SINGLE PROJECT APPROVAL

Statement by Principal Investigator

 

         This form must be typed. Do not leave any blank spaces. If any questions are not applicable, please indicate by NA. If you intend to utilize a questionnaire, please append it to this application. The IRB will utilize a student's on-campus mailbox unless another address is provided.

 

1. Researcher(s):                                                                                                

Permanent Address:                                                                                       

Phone(Daytime):                                      (Home):                                           

 

Specify               Faculty

                  _____Graduate Student(s)

                  _____Undergraduate Student(s)

 

(If Student Project) Student Mailbox #:                                                                

With a Faculty Advisor's Name:                                                                        

     University Phone:                                                                                    

 

 2. Department:                                                                                                                       

 3. College of:                                                                                                             

 4. Research Project Title:                                                                                     

 

 5. Date Research is Scheduled to Begin:                                                                    

 

 6. Are you applying for funding through the Research Foundation, and/or what is your expected source of funds, if any?                                                                                     

 

 7. Date proposal must be submitted to funding agency:                                                 

 

 8.Abstract or summarize your proposed research. (Appended copy of an abstract or summary may be used to respond to this question.)

 

 

 

 

 

9.   Who will be the subjects of the research?

 

 

10.  How many participants do you plan to have in your study?                                       

        

 

 

11  a. Does the research involve (respond to each category Yes or No):

 

Children under 7 years of age?                               YES             NO             

Children 8-17 (under 18 years of age)                       YES             NO            

Students in elementary or high school?                     YES             NO            

Older adults? (over 65 years of age and have cognitive

     impairment and/or are institutionalized)?               YES             NO            

Inmates in penal institutions?                                YES             NO            

Patients in mental institutions?                              YES             NO            

Physically handicapped?                                      YES             NO            

Mentally or emotionally handicapped?                     YES             NO            

Persons incapable of informed consent?                    YES             NO            

 

 

 

Note: If you have checked yes to any of the above categories, and your research study involves at least minimal risk, the proposal must receive Full Review

 

b. In (b) above, if you have checked "Yes" to any category, could the research possibly be done with adults not listed in the above category: YES______ NO              Explain: 

 

 

12. How will subjects be recruited? (Be specific)

 

13.  Will you utilize recruitment advertising materials; such as flyers, newspaper advertisements, etc? YES                          NO                If so they must be submitted to the IRB and receive IRB approval prior to their use.

.

 

14   a. Which of the following will you do with your subjects? (Check all the relevant activities.)

 

         _____Analyze data previously recorded about them

         _____Analyze tissues or fluids previously taken from them

                   Contact by mail

                   Contact by telephone

                   Meet face-to-face in the field

                   Meet in laboratory

                   Interview

                   Administer questionnaire

         _____Test performance

                   Manipulate psychological treatment/conditions

         _____Manipulate physiological treatment/conditions

         _____Manipulate subjects' behavior

                   Record "spontaneous" behavior

                   Record physiological measures

         _____ Other, explain:

 

     b. Describe in lay terms what you will do with your subjects:

 

 

 

 

 

c. If you will be asking questions, testing performance, or manipulating the subject, give examples of the types of questions, types of tests, and types of manipulations or treatment conditions you will use. (You may append copies of questionnaires, tests, interview protocols, or the methods sections of your grant proposal in answer to this item. If you have yet to pick the exact procedures you will be using, then provide specific, concrete examples of the types of test items, treatments, or questions you will use.)

        

        

 

d.    If you will be utilizing an outside agency to conduct your research, have you appended and appropriate letter that appears on the agency's letterhead indicating their willingness to cooperate with your research. YES       NO___

 

15. Will you be recording any identifiable, private information about individual subjects?

YES        NO____.  If you have answered "Yes" to item #12, please read the following statement and sign below:

 

I understand that I am obligated to protect and keep confidential any identifiable, private information gathered about individual subjects through the conduct of my research, and I agree to keep such information confidential unless I obtain the subject's express written permission to do otherwise. 

 

                                                      Signed: ______________________________________

 

 

16. Will you be utilizing audio or videotapes in your research?   YES         NO____   These tapes must be destroyed by a date certain, not to exceed three years from the completion of the research project. If you answered YES to question #12, you will also need to inform the subject of your intent to record your tape and/or video tape, by including this information on the Informed Consent Form.  If the answer to question #13 is yes, please describe in detail what you are doing and the purpose thereof. Also, what will be the disposition of the recorded tapes after completion of your research?

 

 

17       a. Describe any and all potential risks or discomforts that could result to human subject as a result of this research.

 

 

         b. What safeguards will you employ to minimize these risks or discomforts?

 

 

c. Are there any alternative ways to acquire your research information from human subjects that may avoid the risks identified above? YES____ NO                                                                                       

 

If "Yes", explain why the alternatives are not being used:       

 

      d.  Could this information conceivably be obtained from animals or other laboratory models?

 YES____  NO____ 

 

18. If your research involves any conceivable risk or discomfort to subjects, or if your subject pool includes any of the groups identified in item #9b, or any similarly vulnerable group, then you MUST obtain informed, written consent from your subjects and/or (for children and persons incapable of informed consent) from a legally responsible guardian. If the above is applicable, have you attached an Informed Consent form that you will utilize? YES                                                                                                          NO____

 

19.  If your potential human participants have qa language other than English as their primary language of communication or do not have a good comprehension of English, are you providing a translation of the materials, including the informed consent form, together with a back translation to be submitted to the IRB?   YES        No               If  not, please explain.

 

 

20.  When you have completed your contact with the research participant, will there be a debriefing session?  YES                  No               If your answer is YES, please explain the procedure you will use.

 

 

 21. To weigh the direct or potential benefit of this research against the inherent risk to the individual, the IRB requires brief and concise answers to the following questions:

 

a. What specific information will this activity provide, and what is the significance of that information?

 

 

        

 b. Indicate what, if any, benefits may accrue to the human subjects involved:

 

 

c. Indicate what, if any, benefits may accrue to individuals who are not subjects, but  who are similar:

 

 

It is understood that I will keep on file (for at least 3 years) and make available on request by the IRB, copies of signed Informed Consent Forms of all subjects participating in this research.

 

It is understood that any medical procedures or medical treatments of human subjects for the purposes of the present research will be performed by, or under the supervision of, a Medical Doctor currently licensed to practice in the Commonwealth of Massachusetts.

 

It is understood that students at the University of Massachusetts Lowell should be initially recruited as research subjects by public announcements and not by personal solicitation.

 

It is the responsibility of the researcher to ensure that a Final Report is filed if your project involves any risk to the rights or welfare of subjects. Furthermore, any project which exceeds a period of one year in duration must be reviewed and receive IRB approval prior to the beginning of the second and any successive years of the research project.                  

 

I have enclosed the following items collated in the order listed:

 

         Original and copies of cover letter requesting review and specifying whether Exempt, Expedited, or Full

         Original and copies of this form (Single Project Approval Statement)

         If a questionnaire is to be utilized, copies of the actual questions to be used

         Original and copies of official authorizations from cooperating agencies

         If you are using an Informed Consent Form, original and copies signed and dated.

         Copies of the complete research proposal, including Abstract and Methods section

         If you are submitting for funding, copies of the entire grant proposal

 

 

In signing this statement I certify to the accuracy of the information provided and reassert my intention to abide by the University policies and procedures governing research involving human subjects.

 

  

 

 SIGNATURE:                                                                  Date:________________

 (Researcher)

 

 

 SIGNATURE:                                                                  Date:________________

 (Researcher)

 

 

 SIGNATURE:                                                                  Date:________________

 (Faculty Supervisor)