Student Research Guidelines for Faculty
Students conducting research that requires IRB approval need to obtain a faculty sponsor for their research project. This process has been put in place to prevent inadvertent violation of the IRB guidelines and to aid the student with the IRB approval process. The faculty sponsor can be the instructor of the course/project, an advisor, or other qualified faculty member at Landmark College.
Student responsibilities include:
- Submit a request to the faculty sponsor with enough project information for them to determine if they can assist with the project
- Prepare the IRB Proposal and submit it to the faculty sponsor for feedback
- Students are not allowed to start or conduct any human subject research prior to IRB approval
- Students may use classmates or faculty and staff as research participants as long as participation is voluntary and done so that the subject's identity is concealed.
Faculty sponsor responsibilities include:
- Ensure that students follow the guidelines for conducting responsible research as outlined in the Code of Federal Regulations http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- Review and sign the student IRB Research Proposal identifying course information under the Project Support Section of the proposal form (section B)
- Support the student, including meetings to discuss results and where necessary, help to focus (or refocus) the direction of the project.
If all of the conditions below are met, the project does not require Institutional Review Board (IRB) review. If you are unsure, please contact the Chair of the IRB for assistance.
The research is being conducted as part of a class assignment.
In general, student class assignments that involve the collection of data from human subjects do not fall under the federal definition of research as outlined in 45 CFR 46. 102 (d) if they are done as educational exercises designed to teach subject matter or research skills. Some examples of activities that might be conducted by students as part of a class assignment include; interviewing classmates about the effects of meditation, administering a brief questionnaire to students about their study habits, or interviewing vegetarian faculty members about their diets.
The student does not intend to contribute to generalizeable knowledge.
There is no intent on the part of the student to contribute to the body of knowledge through publication or dissemination of results beyond the Landmark College Community. Students may share the results of their project through class presentations or other internal venues such as the Science Fair without review.
The project involves minimal or no risk to subjects.
The level of risk a project poses to research subjects is an important consideration. Areas of risk include physical harm, psychological harm and harm caused by disclosure of confidential data. If a student plans to conduct activities with the potential to cause physical or psychological harm, the project must be reviewed by the IRB. Also, if a researcher intends to collect information on a sensitive topic that could adversely affect research participants if accidentally released, then he/she must seek approval. Examples of sensitive information include diagnosis, medications, GPA, income, sexual history, substance abuse, etc.
The project does not involve vulnerable populations.
When a subject has limited capacity he/she is considered vulnerable. Examples include children and the mentally disabled. Also, if conditions exist such that the voluntary nature of participation is compromised, subjects are considered vulnerable. Situations that might place undue pressure on people to participate include emergency situations, hierarchical structures, economic or educational disadvantage, incarceration, and terminal medical conditions. The majority of student projects conducted at Landmark do not involve the collection of data from vulnerable populations. However, some instances requiring review may exist such as a project that seeks to involve children a Daycare Center.
If all of the above conditions are not met, the project must be reviewed by the Landmark College IRB. The research proposal must be submitted to the IRB Administrator using the Research Proposal Submission for New Projects. Approval for a project can take several weeks, particularly if revisions or modifications are necessary. Therefore, a student should submit his/her research proposal at least 3 weeks in advance of the date he/she wishes to begin data collection.
If you have questions or need more information about the IRB process please contact Dr. Sapna Prasad, the IRB Chair.