol that is to be discussed during a convened meeting.

In accordance with the Office for Human Research Protections guidelines, researchers do not have the authority to make their own exemption determinations at CCSU. The IRB has the sole authority to determine whether proposed research involving human participants meets one of the federal research exemption categories and whether non-exempt research should be processed through expedited or full review.

No research may begin until the IRB has reviewed the submitted protocol and notified the investigator(s) that the research qualifies for an exemption or is approved under expedited or full review. Research deemed exempt or approved by expedited review is not subject to continuing IRB oversight unless modifications are made to the protocol. If a PI requires any changes to the research protocol for a study previously deemed exempt or approved by expedited review, he or she must submit a Protocol Modification Submission Form to describe all proposed changes to the research protocol. As stated under the IRB guiding principles, all researchers at CCSU are required to meet all ethical obligations to participants as articulated in the Belmont Report. These principles of ethical research include obtaining informed consent, protecting confidentiality, minimizing risks, and addressing problems or complaints.

To help determine if a project meets the federal definition of human subjects' research, please refer to "Does my research require IRB review?"

For review purposes, research activities involving human subjects are divided into three categories:

1. Exempt – Upon receipt of the Initial Protocol Submission, the IRB Administrative Team will review the submission to determine if the research is exempt from IRB oversight or if it will proceed to expedited review or review by the convened IRB. The federal guidelines recommend that most research involving protected populations (such as prisoners, individuals with impaired decision-making capacity, or economically or disadvantaged persons, and some research involving children) be reviewed by a convened IRB.
2. Expedited Review – This type of review is used for research protocols which involve no more than minimal risk to human subjects. Minimal risk means that the probability of harm or discomfort resulting from participating in the research would be no greater than that routinely encountered in daily life. The IRB Administrative Team determines whether a submission can be reviewed through expedited status. Expedited review is conducted by a member of the IRB Administrative Team and may include a member of the IRB committee. Occasionally, more complex protocols involving no greater than minimal risk may be sent to the convened IRB for input
3. Full Review – This type of review is used for research protocols that may involve more than minimal risk to human subjects. These research protocols will be reviewed at a convened IRB meeting. Submissions must be received at least two weeks prior to a scheduled meeting to be put on the IRB agenda for review. PIs are encouraged to attend when they have a protocol that is to be discussed during a convened meeting.

In accordance with the Office for Human Research Protections guidelines, researchers do not have the authority to make their own exemption determinations at CCSU. The IRB has the sole authority to determine whether proposed research involving human participants meets one of the federal research exemption categories and whether non-exempt research should be processed through expedited or full review.

No research may begin until the IRB has reviewed the submitted protocol and notified the investigator(s) that the research qualifies for an exemption or is approved under expedited or full review. Research deemed exempt or approved by expedited review is not subject to continuing IRB oversight unless modifications are made to the protocol. If a PI requires any changes to the research protocol for a study previously deemed exempt or approved by expedited review, he or she must submit a Protocol Amendment to describe all proposed changes to the research protocol. As stated under the IRB guiding principles, all researchers at CCSU are required to meet all ethical obligations to participants as articulated in the Belmont Report. These principles of ethical research include obtaining informed consent, protecting confidentiality, minimizing risks, and addressing problems or complaints.

The IRB will consider the following criteria when reviewing protocols for approval:

1. Risks to human subjects are minimized.
2. Potential benefits of the research are maximized, and any potential risk the participants may be exposed to is outweighed by the potential benefits of the research.
3. Participants will be recruited in an equitable, non-coercive manner.
4. Informed consent will be sought from each prospective participant or the participants’ legally authorized representatives (unless waived in limited circumstances). Participants will be fully informed about the risks and benefits associated with participation, and participants will not be exposed to disproportionate risks.
5. All information given to participants as part of the informed consent process will be in accordance with federal guidelines. The IRB may also require that additional information be given to the participants when, in the IRB’s judgment, such information would meaningfully add to the protection of the rights and welfare of those participants.
6. Informed consent will be documented, or, in limited circumstances, waivers of consent will be documented.
7. Where appropriate, there are adequate provisions to protect the privacy of participants and maintain data confidentiality.
8. There are adequate provisions made for monitoring data collection, and all data collection processes ensure the safety of the participants.
9. Where participants are likely to be vulnerable to coercion or undue influence, appropriate safeguards have been included to protect the rights and welfare of these participants.
10. All investigators listed on the submission have demonstrated appropriate ethics certification (CITI training or similar).

If a research protocol was approved by the convened IRB, a continuing review or renewal is required within 12 months of the approval date or within the period of time set for the continuing review by the IRB. The investigators must submit an Approval Renewal Request to the IRB and receive approval of the continuing review or renewal before the expiration date to avoid a lapse in approval. If there is a lapse in approval, all research activities with participants must stop.

Any changes in an approved protocol, including the addition of study materials, additional investigators, changes to procedures, or changes to data analysis and/or data reporting must be submitted promptly for review as a Protocol Amendment. Research activities that are the part of or dependent of the proposed modifications should not be initiated without IRB review and approval of the Protocol Amendment.

The difference between primary data analysis and secondary data analysis outlined by National Institutes of Health (NIH) is that primary data analysis is limited to the analysis of data by members of the research team that collected the data to answer the original hypotheses proposed in the research. All other analyses of data collected for specific research studies or analyses of data collected for other purposes (including registry data) are considered secondary analyses of existing data.

Determining whether proposed research involves secondary analysis of existing data can be challenging. The IRB will only consider proposed secondary data analysis if the investigator had no involvement in the prior data collection or if the data were originally collected for a purpose other than contributing to generalizable knowledge (such as program evaluation or institutional research).

The definition of existing data may include both data provided to the investigator from any source and data already in the possession of the investigator.

Public use data sets (such as portions of U.S. Census data, data from the National Center for Educational Statistics, National Center for Health Statistics, etc.) are datasets prepared with the intent of making them available for the public. The data available to the public are not individually identifiable and therefore their analysis would not involve 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. If the data is "identifiable" or "indirect" identifiers. Direct identifier examples include participants’ names, Social Security Numbers, ID numbers, date of birth, etc.). Indirect identifiers include a coding system in which codes (such as letters, numbers, and symbols) replace direct identifiers and a key to decipher the code exists, which enables linkage of the identifying information to the private information or specimens.

Proposed analysis of existing data which does not meet the definition of human subject (or participant) does not need review by the IRB.

Proposed analysis of existing data that meets the definition of human subject and contains both direct and indirect identifiers and does not require consent is considered exempt from IRB review if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publically available;
2. Information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
3. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA – 45 CFR Parts 160 and 164, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501or for “public health activities and purposes” as described under 45 CFR 164.512(b);
4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501

IRB records required by this policy shall be retained for at least three years, and records relating to research that is conducted shall be retained for at least three years after completion of the research. The institution or IRB may maintain the records in printed or electronic form.

Other records of IRB activities, including meeting minutes and IRB correspondence with investigators, are also stored electronically and retained for at least three years. It is recommended that investigators keep their own research records.

IRB records are stored securely to maintain confidentiality. Researchers and research staff are permitted to view selected portions of their IRB files upon request, but may, in certain cases, receive redacted documents (e.g., removing internal comments or IRB reviewer names). Others who are not listed as key personnel on an IRB protocol will only have access to file documents with explicit permission of the principal investigator(s). All records are accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner. Requests to see IRB records by unauthorized personnel must go through an open records request process.

The IRB expects all investigators associated with IRB-approved research to comply with all ethical standards set forth in all relevant government policies and CCSU policies and procedures. Investigators are also expected to comply with any conditions the IRB has placed upon their research, to follow the research protocols outlined in IRB submissions, and to notify the IRB of any changes to their protocol. Non-compliance is defined as the failure to follow any pertinent federal, state, or local regulations governing human subject research, the University policies related to human studies research, and the requirements set forth by the CCSU IRB.

Special cases of non-compliance may include:

• Serious noncompliance: Willful violation of CCSU policies and/or federal regulations, scientific misconduct*, and/or purposeful deception on official IRB forms may constitute serious noncompliance. Serious noncompliance may increase the risk to participants, damage the reputation of CCSU as a research institution, adversely affect the rights and/or safety of participants, or adversely affect the scientific integrity of the study. A single instance of noncompliance may be deemed as serious noncompliance upon consideration of the facts by the IRB.
• Continuing noncompliance: Continuing noncompliance can be defined as a pattern of noncompliance that, if allowed to continue, may increase the risk to participants, damage the reputation of CCSU as a research institution, adversely affect the rights and/or safety of participants, or adversely affect the scientific integrity of the study.

Reports of non-compliance are reviewed by the IRB Administrative Team, the Associate Vice President of Academic Affairs, and as necessary, the Vice President of Academic Affairs. IRB members may also be consulted to assist with reviewing allegations of noncompliance. If an instance of non-compliance is verified, corrective action may include, but is not limited to:

• Notifying research participants or re-consenting of current research participants;
• Observation and/or monitoring of the research or the consent process;
• Additional education and training for investigators and support staff;
• Modifications to the protocol and/or informed consent documents;
• Modifications to the continuing review schedule;
• Sanctions to achieve compliance or prevent recurrence of noncompliance (as determined by the Vice President of Academic Affairs and the Associate Vice President of Academic Affairs);
• Referral of the PI and/or all of the researchers to another University entity for further investigation, review, and/or sanctions;
• Suspension or termination of research (including, but not limited to, data collection, data analysis, and use of data for presentation or publication);
• Suspension of the privileges of a PI to conduct human studies research at CCSU.

Faculty advisors are responsible for ensuring that their students' projects abide by all ethical standards set forth in this policy. Faculty advisors are obliged to monitor their students' research activities and to report any potential ethical violations to the IRB. Failure to report any known ethical misconduct may result in any of the above corrective actions.

* Scientific misconduct, including allegations of fabrication, falsification, or plagiarism and/or serious or continuing cases of noncompliance are subject to investigation, review, and/or sanctions.