ASM events
This conference is managed by the American Society for Microbiology
Table of contents
No headers

 

Ferrum College 

Institutional Review Board 

Procedures for Submitting Proposals Involving Human Research 

 

            All proposals for conducting human research must be submitted to the Ferrum College Institutional Review Board (IRB) for review. There are no exceptions.   

 

Under no circumstances should human research data be collected prior to written approval or exemption by the IRB.  Collecting data without IRB review may result in serious consequences, including (a) the researcher being asked to destroy any data collected, (b) large federal fines levied against the researcher, (c) large federal fines levied against the institution, and (d) a federally-imposed ban on research at the institution.  The IRB chairperson will investigate any reports of noncompliance, and will consult with the other IRB members about the appropriate course of action.  The decision reached by the IRB will be communicated to the researcher, the supervising faculty member (if applicable), and the department chairperson. 

 

To submit a protocol for IRB review, please follow the steps below:  

 

1. Complete the information required on pages 1 –5 below. 

 

2. After the information on page 5, insert your questionnaires, informed consent form(s), debriefing sheet, and any other materials that will be given to participants. Formats are given in Appendix A thru D.  

 

3. Delete the information and forms in pages 6– 13 you are not using.  

 

4. Your protocol for submission to the IRB should now include the information requested on pages 1-5 and the appropriate completed items from the appendix. Save all of this as a Word file. 

 

5. If you are collecting data at an off-campus institution, please make sure you have a signed Institution Permission Form (see Appendix D) to include with your IRB form.  You must scan it and insert it at the end of your IRB form (this is preferred by the IRB) before your IRB form is sent to the IRB.  The IRB will not accept your IRB form unless the signed permission form is included. 

 

6.  If you are a student, you must have the faculty member who is supervising your research approve this IRB form before it can be reviewed by the IRB. Once the faculty member has reviewed and approved it, the faculty member will send the IRB form electronically to mstpeters@ferrum.edu.  The faculty member should state in the e-mail that he or she has approved the research project and the IRB form. The faculty e-mail sending the protocol to the IRB must also include verification of the faculty member’s NIH certificate of training unless alternative evidence of human research protection training is on file with the IRB. 

 

NOTE: If you have any questions regarding these procedures, please contact Megan St. Peters at 365-6947 or mstpeters@ferrum.edu.  

 

 

 


Ferrum College 

Institutional Review Board 

Protocol Submission Form 

 

Submission Number: (assigned by the IRB) 

  

TYPE OF IRB REVIEW REQUESTED (Researcher must check one):             

 

_______Exempt: e.g., research on effectiveness of instructional techniques (see NOTE below); research involving public observation of behavior, anonymous surveys (except with minors), or existing records/specimens (if publicly available or the information is recorded in such a manner that subjects cannot be identified).  Visit http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 for more exempt categories and additional detail.  Exempt review is performed on a continual basis by the IRB chair or another IRB member.  This review is typically performed within 7-10 working days. 

NOTE: Educational research is exempt only if it (a) occurs in a commonly accepted educational setting, (b) does not involve a significant departure in the time or effort required by students compared to educational practices already in place  and (c) involves normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. When a project that involves minors meets these conditions, parental consent is not required by the IRB.  However, the researcher, faculty advisor, or school official may still decide that parental consent is necessary. 

 

______Expedited: nonexempt research involving minimal risk (i.e., “the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests”).  Visit http://www.hhs.gov/ohrp/policy/expedited98.html for more information on expedited review.  Expedited review is performed on a continual basis by the IRB chair or another IRB member.  This review is typically performed within 7-10 working days. 

______Full: research involving more than minimal risk.  Full review is performed by all members of the IRB.  You should receive the IRB’s decision within 14 working days of their receiving the proposal. 

 

INVESTIGATOR INFORMATION 

 

Principal Investigator:  

 

Training Certificate: **NEW PROCEDURE (as of October 2012)*** 

NIH has changed their website such that copying and pasting the URL for your training certificate no longer provides a direct link to your individual certificate unless you are logged into your account. So, to provide documentation of completion of the training to the IRB, save a copy of your certificate in an image file and then include it in an appendix to your IRB form. 

 

Department:  

 

Phone Number: 

  

E-mail Address: 

  

If student, give campus or home address:  

 

For co-investigators, please list names and include copies of training certificates (Note that co-investigators include research assistants who have contact with subjects.). 

 

 PROJECT INFORMATION 

 

Date of IRB submission:  

 

Title of Project:  

 

Start Date: After IRB Approval (check here) _____ or list later start date here _______________ 

 

End Date: 

  

Place of Data Collection:  

 

Sponsoring Agency (if any):  

 

The following human subjects will be involved in the proposed project: (Check all that apply.  Click on the links for federal guidelines related to each special class of subjects. 

(     ) Minors                            (     ) Cognitively Impaired Individuals 

(     ) Fetuses                            (     ) Elderly/Aged Persons 

(     ) Pregnant Women            (     ) Mentally Retarded 

(     ) Prisoners                         (     ) Institutionalized individuals* 

(     ) None of these groups apply. 

             

*Institutionalized individuals are those individuals who are dependent upon health care workers for their well-being and who may feel pressure, whether perceived or real, to participate in a study in order to continue to receive care.  

 

CONFLICTS OF INTEREST 

1. Except for grant-funded compensation and expenses, do you, or does any member of your immediate family, intend or expect to profit financially in any manner from the results of the research undertaken in this study (including, but not limited to any patent or licensing fees)? 

(     ) YES                          (     ) NO 

 

If “yes,” please provide a detailed description of your financial intentions or expectations: 

 

2. Do you, or does any member of your immediate family, currently have or expect to have an ownership or other financial interest in, or management position with any entity whose procedure, technique, product, or software is used or tested in this study? 

(     ) YES                          (     ) NO 

 

If “yes,” please provide a detailed description of your financial interest or management position: 


RESEARCH PROTOCOL 

 

A. Purpose of the research: a brief statement of purpose and research objectives is required. 

 

 

 

B. Potential Benefits: describe the contributions that the study will make to the health of human beings and/or to the scientific data base. 

 

             

 

C. Research Design:  

i. Subjects:  

a). Describe the age, sex, and approximate number of subjects.   

 

 

 

b). Describe how volunteer subjects will be recruited, and the source of the subject population (e.g., college campus).  (Any advertisements or notices to be used for recruiting subjects must be submitted to the IRB for review.) 

 

 

 

 

c).  Explain how you will minimize or eliminate the possibility that subjects will feel pressured or coerced into participating. 

  

 

 

 

            ii. Procedure: 

a). Research Design: Include a thorough description of how you will collect data for your study, including the procedures, experimental conditions, manipulated variables, monitoring techniques, and measuring instruments. 

 

 

 

 

 

b). Setting: Where will the study be conducted? 

 

 

 

i. If you are obtaining your subjects from an off-campus institution (e.g., school, nursing home, business): Prior to submitting your IRB form, you should obtain written permission to conduct your research from the person(s) legally authorized to give such permission for the off-campus institution.  Include a copy of the signed permission statement with your IRB form (see Appendix D for an example form)The IRB will not accept your IRB form unless the signed permission form is included. 

 

c). Potential Risks:  

i. Minimal Risk: If you applied for exempt or expedited review and you believe your study involves minimal risk, explain why.  (Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”)  

 

 

 

 

ii. Greater than Minimal Risk: If your study involves more than minimal risk, describe any potential risks or discomforts in detail. Use evidence from clinical and/or animal studies to evaluate the level of potential hazards associated with participation in the research. Indicate the methods for detecting and monitoring adverse reactions. Describe the procedures for protecting against or minimizing potential risks. Discuss why the risks to the subject are reasonable in relation to proposed benefits of the study. 

 

 

 

 

 

 

 

d). Deception: Does the study involve deception or withholding information?  Could this be psychologically or physically harmful (if so, explain in detail)?  If your study involves deception or withholding information, attach the debriefing statement that will be given to participants after the study in order to explain the full purpose and procedures of the study. 

 

 

 

 

e). Confidentiality/Privacy:Describe how confidentiality will be preserved. Are subjects aware that data are recorded or that they are under observation? Might any aspect of the study constitute invasion of the subject’s privacy by the experimenter that has not been consented to expressly or implicitly? Explain. 

 

 

 

 

 

i. Confidential Materials:  If your study involves retaining confidential materials that contain the subject’s identity (e.g., academic records, questionnaires, video or audio recordings), explain where the materials will be kept, who will have access to them, how long they will be kept, and what will happen to them once the study is completed.  In addition, include this information in the informed consent form that subjects sign.   

 

 

 

f). Informed Consent:  

i. Minimal Risk Studies: If your study involves no more than minimal risk and does not involve minors, institutionalized individuals, prisoners, or cognitively impaired individuals, you may not need a separate informed consent form. However, a separate informed consent form would be appropriate for some minimal risk studies involving physical activities (e.g., exercise, eating, etc.) If you do not plan to use a separate informed consent form, such as in studies using questionnaires, include an informed consent statement at the top of your questionnaire. Address the elements below and include the following statement: 

 

1.      “Participation in this study is voluntary.  Refusal to participate or discontinuation of participation will involve no penalty or loss of benefits to which you are otherwise entitled. By completing this questionnaire, you indicate your consent to participate in this study” 

 

2.      Indicate that the study involves research and include: 

a.       an explanation of the purpose of the research 

b.      the expected duration of the subject’s participation 

c.       a description of the procedures; identify any that are experimental 

 

3.      Describe the extent, if any, to which confidentiality of records identifying the subject will be maintained. 

 

ii. Studies with special populations (as listed in the Project Informationsection) or those involving more than Minimal Risk: You must use written informed consent forms.  Attach a copy of your form. See “INFORMED CONSENT FORMS” section of this document for information on creating these forms. 

 

g). Compensation/Payment:Describe any compensation or payments for subject participation (or specify “none”). In the informed consent form, provide a detailed account of the terms and timing of payment. If compensation involves a lottery, state the value of the item(s) and provide an estimate of the chances of winning the item(s) in the informed consent form. 

 

 

 

If you are a student researcher and going to ask instructors to offer course credit in exchange for participating in your research, state that here. Also, indicate the department(s) (e.g., Psychology, Social Work, Nursing, History, etc.) of the professors you will be asking.  

 

 

 

h). Questionnaires/Experimental Materials:  At the end of this IRB form, include a copy of all questionnaires, experimental materials, debriefing sheets, and informed consent forms that participants will receive.  If you are applying for full IRB review, include a copy of your complete research proposal that includes a literature review. 

 

D. Data Analysis: Provide a brief description of the evaluation/data analysis procedures to be used. 

 

 

E. Faculty Supervision: If you are a student, please indicate the name of the person supervising this project and state whether this person is your course professor, research advisor, academic advisor, etc.  Does this person work for Ferrum College or for a different institution? 


Tag page
Viewing 1 of 1 comments: view all
Note that there is a training certificate you need to submit with your application. If you have not done so, you might want to start on this.
Posted 12:56, 14 Jul 2013
Viewing 1 of 1 comments: view all
You must login to post a comment.