IRB Frequently Asked Questions

Institutional Review Board Frequently Asked Questions

What is an IRB?

IRB is the acronym for Institutional Review Board for Human Participants. Any institution that receives federal funding to conduct research with human participants, such as Saddleback College, is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research.

The IRB has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at Saddleback College. However, those officials may not approve research that has not been approved by the IRB for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at Saddleback College.

Is Your Project Considered Research?

Research is a systematic investigation, including research development, testing, and/or evaluation, designed to develop or contribute to generalizable knowledge.

Systematic investigation: A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

Generalizable knowledge: The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following: Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied and/or results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study. Studies conducted purely for pedagogical purposes (i.e. that will not be published or presented outside of a classroom setting) are not considered research and are exempt from IRB review.

Your research is considered to be Saddleback College research if it meets either of these criteria:

  1. Saddleback College is receiving funding for the research (including any funding for salary support) through a grant, contract or cooperative agreement directly from a federal agency.
    It does not matter whether some or all of the human subjects activities will be carried out by another organization. 
     
  2. Saddleback College students or paid employees are involved in the research by doing any of the following:
    • Performing research procedures with subjects
    • Manipulating the environment of subjects for research purposes
    • Interacting with subjects for any research purpose
    • Obtaining informed consent from the subjects
    • Obtaining for research purposes any identifiable private information or biological specimens, from any source, even if there is no direct interaction with the subjects.

Does Your Research Involve Human Subjects?

Why this matters

If your research does not involve human subjects, you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.

Human subject: A living individual about whom a researcher obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

Relationship to obtaining consent: Individuals may be human subjects before they have provided consent, if the criteria defining a “human subject” have been met. This is most likely to occur when with screening or “pre-screening” activities, such as examining identifiable medical records in order to select possible participants.

Special cases

Deceased individuals. This refers to individuals who are not alive, as defined by applicable local and national laws. Although deceased individuals are not considered to be human subjects, Washington State law requires IRB approval or research that will use identifiable Washington State PHI without the consent of the patient (whether living or deceased) or the patient’s legally authorized representative.

Specimens, records, data (no interaction or contact with living individuals). Private identifiable specimens, records and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.

“Third party” or “secondary” subjects. This refers to situations in which the researcher obtains information about one individual (“A”) through interaction with another individual (“B”). If the information about A is private and identifiable, then A is a human subject. Example: Subjects in a cancer study are asked about the cancer history of their relatives.  If the information is provided in a way that is not individually identifiable to the researchers, then the relatives are not subjects.  If the information is individually and readily identifiable to the researchers, then the relatives are subjects.

Newborn blood spots. Federal law defines newborn blood spots collected on or after March 18, 2015 as “human subjects”, regardless of whether the bloodspots are identifiable, coded, de-identified, or anonymous. Federally-funded research using these bloodspots must obtain IRB approval.

Do research projects conducted by Saddleback students need IRB approval?

Yes. Projects conducted by Saddleback undergraduate and graduate students need IRB approval, if the project fits the definitions of "research" and "human participants" as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

What is meant by "exempt" protocol? What are the requirements?

Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.

The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult with ORIA to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.

Is Your Human Subjects Research Exempt from Regulations?

Why this matters: If the IRB administrator determines that your human subjects research qualifies for exempt status, you do not need to obtain Institutional Review Board (IRB) approval.

The answer to this question determines which regulations and requirements govern your research.

Criteria for exempt status:

1.Your research involves no more than minimal risk to your subjects.

2. Your research methods must fit into one of seven categories.

3. Your research is not governed by the regulations of the Food and Drug Administration.

4. There are limits on the use of deception.

If my research qualifies as exempt, does this mean that I don't have to submit a protocol for review?

No. The Federal Regulations do make certain categories of research exempt from IRB review. However, Saddleback College policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.

If you think your research may be exempt from IRB review, you may submit an exemption request form. The IRB staff will review the information submitted and make a determination as to whether the exemption can be granted.

Is the Saddleback IRB the Right IRB?

Why this matters

Every IRB has its own application form and submission process. Submitting an application to the wrong IRB means that you will need to repeat all of your work, with a different IRB application and a different IRB’s process. This is frustrating, time-consuming, and will delay the start of your research.

General principles:

The Saddleback IRB must review all Saddleback research unless a formal agreement has been established between the IRB and another organization that will conduct the IRB review.

The Saddleback IRB is usually the right IRB for most Saddleback research in which Saddleback is conducting all of or a majority of the research activities. For some research activities involving a small number of other organizations, the Saddleback IRB may be willing to conduct review for the other organizations involved. This is determined on a case-by-case basis. To ask whether the Saddleback IRB will conduct review for other involved organizations, follow the directions in the More information section at the end of the page to contact the IRB administrator, before submitting your application to the Saddleback IRB.

When the Saddleback IRB is not the right IRB:

NIH-supported multi-site studies in which all of the sites are conducting the same protocol. NIH requires all of the sites to be reviewed by a single IRB (which may not be the Saddleback IRB).

Research involving other institutions in addition to Saddleback. Many studies involve collaboration with other institutions. The Saddleback IRB may be willing to rely upon the IRB of one of the other institutions instead of doing its own review.

When am I required to submit a proposal involving research with human participants to the IRB?

All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures. I am just doing a simple survey; do I need to submit my proposal to the IRB? Yes, if the study meets the definition for research with human participants, as explained above. Saddleback College's Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.

I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?

Yes, if your research project involves active data collection. Federal regulations and Saddleback College policy 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.

However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.

I will be collaborating with another institution. Do I need to submit to Saddleback's IRB and the other institution?

If you are a member of the Saddleback College faculty or staff, or a Saddleback College student, and you are the person responsible for the conduct of the study, you must get Saddleback IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.

My research will be done in another country. Do I have to obtain IRB review and approval from Saddleback?

Yes. If you are a member of the Saddleback College faculty or staff, or a Saddleback College student, and you are the person responsible for the conduct of the study, you must get Saddleback IRB approval to conduct your research regardless of where the research takes place. You should also be aware that your project may need local IRB approval (or the equivalent ethical review) in addition to Saddleback's.

I want to conduct a study that involves the use of deception. Is this allowed? What do I need to consider?

The use of deception in research is not prohibited by either the federal regulations or Cornell. However, because at some level the use of deception in research violates the trust that the participant puts in the researcher, this method should be considered carefully. Deliberate deception of participants may occur only in situations where withholding information about the nature of the study is necessary to ensure valid results, and never to get participants to do something that they would not do if the information was fully disclosed to them.

Researchers should describe for the IRB the method, rationale and the process of informing participants of the purpose of the research as early as is feasible - preferably at the conclusion of an individual's participation (but no later than at the conclusion of data collection) to permit participants to withdraw their data. Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available. Please refer to the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct for further guidance.

When may I begin data collection for my study?

You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval.

How long will it take for me to obtain approval to do my study?

That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 3 weeks for IRB review.

Research projects that involve greater than minimal risk to participants will need to go to the full board for review, which is scheduled for the first Friday of every month. For applications requiring full board review, you should allow at least 6-8 weeks for review and approval of your study (or longer, if application is submitted over the summer, or if changes are required).

Can the IRB approve a project "retroactively?"

No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.

What does the IRB look for in an application? Are there standard criteria for evaluation?

The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html). Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.

Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject's perspective. The IRB's role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.

What does "informed consent" mean? What are its essential components?

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, and other experiments, such as diet, drug and exercise studies.

Are there different types of informed consent? What are they?

The informed consent process can take on various forms:

Signed informed consent is the standard expectation in research with human participants. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the researcher.

In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements.

In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:

A waiver of using a signed consent form (e.g., giving participants an information sheet but not collecting signatures)

A waiver of written consent (e.g., using oral consent procedures)

A waiver of some or all of the elements of informed consent (e.g., in research that involves deception)

Do I always have to obtain the informed consent of research participants?

In general, yes, but there are some limited exceptions. The Saddleback IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons, and regarded as extremely important in conducting ethical research. The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances. A request for waiver of informed consent must be specifically justified by the researcher in the proposal to the IRB.

  1. An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
    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. That 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;
    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.
    4. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.

How can I take the required training?

You can access the CITI human participant training online.

 

When should a modification (amendment) to an approved research study be submitted?

Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study.