Procedures & Responsibilities

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 Central. 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 Central 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

If you reasonably suspect that you might be sharing your data (e.g., in a repository with public access, or with any individuals or organizations outside the investigators on your protocol, etc.), then best ethical practice dictates that you should notify participants prior to data collection. Data that are collected with identifiable information should be deidentified prior to data sharing. Even if data are collected anonymously, as best practice, participants should still be informed about the possibility of data sharing through the informed consent process.

Guidance Related to Data Sharing

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 Central 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 Central IRB.

Special cases of non-compliance may include:

• Serious noncompliance: Willful violation of Central 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 Central 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 Central 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 Central.

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.