Research with Human Subjects/Institutional Review Board

Translation of informed consent and recruitment documents that reflect the study population from whom the researcher wishes to recruit for participation is required. If the PI does not employ a certified translator, they must provide evidence in the form of a statement about their level of proficiency in the language and their experience in translating documents from English into the foreign language relevant to a study population. They must attest that they are the individual who translated the informed consent document(s), that they have the expertise to do so, sign and date. The American Translators Association’s web page provides the required information needed in a translator’s statement.

Investigators must obtain a statement from the individual responsible for the translation, which includes:

• A statement of the translator's qualifications; Identification of the translated document from what language to what language
• A statement affirming the completeness and accuracy of the translated document
• The translator's name, signature, and date.

Those who plan to conduct focus groups must adjust their informed consent documents to recognize researchers’ inability to guarantee participant anonymity. Researchers might find this short PowerPoint presentation or this example of an informed consent useful.

Those who plan to work with participants under age 18 must meet additional informed consent requirements. You might find this short PowerPoint presentation useful.

Research conducted solely for pedagogical purposes may not need IRB review, provided the proposed project meets all the following conditions:

• the instructor’s intention is to teach professional research methods such as interviewing, surveying, or experimental design
• the data are gathered solely for the purposes of teaching students how to analyze them
• the results will remain in the classroom

Most research completed by undergraduate students in senior capstone courses, or individual or group research projects with other undergraduate students will not require IRB review. In contrast, most human subjects research completed by graduate students for publicly presented theses or culminating projects will require review (unless they are oral histories).

However, if instructors (or students) plan to present data collected from “live humans” to the public (beyond the classroom), they are required to apply for IRB approval (even if the project is likely to be classified as exempt). The IRB requires that all documents, application, informed consent, interview questions, survey questions or other materials are submitted with the application. If an instructor would like to create a class project that includes an opportunity for students to present data as part of on campus forums, please reach out to the IRB before the class begins to discuss how best to meet any ethical obligations.

If the proposal is to analyze data that is anonymous, deidentified and publicly available (e.g., transcripts, large surveys, social media posted in the public domain), there is no need for IRB review (however, students and faculty may want to follow best practices for protecting individual’s privacy and confidentiality).

Projects in which students plan to use direct quotes or interview summaries from people who will be publicly identified as an organization representative (e.g., a public relations representative speaking on behalf of the university), or who approve the public identification of their comments (e.g., a publicly recorded interview with an SSU athlete or coach) are considered outside the scope of IRB review (these projects most likely represent journalism or perhaps oral histories).

Pilot studies, no matter how small, must get human subjects approval. You can include the pilot study as a smaller section of the complete protocol, or you can get approval for the pilot study first, then submit again for a review of the full “parent” study. At this stage, you may have modified your research to take into account the results of the pilot study. (For example, you may decide to change the survey questions as a result of the pilot study, or change inclusion/exclusion criteria for research participants.)

The purpose of oral history is to interview informants who have a unique perspective on a particular historical event or life experience. Oral history participants are not anonymous individuals. They are selected because of their personal relationship to the topic under investigation, and the researcher intends for their stories to stand on their own as a “testimonial” or as part of an archive. Oral history interviews are not analyzed as qualitative data are generally analyzed. Researchers do not use content analysis, discourse analysis, thematic coding, or other qualitative data analysis methods. If a project meets these criteria, the research qualifies as an oral history project, which is beyond the scope of federally required IRB review.

However, if the researcher conducts surveys or interviews that promise participants confidentiality or anonymity, it suggests an interest in the development of general knowledge, it does not qualify as an oral history project. Therefore, researchers should submit an IRB application to determine whether the project is exempt, expedited or requires full board review.

Due to the fine distinction between research that qualifies as an oral history and research that does not, please contact the IRB for guidance prior to beginning your research.

Research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data were properly and ethically obtained and to ensure that the objectives of the secondary analysis are in keeping with those for which consent was obtained.

In order for the committee to evaluate research which includes secondary analysis, the researcher will need to provide:

• A complete protocol for the secondary study
• The details of primary data collection (which may include the original protocol, consent and approval, if research), or the source of publicly available data
• If the data are not publicly available, a letter from the source authorizing access to the data or, if the data were purchased commercially, a copy of the contract authorizing the use of the data.

After these documents are submitted, the committee will be able to decide if the research is exempt, non-exempt, requires a new consent, or does not need to be reviewed further.
Some research may not have to be reviewed by the IRB because the data are so anonymous that they no longer implicate human subjects. For example, some public health data, amalgamations of median income and average longevity, statistics from the U.S. Census Bureau are pooled such that anonymity is ensured.

It may not be necessary to get human subject approval if interview questions are with experts about a particular policy, agency, program, technology, technique, or best practice. The questions are not about the interviewee themselves, but rather about the external topic. For instance, questions will not include demographic queries about age, education, income or other personal information.

Human Subjects review will be required when a researcher is interviewing individuals about content, but there is a research question or hypothesis involved, or an “agenda.” The researcher intends to analyze and generalize the results, that is, look for common themes in the collected data, try to universalize the interviewees’ experiences, or quantify the results in some way.

Examples of content expert projects that may not require human subjects review:

In all the following examples, the questions are focused on the facts about the program, policy, software, curriculum, procedures or project. The researcher will simply report the facts as they are related by the content experts. You may not need to submit a protocol or an informed consent form for human subjects approval if:

• you are interviewing managers in a company about their billing procedures, or their use of a particular software program, or
• you are interviewing or surveying teachers about what should be included in the development of a particular curriculum unit, or
• you are interviewing entrepreneurs about the obstacles they faced in starting their own businesses, and how they overcame them, or
• you are asking a panel of nurses and doctors to review your antismoking program for teens for correct medical content, or
• you are interviewing social agency directors about their client intake procedures.

Unaffiliated researchers are researchers from outside SSU who are not connected in any way to SSU. The SSU IRB will review research protocols and IRB approvals from other institutions for unaffiliated investigators who plan to conduct a study that involves members of the SSU university community. If our members are involved in conducting the study, the name and their role must be listed on the protocol submitted to the SSU IRB. In addition, include all relevant materials listed below. If an external researcher is collaborating in conducting the study with a member of the SSU community the researcher from the lead institution will be required to provide an IRB Authorization Agreement (Reliance Agreement). Requests can be submitted by email to [email protected] so that they can be reviewed and tracked properly. In the body of the email provide an explanation of the research and SSU’s employees involvement or lack there off.

• Lead institution’s IRB approval letter
• Original approved human subjects’ application and protocol information
• Informed consent form
• Interview guide, questions, questionnaires or other measures
• Invitation emails
• IRB training certification for all principal investigators
• Flyers or advertisements
• Institutional Review Board (IRB) Authorization Agreement (reliance agreement)
• Other relevant documents

If the goal of a project is to only measure the effectiveness of programs or services, including program evaluations, model curriculums, or needs assessments, the project falls outside the score of federally required IRB review as long as the results will not be compared with other assessments, and there is no plan to present the data to public audiences outside the targeted department or organization. Such activities are not typically designed to be generalizable to the larger community and would not be considered research.

The following activities may not require IRB review. Please contact the IRB to help determine if review is required.

• “Self-Improvement” studies that do not include systematic collection of data from others (for example, where someone reviews their own teaching methods with an eye to becoming a better teacher, but no student artifacts are collected)
• Key Informant Interviews where the information presented is about the program and not the individual
• Curriculum Development where the curriculum is not being evaluated in the field
• Oral History where the information is merely reported, but not analyzed
• Web Design Evaluations, Product Design Assessments
• Secondary/Existing Data that is publicly available
• Classroom projects: If a class project will not be published or presented to a public audience (beyond the classroom)