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Terms & Definitions
Alteration of Informed Consent
An alteration of consent may be approved by the IRB if certain criteria apply to the research (see Waiver of Informed Consent). An alteration is a change in the consent process or elements of consent that differs from what would normally be required under the regulations or in normal practice. For example, the use of deception for which you do not tell the subject the full purpose, all the tasks they are completing for the research, or why certain tasks are being done would require the IRB to approve an alteration of consent. The IRB must approve an alteration of the consent requirement to allow for not providing the true information (in one or more elements of consent) to the participant before the conduct of the research.
Please Note: There is no such thing as “passive consent” – only alterations or waivers of consent.
A study may be considered to collect “anonymous” data or the subjects may be considered to be anonymous when the researcher never has direct contact with the research subject and never collects information that identifies the participant in the research record such that neither the researcher nor anyone looking at the data could identify the individual from whom the data was collected. A study or study data would not be anonymous if the researcher collects participant names, other identifiable information, voice or video recordings, or identifying information on an audio tape (recorded or written on the tape). Additionally, a study or study data might not be anonymous if a combination of data elements, such as birth date, occupation, and zip code, could reasonably be used to determine the identity of the participants.
Data collected prior to the time of application (existing data) to the IRB and without the intention of using them in the current project. These data may have been collected for non-research purposes or on other IRB-approved research projects.
A child’s affirmative agreement to participate in research. In order for children to participate in research, assent for children ages 7-17 is required for all expedited and full board review projects. Even when parental permission is obtained, this does not obligate children to participate in research, and a verbal or written assent process should occur, depending upon which is appropriate for the age and maturity level of the child, to determine child’s interest.
Coded data means that:
- Identifying information (such as the participant’s name) has been replaced with a number, letter, symbol, or combination of coding mechanisms; AND
- A key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
Confidentiality relates to how the research data is protected once it is collected and in the hands of the researcher. Researchers should only collect identifiable information as needed, and may use the following practices to protect confidentiality when identifiable information is collected: substituting codes for identifiers, removing identifiable information (such items as names and addresses) from survey instruments containing data, properly disposing of any printed documents (shredding) or video or audio tapes (erasing), limiting access to identified data, training research staff on the importance of confidentiality and the approved confidentiality procedures, and storing research data in password protected computers or encrypted files, and storing research records in secure locations, such as spaces with limited access or in locked cabinets.
Confidentiality should be maintained exactly as stated in the consent/assent/information sheet documentation, as participants provide information and choose to participate in the research based on their understanding of the information provided to them and the promises made to them related to confidentiality.
For additional information about confidentiality see OHRP IRB guidebook, Chapter III at: www.hhs.gov
Deception involves an incomplete disclosure of the research purpose or elements of the research during the initial informed consent process. If deception is used, it is generally suggested that participants be debriefed about the information that was not fully disclosed to them previously and why the deception was necessary to meet the research goals.
In some instances the debriefing may cause more harm and might not be appropriate. For example, if the debriefing would provide the participant with disturbing information about themselves (i.e., they would be willing to inflict harm on others, or possess a borderline personality), full debriefing may not be necessary. In order for an investigator to use deception, they must request an alteration of consent, because the consent process is altered such that the subject is not fully informed about one or more elements of consent.
The knowledge that is expressed in theories, principles, and statements of relationships that can be widely applied to our experiences. Generally, the term is used to refer to the intent to disseminate the research results and conclusions beyond an individual or internal group. Generalizable knowledge is usually created to share with other people, for example through publication of an article in a journal, presentation at a local or national conference, or preparation of a thesis or dissertation.
The process of making knowledge generalizable would include one or more of the following concepts or methods:
- The knowledge contributes to a theoretical framework of an established body of knowledge.
- The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study (i.e. the benefit of the research is the knowledge gained).
- Publication, presentation or other distribution of the results is intended to inform the field of study or used for professional purposes.
- The results are expected to be generalized or applied to a larger population beyond the site or data collection.
- The results are intended to be replicated in other settings.
A living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual
- Identifiable private information
Identifiers include names, Social Security numbers, medical record codes, and internal code numbers that permit data to be linked to individuals. Audiotapes contain identifiers even if they are not labeled with clear identifiers (e.g. name, initials), the recording does not contain individually identifiable information like someone saying a name, or the tape will not be used for any purpose outside of the research, because the voice itself is considered to be identifiable. Video tapes would include identifiers, even if they are not labeled with codes/identifiers, unless the person’s image is blacked out or blurred such that they cannot be identified and the voice has been disguised.
Private information or specimens are individually identifiable when they can be linked to the individual research participant by investigator(s) or others either directly or indirectly through coding mechanisms. Obtaining identifiable private information or specimens for research purposes falls under the definition of human subjects research (see Obtaining).
A process by which a subject voluntarily confirms his or her willingness to participate in a particular research study, after having been informed of all aspects of the research study that are relevant to the subject's decision to participate. The subject is generally provided the information in a written document, and a verbal discussion of the document with an opportunity for the subject to ask questions is required unless an alteration or waiver of consent is granted. Informed consent refers to the process of explaining the study and insuring the participant understands the study, and usually involves documenting the consent process by obtaining the subject’s written signature.
At times it may be appropriate for the consent process to occur in a format other than using a written document, such as a verbal process, on-line process, or obtaining a waiver of the requirement to obtain a written signature (waiver of documentation).
The probability (likelihood) and magnitude (degree or level) of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Minimal Risk for Research Involving Prisoners
For participants who are considered prisoners under the Federal regulations, minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Receiving or accessing identifiable private information or identifiable specimens for research purposes. Obtaining would include an investigator’s use, study, or analysis of identifiable private information or identifiable specimens already in the investigator’s possession. For example, if an investigator were using data from one research study for a newly proposed research study with differing research aims or goals, this could be human subjects research. Note: The new use of data would require IRB review and approval.
Parent/Legal Guardian Permission
The agreement of the parent(s) or legal guardian for their child or ward to participate in research. This is required for children under the age of 18 (in Illinois) or under the legal age of consent, as determined by the location where the research will be conducted, to be eligible to participate in expedited or full board research (unless a waiver is granted).
Having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Privacy is related to the individual research participant and access to them or their information. Privacy issues in research protocols are related to the method used to obtain information about the participant, such as how they are identified and recruited as research participants. For additional information about privacy, see the OHRP IRB handbook, Chapter III at: www.hhs.gov.
Any planned or unintended changes or deviations from the IRB approved study protocol, consent document, recruitment process, or study materials that were not approved by the IRB prior to implementation. Generally, protocol violations occur after the subject is enrolled in the research. However, some protocol violations, such as deviations from the approved consent process, can occur before the subject is enrolled in the research. Protocol violations may be major or minor in severity, but are always examples of non-compliance. Protocol violations should be reported to the IRB as soon as possible after their occurrence through the Unanticipated Problem reporting process. Please refer to the DePaul Research Protections guidance and forms portion of the web-site for additional information about protocol violations.
This refers to public sources of data, such as telephone books, data bases, libraries, and the internet. Data obtained from data banks, archives, or organizations that make data sets broadly accessible at a reasonable cost to the research community are also considered publicly available.
Recorded by the Investigator
Data “recorded by the investigator” are those data that are transferred from the existing records (usually privately held) to the new research records by the researcher or another member of the research team. For the purposes of category 4 exemptions, members of a research team may look at identifiable data while it remains where it is usually housed (such as medical records in a hospital), so long as no identifiable information (e.g., names, social security numbers, internal codes) becomes part of the research record, whether via written notes, photographs, audio/video recordings, etc.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Unanticipated problems include any unforeseen or unexpected incident or experience (including an unanticipated adverse event) that occurs during the conduct of the research and that was not described in the information reviewed by the IRB (i.e. research protocol, research application, or informed consent document) or was not expected based on the characteristics of the study population. Not all unanticipated problems result in additional risks to subjects or others, or the potential for risk to subjects or others. Therefore, only some unanticipated problems meet the definition of an unanticipated problem involving risks to subjects or others (UPIRSO – see below).
Events that are not UPIRSOs are not required to be submitted to the IRB immediately for review, but should be reported at the time of continuing review. Unanticipated problems can include subject complaints or protocol violations.
Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO)
An incident, experience, or outcome that:
- Is not expected (in terms of nature, severity, or frequency) given:
- The research procedures that are described in the protocol-related documents (such as the research application, protocol, and informed consent document)
- The characteristics of the subject population being studied
- Is related or possibly related to participation in the research
- Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
Waiver of Documentation of Informed Consent
An IRB may waive the requirement for obtaining a signed consent document if:
- The only record linking the participant and the research is the consent document and the principle risk of the research would be potential harm resulting from a breach of confidentiality. In this case each participant should be asked whether they want documentation linking themselves with the research, and their wishes govern the final decision on the matter; OR
- The research presents no more than minimal risk or harm to the participants and involves no procedures for which written consent is normally required outside of the research context. A waiver of documentation does not mean that the consent process itself is waived, but means the requirement to document the consent with a written form is waived. The researcher must still obtain informed consent, generally using a verbal discussion and providing the elements of consent in a written information sheet.