What is an Institutional Review Board?

Federal regulations define an Institutional Review Board as a group of individuals within an institution that have been trained in the ethical principles of human subject research and the federal regulations so that human subject research taking place in or affiliated with the institution be reviewed and approved in accord with 45 CFR 46. The IRB reviews all human subjects research before it can be conducted within/affiliated with the institution.

What is meant by research?

Federal regulations define research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. CFR 46.102 deems certain activities not to be research for purposes of these regulations. These activities include:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

What are human subjects?

Federal regulations define human subjects as a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

What is human subjects research?

Federal regulations define human subjects research as research on a living individual in which the investigator is observing, interacting, testing, recording, obtaining, using, studying, analyzing, or generating private and/or personal information or biospecimens in a way that the individual could be identified.

What is minimal risk?

Federal regulations define "minimal risk" as follows: "The probability and magnitude 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." In broad terms, a project involves minimal risk if:

  1. The participant experiences no pain or physical danger;
  2. The participant experiences no emotional arousal or psychological stress beyond the levels typically expected in everyday life;
  3. The project neither induces nor attempts to induce long-term significant negative change in the participant's behaviors (including attitudes toward self and others);
  4. The data would not embarrass or socially disadvantage the participant, were confidentiality to be violated; and
  5. If the investigator conceals information about the specific purpose of the project, there is no reason to believe the subject would choose not to participate if s/he had known that information initially.

What is meant by a vulnerable population?

Federal regulations describe the following categories as likely to be vulnerable to coercion or undue influence: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. Subjects from these populations may require additional consideration or protection.

What is considered private information?

Federal regulations define private information as including 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).

What is considered personal information?

Federal regulations define personal information as private information provided (disclosed) by the individual for specific purposes and which was intended for that purpose and expected to not be re-disclosed.

What is personal identifying information?

Federal regulations define personal identifying information as data that can personally identify an individual, such as: name, address more specific than a zip code’s last digit, social security number, email, telephone number, electronic device registration, static IP address, or combinations of information, such as: date plus place of birth, biometric records plus mother’s maiden name, or place of employment plus IP address. This includes any information that is linked, can be linked, or is linkable to an individual.

What does informed consent mean?

Fully informing participants of the risks, benefits, and procedures involved in a study is a standard requirement in research with human participants. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to all types of research including surveys, interviews, and observations in which participants are identified.

For information on the basic elements of informed consent, visit the informed consent page on the IRB website.

What is considered identifiable private information?

Federal regulations define private information as private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

What is considered an identifiable biospecimen?

Federal regulations define an identifiable biospecimen as a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

What is considered a clinical trial?

Federal regulations define a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

What is considered intervention?

Federal regulations define intervention as including both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

What is considered interaction?

Federal regulations define interaction as including communication or interpersonal contact between investigator and subject.

Research Subjects

What kinds of risks might research subjects face?

Physical Risk

Physical discomfort, pain, injury, illness, or disease brought about by the methods and procedures of the research.

Psychological Risk

Psychological effects may be experienced during the research situation and/or later as a result of participating. Includes anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and altered behavior.

Social/Economic Risk

Alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and powers in relation to others. Economic risks include actual costs to the subjects for procedures, loss of wages or income, and damage to employability.

Legal Risk

Risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally or civilly liable.

Loss of Confidentiality

Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks include invasion of privacy, as well as the social, economic and legal risks outlined above.

Are there special considerations when children are the research subjects?

Yes. For many procedures, persons under the age of 18 years are not of legal age to provide informed consent. For these procedures, signed consent must be obtained by a parent or legal guardian. Federal regulations define "parent" as the child's biological or adoptive parent and "guardian" as an individual authorized by the state or local law to consent on behalf of the child. In addition to signed consent from the parent or guardian, researchers should also seek assent from the child when possible. "Assent" is defined as the child's affirmative agreement to participate in the research, and should not be construed to mean a lack of resistance to participation. Very young children or children with cognitive impairments may not be able to provide assent. Due to the vulnerable nature of children, the IRB must review all proposals in which children are involved as subjects. However, some types of research with children are exempt from IRB review and oversight as described in Subpart A, 46.101 of the Common Rule. Typically, this type of research is conducted in established or commonly accepted educational settings involving normal educational practices or exploring educational tests.

Do all studies require signed informed consent?

No. The IRB may waive the requirement for signed informed consent if any of the following conditions is true:

  1. That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
  2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
  3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

However, all subjects must be informed of the nature and purpose of the study, what will be asked of them for participation, any risks or benefits of participation, that participation is voluntary, and who to contact for more information, whether or not signed informed consent is required.

Proposals and Reviews

How long will the IRB take to review my proposal?

The IRB makes every attempt to respond to requests for review within 14 days of submission. However, during particularly busy periods, additional time may be necessary. The IRB does not meet during the summer, so any proposal needing review should be submitted by the March deadline.

If a project raises particular issues that the IRB feels are not adequately addressed in the submitted materials, the researcher may be asked to submit additional information, clarify a point, or make revisions. On rare occasions, the researcher and faculty supervisor may be asked to appear before the IRB to resolve matters of procedure, etc.

Does my project get reviewed faster if it gets an "expedited" review?

No. An expedited review does not mean your application is processed faster. In the case of expedited reviews, one reviewer, rather than the full board, reviews your proposal. The IRB makes every attempt to respond to each request for review within 14 days of submission.

What if my project is approved by a non-University of Portland Institutional Review Board?

All research involving University of Portland faculty, staff, or students falls under the purview of the University IRB. Therefore, you are still required to submit your proposal for review to the University of Portland IRB, even though external IRBs may also be required to review the proposal. When multiple IRBs are involved, each board works collaboratively and shares responsibility and liability equally. However, the University IRB may defer to the requirements and preferences of collaborating IRBs in terms of protocols, procedures, and formats of documentation as long as they do not conflict with federal requirements.

Does institutional research need IRB review?

Much research that is conducted by faculty or staff under the heading of institutional research does not require direct IRB review, because in most cases, such research meets the following conditions:

  • The research does not pose more than minimal risk to subjects;
  • No vulnerable populations are involved; and
  • There is no intention or expectation of disseminating the results of the research outside of the classroom or institutional setting.

However, if any of these three conditions are not met, IRB review is required.

Do practice improvement projects need to be reviewed by the IRB?

Practice improvement projects (PIPs) do require review from the IRB unless the project meets all three of the following conditions:

  1. The project involves minimal risk to subjects;
  2. It does not involve vulnerable populations;
  3. Results will never be distributed outside the classroom and/or institutional setting.

If there is even a remote chance that the data, the report, or the manuscript will be used in the future for a conference presentation or a related research project, the research should go through IRB review. This includes dissemination on the Internet in any form.

Do I need to submit my proposal to the IRB for review if I am not collecting any identifying information?

Yes, if your research project involves active data collection. Federal regulations require that all research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.

What happens when my approved project reaches the one year expiration date?

If IRB approval of the research proposal expires, all study procedures related to the proposal must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing research procedures is a violation of federal regulations. You will need to complete a Continuing Review/Revision Form and receive continued approval from the IRB in order to continue research.