Providing education and training for faculty, staff, and students around ethical research is an essential function of an IRB. General educational and faculty-specific resources are provided below.

The History of the IRB

The history surrounding human protection in research is riddled with examples of studies conducted where the rights of human subjects, especially those of vulnerable populations, were violated. Following World War II, atrocities committed by members of the Nazi regime highlighted the importance of protection for human subjects. Out of this specific example, principles to evaluate the impact of such standards were set forth in The Nuremburg Code. Among other standards, this document highlighted the importance of having the informed consent of subjects, and put the onus of securing informed consent in the hands of the investigators. Following this document, other principles, including the importance of approval and ongoing review by an independent ethics committee in research, were discussed in the World Medical Association’s Declaration of Helsinki. (World Medical Association, 1989)

Despite calls for ethical guidelines in research, it was not until 1974 that the National Research Act established clear standards to regulate research involving human subjects. The Belmont Report which, following concerns about the lack of ethical practices during the longitudinal U.S. Public Health Service Syphilis Study at Tuskegee, was written in 1979, continues to inform IRBs The Belmont Report outlines three important ethical principles that should guide the development and practice of research, including respect for persons, beneficence, and justice. (Department of Health, Education and Welfare, 1979)

The importance of IRBs was emphasized within the state of Maryland in October 2002, when the Maryland General Assembly passed House Bill 917, "Human Subjects Research – Institutional Review Boards". The law indicated that research conducted in the state of Maryland involving the presence of human subjects, must follow federal regulations to ensure human subject protection. (Maryland Office of the Attorney General, 2018)

What Research Proposals Need in Order to Obtain IRB Approval

Institutional Review Boards (IRBs) must determine if a proposed research project meets the following criteria to be approved:

  • There is minimal risks to human subjects.
  • The anticipated risks of research are reasonable given the benefits to human subjects and/or the field of study.
  • The selection of human subjects, especially those that represent vulnerable populations (children, prisoners, those with developmental delays) is equitable, and research on vulnerable populations is safe.
  • Informed consent is sought and documented.
  • The research contains adequate situations to protect the privacy and confidentiality of human subjects and the data collected.
  • The researchers do not coerce participation in the research; participation is voluntary and anonymity is preserved.

Why is the IRB Important at Cecil College?

As delineated in the Strategic Plan 2015-2020, Cecil College aspires to following the values of excellence, integrity, innovation, and collaboration. Broadly, the IRB upholds the ethical guidelines surrounding research, which encourages integrity around projects conducted on Cecil College’s campus. Additionally, awareness of research ethics promotes academic excellence within the designated field, fosters collaboration between investigators within the institution, and encourages innovation. The inclusion of an IRB on campus also educates students on proper research ethics, which will aid them as they progress in their academic careers.

To get more information about the Belmont Report and the Common Rule, please refer to the following links:

Key Terms Used in the IRB

Beneficence
Beneficence is an ethical term outlined in The Belmont Report. It discusses two overarching principles including do no harm and protection through the minimization of risks and maximization of benefits to an individual Risk and benefit assessment is influenced by many factors that differ based on diverse communities. It is important to be aware that some populations are more vulnerable to risks.
Coerce
Coercion in research is something to consider and involves an overt or implicit threat of harm that is intentionally forced on one person by another to obtain agreement or compliance. At no point should a PI or other individual involved in the research overtly or implicitly threaten a subject in order to obtain compliance. This may include suggesting that the subject will not successfully complete a course he/she/they are enrolled in if they choose not to participate in the research.
Confidentiality

Confidentiality involves the way in which data or information is treated after it has been gathered. Ensuring confidentiality allows the subject to trust that his/her/their personal information will not be shared without permission or in ways outside the parameters of initial consent. Subjects should be made aware of how data will be stored, who will have access, and how data will be released during the informed consent process. It is the job of the PI to ensure that confidentiality is upheld in the context of the study. HIPPA and FERPA also provide guidance on the disclosure of personal information. Researchers should consider:

  • Will confidentiality of identifiable data be offered?
  • How will data be stored? Are there encryption methods that could increase security?
  • Are there legal/ethical requirements to consider (e.g., HIPAA, FERPA)?
  • Will release of data cause risk of harm?
Human Subjects
The Department of Health and Human Services defines human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains data or identifiable private information through intervention or interaction with the individual.

Informed consent means that human subjects are informed about all aspects of the project relevant to them making informed decisions about participation, including but not limited to the purpose of the research, the role of the subject, the potential risks to the subject, and the voluntary nature of their participation. A central part of the informed consent process is the informed consent document.

The U.S. Department of Health and Humans Services' video, OHRP: General Informed Consent Requirements, explains the process of creating an informed consent document and obtaining informed consent.

Intervention
Includes both physical procedures by which data are gathered (for example, venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes.
Justice
An ethical principle discussed in the Belmont Report, justice discusses fairness in terms of equal burdens and benefits on research subjects and treating subjects similarly. Within research, this addresses using fair recruitment processes and the inclusion of diverse samples.
Minimum Risk
The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Risks can be physical, psychological, social, economic, or legal.
Principal Investigator (PI)
Is the primary contact for research; students must have a faculty or staff advisor who serves as the PI for the IRB process. While students may serve as a co-PI, all correspondence with the IRB will go through the primary PI (faculty/staff), and all research materials must be housed with the primary PI.
Private Information/Privacy

Privacy is ultimately about people and addresses an individual’s control over the amount, timing and circumstances of sharing their information. This 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. As research is reviewed, the IRB takes into account the importance of privacy for the subject, remembering that privacy lies in the eyes of the person, not the researcher. Researchers should consider:

  • The subject's culture. Individual cultures may view specific information as being more private than other cultures.
  • The age of the subjects. For example, younger children may be less concerned about the privacy of specific information than adolescents.
  • The way in which the sample for the study will be recruited. Are the recruitment methods sensitive to the privacy of the individual? For example, rather than having the researcher enter the treatment room of a medical office to recruit subjects before a procedure, a nurse or doctor working with the patient should introduce the study and assess the individual’s interest.
  • The sensitivity of the material being collected.
  • The way in which data will be collected, realizing that there are different privacy concerns between focus groups, individual interviews and observational methods.
Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Research may include surveys, interviews, focus groups or other projects that involve data gathering.

Faculty Data Gathering and Classroom Activities

Courses often require students to participate in data gathering activities within and outside of class. While many of these activities do not require IRB approval, it is important for faculty and students to understand how basic research ethics guide data collection. If you are uncertain as to whether or not your classroom activity needs IRB approval, please refer to 'Does My Project Need Review?'. Cecil College has a Classroom Data Gathering Form that provides recommendations to faculty around data use in the classroom, which is included in annual training requirements. Below are a few items to consider when data is collected as a part of a course:

Teaching Students about Research

Teaching students about basic research ethics, including the role of the IRB, the purpose of informed consent, and the importance of confidentiality is fundamental to academic and research integrity.

Gathering Data in the Classroom

Some classes gather data on students enrolled in the course to help demonstrate theoretical concepts, research methodology, or as a part of a class activity. When gathering data, it is essential for faculty to consider the importance of confidentiality.

  1. If the data collected could be sensitive in nature (i.e., political beliefs; social beliefs; personal experiences), it is important that data is collected in a way that protects the confidentiality of the student. This includes, but is not limited to, not tying demographic data to responses on the questions posed. In small institutions, like Cecil College, it is often easy to identify a student’s data by demographic information collected. Faculty should be aware of these concerns and make efforts during data collection to maintain privacy.
  2. Additionally various types of questions may cause students distress. Asking these questions as a part of a data-gathering measure, not just for personal reflection during class, should be carefully considered. For example, questions about prior criminal or sexual behavior, substance use, mental health status, or traumatic experience should be handled carefully. If faculty feel that these questions are necessary, IRB consultation should be sought.

Student Assignments that Require Data Gathering

Courses may also collect data—via surveys, observation or oral history—on individuals outside of the classroom environment. Some of these activities may qualify for IRB review. A few important considerations are below:

  1. Faculty should be aware that if data is collected with the intention to be used outside of Cecil College, IRB approval is required. If data was initially presented internally, for example at a STEM poster event, and is to be repurposed in the future for an external conference, IRB approval is required.
  2. If students collect data from outside sources, subjects should be aware of informed consent.
  3. Individual identifying information should be left out of the student report on the data. For example, if a student obtains an oral history from a family member, identifying information should not be included in the report write-up, unless informed consent is obtained. All data should be destroyed after the project is completed.
  4. Students should be made aware of how the types of information they are collecting could be sensitive in nature, and instructed on the proper use of confidentiality and the importance of data storage.

Faculty should be aware that data that is used by students in assignments, and submitted via Canvas, may be housed and available to other faculty via SafeAssign. It is important that data is not identifiable. It is recommended that faculty do exclude these assignments from the SafeAssign database when possible.

Additional Faculty Questions

  1. I am doing an oral history for a class project or my students are collecting data to present in class. The projects do not require IRB approval, but I would like them to learn about informed consent. Are there mock documents I can use?

    • Typically oral history class projects do not contribute to generalizable knowledge as defined by the IRB and IRB review is not required. As mentioned below, it is important that individuals included in the oral history project be aware of the intent of the project and how identifying information will be used. Informed consent is key. The IRB has sample Informed Consent documents under New Projects (see Step Four). Additional examples can be found at www.hhs.gov.

  2. When I have my students turn in assignments is there a way to still use Safe Assign, but not include the assignment in institutional or global databases?

    • First, it is always important to talk to students about not including any readily identifying information if possible in the assignment. Again, the goal is to obtain consent from the individual in an informed way so that the person is aware of what data is being collected, how it will be shared, and who will have access to the information.
    • At the point of submission, you can have your students submit their assignments via Canvas and through Safe Assign. After you check for the assignment to be included in Safe Assign, you also need to check the box below that says "Exclude from Institutional and Global Databases."
    • After the course ends and the window for grade challenges is over it is advisable to destroy any assignment that does include de-identifying information. Students should be instructed to do the same.

  3. I have a student or group of students who completed data gathering for a project in class and we would like to present the information at a conference outside of the college. Do we need IRB approval?

Required Training for PIs

PIs and research teams that seek IRB approval will need to complete mandatory training through the CITI program as designated below or a comparable program approved by Cecil’s IRB. A copy of the up-to-date, within past five (5) years, certificate of completion for the PI and any Co-Is is required with submission of IRB documents and will be kept on file within the Academic Programs office. If using the CITI program, PIs and outside entity personnel that are co-PIs must complete the Human Subjects Research Course (HSR). Depending on the nature of the research, the PIs must complete either the Biomedical Basic course or the Social-Behavioral-Educational Basic course. Students must complete the Responsible Conduct of Research (RCR) basic protocol via the CITI program or complete the series of videos provided at www.hhs.gov, including When HHS Regulations Apply, What is Human Subjects Research, What are IRBs, and IRB Review of Research.

To register for the course, please visit citiprogram.org.