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WIDENER UNIVERSITYINSTITUTIONAL REVIEW BOARD

RESEARCH REVIEW APPLICATION

Table of Contents

PART A INVESTIGATOR AND STUDY INFORMATION................................................................................................2

PART B INVESTIGATIONAL PROTOCOL SUMMARY...................................................................................................5

RESEARCH STUDY PURPOSE........................................................................................................................................5BACKGROUND AND REVIEW OF THE LITERATURE...............................................................................................5

SUMMARY OF THE PROTOCOL TEMPLATE..............................................................................................................5DATA COLLECTION INSTRUMENTS & MATERIALS...............................................................................................5

METHODOLOGY...............................................................................................................................................................6ETHICAL ISSUES..............................................................................................................................................................6

CONFIDENTIALITY..........................................................................................................................................................7ALTERNATIVE THERAPIES OR PROCEDURES..........................................................................................................8

COMPENSATION..............................................................................................................................................................8POTENTIAL SIGNIFICANCE OF THE STUDY..............................................................................................................8

REFERENCES.....................................................................................................................................................................8APPENDICES & ATTACHMENTS...................................................................................................................................8

CONFLICT OF INTEREST AND/OR DISCLOSURE STATEMENT...............................................................................10

APPLICATION PART C INFORMED CONSENT.............................................................................................................12

CHECKLIST FOR INFORMED CONSENT FORM.......................................................................................................12CONSENT FORM.............................................................................................................................................................14

ASSENT FORM................................................................................................................................................................15

© Widener University Version Date 3/31/2012 rev062012 Page 1 of 15

PART A INVESTIGATOR AND STUDY INFORMATION

1. Title of Study: Study Title

2. Investigator’s Name: Principle Investigator & Co-investigators

Address: Enter a work or home address

City, State & Zip Code: Enter City, State and Zip Code

Phone: Phone number (fax): Fax number

Widener E-mail Address: E-mail address

Program: Indicate department/unit/program and school

3. For student investigators, identify the faculty research supervisor: Faculty research supervisor name

Faculty Research Supervisor Contact Information:

Phone Number: Faculty research supervisor phone number

E-mail address: Faculty research supervisor e-mail address

4. Projected Research Study Starting Date:

Projected Research Study Ending Date:

5. Level of review being requested: exempt expedited full

Submit this form electronically to [email protected], along with one paper copy of the application materials to:

Marilyn Lehman, Old Main, 1st Floor, Room 10.

DO NOT WRITE IN THIS SPACE – FOR COMMITTEE USE ONLY

IRB Study #: ____________________ Date: ____________________

Approved as submitted _________________________________________________________

Approved pending changes, to be reviewed by IRB chair only ___________________________

Conditionally approved, changes to be reviewed by full IRB ____________________________

Not approved and resubmit _______________________________________________________

Suspension/Termination of previously approved study_________________________________


mailto:[email protected]

6. Does the study require human participants? Yes No

Indicate the type of interaction(s) with the human participants:

Direct interaction/intervention/observation involving a prospective data collection process.

Retrospective participant record review/Review of archival or already existing data.

Other, please describe:

Estimated number of research study participants:

7. Is the data collection process anonymous? Yes No(responses cannot be linked to the identity of the participants in any manner)

8. Does the study involve special or sensitive populations? Yes No (children, prisoners, women who are pregnant, individuals with mentally/physical limitations and disability)

9. Is this research study being funded? Yes No

If yes, please indicate the source of the funding:

10. Indicate the type of risk that the participants be exposed to:

No anticipated or unanticipated risk/No known risk.

Minimal risk: Briefly explain/provide a justification; more details can be provided later in the application.

More than minimal risk: Briefly explain, more details can be provided later in the application.

Some Guidelines for Determining Risk. Risk relates to the probability of harm or injury (physical, psychological, social, economic, legal) occurring as a result of participation in a research study. Risks also include invasion of privacy and loss of confidentiality. Types of risk include: (1) physical - exposure to minor pain, discomfort or injury from procedures that may be permanent or transient; (2) psychological - undesired changes in thought processes and emotion (e.g. episodes of depression, confusion, feelings of guilt, stress and loss of self-esteem, invasion of privacy), which may be transitory, recurrent or permanent; (3) social, legal and economic harm - invasions of privacy and breaches of confidentiality may result on embarrassment within one’s business or social group, loss of employment, loss of insurability or criminal prosecution. Areas of particular sensitivity include HIV / AIDS, information regarding alcohol or drug abuse, mental illness, illegal activities and sexual behavior. A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Loss of privacy is a risk to be considered.

11. Will participants be exposed to deception? Yes No

If yes, how will the participants be debriefed upon study completion?

12. Will this research require the cooperation of other institutions external to Widener University? Yes No

If yes, identify the department/institution and provide a brief summary of the type of collaboration or level of effort required: Provide additional details regarding cooperation and collaboration with other institutions here.

13. Is review by another IRB required? Yes No

If review by another IRB is required, please indicate the responsible institution: Identify the IRB.

Indicate the status of the application review process:

Application not yet submitted for review.

Application submitted, decision pending.

Application submitted and approved on: List the date of approval by the External IRB. Please submit a copy of the approval letter with the application.

Other, please provide details:


14. For those applications that involve research being conducted by one or more students (senior projects, thesis,

dissertations), has the protocol described in the application been approved by a supervising faculty member or committee?

Yes No

Approval Date:

INVESTIGATOR’S ASSURANCES

I certify that the information contained herein is complete and accurate. I agree to conform to the procedures as described and to conduct the research with the highest respect and regard for the participants’ right to be protected from undue risk or invasion of privacy. If changes to the procedure become necessary, I agree to seek prior approval from the IRB.

In the case that a student is the principal investigator, if changes to the procedure become necessary, I agree to seek prior approval from the IRB as well as to inform my research supervisor and the Director of my program. Finally, I agree to keep my research supervisor informed of my progress and of any complications that may arise.

Print Name: .

Signature: __________________________________________ Date: ____________________

All study investigators must sign the paper copy of the application that is submitted. If there is more than one investigator, please print multiple copies of this sheet and sign.

ASSURANCES OF THE FACULTY RESEARCH SUPERVISOR

I certify that the information contained herein accurately represents the student’s complete and final research study and that it has been reviewed and approved by all responsible for the supervision of the work. I agree to periodically review the student’s progress and make sure that the procedures are being carried out as approved.

Print Name: .

Signature: __________________________________________ Date: ____________________


PART B INVESTIGATIONAL PROTOCOL SUMMARY

Please use the following template to summarize your research study as part of the application process. All sections of the application must be completed. Do not leave any section of the application blank.

RESEARCH STUDY PURPOSE

Indicate the purpose(s) and specific aims of the study.

BACKGROUND AND REVIEW OF THE LITERATURE

Describe the background for the study, including a brief literature review with supportive references. You can also state

your hypotheses and/or research question(s) in this section. THE LIMIT IS 4000 WORDS OR THREE DOUBLE

SPACED PAGES.

SUMMARY OF THE PROTOCOL TEMPLATE

Projected number of participants that will be involved in the study:

List the anticipated age range of the participants: Identify the age range of the participants

List the Participant Inclusion Criteria: Participant inclusion criteria

List the Participant Exclusion Criteria: Participant exclusion criteria

Describe the screening process that will be implemented to ensure the participants meet the study enrollment requirements (inclusion and exclusion criteria):

Indicate where participant recruitment will occur: List the recruitment locations or sites.

Is permission necessary to contact and recruit the participants from the identified location or site? Yes No

Has permission been obtained for participant contact and recruitment at the identified site(s)? Yes NoAs part of the application, please submit a signed copy of the permission for recruitment on the letterhead of the organization or institution where recruitment will occur. An e-mail will not be accepted as proof of permission to solicit study participants at the identified locations.

Indicate who will be involved with recruiting the research study participants:

Describe the participant recruitment procedure: Describe the specific procedure for identifying and recruiting the

participants. Indicate how the participants will be initially contacted about the study, describe the selection process, and

indicate how the participants will be assigned to groups.

Will any printed or electronic materials, such as letters, e-mails or posted flyers, be used for participant recruitment? All recruitment materials must be reviewed and approved by the Widener University IRB.

No

Yes. Please include a copy of the materials that will be used for recruitment with the application.

DATA COLLECTION INSTRUMENTS & MATERIALS


In the space below, identify any participant demographics that will be collected as part of the study and describe the instruments that will be used to collect data. Indicate the specific purpose of each instrument in the data collection process and briefly discuss the psychometric properties of the instrument.

Describe the apparatus, stimuli, questionnaires, or any type of measures to be used in the study. Include copies of

questionnaires, interview guidelines, and measures to be used as an appendix or attachment.

When submitting the application, include both paper and electronic copies of any data collection sheets that will be used in the study and a copy of the instruments that will be used to collect data from the participants.

METHODOLOGY

Informed Consent Procedure. Describe the informed consent and/or child assent procedure that will be used once a participant has been identified. Indicate who will be involved with obtaining informed consent, when the process will occur and where the informed consent process will occur.

An informed consent and/or assent procedure is not required for this study because: Provide a rationale

Informed Consent Procedure: Describe the informed consent procedure; indicate how, when and where it will

occur.

Child Assent Procedure: Not applicable Describe the child assent procedure; indicate how, when and

where it will occur.

Indicate who will be responsible for obtaining informed consent and/or child assent:

If participants are not able to read the consent documents due literacy or language problems, how will informed consent be obtained: Not applicable Explain the process that will be used.

Research Design: Identify the research design that will be implemented.

Study Procedure or Protocol. In the space below, describe exactly what the participant will be doing as part of the research study.

Describe exactly what the participant will be doing as part of the research study.

Amount of time required to complete the study: Indicate how much time will be required for the participant to complete the study.

Data Analysis Procedures: Describe how the data will be analyzed. Identify and define the independent and dependent

variables (if appropriate). Include a brief description of the specific data analysis procedures.

ETHICAL ISSUES

Study Risks. © Widener University Version Date 3/31/2012 rev062012 Page 6 of 15

Describe or list the associated study risks.

No anticipated or unanticipated risk/No known risk.

Potential or minimal risk: Describe the possible risks to which participants will be exposed. In considering risk, potential types of harm that might be considered and addressed include: Emotional or psychological harm, for example when a research interaction causes upset or worry Social harm due to stigma or other negative social outcomes (e.g., embarrassment, damage to subject’s reputation) Physical harm of the research procedures themselves or through a breach of confidentiality. For example, physical harm may

occur if a subject reveals information about someone else who may be violence-prone. Such harms may occur when researchers study topics such as domestic violence for example.

Financial harm if revelations can potentially result in loss of employment or insurance coverage, such as when an individual may reveal a heretofore unknown medical condition

Legal harm when illegal activities are disclosed. Such disclosure may lead to arrest for criminal activity or incur civil liability. Moral harm when participation in research strengthens subjects’ inclinations to behave unethically Loss of privacy. Online or electronic data collection processes.

Describe how the investigator or study design will minimize any identified potential risk: Describe the process for

minimizing and managing risk.

Indicate who is responsible for the cost associated with the occurrence of any anticipated or unanticipated risk.

The study participant assumes all responsibility for managing the consequences of any known or unanticipated risk associated with study participation.

Other: Describe the who will be responsible for managing the nsequences of any study risks and what options will

be made available to the participants by the investigator(s).

Benefits.

Participant Benefit. List any potential benefits for the participants associated with study participation.

There is no potential for a direct benefit to the participants.

Study participants may directly benefit in the following manner: Describe the possible benefits for the

participant.

Science and/or Societal Benefit. Describe the potential benefit for society or contribution being made by the research

study. Describe the possible benefits to science/society.

CONFIDENTIALITY

Indicate how long the data will be kept.

In perpetuity/data and all materials collected from the participant will never destroyed.

Materials will be kept for a period of IDENTIFY THE TIME FRAME, then destroyed. Data that will be

destroyed will include: Any printed or paper materials. All electronic copies of the data.

Other, Use this space to explain.

Other, please explain: Use this space to provide additional details about how long the data will be kept

Describe where and how the data will be stored. Indicate where and how the data will be stored.


Describe how the data collection and storage process ensures and protects the participant’s privacy and confidentiality and methods that will be implemented to secure the data.

Discuss how participant’s rights to privacy and confidentiality will be protected. Discuss how and where data will be

stored and the security procedures that will be implemented.

If the research study collects data that is anonymous, describe how the collection process ensures the identity of the participant cannot be linked to responses:

ALTERNATIVE THERAPIES OR PROCEDURES

No study alternative is available. The only option available is not to participate in the study.

The alternative to not participating in the study is as follows: Describe the alternative procedure for the study

participant.

Other, please explain: Use this space to explain.

COMPENSATION Is compensation available for study participation?

No, participation is voluntary; there is no cost to the participant associated with being in the study.

Yes:

Describe the compensation that will be made available to the study participant: Use this space to explain.

Indicate what is required for the participant to receive the promised compensation:

Study enrollment and completion.

Other, please explain, Use this space to explain what the participant must do to receive the promised

compensation.

Indicate when the promised compensation will be provided: Use this space to explain.

Other, please explain: Use this space to explain.

If there is a “token of appreciation” for participation (e.g., pizza and soda; raffle for a gift basket, bookmark; pencils; etc.) please state this and indicate what is required to receive the benefit.

POTENTIAL SIGNIFICANCE OF THE STUDY

Discuss the importance or significance of the study for society, science, and/or knowledge development.

REFERENCES

List supportive references used in the application.

APPENDICES & ATTACHMENTS

The following materials have also been submitted electronically and with the paper of the copy of the application:© Widener University Version Date 3/31/2012 rev062012 Page 8 of 15

Recruitment MaterialsCopies of any e-mails, letters or posters/flyers that will be used to recruit participants have been enclosed as an appendix and submitted with the application in both paper and electronic format.

Research Study Authorizations

Any authorizations or letters of permission necessary to access information necessary to recruit the research study participants have been enclosed as an appendix and submitted with the application.

Any authorizations or letters of permission necessary to conduct the study at a particular site or location have been enclosed as an appendix and submitted with the application.

Research Study Instrumentation and Materials

All instruments used to collect data from the participants are appended to the application including demographic forms have been enclosed as an appendix and submitted with the application.

Consent & Assent Forms

Consent form using the Widener IRB template have been enclosed as an appendix and submitted with the application as a paper and electronic copy.

Child assent form using the Widener IRB Template have been enclosed as an appendix and submitted with the application as a paper and electronic copy.

Other attached materials: Please identify the material and the relationship to the research study

The failure to submit the necessary supportive materials and attachments will delay the review of the application.

The application will not be sent for review by the committee until the printed copies of all required materials have been received by Marilyn Lehman, Room 10, Old Main.

When submitting the application electronically, please include the last name of the investigator as part of the file name for all electronic materials.


CONFLICT OF INTEREST AND/OR DISCLOSURE STATEMENT

Conflicts of Interest are situations in which financial or other personal situations may compromise, or have the appearance of compromising an Investigator’s professional judgment in conducting, reporting or reviewing research.

Please describe the role of the principle investigator at the location where the participants will be recruited and/or data collected: Describe and explain the role of the investigator

ALL INVESTIGATORS ARE REQUIRED TO SIGN THE CONFLICT OF INTEREST DISCLOSURE STATEMENT APPEARING ON THE NEXT PAGE.

ADDITIONAL COPIES OF THE CONFLICT OF INTEREST FORM CAN BE DOWNLOADED FROM THE IRB WEBSITE.


INSTITUTIONAL REVIEW BOARD (IRB)

Conflict of Interest Disclosure Statement

Name: Phone:

Department/Unit: E-mail:

An investigator has a Conflict of Interest in a research study when s/he or any member of his/her immediate family (spouse/spousal equivalent, parents, and children) has interests in the design, conduct, or reporting of the research that might compromise the integrity of the research. Conflicts of interest can be financial, personal, supervisory, academic, or professional. For further guidance, the University’s general Conflict of Interest Policy is set forth on the back of this Statement. The investigator has an ethical responsibility to disclose a potential conflict of interest or a possible appearance of a conflict of interest to the IRB and to potential research subjects as part of the informed consent process. If an investigator or his/her immediate family member is directly involved in potential subjects' health care, professional or academic supervision/evaluation, precautions must be undertaken to avoid the appearance of coercion or conflict of interest in the recruitment process. Please check all applicable boxes.

1. Neither I, nor any member of my immediate family, have any financial conflict of interest (a) that is related to or would reasonably appear to be affected by the proposed research; or (b) in external entities whose financial interests would reasonably appear to be affected by such activities.

2. I am disclosing the following financial conflict(s) of interest:

Salary, consulting fees, or other payments for services Equity or ownership (stock, stock options, partnership interests or other ownership) Intellectual property rights (patents, trademarks, copyrights, licensing rights, etc.) Honoraria, royalties for books, publications or lectures, gifts or other payments Positions in entity related to research (board member, officer, etc.) Other financial interests that could affect or be perceived to affect the results of research or educational activities proposed for funding

3. Neither I, nor any member of my immediate family, have a personal/professional dual role conflict of interest related to this proposed research.

4. I am disclosing the following personal/professional dual role/authority conflict(s) of interest:

Supervisory role as faculty/teacher, direct supervisor/manager for personnel involved in the study, Healthcare provider Family/friend relationships Other, Please provide additional details or describe.

If you have identified any conflict of interest (numbers 2 and/or 4), please provide additional details below. Describe how the investigator plans to manage, reduce, or eliminate the conflict: Describe how any identified conflicts of interest will be managed

I certify, as an investigator* of this research, that I am in compliance with and will continue to comply with Widener University’s policy and procedures pertaining to financial and/or personal/professional CONFLICT OF INTEREST. I further certify that I will comply with any conditions or restrictions imposed by the University IRB to manage, reduce, or eliminate actual or potential conflicts of interest.

I attest to the accuracy of these answers and, should circumstances change in the future, I will contact the Widener University IRB to update this disclosure statement.

__________________________________________________ __________________________Signature Date

*All investigators listed on IRB application must complete and sign a conflict of interest form.


APPLICATION PART C INFORMED CONSENT

CHECKLIST FOR INFORMED CONSENT FORM

All items must be addressed in the consent form. Before submitting the application to the IRB, completion of the checklist below is required for both the electronic and paper copy submission. All investigators must use the Widener University IRB template for consent procedures that requires either an actual or electronic signature from the participant. The consent form template must be used for studies that are anonymous and those studies where completion of a survey constitutes consent.

If in your opinion, any item below is not applicable, please do all of the following: (1) mark the item N/A and (2) provide a brief rationale describing why the item does not apply or should not be required in the consent form.

READING LEVEL OF DOCUMENT

Identify the Flesch-Kincaid grade level of the language used in the

Consent form: Identify the Flesch-Kincaid reading level

Child Assent form: Identify the Flesch-Kincaid reading level Not applicable

Is the language above the expected 8th grade reading level: No Yes, Provide a rationale for a

reading level that is beyond 8th grade

Is a foreign language translation of the consent documents required: No Yes, Describe the process

for creating the foreign language translation.

Completed Not Applicable

RESEARCH STUDY INTRODUCTION/BACKGROUNDA statement that the study involves research has been included.A statement of the study purpose has been provided.A statement about why the participant is being approached to be in the study.The procedure that describes what the participant is required to do is written in lay language.A statement of expected duration of the participant’s participation (e.g., one hour).

STUDY RISKSA description of all reasonably discomforts or foreseeable risks to the participant, as identified in the study and any additional, known and unknown.A description of how the risk will be managed.A description of the availability of treatment if physical or psychological injury occurs and a statement regarding liability for any injury arising out of study participation.

STUDY BENEFITSDescription of the anticipate benefit that the participant may expect by being in the study. If there is no benefit there is a statement indicating no personal benefit can be expected.Description of the benefit for society or science arising from the participant’s study involvement.


Completed Not

Applicable

ALTERNATIVES TO STUDY PARTICIPANTLanguage in the consent form provides disclosure of appropriate alternative procedures or treatment, if any, available to the participant whether or not the participant elects to participate in the study. If the study is a treatment study, what alternatives to participation are available to participants and at what costs (i.e., free or not).A statement that indicates there is no penalty for not participating is included

CONFIDENTIALITYA statement is included that describes the process for ensuring how the participants privacy and confidentially will be protected by the study. The process for securing the data is disclosed.The length of time that the data will be kept is clearly identified.

TERMINATION OF PARTICIPATIONA statement to the effect that participation is voluntary, refusal to participate will result in no penalty or loss of benefits to which the participant is otherwise entitled; the participant may discontinue participation at any time without penalty.A statement is included describing what happens to the data if study participation is terminated.

COMPENSATIONA statement addressing compensation is provided.The section describes what is required to receive the promised compensation.A statement is provided that indicates when compensation will be provided.

QUESTIONSThe name of the contact person for information related to questions about the research (the Principal Investigator), the rights of human participants (the IRB Chairperson), and whom to contact in the event of a research-related injury (the PI).A statement that the investigator has answered and will answer all questions posed by the participant now and in the future to the best of his/her ability.

OTHERA statement regarding injury compensation and institutional or PI liability for any injuries that might occur.A statement indicating voluntary consent has been obtained, including signature lines for participant and investigator, and date.A statement that the participant will receive a copy of the consent form (when an oral summary is read, and short consent form is used, the statement should read that a complete copy of the consent form will be provided to the participant).A statement that the IRB has approved the solicitation of participants for the study; this appears after the signature lines or at the end of the consent document.


CONSENT FORM

Please paste the copy of the consent form in the space below. The template for the consent form must be used and can be found on the IRB website.

If you are using Microsoft Word 2007 or 2010, you can cut and paste the information from the consent form template in the space below. If you are using earlier versions of Microsoft Word, or are unable to cut an paste the text in the space below, please submit a copy of the consent form as an attachment to the IRB application.

Click here to enter text.


ASSENT FORM

If recruiting participants younger than 18 years of age, please paste the copy of the assent form in the space below. The template for the assent form can be found on the IRB website.

If you are using Microsoft Word 2007 or 2010, you can cut and paste the information from the consent form template in the space below. If you are using earlier versions of Microsoft Word, or are unable to cut an paste the text in the space below, please submit a copy of the assent form as an attachment to the IRB application.

Click here to enter text.


Documents

WIDENER UNIVERSITY IRB Web viewA statement is included that describes the process for ensuring how the participants privacy and ... Microsoft Word, ... to the IRB application