• What type of projects require IRB review (or a determination of exemption)?
• When are program evaluation and quality improvement activities considered research?
• I'm collaborating on a project which involves human subjects, is NDSU IRB review also required?
• My course assignment involves conducting an interview or a survey.  Is IRB Review required?
• What is the purpose of IRB review?
• I believe my project is 'exempt,' do I need to submit a protocol?
• Do all surveys require IRB approval?
• Do pilot studies need IRB approval?
• My research will only involve previously collected data (or records, documents, or biospecimens), is IRB Approval required?
• What is the difference between anonymous and confidential?

NDSU IRB review (or determination of exemption) is required when faculty, staff, students, or other representatives of NDSU become engaged in research that will involve human subjects/participants. IRB review is required regardless of funding source.  Collaborative projects require NDSU IRB review when an agent or employee of NDSU will be involved (e.g., receiving funding, project planning/design, participant recruitment, obtaining informed consent, data collection, or handling of identifiable human data). In addition, it is important to note that IRB review would also be required if a project or activity conducted for other purposes (e.g., program evaluation, quality improvement, education), will also involve a research component. IRB approval must be obtained prior to initiating any research involving human subjects.

Human subjects research projects are not limited to the medical, social, or behavioral science fields, but may be conducted in many different disciplines. It is important to consider the regulatory definitions of research and human subjects.

Research

The Department of Health and Human Services (45 CFR 46) defines research:

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

The IRB provides guidance to investigators, and retains the final authority in the classification of projects as 'research', or 'not research'. In general, a contribution to generalizable knowledge could include a journal publication, conference presentation, or dissertation, although this is not the sole factor in making the determination. Further definition and examples can be found in the Standard Operating Procedures.

Human subjects

The HHS defines a human subject as "...a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." 

The FDA defines human subject as "an individual who is or becomes a participant in research, either as a recipient of a test article, or as a control,  A subject may be either a healthy human or a patient."

Some examples:

• Surveys, interviews, focus groups (even if information will be recorded anonymously)
• Educational tests (i.e. cognitive, aptitude, achievement, etc.)
• Observation of public behavior
• Gathering data (academic records, or other data) from students to evaluate educational or other programs
• Obtaining data from individuals to evaluate computer software programs
• Collection of (or use of pre-existing) human blood, tissues, specimens, etc.
• Use of existing medical, educational or other records or data that is not publicly available
• Collection of data through non-invasive procedures (i.e, X-ray, EEG, eye exam, etc.)
• Exercise, strength testing
• Collection of data from human voice, video, or image recordings
• Taste and food quality evaluations
• Gathering data from individuals to evaluate electrical, electronic, or other devices or instruments
• Clinical studies of drugs or medical devices

* NOTE: Some types of projects may also require prior approval from the Food and Drug Administration. It should be noted that the definition for 'medical device' used by the FDA includes anything that will be used for diagnosis, cure, treatment, prevention of disease or other conditions, as well as anything that will affect the structure/function of the body of man or other animals.

The question of what constitutes research may be especially relevant in relation to activities designed to gather data to evaluate a specific program. If there is also an intent to contribute to generalizable knowledge, the activity would also be considered research, and require IRB review. In general, OHRP gives guidance that if the activity will be used to draw conclusions related to a larger entity then the activity is considered research. Therefore, the following considerations should be made:

QA/QI, program evaluation, surveillance, etc. activities would be considered research if any of the following are true:

• there is also an intent to use the data to contribute to generalizable knowledge
• experimental or non-standard interventions will be involved
• there is a random assignment of participants to compare outcomes
• the activities are not normally done as part of standard operating procedures
• results will be used to apply knowledge to other programs
• project is subject to peer review (designed to be used outside of the institution).

Collaborative projects require NDSU IRB review when NDSU employees or agents will be 'engaged in research involving human subjects':

• receive a direct award for human subjects research,
• interact or intervene with individuals for research purposes,
• receive identifiable information for research purposes, or
• direct or oversee other individuals performing these activities.

When a collaborating institution's IRB also has jurisdiction, collaborative review arrangements may be possible. NDSU may choose to rely on a collaborator's IRB, provided that:

• the IRB is registered with OHRP
• the protocol application is at least as comprehensive as NDSU requires
• both institutions agree and sign an IRB Authorization Agreement (for non-exempt research).

Course assignments that collect information about individuals are not normally considered to be research and would not normally require IRB review. In these instances, the project should be clearly represented to individuals as a course assignment, and not as an NDSU research project, to avoid confusion about the need for IRB review. Class instructors are responsible for the conduct of these course assignments.

Sometimes, a student will also want to utilize this data as a part of their thesis/dissertation, or for a publication. This would then constitute a contribution to generalizable knowledge, therefore research. In these cases, IRB review must be sought prior to contacting or collecting any data from participants; the IRB may not grant retroactive approval.

In fulfillment of the terms of NDSU's (Federalwide Assurance) with the DHHS Office of Human Research Protections, the IRB must prospectively review human subjects research to ensure that the rights, safety and welfare of participants will be protected. Specifically, participants should have the right to:

• be told everything they need to know about the research before being asked to participate,
• freely choose whether or not to participate in a research project,
• be aware of any available alternatives,
• be free to quit participating at any time,
• to have their privacy and confidentiality of their information respected,
• know that their safety and welfare come first,
• keep all the legal rights they already have,
• ask questions or voice concerns to the investigator or the IRB.

These rights are extended to participants of all NDSU human research projects, including those eligible under one of the exemption categories. Through the protocol review process, the IRB obtains the necessary information to verify that the project will be conducted so that participants are afforded these rights.

By reviewing all materials that will be shown to participants (e.g. recruitment messages, invitations, and consent forms), the IRB is able to verify that participants will be fully informed of the nature of the research, what is being asked of them, as well as any potential risks and benefits.

All research projects that will involve human subjects, even if they would qualify under one of the exemption categories, require a protocol submission.  Determinations of exemption are made by IRB staff.  Some research qualifying as exempt under Categories 2 and 3 require Limited IRB Review to ensure specific criteria in the Common Rule are met (e.g. Privacy Protections).  

The federal eligibility criteria for exemptions can be complex. There may be situations where a project does not qualify for exemption, as an investigator had anticipated. In these situations, study procedures (including consent processes) may need to be adapted.  The study will be reviewed via expedited or full review procedures in order to ensure adequate protection of subjects and compliance with federal regulations.

Only those surveys that fit the definition of human subjects research (see definition above) require IRB approval. A survey that is not being done for research purposes (does not intend to contribute to generalizable knowledge) would be outside the purview of the IRB. For example, if the survey is being conducted solely for internal, quality improvement purposes, it would not be considered research and would not require IRB approval.

Or, if the survey will not gather any information about living individuals—e.g., their feelings, thoughts, opinions, behaviors, characteristics, actions, etc., the definition of human subjects would not apply, and IRB approval would not be required. An example may be a survey sent to various businesses asking about their supply purchases, level of inventory, and shipping policies.

A pilot is a preliminary investigation of the feasibility of a study, usually done on a small scale (10 or fewer subjects) which is exploratory in nature.  It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design.  Such a pilot would not contribute to generalizable knowledge and therefore is not considered research and does not require IRB review.  Data collected from a pilot study cannot be used as research data.  

Medical interventions or interactions for research purposes, especially those involving invasive procedures, or piloting of procedures with vulnerable groups (e.g. children) do require IRB review regardless of the size of the study.

Generally, an IRB protocol is required for use of potentially identifiable individual-level data, documents or records about living individuals, or biospecimens . In some situations (e.g. when data is publically available, or has been irreversibly de-identified) the IRB may determine that their use does not involve 'human subjects'.

If information to be used is available to the general public, without restriction or limitation, a protocol is not required. This would include public newspapers, journal articles, and public websites. Researchers should be aware, however, that some websites or online communities have privacy expectations or limitations to use of their information and postings; use of this type of information would require IRB approval.

Also, some human specimens are available through commercial sources, and/or have been obtained from deceased individuals; these may not require a protocol to the IRB; however, if an FDA regulated device or drug is being tested, an IRB protocol is required.

When in question, please contact the IRB office for more information.

If researchers are collecting data where no one, not even the researcher, will be able to tell where or from whom the data came, then the data is considered to be 'anonymous.' However, data which may be linked to an individual through use of codes, video/audio recording, or other identifiers would be considered to be 'identifiable data.' If a researcher promises to keep identities of participants private and not to disclose these identifiers to anyone other than the researcher, the data is considered to be 'confidential.'