Policies & Procedures

Policies

Responsible Conduct of Research (RCR) Training Policy

Effective February 1, 2011, all researchers, principal investigators, and key personnel conducting research projects at Landmark College that receive external funding from the National Science Foundation (NSF) and/or the National Institute of Health (NIH) must undergo Responsible Conduct of Research (RCR) Training via the Collaborative Institutional Training Collaborative (CITI) training course.


Landmark College Training Policy for the Protection of Human Subjects

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 re-take 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.

Human Subjects Research Guidelines & the IRB, Administrative Policy
 

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:

  1. 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. 
  2. The rights and welfare of human subjects will be adequately protected.
  3. Informed consent will be obtained by adequate and appropriate methods.
  4. 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. 

The Institutional Review Board makes recommendations to the President, who makes the final decision about the conduct of all research at Landmark College.

Research Recruitment and Advertising Requests from External Entities Policy

Purpose: On occasion, requests for the recruitment of research participants are made at Landmark College by external researchers and recruiting specialists.  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.

Definitions:
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.

Policy Statement: External applicants wishing to conduct research or have Landmark College distribute advertisements (via email, message boards, bulletin boards, etc.) should follow the External Research Proposal Process as outlined on https://intranet.landmark.edu/research-office/policies.cfm.

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.


Status: Approved

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Procedures

Due to Landmark College’s unique mission and population, our research proposal processes have been developed to maintain a balance between the open promotion of scholarly activities, the preservation of a high-quality educational experience for our students, and the assurance that our personnel remain dedicated to the College’s unique mission.

It is the responsibility of the IRB to ensure that all projects are lead by qualified researchers and that all human subjects involved with research are protected from harm. For more questions regarding procedures followed by the College's IRB please see the Institutional Review Board Standard Operating Procedures Manual, October 2012 [PDF].

Internal research requests must be routed through the College's IRB.

External research requests from outside organizations must be routed through the College's IRB. All external projects must be co-sponsored or facilitated by a Landmark College employee. These requests are regularly reviewed by the IRB, who determine the level of benefit and impact on our students, faculty, and staff. While we encourage research at our institution, our small enrollment limits the number of research opportunities available. We must be particularly selective, approving only those proposals that show a strong and direct benefit to students from the knowledge gained.

* Note: Research requests take time to review, especially in cases when the full Institutional Review Board (IRB) must be convened. The entire process can take over 1 month, so please plan accordingly

Internal Research Proposal Process (led by Landmark College Personnel)

Step 1: Initial Approval

  •     Develop research idea
  •     Establish organizational support
  •     Complete the Research Proposal Submission Form for New Projects
  •     Go to Step 2

Goal: Develop concept and secure organizational approval. Research should initially be proposed using the IRB Proposal Form.

Rationale: Access to limited resources. This step is required to ensure fit with the mission and priorities of your organization. Each proposal will be reviewed to ensure equitable access to limited resources (e.g. students, instructors, facilities) for well-crafted research studies. The Institutional Review Board Chair and are available for guidance and feedback on your proposal.

Step 2: College approval/IRB

  •     Submit to IRB for review
  •     Implement study and file Adverse Event, Project Modification Applications, and Project Status and Closure forms as necessary.

Goal: Secure College-level approval and ethical assurance from the IRB. After receiving organizational approval, an IRB review is required for all studies to ensure that human subjects (vulnerable populations) are adequately protected.

External research proposal process (led by an external researcher in collaboration with Landmark personnel)

Step 1. Initial Approval

  •         Secure co-sponsor or facilitator from the Landmark Collge  
  •         Complete the Research Proposal Submission form for New Projects
  •         Go to Step 2

Goal: Propose research idea. A proposal is required for externally sponsored research at Landmark College. At a minimum, the proposal consists of the IRB Proposal Form, but additional materials may be required (including proof of IRB Approval from other institutions involved in the research project). Resources and personnel necessary will be secured to ensure that the research project can be effectively implemented.

Step 2. College Approval/IRB

  •         Submit to IRB for ethics review
  •         Establish needs and resources
  •         Implement study and file Adverse Event, Project Modification Applications, and Project Status and Closure forms as necessary.

Goal: Secure College-level approval and ethical assurance from the IRB. After receiving approval, an IRB review is required for all studies to ensure that human subjects (vulnerable populations) are adequately protected.

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