I.  Getting Started: Does Your Research Project Require IRB Review?

A. Meeting the definition of "research" and "human subjects"

When an investigator plans to conduct research involving human subjects, s/he may want to consider contacting the SBS IRB Staff as early in the process as possible. Aspects of a project that may be problematic can be discussed and alternative procedures suggested.

Activities involving interaction with and the collection of information about living individuals are integral components of the educational practices and administrative processes of the University. Not all of these activities meet the regulatory definitions of "research" and "human subjects." As such, not all of these activities require IRB review.

Only projects meeting both definitions of "research" and "human subjects" as provided below come under the purview of the IRB. The initial determination as to whether a research project should be considered "human subjects" "research" is the responsibility of the investigator. This determination should be made in accordance with the definitions and guidance below and in consultation with the IRB as appropriate.

Research — A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
(45 CFR 46.102(d))

• In general, studies that involve data gathered solely for internal, on-going campus use (e.g., course evaluation or institutional program development), or are part of classroom projects that will not be presented outside the classroom do not need to be reviewed by the IRB. If results of these studies will be disseminated publicly in any way (e.g., conference presentation, publication), then the study is considered to constitute "research." If no dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, the researcher is advised to submit the project for IRB review and approval before initiating the research.

Human Subjects — A living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
(45 CFR 46.102(f))

• Research on deceased individuals is not subject to IRB review.
• Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject (e.g., telephone call, e-mail).
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record).
• Identifiable information means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Only projects meeting both definitions (research and human subjects) come under the purview of the IRB.

B. Research involving existing data sets

The SBS IRB recently reviewed its policies and procedures for reviewing research involving existing data sets and data archives. The IRB recognizes that some research involving existing data sets and archives may not meet the definition of "human subjects" research requiring IRB review; some may meet definitions of research that is exempt from the HHS regulations at 45 CFR 46; and some may require IRB review. For more information and guidance on IRB review policies and procedures for research that involves only the analysis of existing data sets and archives, please click here >>.

II.  Completing a Research Protocol

Once you have determined that your project involves both "research" and "human subjects," you'll want to complete a protocol application in IRBWise, the SBS IRB's online submission website.

New users of IRBWise must set up an SBS IRBWise account by sending a message that includes the user's name, department, University position, and CNET ID to sbsirbwise@listhost.uchicago.edu. Once you have an active account, you can begin to fill out the online application, answering all required questions and attaching all additional research materials.

A. Submitting the protocol application

Once you have successfully logged into IRBWise, select "Submit New Protocol" from the "Tasks" dropdown menu in the upper right-hand corner of the webpage. This will bring up a blank protocol application for researchers to complete.

In addition to answering the protocol questions, the following items, when applicable, should accompany your IRBWise protocol submission. Documents can be uploaded and attached to your protocol directly in IRBWise.

• A copy of any recruitment scripts or materials that will be used in the research;
• A copy of all informed consent scripts or documents that will be used in the research;
• A copy of all questionnaires, surveys, and/or interview questions or guides that will be used in the research;
• A description of the research methodology; and
• Letters of support or approval from performance sites (i.e., some research requires school district or organization permission) on appropriate letterhead. NOTE: Letters of support or approval can be submitted following IRB review, but final approval will be contingent on receipt of these materials.

Note that NIH-funded researchers must receive NIH human subjects research certification. NIH offers a computer-based training program at http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.

For additional training in the area of human subjects research, please also consult the Collaborative Institutional Training Initiative (CITI) Program's online course in the Protection of Human Resource Subjects or Family Health International's online training on Research Ethics.

B. Considering and assessing risks

When answering questions about risk in the protocol application, please consider the following types of risk or discomfort:

• Physical Risks: These risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research. These risks are not commonly encountered in social and behavioral science research.
• Psychological Risks: Psychological risks may be experienced during participation in the research and/or afterwards as a result of participating in the research. These risks include anxiety, stress, fear, confusion, embarrassment, depression, guilt, shock, loss of self-esteem, and/or altered behavior.
• Social/Economic Risks: Social risks include alterations in relationships with others that are to the disadvantage of the subject, and may involve embarrassment, loss of respect of others, labeling with negative consequences, or diminishing the subject's opportunities and status in relation to others. Economic risks include payment by subjects for procedures, loss of wages or income, and/or damage to employability or insurability.
• Legal Risks: Legal risks include risk of criminal prosecution or civil lawsuit when research methods reveal that the subject has or will engage in conduct for which the subject or others may be criminally liable.
• Loss of Confidentiality: Confidentiality is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. Risks from breach of confidentiality include invasion of privacy, as well as the social, economic and legal risks outlined above. Loss of confidentiality is the most common type of risk encountered in social and behavioral science research.

III.  Submitting Your Protocol for IRB Review

After all appropriate questions are answered in your application and all documents have been uploaded, the protocol will be ready for submission to the IRB Office for review.

A. Submitting to the IRB Office

Please note that all IRB submissions must have a university faculty member serve as the Principal Investigator (PI) and that the PI must endorse the submission before it is sent to the IRB Office for review. Thus, student researchers and department administrators should forward their protocols to the PI for endorsement. Once the PI has signed off on the submission, s/he will formally submit it to the IRB Office.

B. The IRB Review Process

There are three (3) levels of review for research involving human subjects: administrative, expedited and full board. Each of these is described below.

All submissions undergo administrative review by the IRB Staff. The IRB Staff can request additional information about the research and/or request modifications to the application form, protocol, and/or informed consent documents prior to review by a member of the IRB. The IRB Staff also makes recommendations to the Chair and IRB members about the level of review (expedited or full board) a given project should undergo.

• Projects that meet exemption requirements undergo administrative review by the SBS IRB Staff. It is estimated that administrative reviews for exempt research typically take 5-7 working days.
• New and continuing projects may be eligible for expedited review if they both involve no more than minimal risk to subjects and meet one of nine specified categories. Estimated times for expedited protocols (in which no additional information or modifications are required) take 10-14 working days on average.
• Projects that involve more than minimal risk or do not fit into one or more of the categories for expedited review must be reviewed by the full board at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary interests are non-scientific. The IRB Chair will assign both a primary and a secondary reviewer for those projects scheduled for full board review. These members are responsible for presenting the research to the committee at the convened meeting. Although these primary and secondary reviewers are responsible for the presentation of the research at the meeting, all members receive a copy of the complete submission, including the application, protocol, informed consent documents, and instruments, and are expected to participate in the review and discussion of the research at the meeting. The IRB Chair may invite ad hoc reviewers to assist in the review of research where additional expertise may be necessary. In order for a given project to be approved, it must receive the approval of a majority of those members present at the meeting.

C. IRB Approval

In order for the IRB to approve a given research project, it must make the following determinations:

• Risks to subjects are minimized: (i) by using procedures that are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
• Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
• Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.
• Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
• When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

If additional information or changes are requested based on the administrative review, the principal investigator will be notified as such by the SBS IRB staff via email. Once the IRB has reviewed the application, the researcher will be notified by email of the IRB's decision. If changes are required or requested, an email detailing these changes will be sent to the investigator. If the research is approved, an email containing the terms of the approval will be sent to the investigator as well as a paper copy of the approval notice through standard mail.

Approval for projects is valid only until the expiration date. All research projects must be reviewed no less than annually. The approval period is determined by the IRB and is based on the level and degree of risk involved in the research.

IV.  After Approval Has Been Issued: Continuing Reviews, Amendments, and Adverse Events

A. Continuing reviews

With the exception of projects that are determined to be exempt from the regulations, the IRB is required to conduct continuing review of research at intervals appropriate to the degree of risk but not less than once annually. For research involving no more than minimal risk, the approval period is generally one year. For research involving greater than minimal risk, the IRB will determine the appropriate approval period. The approval notification from the IRB will specify the date of the expiration of approval.

The SBS IRB will send all investigators a request for continuing review several months prior to the expiration date for approval of the research. Two additional reminder requests will also be sent to the investigator if the SBS IRB Office has not received the required information.

To file a Continuing Review, simply go to the main page of the protocol in IRBWise and select "Request Continuing Review" from the "Tasks" dropdown menu. A new webpage will open containing the Continuing Review application. Please complete the appropriate questions and submit the application to the IRB for processing. Again, keep in mind that PI's must sign-off and endorse all submissions before they are submitted directly to the IRB.

B. Changing and amending your research protocol

All changes in the project that deviate from the original submission must be approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to the subjects. This approval is gained by completing an Amendment application through IRBWise that describes the proposed changes to the research. To access the Amendment application, go to the main webpage of the protocol in IRBWise and select "Request Amendment" from the "Tasks" dropdown menu.

C. Adverse events and/or negative reactions by subjects

Any unanticipated problems involving risks to subjects or complaints from subjects must be reported immediately to the SBS IRB no later than 10 days following the event. This can be done online through IRBWise by selecting "Report Researcher-Initiated Report of Problem" under the "Tasks" dropdown menu. The IRB Chairperson will report in writing any report of adverse events to the Institutional Official, who will in turn report as needed to the relevant Department or Agency Head (sponsor), any applicable regulatory body and OHRP, as mandated in the Federal Regulations.