Human Studies Council

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PROCEDURES AND RESPONSIBILITIES

Guiding Principles

Roles and Responsibilities

Committee Membership

Research Categories

Review Process

Criteria for Approval

Review and Modification Procedures

Secondary Data Analysis

Record Retention

Non-compliance

Guiding Principles

The Human Studies Council (HSC), CCSU’s Institutional Review Board (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 HSC 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 HSC 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 the Code of Federal Regulations 45 CFR 46 and all other applicable laws and regulations. To that end, CCSU’s Human Studies Council 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 as outlined in "The Protection of Human Subjects" from the U.S. Department of Health and Human Services Code of Federal Regulations CFR 45 Part 46.

Roles and Responsibilities

The Human Studies Council (HSC) consists of members of the campus and non-campus community. The HSC Administrative Team consists of the HSC Administrator, HSC Chair, and the Director of Grants and Funded Research, and is responsible for the daily oversight of all HSC activities. The HSC and its Administrative Team serve the campus research community under the direction of the Associate VicePresident for Academic Affairs/Dean of the School of Graduate Studies and the Provost. The HSC is charged with reviewing and approving submissions, requiring modifications, or disapproving proposals for all research activities conducted at CCSU. The HSC must notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure HSC approval of the research activity.

The HSC is required by the U.S. Department of Health and Human Services Code of Federal Regulations CFR 45 Part 46 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; the research involves the recruitment of, identification of, or contact with prospective human research participants on the CCSU campus.

Principal Investigators (PIs) are responsible for ensuring their submissions are complete and accurate, and for allowing sufficient time in their overall research design for their protocols to be reviewed and approved before beginning data collection (as according to the procedures outlined in the Review Process section of this document). Principal investigators must promptly report any incidences of unanticipated problems or adverse events to the HSC. The HSC Administrative Team must forward to the Associate Vice President for Academic Affairs/Dean of the School of Graduate Studies 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 HSC requirements. In consultation with the Provost, if appropriate, a designated University official will also forward the information to the relevant agencies, regulatory bodies, and/or the U.S. Office for Human Research Protections, and, as necessary, include the information in the annual report of research activities submitted by CCSU to the U.S. Health and Human Services Office of Research Integrity. Please refer to the non-compliance section of this document and the CCSU Policy on Misconduct in Research and Scholarship for more information on these topics.

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Committee Membership

In order to maintain a review process that is responsive to the concerns of all involved, the HSC committee members reflect experience, expertise and diversity in academic research interests and professional backgrounds, diversity in racial and cultural heritage, and exhibit sensitivity to community attitudes. HSC members are appointed by the Provost. Administrative oversight is provided directly by the Associate Vice President for Academic Affairs/Dean of the School of Graduate Studies. The HSC committee is comprised of teaching faculty members representing a variety of academic fields, at least one administrative faculty member, and at least one non-University affiliated member. The HSC may, at its discretion, invite individuals with competence in special areas or advocates of vulnerable categories of participants to assist in the review of projects which require expertise beyond or in addition to that of the committee.

Members of the HSC Administrative Team are authorized by the Provost and the Associate Vice President for Academic Affairs/Dean of the School of Graduate Studies to act on behalf of CCSU for exempted projects and expedited review. The HSC Chair may enlist the assistance of a subcommittee from among the HSC committee members to review research that meets the criteria for an expedited review.

No member of the HSC 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 HSC.

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Research Categories

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

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

  1. Exempt – This classification applies to research as described in 45 CFR 46.101 and in the HSC document, "HSC Exemption Categories." Investigators seeking exemption status must complete the HSC New Protocol Submission Form. On the New Protocol Submission Form, investigators may indicate which exemption category they believe applies to their research. The HSC Administrative Team will review each submission to determine if the research is indeed exempt. If the HSC Administrative Team does not feel the research is exempt, the submission will proceed to expedited or full review. The federal guidelines recommend that most research involving protected populations (such as prisoners, pregnant women, and some research involving children) be reviewed by a full committee, as outlined in 45 CFR 46 Subparts B, C, and D.

  2. Expedited Review – This type of review is used for research protocols which involve no more than minimal risk to human subjects (45 CFR 46.110). Minimal risk means that the probability of harm or discomfort resulting from the research would be no greater than that routinely encountered in daily life. The HSC Administrative Team determines whether a submission can be reviewed through expedited status. Expedited review is conducted by one or more members of the HSC or a subcommittee of the HSC with expertise related to the submission. Occasionally, more complex protocols involving no greater than minimal risk may be sent to the full committee 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 fully convened HSC meeting. Submissions must be received at least two weeks prior to a scheduled meeting to be put on the HSC agenda for review

In accordance with the U.S. Office for Human Research Protections guidelines, researchers do not have the authority to make their own exemption determinations at CCSU. The HSC 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 HSC has reviewed the submitted protocol, and notified the investigator(s) that the research qualifies for an exemption or approved the protocol under expedited or full review. Research deemed exempt is not subject to continuing HSC oversight unless changes are made to the protocol. If a PI makes any changes to the research protocol for a study previously deemed exempt by the HSC, she or he must submit a Protocol Modification Submission form to describe all proposed changes to the research protocol. As stated under the HSC guiding principles, all researchers at CCSU, including those conducting exempt studies, 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.

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Review Process

The role of the HSC is both educational and regulatory, and consultation at all stages of the research process is encouraged. The review of submissions is viewed as a collaborative process intended to result in mutually acceptable research procedures that accomplish the principal investigator’s scientific objectives while protecting the rights and welfare of the participants. HSC submissions must be complete and conform to the format set out in the HSC New Protocol Submission Form. If submissions are not complete or are incorrectly formatted, the submission will not be reviewed for content, and the approval process will be delayed. Following are some important points regarding the HSC submission and review process:

  1. Proposals must be reviewed and approved by the HSC before initiation of the research. The HSC cannot and will not review protocols for projects that are already in progress or have already been completed, as per federal regulations. As many journals require documentation of Institutional Review Board approval for research submitted for publication, failure to obtain HSC approval for a research study may also limit possible publication of unapproved studies.

  2. Proposals must be submitted at least two weeks prior to the next scheduled HSC meeting in order to be put on the agenda for full review. The meeting schedule and submission deadlines are publicly posted. As there is typically only one HSC meeting during the summer months, investigators should make every attempt to submit proposals involving greater than minimal risk during the regular academic year.

  3. Investigators should submit their proposals at least one month prior to the anticipated start of their research. Submissions that are eligible for exempt status or expedited review will be reviewed on a continuing basis. If changes to the initial submission are required by the HSC, the approval process may take longer than one month. During the summer months, the approval process may take significantly longer than during the regular academic year.

  4. The HSC requires that all investigators (principal and co-investigators) demonstrate knowledge of research ethics through NIH certification or comparable training/education.

  5. All investigators conducting research involving human subjects must submit an electronic copy of the New Protocol Submission Form (including all supporting documents) as a single email attachment to the Human Studies Council. All forms are available on the HSC website.

  6. All materials in support of the submission (including questionnaires, consent forms, recruitment emails, and gatekeeper letters) should be incorporated as appendices into the New Protocol Submission Form.

  7. A member of the HSC Administrative Team will send written acknowledgement when a submission is received and assign a number to the protocol. Investigators should refer to that protocol number in all correspondence with the HSC.

  8. Investigators have one year to complete the HSC approval process once they submit a new protocol. If an investigator does not complete the HSC review process within a year of the submission date, that protocol will be automatically withdrawn by the HSC Administrative Team. If a researcher wishes to revisit a study that has been withdrawn by the HSC, a New Protocol Submission Form must be submitted, and the study will be reviewed as a new submission.

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Criteria for Approval

The HSC will consider the following criteria when reviewing proposals 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 (Part 46.116 of Title 45 CFR Part 46). The HSC may also require that additional information be given to the participants when, in the Council’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 (NIH training or similar).

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Renewal and Modification Procedures

If a research project is expected to continue for longer than one year past the approval date, or a protocol requires changes, it is the PI’s responsibility to inform the HSC of any necessary modifications or renewals. Protocols deemed exempt do not require renewal, but the PI would still be required to submit a modification form if changes are made to the original protocol.

For studies deemed to be of a high risk to participants, the HSC must determine if a project requires review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred since the HSC approval.

All protocols which receive HSC approval must be renewed annually if data collection is expected to continue beyond one year. If data collection is to be continued, the investigators must submit an Approval Renewal Request Form to the HSC and receive approval of the renewal before the expiration date to avoid a lapse in approval. Approval of a project applies only to the procedures submitted in the proposal. Any changes in the approved project, including the addition of study materials, additional investigators, changes to procedure and/or changes to data analysis and/or data reporting must be submitted promptly using a Protocol Modification Submission Form. Data collection should not be initiated without HSC review and approval of any modifications. If a PI is conducting research for which data collection is expected to continue beyond one year, and that protocol was initially reviewed by the full committee, the PI must submit an Approval Renewal Request Form in a timely manner to allow for full committee review before the protocol approval expiration date to avoid a lapse in approval.

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Secondary Data Analysis

The HSC reviews research involving secondary data analysis to determine whether or not the rights and privacy of the human participants from whom the data were collected are fully protected, and that the original data collection did not violate the rights of the human participants. For studies that involve the analysis of a pre-existing data set, wherein the data to be studied contain information about living individuals, researchers must receive HSC approval before beginning their data analyses. Existing (or secondary) data are defined by 45 CFR 46.101(b) (4) as data that existed "before the research is proposed to an institutional official or the IRB." This provision applies to data "on the shelf" at the time the protocol was written, and not data currently being collected. 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. For further information see: http://grants.nih.gov/grants/policy/hs/faqs_aps_definitions.htm#285.

Determining whether a study involves pre-existing data can be challenging. The HSC will only consider studies to consist of secondary data analysis if the PI had no involvement in the prior data collection or if the data was originally collected for a purpose other than contributing to generalizable knowledge (such as program evaluation or institutional research). Since the HSC cannot retroactively approve studies, it is recommended that researchers seek HSC approval prior to the start of data collection if a study is designed to serve a dual purpose, such as contributing to both institutional research and generalizable knowledge. Furthermore, anytime a CCSU student, faculty or staff member has a contract with an outside agency in which the CCSU researcher is involved in the design of the study, analysis of existing data, and/or is a primary author or investigator for the study, and the research will contribute to generalizable knowledge, the researcher must obtain HSC approval prior to data collection.

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Record Retention

Federal regulations require that records pertaining to human subjects’ research be retained for three years following the completion of the research [45 CFR 46.115(7b)]. HSC submission records are stored in a shared database maintained by the Office of Grants and Funded Research for at least five years from the date of initial review and for at least three years following the completion of the research. Hard copies of all submitted HSC proposals are retained for at least three years following the completion of the research. Other records of HSC activities, including meeting minutes and HSC correspondence with investigators, are also maintained electronically by the Office of Grants and Funded Research in compliance with the procedures outlined in 45 CFR 46.115. It is recommended that investigators keep their own HSC records for an indefinite period following the completion of their study.

HSC records are stored in a way that maintains confidentiality. Researchers and research staff are permitted to view selected portions of their own HSC 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 a HSC file 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 HSC records by non-key personnel must go through an open records request process.

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Non-compliance

The HSC expects the principal investigators and all co-investigators associated with HSC-approved studies 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 HSC has placed upon their research, to follow the research protocols outlined in HSC submissions, and to notify the HSC of any changes to their protocol. Non-compliance is defined as the failure to follow any pertinent federal, state, or local regulations governing human studies research, the University policies related to human studies research, and the requirements set forth by the CCSU Human Studies Council.

Examples of non-compliance may include, but are not limited to:

  • Conducting human studies research as defined by the requirements of the U.S. Department of Health and Human Services (HHS) regulations 45 CFR part 46 without prior approval by the HSC.

  • Deviating from the procedures outlined in the HSC approval process without prior HSC approval of the research modification.

  • Continuing data collection activities past the HSC approval expiration date without submitting a HSC Approval Renewal Request Form and receiving formal HSC approval of the renewal request.

Special cases of non-compliance may include:

  • Serious non-compliance: Willful violation of University policies and/or federal regulations, potential damage to the reputation of CCSU as a research institution, and/or purposeful deception on official HSC forms may constitute serious non-compliance. Serious noncompliance may create an increase of risk to participants, adversely affect the rights and welfare of participants, and/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 HSC.

  • Continuing non-compliance: Continuing non-compliance can be defined as a pattern of noncompliance that, if allowed to continue, may increase risk to participants, damage the reputation of CCSU as a research institution, adversely affect the rights, welfare and/or safety of participants, or adversely affect the scientific integrity of the study.

Reports of non-compliance are reviewed by the HSC Chair in conjunction with the HSC Administrative Team, the Associate Vice-President for Academic Affairs/Dean of the School of Graduate Studies, and as necessary, the Provost. HSC 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:

  • Notification of research subjects or re-consent 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 Associate Vice-President for Academic Affairs/Dean of the School of Graduate Studies and the Provost);

  • 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 HSC. Failure to report any known ethical misconduct may result in any of the above corrective actions.

Cases of research misconduct, including allegations of fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, and/or serious or continuing cases of non-compliance are subject to the procedures outlined in the CCSU Policy on Misconduct in Research and Scholarship.

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