Instructions for Completing the IRB-9 Protocol Application Form

Instructions for Completing the

IRB-9 Protocol Application Form

IMPORTANT - Please review the following as you prepare the protocol application:

• Review the Researcher’s Guide to Ethnographic/Naturalistic Research at

• So that the IRB can properly process your submission quickly and efficiently, please attach the IRB Face Page available at

• The form now uses the underscore key “___” as a guide for where to provide certain requested information. In cases where the underscore key is used to indicate Yes/No, please erase the underscore and place an “X” next to Yes or No. In cases where the underscore key is used to indicate where to place requested information, please erase the underscore and type in the requested information.

• Read each item carefully and provide the information requested where it is requested.

• Place your response below, NOT WITHIN, the box containing each item’s description in sections V and VI.

• **NEW** - Attach Appendix A to provide a complete list of Key Investigators and Study Personnel.

• DO NOT submit a handwritten application.

• Finally, please DO NOT remove or alter sections of the form that may not be applicable to your study (i.e. do not submit a protocol application with section III deleted if your study is not funded). The document must be provided to the IRB intact. If a section is not applicable to the research, please put “N/A” in that answer section.

• DELETE this instruction page from the template in the final document.

Please contact the Office of Research Compliance at 6-8802/0986 with any questions or concerns.

(IRB-9) Protocol Application for Ethnographic/Naturalistic Research

Institutional Review Board, Research Compliance Services

SECTION I: General Information

Study Title: ______

Study Objective (2-3 sentence summary of study): ______

______

______

PI, Student Investigator, Correspondent Information:

Very Important: Complete and attach Appendix A to list all UConn key personnel engaged in research and other non-UConn investigators.

Section II: Collaborating Institutions/Facilities and Other IRB Reviews

Will the research be conducted only at Storrs and/or the five regional campuses, School of Law, or School of Social Work with no involvement of a collaborating institution? ___ Yes ___ No (If yes, skip to Section III)

Collaborating Institutions with a Collaborative Agreement with UConn-Storrs

UConn has formal agreements with the University of Connecticut Health Center (UCHC), Hartford Hospital (HH) and the Connecticut Children’s Medical Center (CCMC) that authorize one IRB to take the lead with some research protocols. This decision is made by the IRBs involved, but the PI may request which IRB he/she prefers to be the IRB of record. See the IRB website for additional information. If you are collaborating with one of the institutions listed below, place an X in the appropriate cell to indicate which institution, based on the preponderance of expected enrollment, you are requesting serve as the IRB of record or that independent IRB approval will be sought from each applicable site. If you request that UConn-Storrs be the IRB of record, place an X in the appropriate cell.

Provide additional comments as needed:

If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution listed above, please explain: ______

Other Collaborating Institutions/Facilities

If you are collaborating with other sites, provide the name of each institution/facility (e.g. other university, K-12 school, nursing home, tribal affiliation, etc.) and describe the type of involvement of each institution (e.g. recruitment, enrollment/consenting, study procedures, follow-up, data analysis). Indicate if IRB approval/site permission is attached (indicate yes, no, or pending). You will need to obtain IRB approval from every collaborating institution that has an IRB before you can initiate research there.

Note: tabbing out of the bottom right cell will insert another row if needed.

Provide additional comments as needed:

If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution listed above, please explain: ______

International Research

Will any aspect of the study take place outside of the United States? ___ Yes ___ No

(If yes, complete table below)

NOTE: You may need to obtain IRB approval in the country where the research is taking place and/or a Federal-wide Assurance with the Office of Human Research Protections (OHRP). Please see the IRB website for additional information.

Provide additional comments as needed:

If the PI, Student Researcher or other Key Personnel has an affiliation/appointment with an Institution listed above, please explain: ______

SECTION III: Funding

It is the responsibility of the Principal Investigator to notify the IRB via an Amendment (IRB-3) or at Re-Approval, on an IRB-2 form if the funding source changes in any way.

For Internal, UConn Funded Studies:

If the research is supported either in whole or in part by internal funds (Internal Program Support, Office of Undergraduate Research, Research Incentive Accounts, etc) one COMPLETE copy of each grant application (if applicable) must be included with this application.

Provide any additional comments as needed:

Note: If there is more than one funding source, copy the table format and add the additional funding source.

For Externally Funded Studies:

If the research is supported either in whole or in part by external funds (federal, state or private), one COMPLETE copy of each grant application or contract must be included with this application.

For each funding source,please identify the following:

NOTE: If the PI on the grant/contract is not the PI on this IRB protocol, submit an e-mail with this application in which the PI who is receiving the grant acknowledges use of this protocol under the grant.

Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) that will be engaged in human participant research? ___ Yes ___ No

If yes, indicate the name of the institution: ______

Provide any additional comments as needed:

Will funds from this contract/grant be awarded to an individual or institution (via a PSA or subcontract) that will be engaged in human participant research? ___ Yes ___ No

If yes, indicate the name of the institution: ______

Provide any additional comments as needed:

Note: If there are more than two funding sources, copy the table format and add the additional funding source.

SECTION IV: Conflict of Interest

At the time of proposal submission to the Office for Sponsored Programs (OSP), all investigators and key personnel are required to submit a Significant Financial Interest Review Form to OSP. For more information, please go to the Conflict of Interest Committee website,

Is any investigator listed on this protocol required to submit the follow-up form, “supplemental” Significant Financial Interest Review Form? ___ Yes ___ No

If Yes, please identify each individual: ______

SECTION V: Human Participants

Please place your answers BELOW the boxes.

Explain how many participants will be enrolled and how this number was determined. If an exact number is unknown, provide a range.

If you are enrolling more than one population describe the anticipated total enrollment for each.

Participant Population(s):Describe characteristics of the participant population(s) including gender, ethnicity,age range, education and income levels, etc.

Recruitment:

Describe who will recruit/approach participants and how they will be identified (e.g. snowball/chain sampling, etc.). If applicable, attach copies of all advertisement/recruitment materials for IRB review. If recruiting at off-campus sites, written permission may be required.

Special Population(s):

Identify any special participant population(s) that you will be specifically targeting for the study.

UConn Students or Employees:

Are you recruiting students who are in a class you teach or for which you have responsibility? ___ Yes ___ No

Are you recruiting employees who report to you? ___ Yes ___ No

If ‘Yes,” explain why this population is necessary to the study:______

SECTION VI: Study Details

Please place your answers BELOW the boxes.

1. Purpose: State the reason for the study and the goals of the proposed study as related to the research question(s).

2. Design/Procedures: Describe what participants will be asked to do. Be sure to submit copies of surveys/interview questions or examples of types of questions to be asked. Describe the research techniques that will be used to conduct this study (i.e., observations, interviews, surveys, collection of artifacts, etc.). Describe the topics or research domains to be covered.

• For field research, explain where the research will be conducted and explain why this particular site was chosen.

• Has the PI or other investigator conducted research at this site or with this population previously? If so, briefly describe this experience. Describe the length of time to be spent in the field site(s). If unsure, provide an approximation. If local collaborators will be involved, explain their role.

• For research that will be conducted in the field, is local governmental or community permission to conduct research required at any of the sites? If so, explain how you will obtain this permission. Sometimes the consent process can be multi-layered in community settings. Describe what the full process is in the setting in which the research will take place. If there is formal documentation of this permission, attach it to the application form or indicate when it will be received and forward to the IRB.

• If a local collaborator (translator, interpreter, etc.) will be used, explain who the collaborator is, what this person’s qualifications are and how they will be involved in the project.

• Explain whether data will be recorded in such a way that it can never be linked to the participants (anonymous data). If you are conducting a survey using the Internet, describe procedures to ensure that the data is not linked to an individual participant (i.e.,will participant’s name, e-mail or IP addresses be recorded?).

• Sometimes participants want their identity to be known. If it is anticipated that this will be the case, please describe why and whether it presents any risk to the participant. This should be described in the consent form or information sheet, if it is known ahead of time.

• Risk of harm in qualitative or ethnographic research is usually limited to what may result from invasion of privacy, stigmatization, or breach of confidentiality. These harms can affect individuals or entire groups or communities. Identify the risks and inconveniences to the participants of this research. Describe what steps will be taken to minimize those risks and inconveniences.

• Will the participants benefit directly from of this research? Are there any other types of benefits (i.e., to society or to the field of study)?

• Describe any economic considerations (i.e. cash payment, donations to the community, in-kind goods or services) provided to participants? Explain how and when participants or the community will receive economic considerations.

• Explain how the data (interviews, observations, etc.) will be analyzed(e.g. discourse analysis, document analysis, content analysis).

• For student initiated research studies, describe the plan for communication between the PI and student investigators (SI) to assure that adverse events and protocol deviations occurring during studies are identified, evaluated, and communicated to the IRB in a timely manner. The plan should document how communication between SI and PI will occur including the method(s) of contact and the frequency of contact. The plan should also document how the SI will communicate directly with the IRB, if needed. This plan is required for all student initiated studies at the University of Connecticut except for studies determined to be exempt from continuing IRB review. It is important to note that researchers may not initiate changes to approved research procedures in the field without first obtaining approval from the IRB.

3. Privacy/Confidentiality

Explain how the privacy interests of participants will be maintained during the study (note that privacy pertains to the individual not to the data). Describe procedures for protecting confidentiality of data collected during the study and stored after study closure. Describe plans for storage and security of electronic data? If identifiable, sensitive information (illegal drug use, criminal activity, etc.) will be collected, state whether a Certificate of Confidentiality will be obtained. Be sure to state whether any limits to confidentiality exist and identify any external agencies (study sponsor, FDA, etc.) that will have access to the data.

• If private information will be stored in the field and transferred when you leave the field, describe what steps will be taken to protect the data.

• If this private information is retained, could it lead to the identification of the research site or study participants? If so, describe any negative consequences this may have on participants. If individually identifiable information will be collected, justify the need to do so.

• The IRB acknowledges that sometimes it is not possible or desirable to maintain anonymity. For example, when a researcher works with a small group of people only found in a particular region with whom others have worked. In order to advance ethnographic knowledge about the group, their identity must be made known. Sometimes individuals or whole communities do not want to remain anonymous. If this is the case, please describe why. If there are differences in the community about this, describe how this will be handled.

4. Informed Consent: Explain how you will introduce yourself as a researcher to potential participants. If you already know them, explain the circumstances. Describe how you will obtain informed consent including who will obtain consent, where and when it will be obtained, and how much time participants will have to make a decision. Will participants provide ORAL or WRITTEN consent? Attach a copy of either the consent form or information sheet. Sometimes the consent process can be multi-layered in community settings. Be sure to describe what the full process is in the setting in which the research will take place.

• If you plan to use an oral consent process, please provide a general script or list of points you will cover. If you plan to collect anonymous data, it may not be appropriate to ask participants to sign a consent form. If you plan to obtain oral consent using an information sheet (see Information Sheet instructions), complete the section below, “Waiver of Signed Consent” and attach a copy of the Information Sheet. If you plan to obtain signed consent, attach a copy of the consent form.

• In some cases, it may not be appropriate to identify yourself as a researcher and to obtain consent from participants, such as when doing so would destroy the natural response of the participant in an interactivesetting. The IRB can waive consent in certain situations. The research must be minimal risk and anonymous.If you are requesting a waiver of consent, please complete the Waiver or Alteration of Consent section below.

5. Waiver or Alteration of Consent: The IRB may waive or alter the elements of consent in some minimal risks studies. If you plan to request either a waiver of consent (i.e., participants won’t be asked to consent) or a waiver of signed consent (i.e., participants will give consent only after reading an information sheet), please answer the following questions using specific information from the study.

Waiver (i.e. participants will not be asked to give consent) or alteration of consent (e.g. use of deception in research):

• Why is the study considered to be minimal risk?

• How will the waiver affect the participants’ rights and welfare? The IRB must find that participants’ rights are not adversely affected. For example, participants may choose not to answer any questions they do not want to answer and they may stop their participation in the research at any time.

• Why would the research be impracticable without the waiver? For studies that involve deception, explain how the research could not be done if participants know the full purpose of the study.

• How will important information be returned to the participants, if appropriate? For studies that involve deception, indicate that participants will be debriefed and that the researchers will be available in case participants have questions.

Waiver of signed consent (i.e. participants give consent only after reading an information sheet):