Frequently Asked Questions

How does Purdue define Research?

Purdue adheres to the federal definitions of research described below If your activity meets either of those definitions, then it will need to be reviewed by the IRB.

Research (Department of Health & Human Services definition) – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Research (FDA definition) – A clinical investigation (i.e., any experiment) that involves a test article and one or more human subjects.

How does Purdue define Human Subject?

Purdue defines Human Subjects” in the following three ways If your activity meets either of the research definitions above and involves an individual as described in any of the three definitions below, you will need to submit either a request for exemption or an application to the IRB for the activity.

Human Subject (Department of Health & Human Services definition) – A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information”. [45 CFR 46.102(f)]

Human Subject (FDA definition) – 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” [21 CFR 56.102(e)] (Drug, Food, Biologic)

Human Subjects (FDA for medical devices definition) – A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or who participates as a control A subject may be in normal health or may have a medical condition or disease” [21 CFR 812.3(p)] (Device)

Does my master’s thesis/doctoral dissertation require IRB review?

Graduate work (thesis or dissertation) associated with earning a masters degree or a doctoral degree typically involves research designed to contribute to generalizable knowledge When such activities involve the conduct of research with human subjects, it requires IRB review.

Do class projects require IRB review?

Activities designed for educational purposes that teach research methods or demonstrate course concepts are not intended to create new knowledge and do not meet the definition of research.  Even though such activities do not qualify as research, they may still present risks, such as undue influence or breach of confidentiality, to students and others Instructors are obligated to ensure these activities are conducted in a safe and ethical manner.

Class-based or lab projects for which the primary goal is to generate new knowledge should be submitted to the IRB for review and approval For example, a pilot project that will be the basis of a publication, a grant proposal, master’s thesis or doctoral dissertation should be reviewed even if it is originally carried out in a class setting.

Do evaluations or quality assurance/improvement activities require IRB review?

Data collected with the limited intent of evaluating and improving existing services and programs or for developing new services or programs does not require IRB review Examples of these activities include teaching evaluations or customer service surveys.

Do pilot studies or feasibility studies require IRB review?

Pilot studies, sometimes called feasibility studies, are typically conducted on a small scale and are exploratory in nature Such studies help the investigator refine data collection procedures and instruments or refine the research design Such studies may also be conducted to support a grant application.

When pilot or feasibility studies involve human subjects, IRB review is required When preparing the IRB application for such a study, investigators should identify it as a pilot or feasibility study so the Board understands the context of the study This is particularly helpful when the Board considers the justification for the sample size or research design.

Does the use of publicly available data sets require IRB review?

Data sets that do not include information that can be used to identify individuals and are publicly available do not require IRB review.  Publicly available data refers to data that are available without restriction or conditions on their use and are freely accessible to anyone For further information please see our guidance Existing Public Use Datasets.

When does the secondary use of data require IRB review?

Secondary data or secondary use data are other names for existing data Existing data refers to data that has been previously collected, typically for a use different than the current research, and is already sitting on the shelf at the time the current research is proposed Whether IRB review is required depends on the type of data used, how they were obtained, level of identifiability and the investigator's relationship to the provider.

Secondary use of publicly available data

Data that are publicly available without restriction or conditions on their use and are freely accessible to anyone, and no investigator on the study have access to information which could identify any individual person does not require IRB review For further information please see our guidance Existing Public Use Datasets.

Data that are publicly available without restriction or conditions on their use AND contain private identifiable information require IRB review Use of such data typically qualifies for exemption under category 4.

Secondary use of data from non-public sources

IRB review is required when investigators receive or obtain data from a non-public source.

Use of such data which are recorded (i.e., abstracted, logged, etc.) in a manner that excludes all direct identifiers, any indirect identifiers from which identities could reasonably be deduced, and no investigator on the study can ascertain an individual’s identity often qualifies for exemption under category 4 If using data that qualifies as private health information (PHI) under HIPAA, only the following data elements may qualify for exemption:  geographic information other than street address (e.g., city, state, zip code), dates (e.g., admission, discharge, service, birth, death, etc.), and ages.

Use of data which includes either direct identifiers or indirect identifiers which could potentially allow identities to be deduced, or from which a study investigator could ascertain an individual’s identity does not qualify for exemption The study should be submitted to the IRB using a non-exempt application

Secondary use of an investigator’s own data

In the course of research investigators may change or expand plans for the use of specimens or data from current or previously-approved research

Secondary use of data which have been completely de-identified (including all 18 elements of PHI if applicable) and if coded, code keys are destroyed/links broken, does not require IRB review.

Secondary use of data which are identifiable or from which individuals can be identified must be reviewed by the IRB Follow the instructions below for the scenario most applicable to your own.

Data analysis plans for a currently approved study have changed.  Submit an amendment to the currently approved study for review of the proposed changes.

Analysis of data from a previously approved study that is now closed.  Submit a new non-exempt application describing the data analysis plan Describe the original study and consent used with the data collection If the original IRB approved study and consent did not include information about the newly proposed analyses, a procedure for obtaining consent from those subjects who provided the data or a request for a waiver of informed consent (and authorization if PHI is involved) should be included with the new application.

Sharing data with a colleague.

If the study is ongoing and does not include provisions for sharing the data, amend the study and revise the consent form to allow sharing of prospectively collected data Once that amendment is approved, the investigator can share only those data from subjects who have consented to that disclosure If the investigator wants to share the data already collected from subjects, s/he will need to include in the amendment that they will re-contact and re-consent subjects before sharing their data   In both of the aforementioned scenarios, the investigator receiving the data will need to submit an application for IRB review.

If the study from which data will be shared is closed, only de-identified data may be shared.  Please consult with us before sharing any de-identified data.

Storage of data to share with colleagues or students in the future.  Submit a non-exempt application to create a data repository.  Describe the original study and consent used with the data collection If the original IRB approved study and consent did not include information about future use, a procedure for obtaining consent from those subjects who provided the data or a request for a waiver of informed consent (and authorization if PHI is involved) should be included with the new application.

My research involves only the use of tissues/specimens. Do I need IRB review?

Use of extra material” for research requires submission of a non-exempt application for IRB review Extra material” is collected above and beyond what is needed for a clinical or diagnostic procedure It is collected during the procedure, but solely for investigational purposes Collecting and using extra material” requires subjects’ written consent.

Waste material” is collected originally for clinical or diagnostic purposes only AND is no longer needed and would otherwise be thrown away Use of waste material” with identifiers or that could be linked to identifiers by any investigator on the study must be submitted for IRB review.*  

Waste material” without identifiers* may still require IRB review To determine if IRB review is required, refer to the guidance Research Involving Private Information or Biological Specimens”.

Other tissues/specimens may require IRB review depending on how they are obtained, level of identifiability* and the investigator’s relationship to the provider To determine if IRB review is required, please refer to the decision tree/guidance Research Involving Private Information or Biological Specimens”.  

Please note that studies involving the use of fetal tissue may require review even if the activities do not meet the definition of research” and human subject” If interested in conducting research involving fetal tissues, please contact our office for further guidance.

* The term identifiers” includes any of the 18 data elements that constitute protected health information (PHI).

My study has approval from a non-Purdue IRB? Does it still require IRB review at Purdue?

Studies conducted by individuals affiliated with Purdue

Yes, any time an individual affiliated with Purdue is involved in the conduct of human subjects research, a Purdue IRB must review the study There are certain specific situations in which Purdue’s HRPP may determine deferral to another institution’s IRB is appropriate An example is a collaborative research project in which the Purdue investigator’s only involvement is the analysis of de-identified data. However the decision to defer oversight to another IRB is made on a case-by-case basis, so be certain to consult with our office.

Studies conducted only by individuals who are unaffiliated with Purdue.

If no Purdue-affiliated individuals are involved in the conduct of the study, then submission to Purdue’s IRBs is not required.

I am a consultant on a non-Purdue research study, do I need to submit an application to Purdue’s IRB?

IRB review at Purdue is required unless the researcher has a clear consulting relationship in which:

  • the researcher is hired on his or her own time and has submitted or will submit a Reportable Outside Activity disclosure,
  • the researcher holds no rights in the work, and
  • neither the researcher nor the University retains any data.

All three of these criteria must be met or IRB review is required.

When do oral histories require IRB review?

Oral history is a data collection method in which interviews are conducted with individuals who participated in a particular historical event or period and is audio or video recorded This data collection method is intended to collect, preserve and interpret the voices and memories of people and communities as a method of historical documentation.

Oral history activity that does not require IRB review

When the intended use of this data collection method is to document a particular past or unique event in history, but not draw conclusion about those events or otherwise generalize those findings, the activity is not research as defined by 45 CFR 46 and does not require IRB review The exercise of professional ethics is expected in the conduct of these activities.

Oral history activity that does require IRB review

If the intended use of this data collection is 1) as described in the paragraph immediately above and 2) create an archive for the purpose of providing a resource for others to conduct research, then the activity constitutes research under 45 CFR 46 and requires IRB review Because the intent of the archive is to create a repository of information for other investigators to conduct research as defined by 45 CFR 46, the creation of such an archive would constitute research under 45 CFR 46 and requires IRB review

Oral history activity that does require IRB review

When the intended use of this data collection method is to document a particular past or unique event in history and draw conclusions, inform policy or generalize findings, the activity is research as defined by 45 CFR 46 and requires IRB review.

Do case studies require IRB review?

A case report study is understood to mean the collection and presentation of detailed information about a particular participant or small group, frequently including accounts of participants themselves A form of qualitative descriptive research, the case study looks intensely at an individual or small participant pool, drawing conclusions only about that participant or group and only in that specific context It may involve collecting data about participants using participant and direct observations, interviews, protocols, tests, examination of records and collection of writing samples Case studies may also involve either retrospective and/or prospective activities and may be clinical or non-clinical in nature.

A retrospective case study looks backwards and examines the incidence of certain factors in relations to an established outcome

A prospective case study looks forward and examines particular individuals or particular outcomes that may be associated with the presence/absence of relevant factors

The question of whether case report studies require IRB review is a difficult one to address because the answer is contingent on a number of factors specific to each study Because of this, the need for IRB review is frequently made on a case-by-case basis The table below identifies which case report activities require IRB review Please feel free to contact us with any questions.

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