Investigator FAQs

If you have questions about whether your project needs IRB review, please reach out to us via email: [email protected]

Does my project require review by the Institutional Review Board (IRB)?

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. 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) for obtaining the information to constitute research involving human subjects.

Quality Improvement or Program Evaluation

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.

IRB Decision Tree dealing with projects. Please contact IRB for more details
Research Data Definitions

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: 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.
    • 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:
    • Names;
    • Addresses, other than town or city, state, and zip code;
    • Telephone numbers;
    • Fax numbers;
    • Electronic mail addresses;
    • Social security numbers;
    • Medical record numbers;
    • Health plan beneficiary numbers;
    • Account numbers;
    • Certificate/license numbers;
    • Vehicle identifiers and serial numbers (including license plate numbers);
    • Device identifiers and serial numbers;
    • Web Universal Resource Locators (URLs);
    • Internet Protocol (IP) address numbers;
    • Biometric identifiers, including finger and voice prints; and
    • 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.
Who can be PI?

Principal Investigator Eligibility & Responsibilities

PRINCIPAL INVESTIGATOR (PI) DEFINITION

Conducting research with humans is a privilege and carries with it ethical and legal responsibilities. By Colorado State University (CSU) policy and federal regulations, the Principal Investigator (PI) is the individual responsible for writing an accurate proposal to utilize human subjects, and for designing practices and implementing the approved use(s) of those subjects. Ultimately, the PI assumes the responsibility for the ethical conduct of the project and for the welfare of the human subjects. The PI should understand and abide by all relevant federal regulations and guidelines for the use of humans in research.

CSU PERSONNEL PI ELIGIBILITY

CSU employees in the following Academic Faculty & Administrative Professional Manual appointment categories have the privilege of serving as a PI on an Institutional Review Board (IRB) protocol, if they have completed the appropriate training and experience to adequately direct the project. The IRB will consider a special request for someone out of these categories to be a PI.

  • Regular Full-time
  • Regular Part-time
  • Multi-year Research
  • Senior Teaching
  • Special Appointment
  • Transitional Appointment
  • Administrative Professionals
  • State Classified

Individuals on Temporary Appointments (e.g. Graduate Research Assistants and Postdoctoral Scholars) are not eligible to serve as PI, but can be a Co-Principal Investigator (Co-PI) with someone from one of the above categories as PI. Individuals on Visiting scholar or Adjunct appointments are not eligible to serve as PI due to the temporary nature of their affiliation with the university.

If you have a unique status that is not listed above, please contact an IRB Coordinator at [email protected].