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SALISBURY UNIVERSITY

COMMITTEE ON HUMAN RESEARCH

APPLICATION FOR RESEARCH INVOLVING HUMAN SUBJECTS

 

Name of Principal Investigator__________________________________________________________

 

E-Mail Address _________________________________________Tel. No.______________________

 

Campus Address ___________________________________________________Zip_______________

 

Name(s) of Co-Investigator(s) __________________________________________________________

 

Department___________________________________________________________________________

 

Project Title ________________________________________Duration (mo/yr-mo/yr) ______________

 

Funding Agency (if applicable) __________________________________________________________

 

[Note: CR 46.101

“(b) Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

(1) Research conducted in established orcommonly accepted education settings, involving normal education practices, such as

  (i) research on regular and special education instructional strategies, or

 (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom    management methods.”]

 

The following examples are for research projects that are not under the purview of the SU CHR:

-using the “self “as the subject

-library research

-Interviews of political figures or experts in a specific field where they are not the subjects of the research

-oral histories except when using minors, institutionalized mentally ill or retarded persons

-public documents

-Academic Program Review

This is neither an exclusive nor an exhaustive list. For further information about whether or not your project needs to be received and reviewed by the Committee on Human Research, refer to Appendix A in the “Researcher’s Packet”

 

Identify the category under which you suggest this research project falls. The Committee on Human Research makes the final determination as to which category is most appropriate.

 

_______Full Committee Review (All research which does not qualify for exempt or expedited review             must be considered by the full committee.)

a.      ______ Research in which more than minimal risks are involved.

 

b.     ______ Research that involves information about the subject that is sensitive or could cause embarrassment (e.g. sexual behavior) if linkages can be made to the subject's name.

 

c.      ______ Research that involves information about illegal behavior such as drug taking or underage drinking. 

 

d.     ______Research that involves children, pregnant women or prisoners.

 

e.      ______Research that involves deception in which the subject cannot be told in advance the purpose of the study and hence informed consent is compromised.

 

f. ______Research that involves use of information that is not publicly available, such as student records or medical charts, if there are identifiers.

 

_______Expedited Review (check all possible categories including those found in Appendix A which             pertain largely to physical aspects of the human body.)

a.      ______ Voice recordings made for research purposes such as investigations of speech defects.

 

b.     ______ Moderate exercise by healthy volunteers.

 

c.      ______ The study of existing data, documents, records, pathological specimens, or diagnostic specimens that are rendered anonymous.

 

d.     ______ Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.

 

e.      ______ Research involving the continuation of a previously approved research protocol for an additional period of time that involves no changes in the protocol.

 

f.      ______ Other categories from Appendix A. Please specify: _________________________________

 

_______________________________________________________________________

 

In addition to the above, please briefly describe further the reason(s) for expedited status rather than full committee review.  Your notation is simply a suggestion to the committee. ______________________________________________________________________________

______________________________________________________________________________

 

 

_______Exempt from full committee review (check all possible categories)

a.     ______Research falls into number _________ of the six categories defined by federal regulation as exempt from review. (See Appendix A for description of the categories)

 

b.     ______ Research is low risk for subjects and confidentiality and informed consent are  assured by the investigator. 

 

c.      _______ Research does not involve pregnant women, children, or prisoners when they are specifically chosen as the subject population. (These topics would require a full committee review process.)

 

In addition to the above, please briefly describe further the reason(s) for exempt status.  Your notation is simply a suggestion to the committee. ______________________________________________________________________________

 

______________________________________________________________________________

 

These conditions are neither exclusive nor exhaustive but represent the most common types of

research at Salisbury University that fall into the categories of full committee review, expedited review and exempt from full committee review. Carefully review the full lists of criteria found in Appendix A of the Researcher’s Packet.


Researchers Checklist: Please be sure the following items are provided to the Committee on Human Research for research involving human subjects.

            _______ Application. 

 

_______Abstract: A narrative of 250 words maximum that clearly describes the purpose of this study, subject selection, the strategies used to protect the subjects and general approach to data analysis.

 

______Procedures: A detailed description of the methods and procedures of the study. Include copies of relevant surveys, questionnaires, recording documents, observation criteria, etc.

 

_____ Risks/Benefits Analysis: A description of the potential risks, including adverse effects, and benefits to the subjects. Include strategies employed to reduce the risks or a justification for continuing despite known risks.

 

            _____ Confidentiality Statement: Describe the steps you will take to protect the privacy of subjects and to maintain confidentiality of identifiable information.  Explain how your procedures accomplish this objective; such as means of data storage, data location and duration, description of persons with access to the data, and method of destroying the data when completed.

 

            ______ Disclosure Statement and Consent Form: Include a copy of the statement provided to the subjects about the investigation. Is any of this information deceptive?  Informed Consent is the requirement that human subjects, or their legally authorized representatives, both understand the nature and purposes of the research andfreely give their consent to be participants in the study. (See a sample Disclosure-Consent form in Appendix B of this packet)

 

 

            ______Letters of collaboration (if applicable)

           

            ______Data collection instrument (if applicable)

           

            ______Human subjects section of grant/thesis proposal or outline of thesis proposal (if applicable)

 

            ______ SEND THE APPLICATION WITH ORIGINAL SIGNATURES TO UNIVERSITY RESEARCH SERVICES (HH 264): ATTENTION:  COMMITTEE ON HUMAN RESEARCH or e-mail to jlscott@salisbury.edu. Submit your proposal at least two weeks in advance of regularly scheduled meetings to insure consideration at that meeting.  You may be asked to attend the meeting if there are questions that need further explanation. You will be notified in writing of the Committees decision. 

 

___________________________________________________________________________________

Date        Principal Investigator (Print)                                  (Signature)

 

___________________________________________________________________________________

Date        Co-Investigator(s)      (Print)                                  (Signature)

 

_____________________________________________________________________________________

Date        Faculty or Administrative Staff Person responsible for Student Investigator

                                                   (Print)                                  (Signature)

 

_____________________________________________________________________________________

Date        Department Chair       (Print)                                  (Signature)

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IRB application
41.5 kB07:21, 3 Jul 2012kquillinActions
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So, it appears you can obtain IRB approval within 2 weeks of submitting an application, which is nice. However, do you know when you can submit an application? Any time? Only once the semester begins? You may want to check with the IRB chair.
Posted 11:43, 18 Jul 2012
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