Prior approval must be sought before research is conducted on Human Subjects. Any research completed without IRB
approval may not be used in public presentations or publications, including but not limited to: journals, books, websites,
blogs, etc.
A. Application
Researchers must submit a complete research plan with accompanying documents (e.g., consent forms, surveys,
questions, scripts, recruiting material, etc.) to be reviewed. To do this, Researchers will complete an application found on
the SMU IRB website and provide all supporting documents to researchcompliance@smu.edu.
Application Form (PDF) (save, then open and edit using Adobe software)
Application Form (Word)
B. Model Application
A model application is now available for your reference.
Model Application
C. Protocol Materials the IRB Must Review
The IRB shall review all materials to be presented (visually or audibly) to subjects participating in research projects. This
includes, but is not limited to, materials such as recruiting flyers, emails, phone scripts, experimental manipulations,
questionnaires, videos, information sheets, debriefing materials, etc. All such materials will be submitted to Research
Compliance along with the other documents required for initial review. These materials will be reviewed by the IRB for
their appropriateness and protection of the study participants.
D. Review Process
The Compliance Staff will review the application for completeness and request any needed information from the
Researchers. Next, Compliance Staff, in consultation with the IRB Chair as needed, will make an initial determination regarding the appropriate level of review for the protocol.
If the study is Exempt: These studies are reviewed throughout the calendar year by Compliance Staff and IRB members. Once approved, an official letter will be sent to the Researcher stating that the study
is exempt. No research may be conducted until the exempt IRB letter is sent.
If the study is Expedited: Expedited review takes place throughout the calendar year. At least one member of the IRB will
review the application and provide the Researcher with a letter requesting any modifications. The Researcher will make
the necessary changes or explanations as to why the change is not feasible. Once the Protocol is approved, the Researcher
will be sent an official letter stating they have approval for the research and if continuing review is required. No research may be
conducted until the IRB final approval is sent.
If the study is Full Board: These studies are reviewed at the monthly IRB meeting. A list of the meeting dates and deadlines
for submission of applications is available below. All members of the IRB will receive a copy
of the study to review. The Researcher may be invited to attend the monthly IRB meeting to present their research and answer clarification questions from the IRB. After the meeting, the Researcher will be sent a letter requesting any needed
modifications. Once the requested modifications have been addressed, the Researcher will re-submit the application
materials to the Research Compliance Staff. Depending on the extent of the required modifications, the Researcher may
or may not be required to come back before the full board. This process will continue until all necessary changes are made
to the study procedures. Once the Protocol is approved, the Researcher will be sent an official letter stating they have approval for
the research and how long the approval is valid – typically one year. No research may be conducted until the IRB final
approval is sent.
E. Submission Deadlines and Meeting Schedule AY 2019 - 2021
The IRB meets on the first Wednesday of every month to conduct Full Board Reviews. Applications must be submitted 2 weeks before a schedule meeting in order to be discussed at the meeting. Depending on the type of research and the level of risk associated with the project, most new protocols, continuing reviews, and amendments will be reviewed on an as-needed basis outside of regular meetings.
Scheduled IRB Meeting |
Submission Deadline for Applications
to be Reviewed at this Meeting |
8/5/2020 |
7/22/2020 |
9/2/2020 |
8/19/2020 |
10/7/2020 |
9/23/2020 |
11/4/2020 |
10/21/2020 |
12/2/2020 |
11/18/2020 |
1/6/2021 |
12/23/2020 |
2/3/2021 |
1/20/2021 |
3/3//2021 |
2/17/2021 |
4/7/2021 |
3/24/2021 |
5/5/2021 |
4/21/2021 |
F. Types of Review
Exempt Review
It is the responsibility of the IRB and Compliance Staff to make fair and consistent decision as to what studies will be qualify for exemption at
SMU. Further, the IRB and Compliance Staff determine exempt status, NOT the Researcher. All Human Subjects Research MUST be submitted to
the IRB for evaluation. Exempt does NOT mean “no review.”
To even be considered for exempt status, the research must involve no more than minimal risk. Next, the research must
fit into one of the following six categories, enumerated in 45 CFR 46.104:
- Research, conducted in established or commonly accepted educational settings, that specifically involves normal
educational practices that are not likely to adversely impact students opportunity to learn required educational
content or the assessment of educators who provide instruction, such as:
- Research on regular and special education instructional strategies
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or
classroom management methods
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior, if at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human
subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the Human Subjects’ responses outside the research would not reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability,
educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human
subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB
conducts a limited IRB review to make the determination that there are adequate provisions to protect
the privacy of subjects and to maintain the Confidentiality of data.
- Research involving benign behavioral Interventions in conjunction with the collection of information from an adult
subject through verbal or written responses (including data entry) or audiovisual recording if the subject
prospectively agrees to the Intervention and information collection and at least one of the following criteria is
met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human
subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
- Any disclosure of the Human Subjects’ responses outside the research would not reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability,
educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human
subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB
conducts a limited IRB review to make the determination that there are adequate provisions to protect
the privacy of subjects and to maintain the Confidentiality of data.
- Secondary research uses of Identifiable Private Information or Identifiable biospecimens, if at least one of the
following criteria is met:
- The Identifiable Private Information or Identifiable biospecimens are publicly available;
- Information, which may include information about biospecimens, is recorded by the investigator in such
a manner that the identity of the Human Subjects cannot readily be ascertained directly or through
identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will
not re-identify subjects.
- Research and demonstration projects which are conducted by or subject to the approval of appropriate Federal
Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
- Public benefit or service programs;
- Procedures for obtaining benefits or services under those programs;
- Possible changes in or alternatives to those programs or procedures; and/or
- Possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies,
- If wholesome foods without additives are consumed, and/or
- If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe,
or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food
and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and
Inspection Service of the U.S. Department of Agriculture.
Expedited Review
Expedited reviews are completed on research that poses only minimal risk to participants, but that is not eligible for an
exemption. In the case of expedited reviews, the proposal will not be reviewed by the full board and can be handled
throughout the year.
The Code of Federal Regulations (45 CFR 46.110) permits research activities in seven categories to undergo
expedited review. More details about eligibility criteria for Expedited Review can be found here.
Full Board Review
Research that does not qualify for exempt or expedited review and/or presents more than minimal risks to subjects shall
be reviewed at a fully-convened board meeting.
Below are some examples of situations at SMU that may require full board review:
- The proposed research involves vulnerable populations
- The proposed research includes video or audio recordings or photos where identification of the subjects could
place them at risk such as legal, employability, reputation, etc
- The Researcher is seeking a waiver or alteration of informed consent
- The proposed research involves deception
- The research involves physically invasive procedures
Chair-Endorsed Administrative Review
Specific amendments and Continuing Review may be reviewed by the Compliance Staff for approval. These reviews would
be allowed for the following:
- Addition / deletion of Personnel
- Change in project title or Funding source
- Continuing Review when no participants have been enrolled, or if the study is continuing with no participant
involvement
de novo Review
Occasionally, studies that have been open for several years and / or studies that have been extensively amended pose a challenge for IRB reviewers because it is difficult to understand the current scope and risk of the study. Therefore, upon request of the IRB reviewer, some researchers may be asked to submit a de novo application for an existing study. This will detail the current status of the study. It will be reviewed as a new application.
G. Criteria Used to Evaluate IRB Proposals
- Have the risks to participants been mitigated or minimized?
- Are the anticipated and potential risks reasonably balanced with the anticipated benefits of the research?
- Are the recruiting and selection processes of subjects fair/equitable (i.e., free from bias and not unintentionally
targeting special groups)?
- Is the consent process such that participants can make an informed and voluntary decision to participate (e.g.,
understandable language, accurately reflect what to expect, anticipated risks, rights, not coerced, etc.)?
- Are the data protected to assure the privacy and well-being of participants?
i. Types of Risk
Examining risk is one of the main foci of the IRB when reviewing an application. It is important to note that it is extremely
common for research studies to have some risk.
No greater than minimal risk: This is where the risk of psychological, physical, social, legal, etc. is no greater than what
would be ordinarily encountered in daily life or during the performance of routine physical or psychological examinations
(45 CFR 46.102(j)).
Greater than minimal risk: When the risk of psychological, physical, social, legal, etc. exceeds what would be ordinarily
encountered in daily life or during the performance of routine physical or psychological examinations.
Emotional Risk: Any research activity such as a survey, questionnaire, viewing of stimuli, or experimental condition that
could possibly result in emotional stress.
Privacy/Confidentiality Risk: Any research activity which could result in negative consequences for participants if their
Confidentiality is broken.
Physical Risk: Any research activity where a participant could be physically harmed.
Legal Risk: Any research activity where illegal activity or information may be uncovered.
Economic Risk: Any research activity where the participant incurs costs or where it could affect a participant’s livelihood.
Social Risk: Any research activity that could harm a participant’s standing in the community or cause them to lose their
job.
ii. Vulnerable Subjects
SMU’s IRB takes a strong stance when it comes to vulnerable populations and their protection. Federal regulations require
IRBs to give additional protection to the defined categories of vulnerable subjects (45 CFR 46 Subparts B-D): pregnant
women, prisoners, and children. However, the guidelines suggest in addition to these defined categories, people with
impaired cognitive ability, or economically and educationally disadvantaged people, may be considered as vulnerable
populations.
Individuals with impaired capacity to consent include individuals who may be unable to legally provide informed consent
related to some impairment. This could include individuals with a severe mental illness (e.g., psychoses, schizophrenia,
severe depression, etc.), developmental disabilities, dementia, traumatic brain injury, and any other reduction of cognitive
capacity. For the additional groups mentioned in the regulations, the IRB will look at the context of the study to determine
whether these additional groups are vulnerable based on the context.
In addition, we look at additional populations that would normally not be considered vulnerable, but the context of study
could make them vulnerable. A vulnerable population does not necessarily trigger a full- board review, although it often
will.
iii. Recruiting of Research Subjects
The IRB shall review all materials used to recruit research subjects. Advertisements should include:
- Name, office address and phone number of the appropriate person to contact for additional information;
- The location of the research;
- Wording that effectively communicates the purpose of the research;
- The eligibility criteria to be used in selecting participants/subjects;
- A truthful description of the benefits;
- If subjects will be compensated; and
- The duration of the project.
In addition, advertisements should not provide misleading, inaccurate, or coercive information. For instance, if
participants will receive payment for participating, this should not be the focus of the flyer.
iv. Equitable Selection of Participants
It is the responsibility of the IRB to ensure equitable selection of participants. To do this, the IRB will review
inclusion/exclusion criteria for the research study and take into account the purpose of the research, the context of the
research, as well as the vulnerability of the participants.
Coercion or Undue Influence
- Dual Relationships: A dual relationship concern can exist when the Researcher or recruiter for the study is in a
position of power or influence over the research participants not connected to the research. For example, a doctor
suggesting a patient participate in a research study may result in a patient thinking they have to participate in the
research. Another example would be a professor in a class recruiting participants for research and the students
feeling they could have a grade lowered or have a negative impression by the professor if they do not participate.
- Remuneration: Remuneration to participants must be perceived as being proportional to the risks and time
related to the study. For example, a large amount of money might overly influence a person who is homeless to
participate in a research study.
v. Remuneration to Participants
Remuneration to participants may be used as an incentive to recruit participants for the research study or to reimburse
participants for their time, travel, or expenses to participate. However, Researchers must avoid remunerations that could
be seen as coercive or having undue influence to potential participants. In other words, compensation must be perceived
as being proportional to the risks and time related to the study. The IRB must approve both the amount and disbursement
of remuneration to assure there is no undue influence or possible coercion from the remuneration. In addition, the
consent document must describe the amount of remuneration, terms to receive the remuneration (e.g., if partial payment
if they withdraw before the study is completed or if they get paid after each research session, etc.). Typically payment
should not accrue if there are multiple parts to the study. If identifying information is needed from the participants to
receive remuneration, then this must be explained to the participants in the consent.
H. Possible Outcomes of the Review Process
Approved
No further action is required from the PI / PD and the research may be started. Researchers are NOT allowed to begin research
until a letter has been received from the IRB stating the study has been approved.
Approved Pending Modification / Training Completion
Minor changes to the Protocol or training completions are needed before research may begin. The IRB will enumerate
the requested changes and/or required training(s), and the applicant must re-submit the modified Protocol for
confirmation.
Denied
The proposed research cannot be conducted as proposed due to the level of risk involved. If this happens, the IRB will
work with the Researcher to find a way to conduct research if possible.
I. Appeals of IRB Decisions
Denied Research
If the IRB feels the risks of study participation outweigh the benefits of the research and the Researcher disagrees with the
IRB’s decision, the Researcher may initiate an appeal requesting reconsideration. The appeal must be submitted in writing
to the IRB chair within 2 weeks of the decision. This appeal should include the Researcher’s arguments for approval and
any additional supportive information. If the IRB chair believes the new information warrants an appeal, the full IRB
committee will hear the appeal at the next full board meeting. The IRB’s determination of the appeal is final. However, if
the appeal is denied, the Researcher may submit a revised Protocol for consideration.
Denied Use of Data
In the event a Researcher has been found out of compliance in their research or does not have an approved Protocol for
research, the IRB may rule that specific data may not be published in affiliation with SMU. If the Researcher disagrees with
the IRB’s decision, the Researcher may initiate an appeal requesting reconsideration. The appeal must be submitted in
writing to the IRB chair within 30 days of the decision. This appeal should include the Researcher’s arguments for approval
and any additional supportive information. If the IRB chair believes the new information warrants an appeal, the full IRB
committee will hear the appeal at the next full board meeting. The IRB’s determination following the appeal is final.
Authority of Appeal Process
In the case of a decision to disapprove, suspend, terminate a project, or disallow usage of data, the decision may NOT be
reversed by any administrator at SMU. The IRB retains the final authority for approval of proposed research with human
subjects.