Research with Human Subjects

The main role of the IRB is to ensure that the rights and welfare of research participants are protected. This is done through the approval of all Human Subjects Research and continued monitoring of previously approved studies.

Authority of the IRB

The Common Rule enumerates the authority granted to the IRB in 45 CFR 46.109. An IRB shall:

• Review and have the authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by 45 CFR 46.
• Require that information given to subjects as part of informed consent is in accordance with 45 CFR 46.116.
• Require documentation of informed consent or may waive documentation in accordance with 45 CFR 46.117.
• Notify investigators and the institution in writing of its decision to approve or disapprove proposed research activities, or of modifications required to secure IRB Approval of research activities.
• Conduct continuing review of research not less than once per year, except for research eligible for expedited review, research reviewed eligible for limited IRB review, and research that has progressed to the point that it only involves data analysis and/or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

Foundations of the Protection of Human Subjects

The Belmont Report (1979) provides the foundation for the three basic ethical principles for conducting Human Subjects Research:

• Respect for Persons: Research participants should understand as completely as possible what is to be done to them, what information will be gathered about them, and what the potential risks and benefits are of participating in a research study. The participant must give his/ her consent freely, without pressure or inappropriate inducement. This is indicated by voluntary and informed consent.
• Beneficence: The IRB is charged with deciding whether risks to a participant are outweighed by the combination of potential benefits to the individual subject and the importance of the knowledge to be gained from the study. In other words, an appropriate balance must exist between potential benefits of the research to the subject and/or to society and the risks assumed by the subject.
• Justice: There must be fair procedures and outcomes in the selection of research subjects and the risks and potential benefits should be evenly spread.

IRB Members

The SMU IRB must have at least five members with varying backgrounds. The composition must include, at a minimum: one member whose primary concerns are scientific areas, one member whose primary concerns are nonscientific areas, and at least one member not affiliated with SMU. It is the goal to have the SMU IRB to reflect the diverse community of Researchers at SMU to adequately review and monitor the research activities at SMU. The Assistant Vice President for Research Integrity and Operations will appoint members to the IRB after consulting with the Director of Research Compliance and the IRB Chair. The IRB members will serve a two-year, renewable term.

IRB Chair

The chair of the IRB is appointed by the Assistant Vice President for Research Integrity and Operations. The chair will be appointed from the tenured faculty at SMU. The chair will serve a two-year renewable term.

IRB Administration

The Director of Research Compliance and the Compliance Coordinator serve as ex officio (i.e. non-voting) members at full board meetings.

Special Consultants

On rare occasions, the IRB Chair may invite an expert to consult on a specific Protocol if the IRB votes that consultation is warranted. An expert may be utilized if no IRB member is knowledgeable about a specific issue or experienced in working with a specific area. Consultants will serve only in an advisory role and will not be allowed to vote.

Who May be a PI / PD at SMU

• Any tenured and tenure-track SMU faculty and SMU librarians who have completed required training.
• SMU Personnel who have a Research title and function at SMU who have completed required training.
• Any instructor, visiting professor, clinical professor, adjunct professor, or professor of practice who has approval from the Department Chair or Dean and has completed required training.
• SMU staff members who feel comfortable that they understand the research process and management thereof AND have the approval from the Dean or Appropriate Representative and have completed required training.
• Any SMU doctoral graduate student past their first semester of graduate school who has completed required training.

Who May NOT be a PI / PD at SMU

• Anyone who has not completed required training.
• Undergraduate students
• Master’s level graduate students
• Anyone not a part of the SMU community

Personnel Responsibilities

Principal Investigator (PI) / Project Director (PD)

• Obtaining IRB Approval before beginning Human Subjects Research
• Assuring the design is appropriate for the research questions
• Protecting the rights of participants
• Ensuring procedures do not unnecessarily expose participants to risk
• Verifying that all research team members are listed on the Protocol and have completed required Human Subjects Research training
• Ensuring research team members follow the approved Protocol
• Seeking approval for any changes in methodology or the Protocol before the changes are implemented
• Contacting the IRB if any incidents arise that harm or have the potential to harm participants of the research
• Seeking a Continuing Review if the research goes beyond the initial one year approval, if applicable
• Notifying the IRB when research is completed

Co-Principal Investigators and Key Personnel

• Being familiar with and employing approved Protocol procedures for the study
• Ensuring participants have given informed, voluntary consent to participate in the study
• Seeking permission from PI / PD before deviating from approved procedures
• Maintaining current required Human Subjects Research training
• Notifying the PI / PD if any incidents arise that harm or the potential for harm of participants in the research
• Treating participants with dignity and respect

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.

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)

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.

Review Process

The Compliance Staff will review the application for completeness and request any needed information from the Researchers. When complete, the Compliance Staff will send application materials to the IRB Chair who will determine the type of review needed: Exempt, Expedited, or Full Board.

If the study is Exempt: These studies are reviewed throughout the calendar year. The IRB chair will make a determination if the study meets the criteria of exempt status. If yes, 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 a 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 a letter stating they have approval for the research and how long the approval is good – typically one year. No research may be conducted until the IRB final approval is sent.

Submission Deadlines and Meeting Schedule AY 2019 - 2020

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
9/4/2019	8/21/2019
10/2/2019	9/18/2019
11/6/2019	10/23/2019
12/4/2019	11/20/2019
2/5/2020	1/22/2020
3/4/2020	2/19/2020
4/1/2020	3/18/2020
5/6/2020	4/22/2020

Types of Review

Exempt Review

It is the responsibility of the IRB to make fair and consistent decision as to what studies will be qualify for exemption at SMU. Further, the IRB determines 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:

1. 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
2. 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.
3. 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.
4. 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.
5. 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.
6. 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

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?

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.

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.

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.

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.

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.

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.

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.

Approval given by the IRB for Full Board level Human Subjects Research (and some Expedited level Human Subjects Research, at the request of the IRB reviewer) is good for one calendar year (12 months) or less. (If research involves extreme risk for participants, approval may be given for a lesser time period.) If the approved study extends beyond the initial approval period, the PI / PD must seek approval again. This process is completed by filling out the Continuing Review Form, which provides an update on the progress of the study. This should be submitted four to six weeks before the research approval runs out to ensure approval is granted before the initial approval runs out. Continuing Reviews must be submitted until all enrollment and analysis on all identified data is complete.  Continuing Review is not required for Exempt level research and most Expedited level research.

Studies Approved Before January 21, 2019

The revisions to the Human Subjects Research regulations, effective January 21, 2019, eliminate the need for Continuing Review of Expedited level research, unless an IRB reviewer requests otherwise.  Both Full Board and Expedited research studies approved before January 21, 2019 remain subject to the pre-revisions regulations, and therefore remain subject to yearly Continuing Review. Upon completion of Continuing Review of "pre-revisions" studies, Research Compliance will determine if these studies can be transitioned to the new regulations.

Continuing Review Form

Lapse in Approval Review

A lapse in IRB Approval of research occurs whenever an investigator has failed to provide continuing review information to the IRB or the IRB has not conducted a continuing review and re-approved the research – with or without conditions – by the expiration date of the IRB Approval. In this case, a Lapse in Approval Form must be submitted. The IRB will determine if the OHRP or applicable Funding agencies should be notified, and if the data usage is available. The research may continue only after the PI / PD receives written approval from the IRB.

Lapse in Approval Form

Closing Out a Research Protocol

It is the responsibility of the PI / PD to inform the IRB once all research activities related to a specific Protocol are completed. To do this, the PI / PD will complete one last Continuing Review to provide an update since the last continuing review and indicate that all research activity has ended.

Informed consent is voluntary agreement to participate in research. Consent is not a document; informed consent is a process that engages research Personnel with potential study participants. (This also suggests that participants may need to have additional information throughout the study to ensure continued informed consent.) The goal of informed consent is to provide enough information so participants can make an informed decision about participating in the study or not. Expedited and Full board studies must demonstrate a consent process; however, Exempt studies may be limited to a verbal consent.

• The informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in such a way that facilitates comprehension. Specifically, the following elements must be clearly presented at the beginning of the document:
  • Statement that the project is research and participation is voluntary
  • A summary of the research, including purpose, duration, and list of procedures
  • Reasonably foreseeable risks or discomforts
  • Reasonably expected benefits
  • Alternative procedures or courses of treatment, if any
• The language of the consent must be in a language easily understood by the participants.
• No coercive language should be used (e.g., you must, your doctor suggested you participate, etc.)
• The legal rights of participants cannot be waived and participants may not release SMU, Researchers, or Sponsors from any liability through the use of exculpatory language.
• It is the Researcher’s duty to make sure participants understand what is being asked of them and that participants are freely choosing to participate in a study
• Investigators must be able to identify participants if the IRB feels that it is necessary in cases where there are crucial eligibility criteria for higher risk studies or studies electing to use photos or videotaping.
• The final approved consent form must have the IRB stamp of approval on it and may not be modified without permission from the IRB.

Essential Elements of Consent

At a minimum, subjects must be provided the following information during the consent process:

• Purpose of the research
• Procedures involved in the research
• Alternatives to participation (if appropriate)
• All foreseeable risks and discomforts to the subject. Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience
• Benefits of the research to society and possibly to the individual Human Subject
• Length of time the subject is expected to participate
• Person to contact for answers to questions or in the event of a research- related injury or emergency
• IRB/Compliance contact information
• Statement indicating that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the subject is otherwise entitled to receive
• Statement regarding the subjects’ right to Confidentiality and right to withdraw from the study at any time without any consequences
• Often additional information will be needed such as payment, costs to participate, how findings will be presented, number of subjects, etc.
• If the research involves the collection of Identifiable Private Information or Identifiable biospecimens, a statement indicating whether or not identifiers will be removed and the information or biospecimens will be used in future research.

Additional Elements

The following additional elements must be included in the informed consent if applicable:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
• Anticipated circumstances under which the subjects participation may be terminated by the investigator without regard to the subjects or the legally authorized representatives consent;
• The consequences of a subjects decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that significant new findings developed during the course of the research that may relate to the subjects willingness to continue participation will be provided to the subject;
• A statement that the subjects biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Templates

Expedited/Full Board Consent

Exempt Consent

Assent Ages 8-13

Assent Ages 14-17

Online Consent (eConsent)

Special Considerations Regarding Informed Consent

There are some special situations that may affect the informed consent process. We have listed examples below and what must be considered differently in these cases - other circumstances may also require additional considerations.

Web Consent: A consent form must be presented to participants before the study starts. A box may be checked by participants in lieu of a signature with a statement that they understand and agree to participate. Electronic signatures may also be used if the signature can be shown to be legitimate.

Non-English Speaking Participants: If the majority of participants are non-English speakers or are not comfortable with English, then the participants MUST be consented in their native language. In this scenario, the IRB will approve an English version of the consent. Before final approval is given to the PI / PD, the translated versions of the consents must be submitted to the IRB. These translations must be done by someone fluent both in speaking and writing of the language. It is the responsibility of the PI / PD to provide a short justification with the translated versions ensuring that the translations are accurate, to the best of their knowledge

Children / Adolescents: If children or adolescents are involved in the research study, additional steps are needed for informed consent. Minors under the age of 18 (there are some exceptions) may not provide legal permission to participate in research. In these cases, parental or guardian permission is necessary. If the study is considered high risk, permission from both parents may be required.

In addition, if the children are between the ages of 8 and 17, written or verbal assent must be sought from the children. Assent is an active affirmation of wanting to participate in the research from someone not legally able to provide consent. The assent process is used to make sure children understand the research and what it means to participate.

Adults with Guardians: When adults lack the capacity/legal authority to provide consent (e.g., cognitively impaired, developmentally delayed, dementia, psychoses, brain damaged, etc.), consent must be obtained from their legal guardian. The IRB may also request that assent is sought from the participant. Assent is an active affirmation of wanting to participate in the research from someone not legally able to provide consent. The assent process is used to make sure the adults still understand the research, what it means to participate, and if they want to participate.

Waiver of Elements of Informed Consent:Waiver of one or more elements of the consent may be obtained from the IRB for some research projects that could not practically be done without an alteration to the required elements (e.g., a study involving deception) or for studies where required elements are not applicable. These waivers are reviewed on a case-by-case basis and must be thoroughly explained in the application. Specifically, the application for waiver or alteration must describe how the project meets the following requirements:

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. If the research involves using Identifiable Private Information or Identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an Identifiable format;
4. The research could not practicably be carried out without the waiver or alteration; and
5. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of Documentation of Informed Consent:Waiver of signature of informed consent may be obtained if documentation of the consent is the only link to a study in which a participant could be compromised AND the principle risk would be potential harm resulting from a breach of Confidentiality (e.g., prostitutes, drug users, etc), or 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. Other potential reasons may be for cultural reasons such as a high illiteracy rate. If there are emails, phone numbers, or other documented ways to followup, then the signature of consent will typically not be waived. Waivers are reviewed on a case-by-case basis and the rationale for the waiver must be thoroughly explained in the application. Ease of the study is NOT a valid reason. When a waiver is granted, a verbal consent is required.

Request for Waiver of Element(s) of Informed Consent

Deception Research: The use of deception may be used when Researchers need to investigate questions that could be confounded by the participants knowing the complete research story. There are degrees of deception from using a vague research statement in the consent process to a complete fabrication of the research purpose in the consent process. It is the IRB’s task to weigh the risk created from type and degree of deception against the overall goals of the study. Typically, if deception is used, the IRB will require a debrief document (either electronic or paper) to be given to the participants at either the completion of their participation or conclusion of the study. This document/process explains the true purpose of the research. It is the Researcher’s job to clearly explain the need for deception and how it outweighs the risk to participants in the risk/benefit section of the Protocol.

Photo / Audio / Video Recording: May be appropriate methods to be used in research studies. However, the rationale for the use of these techniques must be documented in the Protocol. Because these methods are used in a specific domain of study is not an acceptable rationale; the rationale should include why these methods are necessary to the specific study. In addition, the consent document must be clear that these methods will be used and participants must give their explicit consent. This can be accomplished within the consent document or a separate document may be used.

Public versus Private Behavior: Methods to collect data related to private behavior require informed consent.

Secondary Research: This is defined as the research use of information or biospecimens originally collected for non-research purposes or for research studies other than the proposed one. If your secondary research project involves de-identified or publicly available information or biospecimens, the study may be available for an exemption; in that case, documentation of informed consent is not required. If your secondary research project involves identifiable information or biospecimens, documentation of informed consent is required. Therefore, you have three options:

• Gain study-specific consent from all participants from whom data or biospecimens were collected
• Apply for a waiver of informed consent
• Remove all identifiers, making the study eligible for an exemption

Expedited / Full Board Studies

Any proposed changes to the study must be approved by the IRB. This includes, but is not limited to, changes to the consent form, recruitment of participants, assessment information, surveys, study procedures, research Personnel, etc. An Amendment Form must be completed and approved by the IRB before any changes can be implemented. It is the responsibility of the PI / PD to ensure that research staff conforms to the approved Protocol during the study.

Exempt Studies

Most modifications to exempt research may be done at the discretion of the Principal Investigator / Project Director without prior IRB approval. However, major changes to the Protocol and/or changes that might increase the level of risk to the participants do require pre-approval.

Types of Changes to Exempt Protocols Requiring IRB Review

• Addition of key Personnel
• Change in Principal Investigator / Project Director
• Any change that increases the risk to the participant
• Addition of children or prisoner participants
• Addition of completely new data collection instruments and/or participant groups
• Changes in survey or interview questions (addition or deletion of questions or wording) that change the level of risk or addition of questions related to sexual activity, abuse, past or present illicit drug use, illegal activities, questions reasonably expected to provoke psychological anxiety, or would make participants vulnerable, or subject them to financial, psychological or medical risk
• Changes that impact the category of exemption or add additional exemption categories
• Changes that add procedures or activities not covered by the exempt category under which the study was originally determined to be exempt
• Changes requiring additional participant identifiers that could impact the exempt category or determination
• Addition of a new recruitment strategy
• Increase in the planned compensation to participants

Types of Changes to Exempt Protocols NOT Requiring IRB Review

• Removal of procedures
• Document changes that do not modify the intent of the content (e.g., typographical error corrections, improvements for clarity)
• Modification to number of participants

Amendment Form

Research Compliance Auditing Program (RCAP)

The mission of SMU’s Research Compliance Audit Program (RCAP) is to protect all research participants (human and Animal) and to educate our investigators in the conduct of research that is safe and in compliance with federal, state, and institutional regulations. In addition, the RCAP helps to maintain a comprehensive compliance program for the SMU research community and provide assurance that research is being conducted ethically and in accordance with an approved Protocol. The RCAP consists of auditing and/or monitoring of both human and Animal subjects research.

Research Compliance performs human and Animal subjects research compliance audits and submits the resulting audit reports to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and other institutional officials. These compliance audits serve as a confidential quality assurance measure internal to the institution.

What studies are chosen for an audit?

Any study that meets the definition of human and/or Animal subjects research may be selected for a random audit. In addition, studies involving the following factors may be chosen for audit:

• Conducted by or transferred to a new Principal Investigator / Project Director
• Indications that study subjects may be at increased risk (e.g., PIs / PDs with a high volume of studies, studies with minimal or no external oversight, inclusion of vulnerable populations, past or present subject safety or noncompliance issues, involvement of investigational drugs or devices, etc.)
• Excessive Unanticipated Event Report (UER) submissions, as determined by the IRB Chair or Research Compliance

Finally, investigators may request an audit of their own studies to ensure continuing compliance in their research plan.

Questions?

To ask a question, express concerns, or provide suggestions about the RCAP at SMU, please send a message to Research Compliance or call 214-768-2033.

Non-Compliance

Non-compliance occurs when Human Subjects Research is conducted in a manner that disregards or violates Federal, state, and local regulations or SMU policies regarding Human Subjects Research. This includes any unapproved or non-compliant research activity where research subjects are placed at risk. SMU takes has a strong stance on non-compliance as it puts Human Subjects at risk as well as the University as a whole.

Once the IRB becomes aware of potential or Allegations of research misconduct, they are required to investigate the matter. Whether research is suspended during the investigation will be determined by the seriousness of the Allegations as well as the cooperation of the PI / PD. Once the investigation is complete, one of three outcomes will be determined:

• No non-compliance found
• Non-compliance issues found
• Serious non-compliance issues found

If it is determined that the non-compliance is neither serious nor continuing, a corrective plan will be put in place to correct the compliance issues along with a timeframe for the corrections to be completed. The PI / PD may also be required to create an action plan and submit it to the IRB. In addition, the IRB may require additional monitoring of the research.

If it is determined that the non-compliance is serious or continuing the IRB will consider:

• Disallowance of data
• Suspension of the research
• Termination of the research
• Request oversight for the study by another Researcher
• Additional monitoring activities
• Possible notification of OHRP and Funding agency

If the IRB determines that non-compliance has occurred with a research study or if research is suspended or terminated, the IRB must report these incidences to appropriate authorities.

Examples of Non-Compliance Issues

• Conduct of Human Subjects Research without IRB Approval or before official approval has been received by the PI / PD in the form of a letter
• Repeated or deliberate failure to obtain informed consent from participants in the approved manner. This also includes, but is not limited to, not consenting participants, not documenting the consent procedure, missing signatures, using unapproved or outdated consents (consents should have an in-date IRB Approval stamp)
• Modification or deviation from the Protocol without IRB permission. This includes, but is not limited to: survey items, questions, recruitment material, consent forms and process, experimental conditions, etc.
• Enrollment of subjects who do not meet inclusion criteria
• Failure to maintain adequate records
• Failure to report or delay in reporting of unanticipated problems
• Repeated or deliberate omission of risk from the consent process
• Repeated or deliberate failure to provide informed consent in the primary language of the participant
• Failure to train and get research staff approved to work on the study
• Failure to submit study for continuing review before approval expiration date (lapse in approval)

Examples of Serious Non-Compliance Issues

• Bringing harm to participants
• Exposing a participant to possible harm
• Compromising the privacy and Confidentiality of participants
• Engaging in willful non-compliance
• Conducting research that is not ethical according to the IRB ethical principles

All research Personnel, including Personnel outside of SMU, who are listed on an IRB Protocol as a PI / PD, Co-PI / Co-PD, or key Personnel must complete required Human Subjects Research training. The training dates and/or completion certificates of all Personnel must be provided to the IRB on the initial Protocol. If additional research staff is added as the project progresses, an amendment must be filed with the IRB with this information. It is the responsibility of the PI / PD to ensure that all staff has the correct training on file with the IRB. Training is good for 3 years and then must be renewed. Three Human Subjects Research training options are available:

CITI

Research Personnel affiliated with SMU may complete the Collaborative Institutional Training Initiative (CITI) training. Personnel may select one of three human subjects research training courses: Biomedical Research, Social & Behavioral Research, or IRB-Determined Exempt status. You can find assistance with the CITI Program in the documents below.

Assistance with logging in to an existing account and adding the appropriate course(s)

Assistance with creating a new account and registering for the appropriate course(s)

Assistance with associating your existing account with your SMU credentials

fhi360

Research Personnel NOT affiliated with SMU may complete the Research Ethics Training Curriculum provided by fhi360. Instructions for registration may be found below. The fhi360 training completion certificate must be provided to the IRB.

fhi360 Training Instructions

PHRP

Protecting Human Research Participants Online Training is available for a fee of $39.99. This training is available in Spanish. The PHRP training completion certificate must be provided to the IRB.

Reporting Adverse Events and Unanticipated Problems

Unanticipated Event Form

Federal regulations (45 CFR 46.108(a)(4)(i)) require the IRB to ensure that investigators promptly report “any unanticipated problems involving risk to subjects or others.” The reporting requirement applies to all unanticipated problems, including unanticipated adverse events (see definition of unanticipated problem and adverse event). If there are unanticipated problems involving risk to participants, Researchers must notify the IRB Chair and the Director of Research Compliance within 24 hours of the incident at researchcompliance@smu.edu.

An Unanticipated Event Report must be completed and filed with the IRB within seven days of the incident. The reporting of these incidents is critical to ensure that corrective actions are implemented quickly to protect other participants from preventable harm. These regulations also require critical incidents or unanticipated events to be reported to federal agencies (e.g. OHRP, NSF, NIH) by the IRB.

Additionally, other types of events should be reported to the IRB. Examples include:

• Unanticipated changes to a Protocol to eliminate an immediate risk to a participant
• Any event that affects the safety or welfare of participants
• New information that could indicate an unexpected change in the risk/benefit profile (e.g., new publication or research, etc.)
• Complaints of participants

Examples of corrective actions:

• Changes to the Protocol
• Modification of inclusion/exclusion criteria
• Modifications to informed consent to document risks
• Letter to enrolled participants describing new risks
• Re-consenting of participants
• Additional monitoring requirements
• Suspension of enrollment of new participants
• Suspension of the research study
• Training of the research team

Mandatory Reporting

If there is a possibility that child or elder abuse may be discovered during the research process, a procedure outlining the reporting process must be included in the Protocol before a study will be approved by the IRB.

Texas law requires anyone with knowledge of suspected child abuse or neglect to report it to the appropriate authorities. This report may be made to 1) any local or state law enforcement agency; or 2) the Department of Family and Protective Services. Please refer to SMU’s policy on this issue. In addition, Texas law also requires anyone with knowledge of suspected elder abuse or neglect to report it to the appropriate authorities. This report may be made to 1) any local or state law enforcement agency; or 2) Adult Protective Services.

Secondary Data

Secondary use of data applies to activities that involve secondary analysis of information or biospecimens originally collected for non-research purposes or for research studies other than the proposed one. Examples include data collected from previous studies, data originally collected for a different purpose, audio/video recordings from other studies, student records, etc. The data need not exist at the time of the application to the IRB, as long as it is not collected specifically for the study in question.

Secondary use of data may not fit the definition of Human Subjects Research, or it may qualify for an exemption (see exemption category 4). As with any other Human Subjects Research, the determination as to whether secondary data use is considered Human Subjects Research and/or exempt must be made by the IRB, and not by Researchers. Below are some examples of secondary data that may not be Human Subjects Research and/or qualify for and exemption:

De-Identified Data

These are data sets that have had all of the identifying information removed and there is no way that the data can be linked to specific individuals. This means the data cannot contain any previous coding mechanisms, or any characteristics which could make individuals’ identities known through a combination of data such as age, gender, and job title, or be Identifiable through video or photographs.

Coded Data

If data sets are coded and there is an agreement in place where the key may not be released, this use does constitute Human Subjects Research. For instance, school districts often use Data Share Agreements with Researchers to provide certain data for analysis. A copy of these agreements must be provided to IRB for review.

Publicly Available Data

These are data sets prepared with the intent of making them available to the public and have no individually Identifiable Private Information. For instance, SMU department faculty website information or census data.

If the IRB determines that the use of secondary data is Human Subjects Research and does not qualify for an exemption, the IRB must review the research Protocol before the data may be used. In such cases, the research will be considered as having expedited or full-board review status depending on the parameters of the research. As with any Human Subjects data, appropriate consent must be obtained. If it is not possible to obtain consent for the previously collected data, a waiver of consent for the secondary data usage may be sought. The research cannot be completed if a waiver of consent is not granted.

Data Protection

More information coming soon

Retention of Records

Once a research study is completed, data must be maintained for a specific amount of time. Federal IRB regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46.115). However, other regulations or agencies may require data to be retained for a longer period of time. The records must be kept for the longest period of time.

Classroom Research

This includes any research involving Human Subjects conducted as part of a class. Most types of classroom research would not fit the definition of Human Subjects Research, according to 45 CFR 46. However, it is important to note that federal guidelines are clear that the IRB makes this determination, not the faculty member. The faculty member can complete the Exempt status determination form and submit it to the IRB for review, or an informal review of the proposed classroom research can be performed via communication (e-mail or phone) directly with Research Compliance and the IRB. In order to qualify as classroom research, the data must only be used for the purpose of teaching the class and the results can be only presented in the class. In addition, all of the following requirements must be met to be considered classroom research. Again, the IRB will make the final determination when considering the following points:

• The project involves minimal risk.
• The project does not include any vulnerable populations.
• Participants are not pressured or coerced into participating.
• The data collected in such a manner that the subjects are not Identifiable (names, emails, any audio/videotaping or pictures, etc. make the data Identifiable).
• The project does not ask about sensitive topics (e.g., substance abuse, mental health issues or well-being, traumatic experiences, sexual abuse or orientation).
• No support or Funding from an external organization was used for collecting, analyzing, or reporting of the project.

Student Research Projects

Student research projects that use systematic data collection with Human Subjects with the intent to contributing to general knowledge (intent to publish) fall under the normal IRB guidelines, and are therefore subject to the IRB Approval process. It is important to note that these studies do NOT necessarily have to be published to be considered research. In addition, student research projects require sponsorship by a qualified Principal Investigator / Project Director.

Research Conducted Internationally

Research conducted outside the United States must still comply with SMU’s IRB policies and go through the IRB Approval process. In addition, the research must comply with the host country’s standards for research involving Human Subjects. It is the responsibility of the PI / PD to be familiar with the host country’s standards Human Subjects Research. Further, the IRB understands that local customs and cultures may impact the research Protocols; however, Researchers are responsible for providing the IRB with the appropriate information needed for special considerations. Please complete the International Research Supplement and include in your application submission.

International Research Supplement

Reliance

Some Human Subjects Researchprojects involve collaboration between Researchers from several entities. In order to reduce the administrative burden of IRB oversight at several sites, the collaborating entities can enter into a Reliance Agreement. This establishes a single IRB of Record and one or more Relying IRBs. The IRB of Record is responsible for all review and oversight of the project at all locations, and the Relying IRBs agree to support the IRB of Record as needed. If you would like to establish a Reliance Agreement, contact the Director of Research Compliance.

Currently, collaborative research funded by the NIH must be reviewed by a single IRB through Reliance Agreements. Proposals for NIH Funding must include a plan for assigning the IRB of Record and the Relying IRB(s). Beginning in 2020, all federally funded collaborative research must be reviewed by a single IRB through Reliance Agreements.

Data Collection and Recruitment at External Sites

If a research study and/or recruitment is being conducted onsite at multiple universities, the SMU IRB must ensure that IRB approval has been obtained at each participating university before research commences at the site. This can involve the external university IRB relying on the SMU IRB’s approval of the protocol, or it can involve full IRB approval at the external university. In general, a collaborator/sponsor at the external university must be established, and the SMU-approved protocol and all associated materials must be submitted to the external university IRB for review.

One strategy for expediting approval of a study involving multiple external university study sites is to limit the number of external university study sites listed on the initial application, or by including only SMU as a study site on the initial application. Once approval of the initial application is granted, additional external study sites can be added via amendments.

1. Choose your external recruitment and/or data collection site(s).
2. Establish an agreement with a contact, sponsor, or collaborator at the external site.
3. Obtain a Letter of Support from your external site contact.
4. Submit your application to the SMU IRB for review. Include the proposed external site(s) and Letters of Support with your submission. As mentioned above, the process can be expedited by limiting the number of external sites on the initial application, or by including only SMU as a study site on the initial application.
5. Concurrently, contact the external site IRB to inquire about the process for obtaining approval for recruitment and/or data collection.
6. Be prepared to submit all study documents to the external site IRB for review.

Research Compliance can help guide you through the process and facilitate communication with external sites.

Transfer to SMU

If you are joining SMU and plan to continue an existing research project, you must submit a new application to the IRB for review. SMU is not able to accept transfers of existing studies.

Leaving SMU

When you leave SMU, you are no longer meet the requirements to be a Principal Investigator / Project Director on an IRB Protocol. Therefore, before you leave you must complete one of the following:

• Transfer IRB oversight of the research Protocol to your new institution (if the institution is willing to accept transfers)
• Amend the study to replace yourself with an appropriate Principal Investigator / Project Director
• Close your study at SMU and re-apply for IRB Approval at your new institution

ClinicalTrials.gov

Some clinical trials must be registered on the ClinicalTrials.gov website. In order to be considered an Applicable Clinical Trial, thus requiring registration, all of the following criteria must be met:

• The study must be interventional (i.e., participants are assigned prospectively to an Intervention or Interventions according to a Protocol to evaluate the effect of the Intervention(s) on biomedical or other health-related outcomes)
• At least one study facility must be located in the United States or a U.S. territory OR the study must be conducted under a US FDA Investigational New Drug application (IND) or Investigational Device Exemption (IDE)
• The study must evaluate at least one drug, biological, or device product regulated by the US FDA
• The study must be other than a Phase 1 trial of a drug and/or biological or device feasibility study

The Responsible Party (usually the Principal Investigator / Project Director) is required to keep the ClinicalTrials.gov registration current and free of errors. If an investigator chooses to voluntarily register his or her Human Subjects Research study on ClinicalTrials.gov, s/he is also required to keep the registration current and free of errors.

Posting of Informed Consent Forms

If your study meets the NIH definition of a clinical trial, and is supported by federal funds, you must post a copy of your IRB-approved Informed Consent document on one of the following websites post-recruitment and no later than 60 days after the last study visit by any subject:

• ClinicalTrials.gov
• Regulations.gov

The following questions can help determine if your study is a clinical trial according to the NIH:

1. Does the study involve human participants?
2. Are the participants prospectively assigned to an Intervention?
3. Is the study designed to evaluate the effect of the Intervention on the participants?
4. Is the effect being evaluated a health-related biomedical or behavioral outcome?Formats the Html codes.

Flow charts can act as a guide for IRBs, investigators, and others to decide if an activity is research involving Human Subjects that must be reviewed by an IRB. You can find Decision Flow Charts here.