Insert Study Title

RESEARCH PROTOCOL

TO:Kettering Health Network Institutional Review Board

FROM:Principal Investigator: Click here to enter text.

Phone Number / Fax Number: Click here to enter text.

Email Address: Click here to enter text.

DATE:Click here to enter text.

STUDY TITLE:Click here to enter text.

VERSION #Click here to enter text.

Version Number: Click here to enter text.Page 1of8

Version Date: Click here to enter text.Protocol Template Revised 4/20/2016

Insert Study Title

Study Summary

Summarize the study in a few sentences. Use multiple paragraphs if needed.

Purpose

Describe the objectives of the research. What questions do you want to answer?

Background and Significance

Provide support for the purpose of the study. Include information such as:

  • Data from previous animal/ human studies
  • Preliminary studies conducted by the investigator pertinent to this study
  • Critical evaluation of existing knowledge (relevant literature). Note: any literature cited should be relevant, current, and pertinent to the proposed research.

Describe the contribution the study will make to the health of human beings and/or to scientific knowledge. Why is it important to answer the research question?

Use separate paragraphs and include bullets as needed to improve readability.

Human Subject Population

Method of Subject Identification

Describe the methods that will be used to identify prospective subjects/ participants, such as by advertisements, from medical records, or through a primary care physician.

  • See the Guide to Participant Identification and Recruitment in IRBNet for more information.
  • If existing records will be queried or reviewed, specify how, by/from whom and from where information will be obtained. Complete next section unless HIPAA waiver is provided.HIPAA waiver must be used if individuals not employed by the covered entity will review / obtain protected health information (PHI) for/ from recruitment or prescreening purposes (e.g. external monitor review of screening logs.)
  • If an individual or department will identify specific records matching inclusion criteria, specify who will provide the list of record numbers. If researchers will sort and/or filter records directly, provide specifics.
  • Note: If a HIPAA waiver is needed to identify prospective participants, information in this section should match applicable information on the HIPAA waiver form.
  • When applicable, specify a time range associated with the records (e.g., records from January 1, 2006 – December 31, 2010).

Use separate paragraphs and include bullets, as needed, for clarity and readability.

Use of PHI for Prescreening/ Recruitment (Activities Preparatory to Research)

☐Check if existing records (e.g. medical records, patient logs) will be queried or reviewed to identify or prescreen potential participants andno HIPAA waiver will be requested. By checking, investigatorattests to the following:

  • PHI will be collected or obtained (reviewed) only for recruitment/ prescreening purposes. PHI collected will be stored confidentially and will be destroyed per KHN standards as soon as no longer necessary for the research.
  • The requested use or disclosure under this section is solely to review patient information / PHI as necessary for purposes preparatory to research (e.g. to identify or prescreen potential participants for recruiting purposes).
  • The PHI will not be removed from KHN in the course of the review.
  • The PHI for which use or access is requested is necessary for the research.

Recruitment / prescreening activities will be stopped byspecify date.

PHI from ☐≥ 50☐ 50patients will be accessed for prescreening / recruitment activities. If PHI from < 50 patients will be accessed, specify who will track HIPAA disclosures.

Method of Recruitment

Insert “N/A” if no recruitment will occur (for example, when research involves only retrospective chart reviews). Otherwise, provide a narrative of the methods to be used to recruit study participants, such as advertisements, mailers, flyers, emails, internet postings, etc. Specify how, by whom, when and where recruitment efforts will be conducted. See the IRBNet Guide to Participant Identification and Recruitment for more information.

Data / Tissue Sources or Repositories

Excluding data or samples collected or provided by research participants, describe all sources from which data or specimens will be obtained (e.g. where the records are stored, for example KMC Pet Department, GV Medical Records, Physician’s office records, Epic, etc.). Specify specific departments, personnel or entities that will be asked to provide information and sources the researchers will access directly to collect information.

Differentiate between sources that will provide information (e.g. a department) and sources that researchers will access directly (e.g. imaging records).

Subject Payments

Describe how and when participants may receive payment, gifts or compensation for participation. Include pro-rated payments, payments for completion, etc.

Insert “N/A” if no compensation for participation will occur.

Gender of Subjects Choose an item.If participants will be restricted to one gender, provide applicable ethical justification in Research Design and Methods sections. Delete these instructions before submission.

Number of Subjects

Up toinsert numbersubjectsmay participate at KHN. Up to insert number subjects may participate at all locations.(removeif only KHN subjects will participate.)

Age Range of Participants

List the age range of subjects to be included. Example: Ages 18 through 89 inclusive.Special Considerations include:

  • If the research involves children (under the age of 18) special rules apply. Contact the IRB Office for more information.
  • If a HIPAA Waiver will be used, ages over 89 are considered to be identifiers.

Inclusion/Exclusion Criteria

Inclusion Criteria

  • Bullet criteria. Include CPT, DRG, ICD codes or diagnoses, as applicable.
  • For record reviews, specify the date ranges of the information to be accessed.

Exclusion Criteria

  • Bullet criteria which will eliminate potential participants from the project.

Vulnerable Subjects

Federal regulations specificallyidentify the following groups as vulnerable populations: pregnant women, neonates, fetuses, children, and prisoners.

List these and any other subject groups who may be vulnerable to coercion or undue influence. Types of vulnerabilities include: cognitive or communicative vulnerability (including language barriers), economic vulnerability, institutional vulnerability (e.g. employer/employee relationships), vulnerability for medical reasons (e.g. coma, injury, medications, disease progression, etc.).

Consider how you will protect the rights and welfare of any vulnerable subjects and address in the appropriate section (for example, the Informed Consent section). Some examples of additional protections for vulnerable subjects: use of legally authorized representatives, obtaining parental permission, use of a consenting process that includes “teach-back” methods to ensure subject understanding.

ResearchDesign and Methods

Describe the study design and methods to be used. Provide specific details for how the research project will be conducted, similar to a “recipe.”

  • Identify procedures/tests/interventions that will be used for the study that would occur regardless of the research. Specify the procedures/tests/interventions that will be performed solely for the research (the “experimental” procedures).
  • Provide a schedule listing the days/time required as a study participant [e.g., activities in which they will participate, the length/time of involvement, and the circumstances under they will provide data (e.g., phone calls, interviews, video/audio taping, surveys, etc.)]. Note:
  • This information should match the information provided on the consent document, when applicable.
  • For record reviews, specify what data is to be entered on the data collection tool.

Use separate paragraphs and include bullets as needed for clarity and readability.

In IRBNet, attach a copy of each data collection tool and any linking (ID) key to be used.

Surveys / Interviews / Questionnaires

If surveys/interviews/questionnaires will be performed as part of the research, specify:

  • Who will conduct the survey/interview/questionnaire. Include their qualifications
  • Where the survey/interview/questionnaire will be conducted.
  • How the instrument will be administered (e.g., telephone, group, one-on-one, etc.)

Attach a copy in IRBNet of each instrument to be used. For copyrighted materials, include permission for use or address purchase of instrument in study budget.

Risks/Discomforts

Remove this control before submission. Identify each intervention/study procedures/test article with a subheading and list the associated risk(s). Bullet each risk if appropriate to improve clarity and readability. All reasonably foreseeable risks and discomforts must be listed.

  • Note: the most serious and common risks should be addressed first followed by less serious and uncommon risks. Provide incidence data if available and appropriate.

If standard treatment/care is to be withheld, state the associated risks.

For any types of risks that are not applicable to the study, state “No known risks”.

Physical risks or discomforts

Include risks or discomforts that may arise from the study procedures, the use of test agents, radiation, etc., or standard procedures withheld due to study participation. Examples: pain or swelling at an injection site; nausea, vomiting; liver damage.

Psychological risks or discomforts

Risks or discomforts that may arise from participation in interviews, questionnaires, psychological tests, or from deception. Examples: feelings of betrayal, embarrassment, stress, frustration.

Social risks or harms

Insert risks that may arise from actual or potential breaches of confidentiality, loss of anonymity, or return of genetic testing results. Examples: a breach of confidentiality may harm interpersonal relationships, cause damage to reputation, loss of social standing, or stigmatize subjects.

Economic risks

Insert risks that may affect an individual’s employability, insurance, financial status, or employment status. Examples: expenses to participants due to their participation in the study from procedures not covered by insurance; loss of long term care insurance due to genetic testing results.

Legal risks

Insert risks that may lead to legal action such as an investigation or arrest. Example: risk of arrest due to completion of a survey concerning illicit drug usage.

Procedures to Minimize Risks (describe for each risk listed above)

  • Breaches of confidentiality: see Data Storage and Confidentiality section
  • Describe procedures that will be taken to minimize each of the listed risks unless previously addressed in the risks section above.

Specify who will evaluate adverse events / serious adverse events (AEs/SAEs) to identify and report unanticipated problems:Click here to enter text.

Diagnostic/treatment(non-research) proceduresto be used for the study

List those procedures that will be performed whether or not the individual chooses to participate in the study. If appropriate, use bullets or separate paragraphs for clarity.

Benefits

Potential benefits to participants

State potential benefits, if any, to subjects. If there are no anticipated benefits, state such, e.g. “There are no direct benefits to participants in this study.

Potential benefits to others / contributions to knowledge

State potential benefits to others from knowledge to be gained from the study.

Data Analysis

Specify the statistical/analytical methods to be used. Use a statistical/analytical method that supports the research design and proposed volume of data to be collected. Specify who will analyze the data: will the researchers analyze the data or will the data be sent elsewhere for analysis?

Data Monitoringto EnsureSafetyof Subjects

(Remove this section before submission) For studies that involve interventions and more than minimal risk, specify who will monitor the data to ensure the safety of subjects. This might be a study monitor, the principal investigator, or a data safety monitoring board (for large, multi-center trials).

  • For studies that require a data monitoring board, provide a detailed description of its operation (membership, frequency of review, stopping rules).
  • When applicable, describe how the data will be monitored.

☐Check if this study involves treatment or intervention and provide narrative of plan to monitor data to ensure safety of subjects below:

Click here to enter text.

Privacy Protections

Describe how subjects’ privacy will be protected during recruitment, the consenting process, study procedures, and with study data. Privacy refers to a person’s ability to control access to himself or herself by others. This includes others ability to see the person, hear the person, touch the person, or access the person’s private information. Examples of privacy protections:

  • Collecting data without personal identifiers (anonymous data. Data are anonymous only if it is impossible under any circumstances to identify the individual from the data).
  • Collecting coded data: data for which personal identifiers are removed and secreted from the data but which are still traceable through the matching code to the individual.
  • Conducting recruiting and consenting processes in non-public locations.

Privacy expectations vary due to culture, circumstances, and expectations. For example, children and teens have very different privacy expectations when using computers.

Data Storage and Confidentiality

Check all of the following which will be used to access (review), collect, receive, and/or transmit study information:

☐ Email ☐ Camera/CameraPhone☐ Portable media (flash drive, CD/DVD, hard drive, etc.)

☐ Laptop☐ Wireless Device ☐ Internet data access/data entry

☐ Paper ☐ KHN Workstation ☐ Non-KHN computer

☐ Other (specify):Click here to enter text.

Describe where data/records/samples will be stored and how they will be kept secure:

To maintain confidentiality of data, describe how data security will be protected and unauthorized access prevented during transmission, entry and storage. Note: KHN requires encryption of protected health information (PHI) for external transmission or storage on portable or non-KHN devices.

Specify who will have access to study information/ to whom it will be released (if applicable):

Click here to enter text.

Describe plans for storage, destruction, and/or return of study data and records after closure:

Describe where and how study records will be stored and/or when they may be destroyed. Regulations require research records to be kept for at least three years after completion of the study. HIPAA documentation must be kept for at least six years after closure. Other retention requirements may apply due to child participants, sponsor requirements, FDA or VA regulations, etc.

☐Check if data or specimens will be saved or stored for future use and provide details:

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Estimated Period of Time to Complete the Study (after IRB Approval)

Recruitment/data collection/active participation:Click here to enter text.

Follow up:Click here to enter text.

Data analysis/write-up:Click here to enter text.

Consenting Process and Location(s)

Initial consenting process

Specify who (e.g. principal investigator and study coordinator) will be involved in the consenting of subjects. State where and how consenting process will be conducted. Estimate how much time the consenting process will take for each subject.

If children will be involved, describe the assenting process and for which children it will be used (based on age or other criteria). Provide the assent document.

Consenting process after first visit

Insert “N/A” if subjects will not participate for more than one visit. Otherwise, describe how the consenting process will take place at subsequent visits. If subjects may become unable to consent during the course of the study, describe how this assessment will be made and how the consenting process will be altered, for example, by obtaining consent from the subject’s legally authorized representative.

Documentation of consent (check all that apply):

☐Subjects’ written, signed consent will be obtained.

☐Waiver of consent is requested (attach Consent Form – Application for Waiver*)

(Information is collected without subject knowledge: e.g. chart reviews)

☐Waiver of a signed consent is requested (attach Consent Form – Application for Waiver*)

(Individuals participate directly but do not sign a consent form: e.g. anonymous surveys)

☐Alteration of consent is requested (attach Consent Form – Application for Waiver*)

(Consent to be signed is not accurate or complete: e.g. study involving deception)

*for non-exempt submissions

Grant Application

Insert “N/A” if not applicable. Describe any proposed or approved grant funding. Provide details, including funding source, grant number, and term of grant, if known. Submit a copy of the grant application. For funded projects provide financial disclosures to the Conflict of Interest Committee before grant submission / IRB submission.

StudyBudget: Funding, Resources, and Expenses

Resources needed

  • Provide a bulleted list of resources needed to carry out the study (paper, stamps, lab expenses, administrative support, etc.)

Expenses to be incurred

  • Institutional Review Board administrative and review expenses

Funding and sources of funds

Click here to enter text.

References

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Version Number: Click here to enter text.Page 1of8

Version Date: Click here to enter text.Protocol Template Revised 4/20/2016