Does it meet the definition of Research?

• The activity is a systematic investigation: an activity that involves a prospective plan which incorporates data collection, either quantitative and/or qualitative, and data analysis to answer a question

• The activity is designed to develop or contribute to generalizable knowledge: designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

If the project meets the definition of Research, does it involve human subjects?

The CSU IRB reviews all research projects involving human subjects. The definitions of “Research” and “Human Subject” come from the US Department of Human and Health Services (HHS).

Does it meet the definition of Research?

HHS Definition of Research – Both must be true:

• The activity is a systematic investigation: an activity that involves a prospective plan which incorporates data collection, either quantitative and/or qualitative, and data analysis to answer a question

               AND

The activity is designed to develop or contribute to generalizable knowledge: designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.

If the project meets the definition of Research, does it involve human subjects?

HHS Definition of Human Subject–

The research involves living individuals about whom an investigator will obtain either of the following:

Data through intervention or interaction with the individuals. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

Identifiable private information.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Collaborative Research

Multi-Site Research and IRB Reliance

Multi-site Research refers to human subject’s research conducted at more than one site, involving external sites that are not components of Colorado State University (CSU) (Fort Collins Campus and Spur Campus). There are different requirements for IRB review based on whether the external site or its employees are engaged in human subject’s research conducted by a CSU investigator.

To ask that CSU IRB serve as the IRB of record for a collaborative study or to request to cede oversight to another IRB of record, please contact us at  CSU_IRB@colostate.edu.

Engagement

The IRB determines whether an external site is engaged in research using guidance from the Office of Human Research Protections guidance, “Guidance on Engagement of Institutions in Human Subjects Research.” External sites may need to consult their local IRB to determine whether their institution considers them to be engaged in the research.

IRB Reliance

When the research involves multiple sites, it’s common, and often required by the funding source for institutions to rely on one another for IRB review. CSU may enter into an IRB reliance agreement or an Institutional Authorization Agreement (IAA), which documents which institution’s IRB will serve as the IRB of record, and which institutions IRB will rely on the IRB of record.

NIH Single IRB Requirements

The Final NIH Policy on Use of a Single IRB for Multi-Site Research documents the expectation that all US sites participating in non-exempt multi-site studies funded by NIH are required to use a single Institutional Review Board (sIRB).

If your research is NIH-funded multi-site research, please reach out to the CSU IRB as soon as possible, to allow sufficient time for the reliance agreement process.

Revised Common Rule

When a CSU investigator is seeking funding from a Federal department or agency for research involving human subjects in research and their research is a non-exempt, collaborative project, they must agree to use a Single IRB. Exceptions to this rule must be approved by the funding agency program officer and the CSU IRB.

SMART IRB

CSU is a participating SMART IRB Institution. SMART IRB (Streamline, Multisite, Accelerated Resources for Trials IRB Reliance Platform) is an NIH-Funded platform designed to harmonize and streamline the IRB review process for multi-site research.

Types of Reliance Agreements

• Institutional Authorization Agreement (IAA)
  • An IAA may cover all human subjects research that engages an institution or requires IRB review between two institutions or be used to document reliance on a specific study. Each institution retains the authority to determine whether to conduct its own review on a project-specific basis.
• Individual Investigator Agreements (IIA)
  • IIAs are a formal agreement between CSU and an independent investigator collaborating on a CSU research study, by which CSU agrees to extend it’s (FWA) to the individual, and through which the independent investigator agrees to fulfill specified training and conduct while collaborating on the project. IIAs are subject to review and approval by CSU’s Institutional Official or designee.

Please contact the CSU IRB to inquire about reliance agreements or Individual Investigator Agreements. CSU_IRB@colostate.edu

IRBs are frequently presented with questions regarding when Quality Improvement (QI), Demonstration Projects, and other similar activities also meet the definition of human subject research and require IRB review and approval.  While many QI and demonstration activities do not meet the definition of human subject research under the Common Rule or FDA, it is essential to understand that some projects may.  This is the case when the QI or demonstration activity is designed to accomplish a research purpose as well as the purpose of improving the quality of care or demonstrating the success/value of a program.  The following materials are included to assist the investigator and the IRB in assessing whether or not individual projects require IRB review and approval.

The intent to publish is an insufficient criterion for determining whether a QI or demonstration activity involves research.  Planning to publish does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities.  Conversely, an activity may involve research even if there is no intent to publish the results.

To determine whether or not IRB review and oversight applies, the following questions should be addressed in order:

1. Does the activity involve research?
2. Does the research activity involve human subjects?
3. Does the human subjects research qualify for an exemption? (Note: At most institutions, the authority to determine a project exempt is assigned to individuals within the Human Research Protection Program and/or IRB )

National Bioethics Commission Statement

“These activities, generally referred to as program evaluation or quality improvement, are not intended to have any application beyond the specific organization in which they are conducted.  As is true in the area of public health, because populations are the subject of study and because the methods used in program evaluation or quality improvement are the same as those used in research, it is often difficult to determine whether an activity is research that falls under the oversight system.

Definitional issues regarding program evaluation or quality improvement are not limited to health care delivery. They also occur in industrial or educational settings and in social science and operations research. However, if the purpose is to assess the success of an established program, and the information gained from the evaluation will be used to improve that program, the activity should not be considered research involving human participants. Evaluation is a program monitoring tool, and the information gained will immediately benefit the program and/or the individuals involved.

However, when quality improvement involving human participants is undertaken to test a new, modified, or previously untested intervention, service, or program to determine whether it is effective and can be used elsewhere, the activity is human participant research and subject to the oversight system.”

If your project has one or more of the characteristics in the human subject research column, the project may require IRB review. If your project falls squarely into one of the other columns, then IRB review is not required.

Anonymized Data: Anonymized data may have previously been identifiable, but have since been de-identified, and a code or link no longer exists. An investigator has NO means of linking anonymized data back to a subject.

Anonymous Data: Anonymous data is data that was never linked to an individual. Coded data is not anonymous.

Coded Data: Data is coded when a link will exist between a unique code and an individual subjects’ identifiers such as name, medical record number, email address, or telephone number. Generally, the study is collected with a “STUDY ID”, and a key is maintained where the STUDY ID is associated with the subject’s identifiers. As long as a link exists, data is considered indirectly identifiable and not anonymous, anonymized, or de-identified.

De-Identified Data: A record in which identifying information is removed.

Under the HIPAA Privacy Rule, data are de-identified if:

1. the data do not include any of the 18 identifiers (of the individual or his/her relatives, household members, or employers) which could be used alone or in combination with other information to identify the subject. Note that even if these identifiers are removed, the Privacy Rule states that information will be considered identifiable if the covered entity knows that the identity of the person may still be determined.
2. Expert Determination Method

Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual, and that the individual can reasonably expect will not be made public (e.g., a medical record).

Examples of Identifiable Private Information

• Names
• Date of Birth
• Medical Record Numbers
• Email Addresses
• Street Addresses
• Photographs
• Audio or Video Recordings
• IP Addresses

Limited Dataset: A set of data in which most of the protected health information has been removed. The following identifiers of the individual or of the individual’s relatives, employers, or household members must be removed:

1. Names;
2. Addresses, other than town or city, state, and zip code;
3. Telephone numbers;
4. Fax numbers;
5. Electronic mail addresses;
6. Social security numbers;
7. Medical record numbers;
8. Health plan beneficiary numbers;
9. Account numbers;
10. Certificate/license numbers;
11. Vehicle identifiers and serial numbers (including license plate numbers);
12. Device identifiers and serial numbers;
13. Web Universal Resource Locators (URLs);
14. Internet Protocol (IP) address numbers;
15. Biometric identifiers, including finger and voice prints; and
16. Full-face photographic images and any comparable images.

Protected Health Information (PHI): PHI is individually identifiable health information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. PHI excludes individually identifiable health information in education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g, records described at 20 U.S.C. 1232g(a)(4)(B)(iv), and employment records held by a covered entity in its role as employer.