This guide is designed to help researchers navigate the IRB approval process. The approval rate is high for researchers who follow these steps and construct their proposals as suggested. If you have questions, please contact IRB Chair Dr. Adam Lalor.
Landmark College Faculty and Staff
External Researchers
Landmark College Students
Landmark College Faculty and Staff
Recommended Steps for Proposing a Project:
- Develop research idea based on existing literature and established research methods.
- Establish organizational support—check in with your supervisor and the IRB chairperson to determine the feasibility and timeliness of your project. If you are using a survey, contact the Office of Institutional Effectiveness (OIE) to comply with the survey policy.
- Complete or update CITI training for researchers. All researchers must complete the CITI course Group 2 Social/Behavioral Investigators and Key Personnel.
- Complete and submit the Research Proposal Submission Form for New Projects to the IRB. Be sure to include consent forms, CV, and copies of instruments.
- Revise proposal as needed. Typically there are one to three rounds of revisions to the research proposal. This is normal and part of the process of ensuring the ethical treatment of human subjects.
After your proposal and supporting documents have been approved by the IRB, you may start collecting data. Please follow guidelines for Active Studies during the course of your research.
External Researchers
We encourage research at our institution; however, enrollment limits the number of research opportunities available. Thus, we are selective and approve those proposals that may provide direct or indirect benefit to students who learn differently. All external projects must be facilitated by a Landmark College employee—this person serves as an on-campus contact for matters related to the project. The IRB will assist in locating a facilitator for external researchers; however, we are unable to guarantee facilitation.
Recommended Steps for Proposing a Project (External Researchers):
- Contact IRB chair or IRB administrator to discuss your project idea and determine if our institution may be a good fit.
- Submit one-two page summary of research idea to IRB chair and IRB administrator. This will enable the IRB to determine the feasibility of your project and locate a potential facilitator. The summary must include:
- Topic of research & research question.
- Importance and relevance of your research, especially as it pertains to the betterment of individuals who learn differently.
- Methodology.
- Target number and characteristics of participants.
- Research activities for participants. What will they be asked to do?
- Projected tasks for the facilitator. What do you predict needing the facilitator to do? Examples of facilitator roles include but are not limited to: Recruiting subjects, scheduling space, scheduling interviews or other data collection activities, being present during data collection, collecting and holding data, etc...
- Estimated time commitment for facilitator.
- Note: It is recommended that you confirm on campus facilitation before continuing with the proposal process.
- Communicate with facilitator about how you will work together.
- Complete or update CITI training for researchers. All researchers must complete the CITI course Group 2 Social and Behavioral Investigators and Key Personnel.
- Complete and submit the Research Proposal Submission Form for New Projects to the IRB. Be sure to include consent forms, CV, and copies of instruments.
- Revise proposal as needed. Typically there are one to three rounds of revisions to the research proposal. This is normal and part of the process of ensuring the ethical treatment of human subjects.
After your proposal has been approved by the IRB, you may start collecting data. Please follow guidelines for Active Studies during the course of your research.
Landmark College Students
Landmark College encourages research by students. Research using human subjects is a key part of academic disciplines including the sciences, statistics, education, psychology, and business. This guide will help student researchers through the IRB process.
Research led by students may or may not need IRB approval. Answer the following four questions. If you answer YES to one or more questions, you will need an IRB Application.
- Is my research project separate from my Landmark College coursework?
If you are doing research that is separate from class work, then IRB review is needed. Most class projects that involve data collection are exempt from review if they are done as educational exercises designed to teach subject matter or research skills.
- Do I intend to add to generalizable knowledge?
Adding to generalizable knowledge means publishing, posting, or presenting the results of research beyond the Landmark College Community. If you plan to distribute your findings outside the College, then IRB review is needed.
- Does my research involve risk for participants?
Risk includes physical harm, psychological harm, and harm caused by the disclosure of sensitive information. Psychological harm may occur in studies that involve tricking participants, or in studies that trigger traumatic memories (such as bullying or sexual assault). Sensitive information is content that could negatively affect participants if released. Examples of sensitive information include diagnosis, medications, GPA, sexual history, substance abuse, etc...
- Will my research involve vulnerable populations?
Vulnerable populations have a limited capacity to voluntarily participate in research. Vulnerable populations include children under 18 years of age, individuals with intellectual disabilities, prisoners, and pregnant women. The vulnerable population most likely to be studied at Landmark College is children, either in school or a childcare center.
IRB Application for Students
If you are a Landmark College student seeking IRB approval, you must follow the steps below as part of the application process.
- Find a Faculty Sponsor. Students conducting research that requires IRB approval must obtain a faculty sponsor. The faculty sponsor can be the course instructor, advisor, or other faculty member at Landmark College. The student must provide enough information up front so the faculty member may determine if he/she can serve as a sponsor.
- Communicate with faculty sponsor about how you will work together.
- Complete or update CITI training for researchers. All researchers must complete the CITI course Group 2 Social/Behavioral Investigators and Key Personnel.
- Complete the Research Proposal Submission Form for New Projects.
- Submit proposal to IRB for review.
- Revise proposal as needed. Typically there are revisions needed on the research proposal. This is normal and part of the process to ensure the ethical treatment of human subjects.
- Wait until you have approval before starting to collect data. Note: Approval for a project can take several weeks, particularly if revisions or modifications are necessary. Therefore, a student should submit the research proposal at least 3 weeks in advance of the date he/she wishes to begin data collection.
Faculty sponsor responsibilities:
- Ensure that students follow the guidelines for conducting responsible research with human subjects as outlined in the Code of Federal Regulations.
- Review and sign the student IRB Research Proposal identifying course information under the Project Support Section of the student’s IRB proposal.
- Support the student, including meetings to discuss results and where necessary, help to focus the direction of the project.
After your proposal has been approved by the IRB, you may start collecting data. Please follow guidance for Active Studies during the course of your research.
IRB Expectations for Active Studies
Researchers are responsible for the following during an active study:
- Implement study exactly as described in approved research proposal.
- File Project Status and Closure Form or Renewal Application annually as requested by the IRB administrator. The IRB continues to review studies for the duration of time that human subjects or their data is being collected.
- File Project Modification Application if needed. Changes to your project, including the inclusion of a new researcher, change in protocol, change in variables, change in instrumentation, etc… must be reviewed and approved by the IRB.
- File Adverse Event Report if needed. The Adverse Event Report documents “unanticipated problems that arise and pose risk to subjects or others.”
Policy to Protect Human Subjects of Research
Training Policy for Researchers
Training Policy for IRB Members
Policy on Recruitment and Advertising Requests from External Entities
Policy to Protect Human Subjects of Research
It is the policy of Landmark College that any research project, which requires access to Landmark College faculty, staff, students, their families, data or records (past or present), must be reviewed and approved by the Landmark College Institutional Review Board (IRB).
Landmark College adheres to regulations of Title 45, Part 46 of the Code of Federal Regulations (45CFR46) to assure the following:
- The benefit to the subject and the importance of the knowledge to be gained outweigh the risks to the subject to the extent that the decision to allow the subject to accept these risks is warranted.
- The rights and welfare of human subjects will be adequately protected.
- Informed consent will be obtained by adequate and appropriate methods.
- The research project may be reviewed at regular intervals to insure the rights and welfare of human subjects continue to be safeguarded.
The Landmark College Institutional Review Board (IRB) ensures that research conducted adheres to high scientific, as well as ethical, standards. Proposals are reviewed for methodology and research design considerations.
The IRB also ensures the integrity and relevance of research proposals with regard to judicious use of College resources.
All research proposals must be submitted using the Landmark College Institutional All research proposals must be submitted using the Landmark College Institutional Review Board Research Proposal Submission Form.
Training Policy for Researchers
Purpose: Landmark College maintains professional standards in research by requiring that all researchers complete the CITI course titled Group 2 Social/Behavioral Investigators and Key Personnel (“SBE” in this document).
Scope: This policy applies to all researchers at Landmark College and external research partners including, faculty, staff, college employees, as well as undergraduate students, graduate students, and postdoctoral researchers participating in the research project.
Definitions: Research [on human subjects] means 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.
Policy Statement: Landmark College promotes a culture of ethical research activities. To maintain professional standards, the College requires that researchers continually build a foundation in the ethics and practice of protecting human subjects while engaging in research and scholarly activities. The required CITI Social/Behavioral Investigators and Key Personnel course supports this goal by providing content in the following areas:
- The definition of research with human subjects
- The ethical principles of research and their application (respect for persons, beneficience, justice)
- The definition and rights of human subjects and vulnerable populations
- Informed consent
- What constitutes harm in research
- Privacy, confidentiality, and anonymity
- Research in special contexts, including schools and overseas
- Internet research ethics
- HIPAA and FERPA
Procedures: Go to the CITI link on the IRB website and follow directions to register for the course. After taking the course, provide a completion report to the IRB Administrator.
SBE training must be completed prior to the start of any research project. Proposals are subject to the IRB review and approval is not contingent upon this policy or the completion of SBE Training.
Principal investigators of grant-funded projects are responsible for submitting CITI certificates to the Grants Administrator. Investigators working on grants are also responsible for meeting the funding agency’s requirements, including requirements for specific trainings not covered as part of this policy.
Responsibility: The Institutional Review Board (IRB) at Landmark College, specifically the IRB Chair and the IRB Administrator are responsible for this policy.
Effective Date: 11/1/2014
Training Policy for IRB Members
All members of Landmark College’s Institutional Review Board (IRB) must complete with a passing grade the College’s human subjects’ protection research educational program within 60 days of becoming a member of Landmark College’s IRB. Failure to do so in a timely manner will result in the suspension of IRB member status until such time that the training is completed. All IRB members must continue to take the training every two years, per College policy.
The following exceptions apply:
- If an IRB member joins Landmark College having had training from a previous institution and that training is current within the two year time frame set by Landmark College policy, that person shall not need to retake IRB training until such time that their two year period is up, provided that written documentation of prior training is provided to Landmark College’s IRB Administrator.
- If an IRB member remains a full-time employee of another college or university, that college or university’s IRB guidelines for IRB training shall remain in effect for that IRB member.
Policy on Recruitment and Advertising Requests from External Entities
Purpose:
External Research Requests:
Advertising: Because all advertisements for research must be reviewed and approved by an IRB and adhere to the Code of Federal Regulations 45 CFR Part 46, Landmark College will not distribute fliers, emails, posters, etc. that have not gone through the College’s Institutional Review Board (IRB) process.
Scope: This policy applies to any external researchers or recruiting specialists wishing to advertise or recruit research participants at Landmark College.
Institutional Official: The Institutional Official is the acting authority for Landmark College and assumes overall responsibility for compliance with federal regulations for the protection of human subjects and the College’s IRB. The Institutional Official at Landmark College is the President or his designate.
IRB Chair: The IRB Chair is the appointed official responsible for the day to day management of the IRB work of all IRB members and the IRB administrator. The IRB Chair ensures that the IRB composition is adequate and adheres to federal regulations. The IRB Chair at Landmark College is a qualified faculty or staff member and normally has an earned doctorate.
IRB Administrator: The IRB Administrator is an appointed faculty or staff member that works under the administrative direction of the IRB Chair. The IRB Administrator at Landmark College is a qualified faculty or staff member and normally has experience in research and daily administrative duties.
Recruiting specialists: Any person or business seeking to enlist human research subjects for research studies; recruiters can be directly associated with the institution seeking participants or indirectly (for-hire company/person) associated.
Procedures:
If requests of this nature come into Landmark College they should be directed to the IRB administrator and the following process will take place:
- The IRB Chair or the chair designate will contact the person requesting to have information distributed and give instruction on the External Research Proposal Process.
- When the formal proposal process for external research has been completed, the IRB Chair will send the proposal and related information to the Institutional Official (IO) or the IO designate to see if the project is consistent with our mission.
- If the project is determined to be consistent with the Landmark College mission, the IRB application form will be completed and sent to the IRB Chair for review. Prior to final approval, the IRB request will be reviewed by the Institutional Official.
- If the project is determined not to be consistent with the Landmark College mission, the IRB administrator will send a letter to the research applicant with feedback obtained from the IRB.
- When/if IRB approval is received, the IRB administrator will distribute advertisements as outlined in the IRB application form.
Responsibility: The Institutional Review Board and the College’s Institutional Official.
To ensure that human subject research is conducted by qualified personnel, Landmark College requires a training course on the ethics and practice of research. All researchers and facilitators must complete the CITI course titled Group 2 Social/Behavioral Investigators and Key Personnel. Landmark College employees and students may register free of charge. Please submit a “Completion Report” to the IRB administrator.