APPLICATION FOR INITIAL REVIEW

APPROVAL OF A PROJECT INVOLVING HUMAN SUBJECTS

Biomedical, Health Sciences Institutional Review Board (BIRB)
Social Science, Behavioral, Education Institutional Review Board (SIRB)
207 Olds Hall, Michigan State University
East Lansing, MI 48824-1047
Phone: (517) 355-2180
Fax: (517) 432-4503
E-mail: irb@msu.edu

Office Hours: M-F (8:00 A.M.-5:00 P.M.)

 

IRB#: 07-020
ID# i026594

 

1a.

Responsible Project Investigator:

Name: Kenneth FRANK
ID#: XXX-XX-6558
Department: CEPSE
College: EDUCATION
Academic Rank: Associate Professor
Mailing Address: 462 Erickson Hall

Phone: 355-9567
Fax: 353-6393
Email: kenfrank@msu.edu
1b.

Secondary Investigator:

Name:
ID#:
Department:
College:
Academic Rank:
Mailing Address:

Phone:
Fax:
Email:
1c.

Additional Investigators:

2.

Study Coordinator:

Name: Kenneth FRANK
ID#: XXX-XX-6558
Department: CEPSE
College: EDUCATION
Academic Rank: Associate Professor
Mailing Address: 462 Erickson Hall

Phone: 355-9567
Fax: 353-6393
Email: kenfrank@msu.edu
3. Title of Project: ANALYZING THE FLOW OF NETWORK-EMBEDDED EXPERTISE IN SCHOOLS: A LONGITUDINAL STUDY OF INDIVIDUAL AND ORGANIZATIONAL
4. Have you ever received preliminary approval or a 45 CFR 46.118 designation for this project?

(a) IRB Number: 026594

YES
5.

Category of Review

1 EXEMPT

6.

Is this project being conducted to fulfill the requirements of an education/training program?

Project Is Not Primarily An Education/Training Activity
7a. Funding:

(1) List all external funding sources:

NSF: l 0624307 / 0624284

(2) List the MSU Contracts & Grants Application number:94619

Project is externally funded
7b.

The protection of human subjects often requires resources be dedicated for things such as the consent process (space, personnel), the performance of the research (trained personnel interacting with subjects, time, access to subjects, access to facilities) care of subject issues or injuries (counseling, medical care), confidentiality of data (space, equipment) and other monetary and non-monetary resources. Describe the resources that are available for this project for the protection of human subjects.

Data are housed at SRI and are accessible only to members of the project team

8a.

List all sites where this research will be conducted.

Michigan State University,
secondary investigator's personal machine
SRI

8b. Do any of these sites have their own IRB? YES
8c.

Will MSU units outside the control or supervision of the investigator be involved in the conduct of the research?

9. Do you have any related project that were approved by an MSU IRB?

(a) IRB Numbers: 06-183

YES
10. Have you or will you submit this to any non-MSU IRBs?

(a) Name of instititution(s): SRI International

(b) Category of review submitted: Exempt

(c) Status of review (approved, not approved, pending): Pending

YES
11. Is another institution(s) relying on MSU's IRB as the IRB of record?

NO
12. Are you using an FDA approved drug/device/diagnostic test? NO
13. Are you using an FDA approved drug/device/diagnostic test for a non-FDA approved indication? NO
14. Has this protocol been submitted to the FDA or are there plans to submit it to the FDA?

NO
15. Does this project involve the use of Materials of Human Origin (e.g. human blood, tissue, or cell lines)?

NO

16.

Research Category

Education Research Yes          Gene Transfer Research Yes         

Clinical Trial Type
Surgical
Therapeutic
Prevention
Other
Investigator Initiated

Clinical Trial Phase
Phase I
Phase II
Phase III
Phase IV

Survey/Interview Yes   Fetal Research Yes  
Audio/Video Recording Yes   Medical Records Yes  
Oral History Yes   Stem Cell Research Yes  
Internet-based Yes   Medical Imaging Yes  
Analysis of Existing Data Yes   Oncology Yes  
International Research Yes   Clinical Research Yes  
      Other Yes  

17.

Project Description (Abstract)

We will study how teachers in 10-20 schools from our previous study respond to the effects of No Child Left Behind. We will conduct surveys and interview of principals to see how relationships between teachers change, between teachers nad parents, and how teachers' classroom behaviors change.
Our prior studies identified patterns of access to expertise that play a strong role in determining how teachers change and consequently whether organizational change succeeds or fail. By extending this study across the critical period during which provisions of a dramatic new policy take effect, we have a unique opportunity to observe the smooth, discontinuous, or chaotic evolution of social networks under a wave of pressure and relate it to existing patterns of change.

18.

Procedures

We will survey faculty in 12 schools using the attached instrument. We will interview principals and administrators in the corresponding shcools and school districts.

Surveys will be conducted at faculty meetings.

19. Does your investigation involve incomplete disclosure of the research purpose or deception of the subjects?

NO

20a.

Subject Population

School teachers, administrators and other staff in approximately 12 schools

20b. Age range of subjects 21 to 80

20c1.

It is planned or expected that the following study population will be included in the research:

Minors
Pregnant Women
Women of Childbearing Age
Institutionalized Persons
Students
Low Income Persons
Minorities
Prisoners
HIV/AIDS Individuals
Psychiatric Patients
Incompetent Persons
Wards
None of These
20c2.

Will some or all of the subjects likely be vulnerable to coercion or undue influence?

20d. Total expected number of subjects (including controls) for the entire project period 400
20e.

Justify your sample size.

Study is for comparing innovations within and across schools so we need full network data within each school as well as data on enough schools (approx 12) to compare processes between schools.

20f.

Describe the criteria for the inclusion of subjects.

Teachers and administrators from 12 schools for initial study

20g.

Describe the criteria for the exclusion of subjects.

None

20h(1).

How will the subjects be identified, recruited and enrolled? Include who will make initial contact with the subjects, who will recruit the subjects, and who will enroll the subjects.

Those who were in previous study will be contacted to see if they will consider participating. School leaders and administrators will be the initial contacts

20h(2). Will an advertisement be used?

NO
20i.

Are you associated with the subjects?

NO

20j.

Will someone receive payment for recruiting the subjects?

NO
20k.

Will the research subjects be compensated?

(1) Details concerning payment, including the amount and schedule of payments including any conditions:

honoraria will be provided to 400 faculty for completing surveys ($10/teacher); honoraria will be provided to 12 school leaders ($100/person) for interviews;

YES
20l.

Will the subjects incur additional financial costs as a result of their participation in this study?

NO
20m. Will this research be conducted with subjects in another country?

NO
20n.

Will this research be conducted with subjects in the U.S. from an ethnic group of sub-group or other non-mainstream minorities (including non-English speakers)?

(1) What country/sub-group are they from?

Subjects may include Latinos or Hispanics.

(2) Does the different cultural context present any problems or risks that need to be addressed? If so, describe the issues and how you will address them.

Since subjects are all teachers and administrators and staff in US schools, instruments will be in English.

YES
21a.

Risks and Benefits for subjects: Describe and assess any potential risks (physical, psychological, social, legal, economic) and assess the likelihood and seriousness of such risks.

There is a minimal risk of discomfort to subjects. That risk stems from the collection of data about the professional interactions amongst colleagues at a school. It may be that some subjects are isolated in their professional practice and they may not want to be identified as such.

21b.

Describe procedures for protecting against or minimizing potential risks and provide an assessment of their likely effectiveness.

We understand a great deal about the potential risks and protections we need to provide for subjects from preliminary work. In this research, we identified a method for keeping teachers’ nominations of the colleagues with whom they collaborate confidential. We will use a school roster that is separate from the survey to provide numerical codes for nominating teachers instead of names. We also recognize that we must present to schools their social network data in ways that do not allow individuals to be identified; we will not label the sociograms with identifying information, neither by name nor by grade level or other cluster information which might allow teachers to identify themselves or others.

Participation, moreover, will remain voluntary for individuals, in all interviews, observations, and surveys. The potential risks we have identified will be shared with teachers as part of the oral instructions along with the consent form. This minimal risk includes concern about the consequences of having information about who one’s closest colleagues are more widely and explicitly available in the school. We will also explain the methods we will use to protect against this potential risk.

A key part of the consent form to be signed by all participants, including school leaders and principals, will be that data cannot be used in any way to deny teachers any benefit that would otherwise accrue to them as a faculty member of that school.

21c.

Assess the potential benefits (if any) to be gained by the subjects in this study, as well as benefits which may accrue to society in general as a result of the planned work.

Subjects can learn how the social structures of their schools can be drawn upon to implement innovations and reforms. This can help those shcools in particular better respond to future changes as well as current reforms. Knowledge gained form the study can help schools, in general, better implement changes and reforms related to NCLB that can improve schools from the standpoint of education as well as as social organizations.

22a.

How will the subject's privacy be protected? Include a description of who will be interacting with the subjects or accessing and abstracting data from the subject's records (academic, medical, etc.) and where the study will take place. For example, will individuals not associated with the research study be present during the consent process and the conduct of the study?

We will use a school roster that is separate from the survey to provide numerical codes for nominating teachers instead of names. We also recognize that we must present to schools their social network data in ways that do not allow individuals to be identified; we will not label the sociograms with identifying information, neither by name nor by grade level or other cluster information which might allow teachers to identify themselves or others.

22b.

Where will the data be stored and for how long?

in a locked cabinet at SRI

22c.

Who will have access to the research data?

Researchers on the project at SRI as well as those liste don this application and a graduate student supervised by Professor Frank

22d.

How will you ensure the confidentiality and/or anonymity of the research data? Include a description of the procedures and safeguards you will use, including if identifying information will be stored with the data.

SRI will maintain conditions to preserve the data.

22e.

Is it appropriate for your research to have a monitoring plan to periodically assess the data to ensure the safety of subjects or to ensure negative outcomes do not occur (e.g., ongoing study of domestic abuse, clinical trial, full board projects)?

23. Does this project involve protected health information as defined by HIPAA? NO

NO
24. (a) Select appropriate consent option. Approval of a consent form and process
 

(b) Consent Procedures:

Researchers employeed by SRI will inform subjects of possible risks and obtain active consent by asking subjects to sign a waiver that includes the following language:

We are not here to evaluate the effectiveness of your efforts. We will keep your individual responses private. We will not identify any person with any response. No data that would allow you to be identified as an individual will be shared with anyone at your school. There are no foreseeable risks or discomforts to you as a result of participation. You will receive no direct benefit from participation in this study. However, you will be given an honorarium in recognition of your contribution to this research.

Your participation is voluntary. You will be free to cease participation at any time. If you decide not to participate or later withdraw from participation, you will not be subject to any penalty.

If this explanation leaves you with any unanswered questions, please ask and obtain answers before signing below. If you have questions later, please call Dr. William R. Penuel at (65p) 859-5001. Additional inquiries may be addressed to the Human Subjects Committee, SRI International, 333 Ravenswood Avenue, Menlo Park, CA 94025, or (650) 859-2686. We thank you for your willingness to participate in this research.



I understand that my responses will be kept confidential and that I am free to decline to answer any of the questions that are asked in this survey.

Name _______________________________________ Date __________________

Signature ______________________________________________________________


(b)(2)Will the subject or legally authorized representative sign a consent document(s)?

 
25a.

Does any person responsible for the design, conduct, or reporting of findings of this protocol have a Significant Financial Interest (as defined for the MSU Faculty Conflict of Interest Policy) or other opportunity for tangible personal benefit related to the conduct of the research that might compromise, or reasonably appear to compromise, the independence of judgment with which their responsibilities would be completed under this research protocol? A reportable financial interest includes, but is not limited to, a financial interest in the sponsor, product, or service being tested, or in a competitor of the sponsor or product or service being tested.

NO
25b. Has any financial arrangement, including compensation, ownership interest, stock options, or other ownership interest, (e.g., compensation that is: explicitly greater for a favorable result; in the form of an equity interest in the sponsor of a covered study; or in the form of compensation tied to sales of the product, such as a royalty interest) been established whereby the value of compensation or ownership interest to investigators conducting the study could be influenced by the outcome of the study?

NO
25c.

Is this a clinical study where the results may be used to support marketing applications for new human drugs and biological products and marketing applications and reclassification petitions for medical devices to the FDA, as required by law?

25d. Have you or will you submit an FDA form 3454 or 3455 (Conflict of Interest)? NO
26a. When would you prefer to begin this project? 4/1/2007
26b. Estimated duration of project (including identifiable data analysis): 04/01/2009
ADDITIONAL DOCUMENTS/ATTACHMENTS

01. 9/12/2007 Survey Instrument (i026594_9-12-07_CNE_FacultySurvey_Consent_Spring.pdf)


 COMMENTS COMMENT AFTER REVIEW / EDIT BY IRB STAFF (Viewable by PI) PI RESPONSE
Comment #1
Reviewer #98  
 
 9:52:44  3/27/2007 10:13:07 

Investigator(s)

Upon the initial review of your protocol(s) ,06-183 as well, are you now just performing data analysis with the schools researched in California? Please explain the scope of this research as it relates to IRB#06-183.

Note IRB#06-183 has the expiration date of 3/30/07 so it will need to be renewed if needed otherwise submit a closure form.

Thank you  

 
It wasn't clear to me which previous study I should cite, so here's the deal.
The original study was
IRB# 04-669 / APP# i020656

This is where we collected the data and did initial analyses.

Then I was funded to do further analyses under 06-183.

Now we will do at least 2 things:
1) go back to 12 of the original schools and collect more data
2) continue with analyses that will inform the new study.

Since 06-183 had not yet expired, I figured it was better to link to that one, and, instead of renewing, I thought I would just fold them both into this one. Which should I do?

I will renew the anlaysis one separately -- faxing to you today.

Comment #2
Reviewer #98  
 
 15:45:50  3/29/2007 13:28:20 

Investigator(s)

Thank you for the response.

If the research has the same scope/focus it probably would be best to stay with the one IRB research protocol being 06-183. From this research protocol which needs to be renewed you may also submit a revision form to address the changes that you would like to make.

Note that the IRB only receive letters of support from three schools: Central, Jefferson and Emerson. If you do have letters of support form the other schools, please submit them to the IRB.

Thank you  

 
I have submitted a revision via fax and email. Consent letters to come, but we are still securing them.