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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...................................................................................................6

RESEARCH STUDY PURPOSE........................................................................................................................................6BACKGROUND AND REVIEW OF THE LITERATURE...............................................................................................6

PARTICIPANT RECRUITMENT......................................................................................................................................6DATA COLLECTION INSTRUMENTS & MATERIALS...............................................................................................7

STUDY METHODOLOGY AND PROTOCOL................................................................................................................8ETHICAL ISSUES..............................................................................................................................................................9

CONFIDENTIALITY........................................................................................................................................................10ALTERNATIVE THERAPIES OR PROCEDURES........................................................................................................10

COMPENSATION............................................................................................................................................................10POTENTIAL SIGNIFICANCE OF THE STUDY............................................................................................................11

REFERENCES...................................................................................................................................................................11APPENDICES & ATTACHMENTS.................................................................................................................................11

CONFLICT OF INTEREST AND/OR DISCLOSURE STATEMENT...............................................................................13

APPLICATION PART C INFORMED CONSENT.............................................................................................................15

CHECKLIST FOR INFORMED CONSENT FORM.......................................................................................................15CONSENT FORM.............................................................................................................................................................17

ASSENT FORM................................................................................................................................................................18

RECRUITMENT MATERIALS...........................................................................................................................................19

© Widener University Version Date 08/30/2016, rev 09/26/2019 of 19

PART A INVESTIGATOR AND STUDY INFORMATION

Application Submission Type:☐ New Application ☐ Revised Application Submission ☐ Final

1. Title of Study: Study Title

2. Investigator’s Name: Click here to enter text.

Address: Click here to enter text.

City, State & Zip Code: Click here to enter text.

Phone:Click here to enter text. (fax):Click here to enter text.

Widener E-mail Address: Click here to enter text.

Personal E-mail Address: Click here to enter text.

Program/Department: Click here to enter text.

3. For student investigators, identify the faculty research supervisor: Faculty Research Supervisor Name

Faculty Research Supervisor Contact Information:

Phone Number: Faculty Research Supervisor Number.

E-mail address: Faculty Research Supervisor Email Address.

4. Projected Research Study Starting Date: Click or tap to enter a date.

Projected Research Study Ending Date: Click or tap to enter a date.

5. Level of review being requested: ☐ exempt ☐ expedited ☐ full

Submit this form electronically to [email protected]

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: Click here to enter text.

Identity the estimated number of research study participants: Click here to enter text.

7. Is the data collection process anonymous? ☐ Yes ☐ No(Yes means that the identity of the participants is not known to the investigators and 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: Click here to enter text describing the funding source.

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

☐ No anticipated or unanticipated risk/No known risk.

☐ Minimal risk: Click here to enter text that briefly describes the risk.

☐ More than minimal risk: Click here to enter text that briefly describes the risk.(For minimal and more than minimal risk, briefly explain the reason for the response. Additional details will be provided later regarding the management of the risk.)

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, describe how will the participants be debriefed upon study completion? Click here to enter text.

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: Click here to enter text.


13. Is review by another IRB required? ☐ Yes ☐ No

If review by another IRB is required, please indicate the responsible institution: Click here to enter text..

Indicate the status of the application review process:

☐ Application not yet submitted for review.

☐ Application submitted, decision pending.

☐ Application submitted and approved on: Click or tap to enter a date. Please submit a copy of the approval letter with the application.

☐ Other, please provide details: Click here to enter text.

14. Has Human Subjects Research Training been completed? (All investigators must complete the training within 3 years of the application; renewal must occur every 3 years)

☐ Yes – identify the date: Click or tap to enter a date.☐ No

15. 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: Click or tap to enter a 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: Click here to enter text. .

Signature: __________________________________________ Date: Click here to enter a date.

All study investigators must sign the electronic version of the application that is submitted.

If there is more than one investigator, please use multiple copies of this sheet and sign.

This page can be submitted as a separate PDF document with signatures if necessary

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: Click here to enter text. .

Signature: __________________________________________ Date: Click here to enter a 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. PLEASE LIMIT YOUR RESPONSE TO 3 DOUBLE

SPACE PAGES OR LESS.

PARTICIPANTS

Identify the projected number of participants that will be involved in the study: Click here to enter text.

List the anticipated age range of the participants: Click here to enter text.

List the Participant Inclusion Criteria: Click here to enter text.

List the Participant Exclusion Criteria: Click here to enter text.

Describe the screening process that will be implemented to ensure the participants recruited meet the study enrollment requirements (inclusion and exclusion criteria). Include a copy of the script or form that will be used to screen participants.

Click here to enter text describing how the participants will be screened to ensure study enrollment criteria are met.

Participant Recruitment.

Indicate where participant recruitment will occur: Click here to enter text describing where recruitment will occur.

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 recruiting the research study participants: Click here to enter text.

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.


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 and describe the selection process. Include specific details outlining the

recruitment process. Indicate how the participants will be assigned to groups (if applicable).

Include a copy of the script that will be used for recruitment.

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.

Participant Demographics.

☐Participant demographics will NOT be collected.

☐Participant demographics will be collected and include the following: Click here to enter text.

Study Instruments & Outcome Measures.Provide the following information in the space below that addresses all of the following: (1) describe and/or identify the apparatus, stimuli, questionnaires, or any type of measures that will be used in the study; (2) identify the purpose of each apparatus/instrument/outcome measure as it relates to the study purpose and aims; (3) briefly describe the development of the instrument relative to its intended study purpose; and (4) describe the psychometric properties of each instrument.

Click here to enter text.

☐ Copies of all questionnaires and instruments, including qualitative interview questions have been included with the application in an Appendix.

☐ Copies of the questionnaires and instruments could not be included with the application for the following reason(s): Click here to enter text.

When submitting the application, include both electronic copies of all materials that will be used to collect data from the participants.

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 for not

requiring the participant to provide informed consent or assent.


Adult Informed Consent Procedure. In the space below, describe the informed consent procedure by

addressing all of the following: (1) location where informed consent will occur; (2) when it will occur; (3) the

method used to explain the study; and (4) the method for return of the informed consent document

Click here to enter text describing the informed consent procedures.

Child Assent Procedure. In the space below, describe the child assent procedure by addressing all of the

following: (1) location; (2) when it will occur; (3) the method used to explain the study; and (4) the method for

return of the child assent document

☐ Not applicable – minors are not involved in the study.

☐ Child assent is not required – please explain why: Click here to enter text.

Click here to enter text describing the child assent procedure.

Indicate who will be responsible for obtaining informed consent and/or child assent: Click here to enter text.

If participants are not able to read the consent documents due literacy or language problems, how will informed consent be obtained:

☐ Not applicable – study enrollment requires that the participant read and understand English

In the space below describe the process that will be used to obtain informed consent for individuals who are unable to read or understand English


STUDY METHODOLOGY AND PROTOCOL

Research Design. Click here to enter text describing the research design that will be implemented.

Study Procedures or Protocol. In the space below, describe exactly what the participant will be doing as part of the research study in a logical and stepwise manner. If applicable, include information about how participants will be assigned to groups and/or randomized. If standard educational protocol is part of the methodology, clearly indicate the component of the protocol that is the standard educational practice.


Amount of time required for the participant to complete the study: Click here to enter text.

Data Analysis Procedures. In the space below, 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.

Click here to enter text describing the data analysis procedures.


ETHICAL ISSUES

Study Risks.

Describe or list the associated study risks.

☐ No anticipated or unanticipated risk/No known risk.

☐ Potential for minimal risk: Click here to enter text describing the possible risks to which participants will be

exposed.

☐ Potential for moderate or greater risk: Click here to enter text describing 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. In-person, online or electronic data collection processes allows others to know who was a study participant.

In the space below, describe how the investigator or study design will minimize any identified potential risk

Click here to enter text describing 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.

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

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

In the space below, describe the options that will be made available to the participants for managing the consequences of any study injury by the study investigators or sponsoring organization.

Click here to enter text describing what options will be made available to the participants by the investigator(s) and/or

organizations sponsoring the study.

Benefits.

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

☐ There is no 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. In the space below, describe the potential benefit for society or contribution being

made by the research study.

Click here to enter text describing the possible benefits to science/society.© Widener University Version Date 08/30/2016, rev 09/26/2019 of 19

CONFIDENTIALITY

Indicate how long the data will be kept.

☐ In perpetuity/data – no materials collected from the participant will be destroyed.

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

destroyed 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 details about how long the data will be kept.

Identify where data will be stored. Click here to enter text.

Describe how the stored data will be secured: Click here to enter text.

In the space below, describe how the data collection and storage process ensures and protects the participant’s privacy and confidentiality.

Discuss how participant’s rights to privacy and confidentiality will be protected by the data storage process and what

security procedures will be implemented.

If the research study collects data that is anonymous, describe how the collection process addresses all of the following: (1) prevents the investigator(s) from knowing who participated in the study and (2) ensures the identity of the participant cannot be linked to specific 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: Click here to enter text describing 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 specific compensation that will be made available to the study participant: Click or tap here to

enter text.

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


☐ Study enrollment and completion.

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

compensation.

Indicate when the compensation will be provided: Click or tap here to enter text.

☐ Other, please explain: Click or tap here to enter text.

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 STUDYIn the space below, describe and discuss the importance or significance of the study for society, science, and/or knowledge development.

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

REFERENCES

List the supportive references used in the application (not all references).

List supportive references used in the application.

APPENDICES & ATTACHMENTS

The following materials have also been submitted electronically with the application:

Recruitment Materials☐ Copies 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.

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.

☐ Child assent form using the Widener IRB Template have been enclosed as an appendix and submitted with the application.


☐ Other attached materials: Please identify the specific material(s) and the relationship to the research study.

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

ALL applications should be submitted as a WORD document in a single file.

Signed forms, materials or attachments in a PDF format may be submitted separately in a single file.

The IRB application will not be sent for review until all required documents and materials have been uploaded electronically to the [email protected].

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


mailto:[email protected]

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.

In the space below, please describe the role of the principal investigator at the location where the participants will be recruited and/or data collected:

Click here to enter text that describes and explains 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: Click or tap here to enter text.Phone:Click or tap here to enter text.

Department/Unit: Click or tap here to enter text.E-mail: Click or tap here to enter text.

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 – provide details: Click or tap here to enter text.,

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. If there is more than one study investigator, additional forms are available for download from the IRB Campus Cruiser website. All study investigators must complete 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 the 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 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

Adult Consent Form: Identify the Flesch-Kincaid reading level.

Is the language in the Adult Consent Form above the expected 8th grade reading level?

☐ No ☐ Yes, Provide a rationale for a reading level that is beyond 8th grade.

Child Assent Form: Identify the Flesch-Kincaid reading level. ☐ Not applicable

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/BACKGROUND☐ ☐ A 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 RISKS☐ ☐ A 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 BENEFITS☐ ☐ Description 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 PARTICIPANT☐ ☐ Language 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 interventional study, the alternatives to participation are described to participants and at the costs (i.e., free or not).

☐ ☐ A statement that indicates there is no penalty for not participating is included.

CONFIDENTIALITY☐ ☐ A statement is included that describes the process for ensuring how the participant’s 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 PARTICIPATION☐ ☐ A 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.

COMPENSATION☐ ☐ A 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.

QUESTIONS☐ ☐ The 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.

OTHER☐ ☐ A 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 and 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 OR CUT AND PASTE TEXT. PLEASE USE THE WIDENER UNIVERSITY IRB CONSENT FORM TEMPLATE.


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 and 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 OR CUT AND PASTE TEXT. PLEASE USE THE WIDENER UNIVERSITY IRB ASSENT FORM TEMPLATE.


RECRUITMENT MATERIALS

Please paste a copy of any recruitment materials that will be used in the study in the space below. This includes flyers that will posted and any electronic materials that will be distributed such as emails.

If you are using Microsoft Word 2007 or 2010, you can cut and paste the information in the space below. If you are using earlier versions of Microsoft Word, or are unable to cut and paste the text in the space below, please submit as electronic copy of the materials as an attachment to the email with the IRB application.

CLICK HERE TO ENTER OR CUT AND PASTE TEXT FROM RECRUITMENT FLYERS, RECRUITMENT SCRIPTS AND EMAILS.


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