Human Subjects Research Review

The Human Subjects Research Review Committee (HSRRC) is responsible for ensuring that all research at Daemen College involving human subjects is appropriately documented in accordance with pertinent legal and ethical requirements. Faculty and students who receive the committee's approval for research projects are responsible for conducting the research as approved, without changes pertaining to the treatment of subjects, and are responsible for maintaining ethical standards while conducting research.

This web page is established to provide faculty and students with the necessary information to conduct, report and seek approval of the research in the most appropriate and efficient manner.

Spring 2014 HSRRC Meeting Dates & Deadlines (for Proposals Requiring Full Review):

Meeting Date

Full Review Submission Deadline

Thursday, February 20, 2014

Tuesday, March 18, 2014 (4:30 pm)

Thursday, May 8, 2014

Thursday February 6, 2014

Thursday, March 6, 2014

Thursday, April 24, 2014

 

Please note that proposals submitted for Expedited review and Certification of Exemption are considered on a rolling basis (i.e., no deadlines).  For your research planning, please expect a minimum of 2-3 weeks turnaround time for review of applications for Certification of Exemption, and a minimum of 3-4 weeks turnaround time for review of applications for Expedited review.  Please note these guidelines are ONLY for proposals that are accurately and completely submitted. 

Before submitting proposals, researchers must consult the Daemen College Research Review Policy, including its description of criteria for Exempt, Expedited and Full Review Proposals, and required elements of informed consent.

NOTE:  ALL proposals (full, expedited, exempt) submitted to HSRRC for review after May 31, 2014 must include current verification of CITI training.  Certificates from all investigators (including all student researchers and faculty sponsors) must be attached to the proposal.  Students/faculty needing CITI training may access this process through www.citiprogram.org

For Requesting Certification of Exemption:

If the researcher(s) determine that an Application for Certificate of Exemption is appropriate,  Researchers and faculty supervisors must initial each part of this checklist/application (once the applicable parts are included).

For Expedited or Full Reviews:

If the researcher(s) determine that the proposal requires an expedited or full review, please download and complete the Application for Investigation Involving Human Subjects.

For Modifying Approved Proposals

Once a research study has been approved by the HSRRC, the principle investigator must conduct the study exactly as approved. No changes in approved research should be initiated without prior HSRRC review and approval, except where necessary to eliminate apparent immediate hazards to participants (and then the amendment should be filed immediately thereafter). This includes changes to approved documents, such as consent forms, personnel, recruitment materials, or instruments to be used in the study. Updated documents may NOT be used until the new versions are approved by the HSRRC. To modify the approved study and/or documents, or to request a continuation of a previously approved protocol, please complete the Application for Modification to an Approved Proposal and append supporting materials.

 

Once this form is completed, the Faculty Member (including those who are supervising student projects) should submit an electronic version in MSWord format to hsrrc.chair@daemen.edu, with a carbon copy to all associate investigators on the project to daemen.edu e-mail addresses only.  Hard copies are not needed unless one or more of the associate investigators are not affiliated with Daemen College. In this case, a hard copy of the application with all signatures is needed.

Submission Instructions for all Review Requests:

All proposals must be completed in full.  Failure to follow these instructions will result in delays of the review process.  Once completed you may submit your entire application electronically if you complete all of the following:

  1. Send the application to hsrrc.chair@daemen.edu
  2. If the project involves student researcher(s), the application must be sent by the Daemen faculty member supervising the project. Submissions will be returned and NOT reviewed if submitted by anyone other than supervising faculty.
  3. Include a meaningful subject line in your e-mail (e.g., HSRR Expedited Review Request: K. Smith) and a body in your message.
  4. Send the application from your daemen.edu e-mail address
  5. Copy the submission e-mail to all affiliated associate investigators' daemen.edu e-mail addresses
  6. Copy the submission e-mail to all non-affiliated associate investigators' professional e-mail addresses.
  7. The file name of your attachment must be in the following format:
 Last Name First Initial - HSRR - Date (e.g., Smith K HSRR 10-18-11.doc)

All proposals must be submitted as a single e-mail attachment in MSWord format to the HSRRC chairperson at hsrrc.chair@daemen.edu with a copy to Mrs. Arlene Lina at alina@daemen.edu

A hard copy of proposal applications is required only if one or more of the researchers is not affiliated with Daemen College. This copy must be signed and dated by all investigators.  In addition to an e-version sent to hsrrc.chair@daemen.edu, please submit one hard copy of the research proposal to the HSRRC Chairperson, Daemen College Human Subjects Research Review Committee, P.O. Box 965.

If the proposal contains material which cannot be appended within the single application e-mail attachment (e.g., diagrams, photocopies from another source, or copyrighted test forms), please include this material with the full application in hard copy and make reference to its hard-copy availability in your application.) 

Informed Consent Forms are required for Expedited and Full Review Proposals and must be prepared according to the Consent Form Template, and appended to your application.

 

Recruitment Requests by Investigators Unaffiliated with Daemen College:

Researchers who are unaffiliated with the College but who wish to recruit participants on the Daemen College main campus or any of its satellite campuses must request and obtain permission from the Human Subjects Research Review Committee before any recruitment may take place.  Recruitment may take place via approved flyer or poster only.

If you would like to recruit on the campus, please submit one copy of the materials (application and all supporting documents) that were submitted to your home institution IRB, along with the letter of IRB approval to hsrrc.chair@daemen.edu.  The HSRRC chairperson or his/her designee will review the request. Approved requests will be acknowledged by a letter of permission to recruit on campus.

On occasion, the HSRRC chairperson may decide that requests for permission to recruit on campus go to the full HSRR committee for review and/or approval.

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