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 HSC/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/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 HSC/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 HSC/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.

Roles and Responsibilities

 

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

 

The HSC/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; 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 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/IRB. The HSC/IRB 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/IRB 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/IRB 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/IRB 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/IRB 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/IRB 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/IRB 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 an experienced HSC/IRB review research that meets the criteria for an expedited review.

No member of the HSC/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 HSC/IRB.

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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/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 HSC/IRB document, "HSC/IRB Exemption Categories." Upon receipt of the Initial Protocol Submission Form the HSC/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 HSC/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 the research would be no greater than that routinely encountered in daily life. The HSC/IRB Administrative Team determines whether a submission can be reviewed through expedited status. Expedited review is conducted by the HSC/IRB Chair or by a member of the HSC/IRB designated by the Chair. Occasionally, more complex protocols involving no greater than minimal risk may be sent to the convened HSC/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 HSC/IRB meeting. Submissions must be received at least two weeks prior to a scheduled meeting to be put on the HSC/IRB 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/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 HSC/IRB 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 or approved by expedited review is not subject to continuing HSC/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, he or she must submit a Protocol Modification Submission Form to describe all proposed changes to the research protocol. As stated under the HSC/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.

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Review Process

The role of the HSC/IRB 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 investigator’s scientific objectives while protecting the rights and welfare of the participants.

The HSC/IRB cannot retroactively approve research, so it is recommended that researchers seek HSC/IRB approval prior to the start of data collection if a study is designed to contribute to 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/IRB approval prior to engaging in the research activities.

HSC/IRB submissions must be complete and conform to the format set out in the HSC/IRB Initial 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/IRB submission and review process:

  1. Proposals must be reviewed and approved by the HSC/IRB before initiation of the research. The HSC/IRB 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/IRB 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/IRB 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/IRB 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/IRB, 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/IRB requires that all investigators (principal and co-investigators) demonstrate knowledge of research ethics through CITI certification or comparable training/education.
  5. All investigators conducting research involving human subjects must submit an electronic copy of the Initial Protocol Submission Form (including all supporting documents) as a single email attachment to the hsc@ccsu.edu. All forms are available at HSC Forms.
  6. All materials in support of the submission (including questionnaires, consent forms, recruitment emails, and gatekeeper letters) should be incorporated as appendices into the Initial Protocol Submission Form.
  7. A member of the HSC/IRB Administrative Team will send written acknowledgement when an initial submission is received and assign a number to the protocol. Investigators should refer to that protocol number in all correspondence with the HSC/IRB.
  8. Investigators have one year to complete the HSC/IRB approval process once they submit an initial protocol. If an investigator does not complete the HSC/IRB review process within a year of the submission date, the protocol will be automatically withdrawn by the HSC/IRB Administrative Team. If a researcher wishes to revisit a study that has been withdrawn by the HSC/IRB, an Initial Protocol Submission Form must be submitted, and the study will be reviewed as an initial submission.

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Criteria for Approval

The HSC/IRB 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. The HSC/IRB may also require that additional information be given to the participants when, in the HSC/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).

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Renewal and Modification Procedures

If a research protocol was approved by the convened HSC/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 HSC/IRB. The investigators must submit an Approval Renewal Request Form to the HSC/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 procedure and/or changes to data analysis and/or data reporting must be submitted promptly using a Protocol Modification Submission Form. Research activities that are the subject of the proposed modifications should not be initiated without HSC/IRB review and approval of the modifications.

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Secondary Data Analysis

 

The difference between primary data analysis and secondary data analysis suggested 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 HSC/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. For further information see: http://grants.nih.gov/grants/policy/hs/faqs_aps_definitions.htm#285.

 

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 data sets 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. 

 

Whether proposed research involves the analysis of secondary data will require HSC/IRB review is determined in part on whether the meets the definition of human subject research.

 

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" that is data may contain "direct" identifiers such as human subjects’ (participants’) names, Social Security Numbers, student numbers, date of birth, or "indirect" identifiers that is, a coding system in which codes (letters, numbers, symbols, or a combination of those) replace direct identifiers; and a key to decipher the code exists, enabling 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 HSC/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 HSC/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 164.501 or 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 nonresearch 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 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

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Record Retention

The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically.

HSC/IRB submission records are stored in a secure database for at least three years from the date of initial review or for at least three years following the completion of the research. Hard copies of all submitted HSC/IRB proposals are retained for at least three years following the completion of the research. Other records of HSC/IRB activities, including meeting minutes and HSC/IRB correspondence with investigators, are also maintained electronically. It is recommended that investigators keep their own research records.

HSC/IRB records are stored securely to maintain confidentiality. Researchers and research staff are permitted to view selected portions of their HSC/IRB files upon request, but may in certain cases receive redacted documents (e.g., removing internal comments or HSC/IRB reviewer names). Others who are not listed as key personnel on a HSC/IRB 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/IRB records by non-key personnel must go through an open records request process.

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Non-compliance

The HSC/IRB expects all investigators associated with HSC/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 HSC/IRB has placed upon their research, to follow the research protocols outlined in HSC submissions, and to notify the HSC/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 HSC/IRB.

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/IRB 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/IRB.
  • 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/IRB Chair in conjunction with the HSC/IRB Administrative Team, the Associate Vice-President for Academic Affairs/Dean of the School of Graduate Studies, and as necessary, the Provost. HSC/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:

  • 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 Policy on Misconduct in Research and Scholarship.

 

 

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