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Okay, I've applied for IRB approval twice at my institution and both times have been told that my work is "exempt". Does this mean that I don't have to apply? What does this mean when I go to publish my work?

Here's the official application form:

 

FROSTBURG STATE UNIVERSITY
Institutional Review Board (IRB)

APPLICATION FOR INITIAL REVIEW OF RESEARCH
USING HUMAN PARTICIPANTS

Name of Principal Investigator:

Department:

Tel.:

Name of Co-PI:

Department:

Tel.:

Project Title:


Funding Agency (if applicable):

Project Duration (mo/yr – mo/yr):


Please send completed applications to the Office of Research and Sponsored Programs, 511 Ort Library.

A. Research:
 “a systematic investigation designed to contribute to generalizable knowledge”

Is this project more than an instructional exercise?    Yes     No
If so, what is its purpose?

 

 


Will the results ever be published or presented?    Yes     No
If so, where?

(Will the results contribute to generalizable knowledge?)

 


If you answered “no” to both these questions, stop.
 Your project does not need to be reviewed by the IRB.

Please note that if the project does not need to be approved by the IRB, then the instructor is responsible and liable for the appropriateness of the activities.


B. Human Participants:
“a living individual about whom an investigator obtains (a) data through intervention or interaction or (b) identifiable private information”

Will you collect data about living individuals?   Yes     No
If so, who are the participants (check all that might apply)?

 FSU Students  General Public  Prisoners
  (Adults)  Pregnant Women
 Other  _________________ Children or Minors

Will you interact with the participants in any way? Yes     No
(On-line information gathering is considered interaction.
Simple observation is not.)

Will you use private information that could identify individuals?   Yes     No

If you answered “no” to two or more of these questions, stop
 Your project does not need to be reviewed by the IRB.

Please note that if the project does not need to be approved by the IRB, then the instructor is responsible and liable for the appropriateness of the activities.

C. Information for Review

Please provide the following information, taking care to communicate in a manner that will be intelligible to educated persons who are not specialists in your field.
  
1. Abstract:  Provide an abstract of the research proposed (maximum 200 words).

 

 

2. Participant selection:  Who will be the participants? On what basis will the participants be selected? How will you enlist their participation?  If you plan to advertise for participants, please include a copy of the advertisement.

 

 

3. Procedures:  What precisely will be done to the participants?  Explain in detail your methods and procedures in terms of what will be done to participants.  If you are using a questionnaire or handout, please include a copy with each copied set of application documents.

 

 

4. Risks and Benefits:  Are there any risks to the participants?  If so, what are these risks?  What potential benefits will accrue to justify taking such risks? How do you propose to minimize these risks?

 

 

5. Confidentiality:  Adequate provisions must be made to protect the privacy of participants 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.

 

 

6. Information and Consent Forms: 
State specifically what information will be provided to the participants about the investigation.  State how the participants’ informed consent will be obtained.  Include a final draft of the consent form, which you propose to use.

FSU faculty, staff, and students must obtain the informed consent of any potential human participant before involving that person in research that is not determined by the IRB to be "exempt." Typically, you do this by providing the participants with an informed consent document written in simple, lay language. The IRB may waive the consent form requirement under federal regulation section 45 CFR 46.116 and 46.117
The following pertain to all consent forms:
General Language: The informed consent form should be written in simple, lay language. Consent documents are more understandable if they are written just as the clinical investigator would give an oral explanation to the subject, that is, the subject is addressed as 'you' and the clinical investigator as 'I/we.'
Purpose and Description: The opening paragraph should state that it is a research study and give sufficient details for participants to be informed of the purpose of the study along with such details as where the study will be conducted, its duration and dates, the nature of participant's participation, and the number of participants in the study.
Procedures: Describe the procedures to be followed, including any that are experimental, and any discomforts and risks. Specify the amount of time participation will take.
Participant Benefits: Describe any benefits, if any, to the person participating and, if significant, any available alternatives to obtaining these benefits. If there are not any benefits for participation, indicate this also. (Do not include benefits to society or benefits to the researcher.)
Participant Risks: Describe any risks--psychological, emotional, physical, etc.--however slight. Include a statement, if appropriate, that a particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
Voluntary Participation and Withdrawal: Include a statement that participation is voluntary and that participants can withdraw from the study at any time. Clearly state the consequences of withdrawing. For instance, if applicable, state that withdrawing from the study will or will not affect such things as medical treatment, employment, benefits, grades, payment, course credit, etc. If there will be no such consequences, say so.
Confidential or Anonymous: State if the study is confidential or anonymous. Note that it is impossible for it to be both. "Confidential" means that the information provided by the participants may be connected to the participants, but that identities will be protected. "Anonymous" means that the information provided cannot be connected to the participant. For confidential research, explain how you will maintain confidentiality of records and data (e.g. by using coded responses or secure storage).
When Child Abuse May Be Uncovered: In all non-anonymous situations (that is, whenever the personal identifying information is collected, regardless of whether it is kept confidential or not), the following statement must be included: "In accordance with legal requirements and/or professional standards, we will disclose to the appropriate individuals and/or authorities information that comes to our attention concerning (past or present) child abuse or neglect or potential harm to you or others."
Contact Information: Include your name, address, and telephone number, as well as the following statement: "This research study has been reviewed and approved by the Institutional Review Board (IRB) of Frostburg State University. For research-related problems or questions regarding participants' rights, contact the IRB through the Director of the Office of Research and Sponsored Programs at 301-687-3101."
Final Statement: The final statements of the informed consent form should include the following: "I have read and understand the explanation provided to me and have been given a copy of this consent form. I have had all my questions answered to my satisfaction, and I voluntarily agree to participate in this study."
Signatures: The informed consent must be signed and dated by both the participant and the principal investigator or authorized representative.
Page Numbering: Consent forms with more than one page should be initialed and dated by the participant on each page and the pages should be numbered like this: "page 2 of 3"

Please see http://www.frostburg.edu/admin/orsp/irb-informedconsent.htm for other important required elements that pertain to specific situations.

 

7. Supporting Documents: Include all relevant supporting documents, such as consent forms, interview questions, surveys, letters sent to recruit participants, questionnaires completed by participants, and any other material germane to human subjects review.

SIGNATURE ASSURANCE SHEET

Principal Investigator/Student Assurance Statement

I understand Frostburg State University’s policy concerning research involving human participants and I agree:
 
1. To obtain prior approval from the Institutional Review Board before beginning this research study;
2. To accept responsibility for the scientific and ethical conduct of this research study:
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or implementing changes in the approved consent form:
4. To immediately report to the IRB any adverse reactions and/or unanticipated effects on participants which may occur as a result of this study;
5. To complete, on request by the IRB, the Continuation/Final Review Forms.

SIGNATURE: ___________________________DATE: ___________________

TYPED NAME: ___________________________________________________


Faculty/Research Advisor’s Assurance Statement:

I certify that I have read and agree with this proposal, that the P.I. has received adequate training to perform this research, and will receive adequate supervision while performing this research.

SIGNATURE: ___________________________DATE: ____________________

TYPED NAME: ____________________________________________________

*If the Principal Investigator is completing this project to meet the requirements of Frostburg State University academic program the student’s faculty/research advisor must also sign the Signature Assurance Sheet.

 

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So, to answer your question, you need to find out what your IRB meant. Did they mean you are exempt from applying or your research is of exempt status according to 45cfr46. If it is exempt status usually you do need to submit an application but it does not have to undergo full IRB board review. Possibly only the IRB chair will review it. I would clarify this with your IRB chair. In the application you posted, it states the IRB determines the work is exempt, which to me indicates you would have to submit something. Also, be transpartent with your IRB chair and inform him/her that you intend to publish your results. Many journals are now inquiring about IRB approval. edited 10:24, 18 Jul 2012
Posted 10:23, 18 Jul 2012
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