Protocol Forms for Review by the UWC Institutional Review Board

INSTITUTIONAL REVIEW BOARD PROTOCOL

FOR RESEARCH PROJECTS INVOLVING HUMAN SUBJECTS

______

IRB USE ONLY

Date Received: ______Protocol # ______

Date Approved: ______training certificate # ______

Re-approval Date: ______training certificate date _____

Re-approval Date: ______training certificate type _____

IRB Chair or Coordinator Signature: ______

Form of review:☐ exempt☐ expedited☐ full

This application is to be submitted to the Institutional Review Board prior to the initiation of any investigation involving human subjects or material. Please submit one document in MS Word format.

  1. COVER SHEET (please type)

DATE:

PROJECT TITLE:

PRINCIPAL INVESTIGATOR (PI):

______

(Name) (Campus) (Telephone number)

______

(Name of Faculty Sponsor, if PI is a student) (Department) (Rank)

Each educational institution is asked to insure that persons doing research at their institution have recent training on the rights of participants in research. The UW Colleges requires each Principal Investigator to have completed this training.Please append a copy of a recent (within the past 3 years) certification of completion of NIH, CITI, or other relevant training when you submit this document.Links to free training modules can be found here: For further information, see the “guidelines” document.

SUPPORTING AGENCY (if applicable)

______

(Name) (Grant number)

Is the project federally funded? ☐Yes ☐No

NOTE: If project is federally funded, please provide a name and address of the individual to whom official notification should be sent.

SIGNATURES: (electronic signatures will suffice)

By signing this form, the Principal Investigator*certifies that:

a) s/he has read and understands UW Colleges policies regarding the protection of human participants in research;

b) s/he has not begun recruitment or testing of research participants and will not do so until formal notification of IRB approval of the proposed project has been received;

c) s/he will seek approval from the IRB in advance of implementation of any changes in procedures or the consent process/forms for this project have been approved (except when necessary to eliminate apparent immediate hazards to the subject); and

d) s/he will immediately inform the IRB of any adverse events or other negative consequences incurred by participants in this research.

*Although your project may have multiple co-investigators, please designate one principal investigator who will be the person who communicates with the IRB. The project will also be filed under this person’s name. If the PI is a faculty or staff member, s/he also a) is required to send a certificate of recent training in human subjects protection, b) agrees to be responsible for the ethical conduct of the study, and c) is responsible for the training of other staff members in the protection of human subjects. If the PI is a student, the faculty/staff advisor is responsible for the latter three items.

Principal Investigator: ______

Faculty/Academic Staff Sponsor:______

(required only if principal investigator is a student)

By signing this form, the Faculty/Academic Staff Supervisor designated above certifies that:

a) s/he has provided appropriate training in the ethics of human research to the student signing above;

b) s/he takes responsibility for the research design, and for compliance of the student investigatorwith the

requirements of the UW Colleges IRB; and

c) s/he will provide adequate supervision of the above student in the conduct of this research.

Check if any of the following is true of your proposal:

☐ you are studying prisoners

☐ you are studying pregnant women and/or fetuses

☐ your target population includes medical patients, emotionally disturbed persons,

and/or individuals with a cognitive delay

☐ the objectives of your research cannot be accomplished if you completely inform

participants of your purposes and procedures (that is, if deception is involved)

☐ the study involves the administration of any chemical substance, pain or other

physical risk to participants

☐ the study involves substantial risk to participants’ emotional well-being by

subjecting them to significant stress

☐ the topic of your research involves illegal activity (crime, drug use, etc.) or other

topics such that a breach of confidentiality could have serious consequences for

participants

If any of the above is true, your proposal will require review by the full committee at a convened meeting.

If you are requesting that your research project be declared “exempt,” which sub-part of Category 1 (1-6) do you believe applies? ______(See UWCAP#15 “Guidelines for Actions by the IRB” pp.2-4 for more information.) A decision tree for determination of exempt status can also be found at

If you are requesting that your IRB review be “expedited,” which sub-part of Category 2 (F1-F9) do you believe applies to your project? ______(See UWCAP#15 “Guidelines for Actions by the IRB” pp. 4-7 for more information.) A decision tree for the various categories of expedited review can also be found at

  1. PROJECT DESCRIPTION
  1. What is the purpose of the research? What question(s) do you hope to answer?
  1. Expected duration of data collection: from ______to ______
  1. Describe the location in which the research will be conducted. (Is it a public place, like a shopping mall? Your place of employment? A campus or class where you are a student or instructor?)
  1. Briefly (no more than two pages, double-spaced, 12-pitch font) describe research that has already been done in this area. How will your study contribute to this knowledge base?
  1. Research Design – What are you asking participants to do? What are the variables of interest? What groups are being compared? Is your study exploratory, correlational or experimental? Include copies of (or links to) ALL instruments/questionnaires/tests that are involved in this research project.
  1. PARTICIPANTS
  1. Human Subject Selection

Number of participants or anticipated sample size:

Sex, race or ethnic group, age range, etc. (note any criteria for inclusion in this sample):

Participants’ general state of health (physical and mental):

Will your target population include any minors as participants? (Might you include

university students who are not yet 18 years of age?) ☐ yes ☐ no☐ unsure

  1. Why have you chosen to study this particular group?
  1. What is your relationship to the participants? (Are you their classroom instructor, a nurse in a clinic where participants are seeking medical care, etc.?)
  1. If there is an authority relationship (e.g., doctor/patient, teacher/student, employer/employee) between you and the participants, describe the measures you will take to ensure that participation is voluntary.

i. Will you have someone else (not in a position of authority) manage the consent process and retain consent forms? ___ yes ___ no If yes, describe your process. If no, describe why this would not be a reasonable precaution for this particular project.

ii. Will you have someone else (not in an authority relationship) collect and retain the data? ___ yes ___ no If yes, describe your process. If no, describe why this would not be a sensible step for this particular project.

iii. Will you have someone else give the data to you in a de-identified format, such that you will never know who did and did not participate? ___ yes ___ no If yes, describe your process. If no, describe why this would not be feasible for this particular project.

iv. If you checked “no” for any of the above, what alternative procedure will you use to overcome any perceived obligation on the part of students/employees/family members to say “yes” even when they’d rather not participate?

  1. RECRUITMENT
  1. Will participants be recruited? ☐ yes ☐ no (Recruitment may not be relevant in some types of record review and/or some types of classroom research.) If not, explain:
  1. Identify the people who will approach potential participants. If these people have a dual or authority relationship (e.g., caregiver, teacher, employer) with potential participants, describe the nature of the relationship.
  1. Describe the process that will be used to approach participants. If the approach will be verbal, provide a script. If by advertisement, letter or poster, provide a copy.
  1. If you will exclude certain classes (by age, employment status, disease or defect, etc.) of individuals from your recruitment, describe and justify the criteria for exclusion. Describe the method you will use to identify and exclude those individuals (e.g., minors) from the study.
  1. PROCEDURES
  1. Describe the setting in which the study will take place. Where will participants be? Will they be alone or in a group? Will there be any specific conditions such as darkness, specific background noises or music?

a. If the study will be explained to potential participants in a group setting and/or if data will be collected in a group setting, what will you do to insure that the privacy of each person’s choice to participate or not participate is maintained? (For example, non-participants might be instructed to “doodle” on a questionnaire while participants answer the questions. Since everyone is busy with paper and pencil, no one knows who is and is not participating.)

  1. What will they do or what will be done to them?
  1. Will you be the one administering the procedure, or will someone else do it for you? If someone else, describe how others will be involved.
  1. How long will the procedure take? How many times will the procedure be done and over what time span?
  1. Are participants expected to experience any discomfort (physical and/or emotional)?

☐ yes ☐ no If yes, explain

  1. DECEPTION
  1. Are you planning to give potential participants a brief but yet honest and accurate summary of your purposes and procedures? ☐ yes ☐ no
  1. If not, explain why deception is necessary for the conduct of this study.
  1. Describe how you will debrief participants, and procedures you will follow if a participant decides to withdraw consent after being debriefed.
  1. RISK/BENEFIT ANALYSIS
  1. Will the participants benefit from being a part of this study? If so, how?
  1. What are the potential benefits to the discipline or to society at large that may accrue as a result of this research?
  1. Are there other benefits?
  1. Will you offer incentives, reimbursement of costs, or other compensation? ☐ yes ☐ no

If yes, answer the following:

  1. What will you offer as incentive, reimbursement or compensation?
  2. What conditions must a participant meet to receive these benefits?
  3. Justify this benefit as necessary to the research, adequate to meet your research purposes, and explain why it will not contribute to perceived or actual coercion of participants.
  1. Describe all risks, physical and/or emotional and/or social (including risk to reputation, financial well-being, social standing, etc.), that participants might encounter during this study. (A response of “no risks” is not acceptable.)
  1. Do you believe the risks described above to be no greater than minimal? ☐ yes ☐ no. If yes, explain why you believe this project involves risk not greater than that encountered in daily life:
  1. If risks are greater than minimal, describe the following:
  1. What have you done to minimize risks, to the extent possible without compromising your research objectives?
  2. What protections have you put in place to minimize the consequences of risks, should they become realized?
  3. What procedures have you established for reporting adverse events, should they occur?
  4. Explain why these risks are essential to the conduct of your study.
  1. CONSENT – The process of obtaining informed consent should reflect a fundamental respect for the right of persons to self-determination. Thus, the research process should be described as clearly and as simply as possible, should allow ample time for clarification, and be free of any coercion. A signature on a page is meaningless if the afore-mentioned conditions have not been met.
  1. Describe how you will obtain informed consent from participants: in what setting? Who will be present? What information will be provided? By whom? Will there be an opportunity for questions to be asked and answered? (In certain circumstances, a waiver of the informed consent process may be warranted – see section I. for details.)
  1. Describe the precautions you have taken to ensure that consent is freely and voluntarily obtained.
  1. If you wish to request a waiver of documentation of informed consent, explain how your research plan meets each of the criteria below:

a. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

b. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

  1. Attach the consent form/s that you will use to document the informed consent for each participant. If you are requesting a waiver of documentation of consent, please attach the verbal script or information sheet that you will use to describe the study to potential subjects.
  1. Attach a copy of the debriefing script or information that you will provide to participants for their reference (if deception will be utilized).

Informed consent must not include any exculpatory language by which the participant (or his/her representative) is made to waive, or appear to waive, any of the subject’s legal rights. Informed consent must also not release, or appear to release, the investigator, the sponsor, the institution or its agents, from liability for negligence.

I. REQUEST TO WAIVE THE CONSENT PROCESS:If you are requesting a complete

waiver of the informed consent process, you must either document that:

1. a. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

(i) public benefit or service programs;

(ii) procedures for obtaining benefits or services under those programs;

(iii) possible changes in or alternatives to those programs or procedures; or

(iv) possible changes in methods or levels of payment for benefits or services

under those programs; and

b. The research could not practicably be carried out without the waiver or alteration,

OR

2. a. The research involves no more than minimal risk to the subjects;

b. The waiver or alteration will not adversely affect the rights and welfare of the

subjects;

c. The research could not practicably be carried out without the waiver or alteration;

and

d. Whenever appropriate, the subjects will be provided with additional pertinent

information after participation.

J. CONFIDENTIALITY/ANONYMITY – In much social/behavioral research, the primary risk to participants is breach of confidentiality. Risks to reputation, financial well-being, or social standing can be minimized with appropriate protections for privacy and confidentiality of data. When possible, complete anonymity (the identity of the person to whom a particular set of responses pertain is completely unknown, even to the researcher) is desirable. When anonymity is not possible, the researcher is responsible for safeguarding the identities, responses, and other private information of research participants.

1. If the data collected in your research will be anonymous, explain the procedures you will

use to create and preserve anonymity.

2. If the data will not be anonymous, explain the procedures you will employ to protect the

confidentiality of your data.

During the data collection process:

While the data are being analyzed:

In publication or other reporting of results:

In storage after research is complete:

3. At each of the above phases of the project, who will have access to the data? Will that

access be with or without identifying information?

4. Where will raw data, transcripts, consent forms, and other materials that may contain

identifiers be stored upon completion of the project? (NOTE: All materials must be

retained and available for inspection by the faculty advisor [if student research], the IRB

and/or an IRB audit for a minimum of three years.)

K. / Disclosure of Financial Interest
If yes to any of the questions below, disclosure in the consent may be required by the Institutional Review Board (IRB) and you must also complete section L below.
K.1. Do any members of the investigative team or members of their immediate families receive from the sponsoring entity salaries, consulting fees, or other compensation for services that exceed $5,000 in any twelve month period?
Yes / No
K.2. Do any members of the investigative team or members of their immediate families have an equity interest that exceeds $5,000 in value or represents more than 2% ownership interest in the sponsoring entity?
Yes / No
K.3. Do any members of the investigative team or members of their immediate families have any intellectual property rights (inventorship, patents, copyrights, royalties) in any article(s), product(s), drug(s), device(s), or other material(s) that will be involved in this research?
Yes / No
K.4. Do any members of the investigative team or members of their immediate families have any financial interests similar to those described above in an entity other than the sponsor that would, to a reasonable objective observer familiar with such issues, appear to affect or be affected by the research being undertaken?
Yes / No
L. / If you answered “yes” to any question in section K above, please answer the following additional questions.
L.1. Provide the names of all individuals with potential conflicts with a description of their roles and activities in this project, e.g., determine eligibility, recruitment, obtain consent, data analyses, conduct other study procedures (describe), etc.
L.2. What is the amount (dollar value) and nature of the conflict (consulting fees, serving as director or on advisory board, intellectual property royalties, etc.)?
L.3. Describe how the project outcome may or may not affect this financial interest, e.g., a good result would lead to more consulting or a product that I/we/they have invested in may appear more effective and have higher sales.
L.4. What actions do you think are appropriate to reduce or manage any potential harmful effects on human subjects arising from the potential conflict? Consider actions to preserve scientific objectivity, guard against coercive recruiting, objectively determine subject eligibility, etc.
L.5. Please provide any additional information that may be helpful to the IRB in reviewing the potential conflict.

Revision approved by the UW Colleges Institutional Review Board --September 28, 2016