LPN

Application for Protocol Review

OHIO DEPARTMENT OF HEALTH (ODH)

Institutional Review Board (IRB)

Instructions: Fill out the form below and include all of the additional materials as required for your request. If you will be requesting ODH data, contact the relevant ODH program to determine the guidelines for data release. Some ODH programs may offer guidelines to use in applying for data. The IRB requires the ODH program involved review requests prior to submission.

The IRB meets on the fourth Tuesday of each month except for November and December. The meeting for those two months is combined and held on the first Tuesday of December. To be considered for review, protocol must be received by the chair 14 calendar days prior to the scheduled meeting.

(1)Provide the following materials (mandatory):

a.Completed application for protocol review

b.A formal study proposal

c.Completed Curriculum Vitae form for all persons who will have access to the data as part of the study

d.Signed confidentiality agreements for all persons who will have access to data as part of the study

(2)Provide the following materials (if applicable):

a.Your institution’s IRB approval

b.Consent forms

c.Expedited Review – Initial Review form

All items are to be sent electronically to: ******@***.****.***

Questions may be directed to Lisa Locklin – ****.*******@***.****.***

1.PROJECT TITLE

CDC or HHS Federal Project Number (if any):

2.PRINCIPAL INVESTIGATOR (PI)

Name (Last, First):

Degree(s):

Title:

Agency/Institution:

If ODH, Bureau & Div.:

Mailing Address:

E-mail:

Fax:

Phone:

Emergency phone:

3.ADDITIONAL CONTACT(S)

Specify the additional contact person(s) (e.g., study or regulatory coordinator, research assistant, etc.) in case the PI is not available. If more than three, attach additional page with their information.

N/A

Name (Last, First):

Phone:

E-mail:

Fax:

Name (Last, First):

Phone:

E-mail:

Fax:

Name (Last, First):

Phone:

E-mail:

Fax:

4.CO-INVESTIGATORS & KEY PERSONNEL

List any other staff who will be participating in this research. You will need to provide signed confidentiality agreements and CVs for each member of the team. Attach additional page if necessary.

N/A

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

Name (Last, First):

5.ODH CONTACT(S)

Please list any ODH staff members you are working with on this protocol.

N/A

Name (Last, First):

Phone:

E-mail:

Fax:

Signature:

Name (Last, First):

Phone:

E-mail:

Fax:

Signature:

6. OTHER INSTITUTIONAL REVIEW BOARD APPROVALS

Check all that apply and provide applicable documentation. Attach additional page if necessary.

Centers for Disease Control and Prevention

Univ./Institution

Name:

Status:

State IRB

Name:

Status:

Other

Name:

Status:

7. EXPEDITED REVIEW

Are you requesting Expedited Review?

Yes Complete Expedited Review Form

No

8. SUMMARY OF THE RESEARCH

Summarize the proposed research using non-technical language that can be readily understood by someone outside the discipline. Explain briefly the background, research design, years of data being examined and procedures to be used.

9.RESEARCH OBJECTIVES

a.List the specific objectives of the research study.

b.Explain what will be done with the results of your study when it’s concluded.

10. RESEARCH METHODS

a.Briefly describe the methods to be used in the research study. What is the nature of the measures or observations that will be made? Please provide a copy and a brief description of any questionnaires, tests or other instruments.

b.Check all research activities that apply, if applicable:

Invasive Procedures

Investigational Device or Apparatus

New Drug, Vaccine or Diagnostic Test

Existing Data

11. DURATION

Estimate the time required to complete this research. If working directly with subjects, please also include information regarding the time required from each participant, including individual interactions, total time commitment, and long-term follow-up, if any.

12. SUBJECTS

a.Describe the population of subjects for whom you will be collecting data.

b.If you will be contacting subjects directly, how will they be solicited or contacted?

N/A

13.SOURCE OF DATA

Where will you obtain your data? (check all that apply)

ODH We are gathering the data ourselves

Another State of Ohio agency (if gathering your own data only, skip to Question 13c)

An outside source

a.Please list all state agencies and/or other sources of your data. (For all sources other than ODH or your own employer, please provide documentation that you have a data sharing agreement in place.)

Data Source:

Program Area:

Data Steward:

Data Source:

Program Area:

Data Steward:

Data Source:

Program Area:

Data Steward:

Data Source:

Program Area:

Data Steward:

Data Source:

Program Area:

Data Steward:

Data Source:

Program Area:

Data Steward:

b.Specify what data sets you’ll be requesting, including source, year(s) of data, data fields, etc.

Check here if a separate list of the variables is attached to this application

c.How long will the data be kept and when will it be returned to its source or destroyed? (Note: data must be returned to its source, or certified that it has been appropriately destroyed, no later than a year after date of IRB approval. Requests to keep the data longer than one year will require that an extension be requested from the IRB.)

14.NUMBER OF PARTICIPANTS

The number of participants is defined as the number of individuals who agree to participate (i.e., those who provide consent or whose records are accessed, etc.) even if all do not prove eligible or complete the study. The total number of research participants may be increased only with prior IRB approval.

a.Provide the total number of participants (or number of participant records, specimens, etc.) for whom you are seeking IRB approval.

b.Explain how this number was derived (e.g., statistical rationale, attrition rate, etc.).

c.Will your work with the participants take place at multiple locations?

Yes Indicate the total number of participants to be enrolled across all locations:

No

d.

15. PARTICIPANT POPULATION

a.Specify the age range of the individuals who are being included in the research/data request:

Age(s):

or All

b.Specify the participant population(s) or subject category/ (categories). Check all that could apply:

Adults Economically or Educationally Disadvantaged Persons

Minors (< 12 years of age) Prisoners

Adolescents (12-17 years of age) Individuals with Impaired Decision-Making Capacity

Fetuses – Live or Dead Wards of the State or other Agency, Institution or Entity

Abortion Human In Vitro Fertilization

Tissues

c.Describe the characteristics of the proposed participants, and explain how the nature of the research requires/justifies their inclusion.

d.Will any participants be excluded based on age, gender, race/ethnicity, pregnancy status, ability to speak English, education, or financial status?

Yes

No

If Yes Explain the criteria and reason(s) for each exclusion. Consider the study’s scientific or scholarly aims and risks.

If you are not contacting subjects, please skip to Question 20.

16.PARTICIPANT IDENTIFICATION, RECRUITMENT, & SELECTION

a.Provide evidence that you will be able to recruit the necessary number of participants to complete the study.

b.Describe how potential participants will be identified (e.g., advertising, individuals known to investigator, record review, etc.). Explain how investigator(s) will gain access to this population, as applicable.

c.List the names of investigator(s) and/or key personnel who will recruit participants and their qualifications.

d.Describe the process that will be used to determine participant eligibility.

e.Describe the recruitment process; including the setting in which recruitment will take place. Provide copies of proposed recruitment materials (e.g., ads, flyers, website postings, recruitment letters, and oral/written scripts).

f.Explain how the process respects potential participants’ privacy.

g.Are any of the participants likely to be vulnerable to real or perceived coercion or undue influence? Consider students, employees, prisoners or anyone else who might be susceptible to pressure in order to participate due to factors including, but not limited to, health, age, or mental, economic or legal status.

Yes

No

If Yes Describe additional safeguards to protect participants’ rights and welfare. Consider strategies to ensure voluntary participation.

17.INCENTIVES TO PARTICIPATE

Will participants receive compensation or other incentives (e.g., free services, cash payments, gift certificates, parking, classroom credit, travel reimbursement) to participate in the research study? Compensation plans should be pro-rated (not contingent upon study completion) and should consider participant withdrawals, as applicable.

Yes

No

If Yes Describe the incentive, including the amount and timing of all payments.

18. INFORMED CONSENT PROCESS

Indicate the consent process(es) and document(s) to be used in the study. Check all that apply. Provide copies of documents.

Informed Consent – Form

Assent – Form

N/A

Informed Consent – Verbal

Assent – Verbal Script

Informed Consent – Addendum

Parental Permission – Form

Translated Consent/Assent – Form(s)

Parental Permission – Verbal Script

b.List the names of investigator(s) and/or key personnel who will obtain consent from participants or their legally authorized representatives.

N/A

c.Who will provide consent or permission (i.e. participant, legally authorized representative, parent and/or guardian)?

N/A

d.Describe the consent process. Explain when and where consent will be obtained and how subjects and/or their legally authorized representatives will be provided sufficient opportunity (e.g., waiting period, if any) to consider participation.

N/A

e.Explain how the possibility of coercion or undue influence will be minimized in the consent process.

N/A

f.Will any other tools (e.g., quizzes, visual aids, information sheets) be used during the consent process to assist participant comprehension?

Yes Provide copies of these tools

No

g.Will any other consent forms be used (e.g., for third parties being questioned, marketing of products or services, etc.)?

Yes Provide copies of these forms

No

19. PRIVACY OF PARTICIPANTS

a.Describe the provisions to protect the privacy interests of the participants. Consider the circumstances and nature of information to be obtained, taking into account factors (e.g., age, gender, ethnicity, education level, etc.) that may influence participants’ expectations of privacy.

b.Does the research require access to personally identifiable private information? (Includes any information that can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, or biometric records; and any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information.)

Yes

No

If Yes Describe the personally identifiable private information involved in the research. List the information source(s) (e.g., educational records, surveys, medical records, etc.).

20. CONFIDENTIALITY OF DATA

a.Explain how information is handled, including storage, security measures (as necessary), and who will have access to the information. Include both electronic and hard copy records. Methods for handling and storing data (including the use of personal computers and portable storage devices) must comply with Federal, State and Ohio Department of Health policies. Restricted data, including protected health information, must be encrypted if stored or used on portable devices, if removed from a secure location, or if electronically transmitted.

b.Will any aspect of the data be made part of any permanent record that can be identified with the subject?

Yes

No

If Yes Please describe

c.Will any data from files or archival data be used?

Yes

No

If Yes Please describe

d.If no aspect of the data is to be made part of any permanent record, how will the data be destroyed?

e.Choose the option which best describes how issues of small cell size will be addressed so that confidentiality is maintained.

Tabulations of confidential fata shall be suppressed when the table denominator value minus the table numerator value is less than 10, as per the ODH Data Methodology Standards for Public Health Practice, Disclosure Limitation Standard.

My organization/institution has a small cell size policy which is more stringent than ODH’s policy.

If Yes Please describe

f.Will a subject’s participation (or lack of) in the study be made a part of any permanent record available to supervisors, teachers or employers?

Yes

No

If Yes Please describe

g.Explain if any personal or sensitive information that could be potentially damaging to participants (e.g., relating to illegal behaviors, alcohol or drug use, sexual attitudes, mental health, etc.) will be collected.

N/A

h.Explain any circumstances (ethical or legal) where it would be necessary to break confidentiality (i.e. as per Ohio’s mandatory reporting requirements).

N/A

i.Explain what process you will use in the event of an adverse event and/or mandatory reporting situation.

21. HIPAA RESEARCH AUTHORIZATION

Will individually identifiable data (Protected Health Information [PHI]) subject to the HIPAA Privacy Rule be accessed, used, or disclosed in the research study? (Includes information, including demographic data, that relates to the individual’s past, present or future physical or mental health or condition; the provision of health care to the individual; or the past, present, or future payment for the provision of health care to the individual; and that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.)

Yes

No

If Yes Please describe

22.REASONABLY ANTICIPATED BENEFITS

a.List the potential benefits that participants may expect as a result of this research study. State if there are no direct benefits to individual participants. Compensation is not to be considered a benefit.

b.List the potential benefits that society and/or others may expect as a result of this research study.

23. RISKS, HARMS, & DISCOMFORTS

a.Describe all reasonably expected or anticipated risks, harms, and/or discomforts that may apply to or result from the research. Discuss severity and likelihood of occurrence. Consider the range of risks, including physical, psychological, social, reputational, legal, and economic. All research carries some risk. “No Risk” is not an acceptable answer.

b.Describe how risks, harms, and/or discomforts will be minimized. If testing will be performed that might identify individuals with a previously unknown medical condition, address timing and method of testing; include how positive test results will be handled. Since all research carries some risk, you must provide a response to how those risks will be minimized. “N/A” is not an acceptable answer.

c.If you are working with subjects and asking about emotionally-charged subjects including, but not limited to, infant mortality, terminal cancer, abuse, etc., explain how you will offer counseling support to subjects who become distressed while participating in your research.

N/A

24. MONITORING

Does the research involve greater than minimal risk (i.e., are the harms or discomforts described above beyond what is ordinarily encountered in daily life or during the performance of routine physical or psychological tests)?

Yes

No

If Yes Describe the plan to oversee and monitor data collected to ensure participant safety and data integrity. Include the following:

The information that will be evaluated (e.g., incidence and severity of actual harm compared to that expected);

Who will perform the monitoring (e.g., investigator, sponsor, or independent monitoring committee);

Timing of monitoring (e.g., at specific points in time, after a specific number of participants have been enrolled); and

Decisions to be made as a result of the monitoring process (e.g., provisions to stop the study early for unanticipated problems).

25. ASSESSMENT OF RISKS & BENEFITS

Discuss how risks to participants are reasonable when compared to the anticipated benefits to participants (if any) and the importance of the knowledge that may reasonably be expected to result.

26. PARTICIPANT COSTS/REIMBURSEMENTS

a.List any potential costs participants (or their insurers) will incur as a result of study participation (e.g., parking, study drugs, diagnostic tests, etc.).

N/A

b.List any costs to participants that will be covered by the research study.

N/A

27. ASSURANCE - PRINCIPAL INVESTIGATOR

I agree to follow all applicable federal regulations, guidance, state and local laws, and ODH policies related to the protection of human subjects in research, as well as professional practice standards and generally accepted good research practices for investigators.

I verify that the information provided in this Initial Review of Human Subjects Research application is accurate and complete. I will initiate this research only after having received notification of final IRB approval.

Signature of Principal Investigator (Electronic Signatures are acceptable)

Date

Printed name of Principal Investigator

28. APPLICATION CONTENTS

Indicate the documents being submitted for this research project. Check all appropriate boxes. Bold = Mandatory

Initial Review of Human Subjects Research Application

Research Protocol

Signed Confidentiality Forms for all Persons Handling Data

Curriculum Vitae Form for all Persons Handling Data

May also be required depending on your specific protocol

Expedited Review – Initial Review Request

Consent form(s), Assent Form(s), Permission Form(s), and Verbal Script(s), including translated documents

Data Collection Form(s) for Investigator-Initiated Studies

Data Collection Form(s) involving protected health information

Recruitment Materials (e.g., ads, flyers, telephone or other oral script, radio/TV scripts, internet solicitations)

Script(s) or Information Sheet(s), including Debriefing Materials

Instruments (e.g., questionnaires or surveys to be completed by participants)

Other Committee Approvals/Letters of Support

Other supporting documentation and/or materials

Contact this candidate