human subjects committee - wesley...

Human Subjects Committee

12

Human Subjects Committee

Human Subjects Non Exempt Approval Request

Wesley College

SUBMISSION OF ALL PROPOSALS SHOULD BE AS AN E-MAIL ATTACHMENT TO [email protected]. Please include all material in ONE WORD or PDF document. Please do not use any other format. Complete all questions in this document in the space immediately following each question. Note: all informed consent documents must be kept for a minimum of 3 years. These may be electronic records.

1. Project title

(This is the title of the project not the title of the paper). Chose a title that lets your participants know what topics the study will examine, but it should not give away your hypothesis.

2. Name of Principal investigator:

3. Phone Number of Principal investigator:

4. E-mail address of Principal investigator :

5. The principal investigator is a Wesley: _________________ (e.g. Faculty member, Staff member, Graduate Student, Undergraduate Student) If the PI is not affiliated with Wesley please indicate her/his place of employment.

6. If the PI is an undergraduate or graduate student, please indicate the faculty advisor.

List the Faculty advisor name and contact information here.

7. If there are additional researchers, please list the names and contact information for all others involved with the project as an Appendix. If new researchers are involved at a later point, you must submit a revision to notify the IRB.

I have included this appendix ______ Not Applicable _____

8. Is any part of your study funded by a grant? Yes _____ No _____ If yes, please indicate the sponsoring agency below. (If you have funding of any type all sources must listed below).

9. If the research has federal funding, has each person who has contact with the participants or access to the data completed the appropriate on-line research ethics training and filed a copy of the certificate with the IRB Chair? (Contact the IRB Chair if you have questions about this). Yes ____ No ______ NA _____

10. Location of study : (If it is on the Wesley College campus just state that, if it is at location other than Wesley College, please be attach a letter indicating that you have their permission to conduct the study at that location, be aware that you may need to get IRB approval at that location as well).

The location of my study is Wesley College Yes _____ No____ If No, type the location of your study here and attached a letter from that location giving you permission to recruit participants from that location. :

11. Will you use a sample or population that is considered vulnerable or at risk? Yes ___ No ___

a. If yes please indicate if your study population will include (check all that apply) ___Pregnant Women ___Prisoners ___Minors (under the age of 18) ___Fetuses ___ Individuals with a Developmental Disability or a Mental Disorder.

Authorized Signatures: you may type this, but if student project, the submission must be approved by the faculty supervisor before it is submitted. To verify that the faculty supervisor has approved this application please cc the faculty advisor on the email submission.

Principal Investigator ________________________________________Date __________________

Advisor (if student project) ____________________________________Date __________________

Research Protocol

You must provide a response for each of the sections, if you fail to provide a response or an explanation why this does not apply to your study the application will be returned to you without review.

A. Hypothesis/Objectives: Include the specific hypothesis that will be tested by your project and a description of the background information that provides justification for this hypothesis. First, state the hypothesis that will be addressed by this project. Next, include a short discussion of how this study will add to the body of knowledge in this area of study. The goal of this section is to provide the IRB with enough information to decide if the knowledge gained by your project exceeds the risks to participants. So tell us what your study will investigate that has not been done in the past. This need not be a full literature review, just briefly explain the hypothesis of the study, and then provide enough background (with empirical citations) so that the IRB members can do a risk benefit analysis for your project (about one or two paragraphs). The greater the risk the more detailed this section should be. Type your responses below.

1. Hypothesis or main research question:

Type your response below.

2. Empirical rational for this project:


B. Method/ Research Design: Include the research design and all of the variables that will be examined in the project. If there is a manipulated independent variable, list all possible values. If it is a correlational or observational project, include the predictor and criterion variables. If it is a qualitative study, list the main issues and questions that the study will address. If you will use surveys, what surveys will you use? Place the surveys or other materials in an appendix and then refer to the appropriate appendix as you describe the materials in the text below. The IRB must see all questions you will ask in order to determine if you are correctly judging the level of risk to your participants.

1. Research design: (e.g. correlational, experimental, observational, phenomenological or?)

Type your response below

2. Independent variable(s)/Criterion or predictor variable(s): state the variable(s) and how will it/they be manipulated, measured or how will you categorize the participants into groups. (e.g. if your IV or predictor variable is aggression, how will you manipulate aggression or place participants into the various conditions, or how will you assess the level of aggression to predict the outcome variable), This could be as simple as a single question or a demographic question, or a survey or scale that places participants into groups, or a manipulated situation that manipulates the level of that variable. If it is a survey provide a copy of the survey/ measure, question in an appendix. If is a manipulation describe the manipulation and provide any materials that will be used in an appendix or attachment or URL.


3. Dependent variable(s)/Outcome variable(s) and how will they be measured: (e.g. if you are measuring aggression as a DV or outcome variable, how will you measure aggression, e.g. a survey or scale? Or perhaps a single question?) If it is a published measure/questionnaire cite the measure/questionnaire, if it is a measure/questionnaire you created, state that. In all cases, provide a copy of the questionnaire/ measure in an appendix and refer to this in the text of this section.


4. Demographic questions: Provide a copy of all demographic questions in an appendix and refer to this in the text of this section.


5. Will there be any deception in your study: If so describe the deception and the justification for the deception.


C. Procedure: Provide a step by step outline of what the participants will experience from the moment they are approached to participate to the very end of the study.

1. Outline of procedure


D. Participant and Recruitment: Researchers should state the desired number of participants, if the exact number is not known prior to recruitment, a minimum/ maximum range is acceptable. Also, state any inclusion or exclusion criteria (who can be a participant and what would disqualify someone from participation). Discuss the population from which you are recruiting participants and how diverse the sample population in respect to the demographics you are collecting. The goal of this section is for the IRB committee to be able to determine if the demographic information may actually identify the participant, (In a small population, things like age, gender and ethnicity combined may provide enough information to identity a participant). Finally, discuss your relationship with the participants. In this section, the IRB committee is trying to assess whether the participants might feel obligated to participate in your study due to any professional or personal relationship they have with you. (Be sure to include a copy of any advertisements, flyers, or posters to be used in an Appendix.) These materials may not be coercive. Faculty should be very careful when recruiting their own students. There is an implied coercion when you ask your students to participant in your studies, especially if you offer extra credit. In the same vein, student researchers should not put pressure on their friends, fellow fraternity or sorority members to participate in their study. In both cases, if you have a relationship, explain how you will make it very clear to participants that their grade, job or other relationship with the researcher will not be affected by their refusal to participate in the study. Moreover, if extra credit is offered to students a non-research option for the same amount of credit must be offered as an alternative. This option should not require any more time or effort than the research option. Please contact the IRB Chair if you need advice on how to do this

1. Desired number of participants: (you cannot exceed this number without informing the IRB but you can collect fewer).


2. Are there any inclusion or exclusion criteria for participating in your study? If so, state these.


3. State the make-up of the sample population (discuss the make-up of the sample population and indicate that that the population is large enough or diverse enough on the variables you are including in the demographic survey so that the demographic information will not identify the participants. If not what precautions will you take to protect the participants identity?


4. Do you have a relationship with the population? Do you have a professional or personal relationship with the sample population? In addition, if so, how will you minimize the implied coercion so that they do not feel compelled to participate in your study?


5. Will you use advertisements/ posters? If so, include these in an appendix.

Yes____ No______

E. Time Required for Individual Participants: State the amount of time required from a single participant. If more than one session/contact is required, list all activities and time required.


F. Compensation to Participants: Include any financial and/or any other forms of compensation. Be explicit about what portion(s) of the study the participant must complete to obtain the compensation. If this is a college class that will offer extra credit for participation, it must be stated that alternative opportunities to obtain extra credit are available for equivalent amounts of work. You may not offer extra credit for research participation without approval of the IRB.

1. Will you offer financial compensation? If so, explain this.


2. Will you offer extra credit to students? If so, explain what percentage of the final grade that the extra credit will be and the non-research alternative that will be offered.


G. Benefits to Participants: If the participants will directly benefit from the results of the study, this should be listed. If the participants will probably not benefit in any way, list none. If this is to be an educational benefit for students in a college course, then state how you will provide this educational experience (e.g. a debriefing that explains the hypotheses and methods of the study and the importance of the potential findings).


H. Risks to Participants: Please evaluate and discuss all potential risks of the study. Any social, physical, emotional, economic or other risks must be listed. Risks may be classified as no greater than minimal or greater than minimal risk. If you believe there are no known risks in participation, please indicate that there are no known or no foreseeable risks. All studies have some risks (you may just not know them yet). If an unforeseen risk becomes apparent during the course of the study, you must report this to the IRB chair immediately.


I. Risk Reduction: (If there are known risks such as potential psychological or social harm. List the steps taken to reduce or prevent risks listed in H.


J. Confidentiality: List the steps taken, if any, to keep the identity of the participants confidential, including the location of storage for information and a date for the destruction of personal information. Any project conducted via the Internet must detail measures to assure appropriate computer security issues. For example, will the site save IP addresses, and you may not have participants return surveys by email (there is no way to make these confidential).


K. Informed Consent: Include copies of all forms that will be used to obtain the informed consent of human subjects or their legal representatives. There are three templates for the most common types of informed consent documents. You do not need to use all of these. Choose the one or two that best fit your study. They should be modified to fit your individual project. Items in bolded italics and other sections should be modified for your project or deleted if not appropriate. Please turn in the document that you will provide to your participants. So delete any instructions, and anything that you will not present to the participants. The three examples are as follows. Please contact the IRB Chair if you would like to use a different format. There are other options.

1. Consent for online projects- This form is usually used for online surveys and when recruitment is done at a distance. In this case, you provide the consent document as the first question of the online survey and the participants indicate that they have read the document and are consenting to the study as the first question in the online questionnaire. This is considered an online signature or implied consent.

2. Consent/Assent Form- This is the preferred form unless this should be used in all cases unless you are doing an online survey. In rare cases, the signature can be waived for participants if the signing the document places the participant in social, legal, or emotional risk. Please contact the IRB chair if you have questions about how to get an exemption from obtaining a signature on the informed consent document. In the case of those under the age of 18 or those with a legal guardian, this document can be modified into what is called an assent document. In this case, investigators should obtain assent from the participants and legal consent from their parent or legal guardian using the permission form. The participants should be allowed to refuse to participate or stop their participation even if the legal guardian gives approval.

3. Parental/Legal Representative Consent Form- This form must accompany the Consent/Assent form when a participant is under 18 years of age or is not able to give legal consent. It was designed for use with children but can be modified for use with other vulnerable populations that may require the permission of a legal representative.

For Online Projects: Place this document on the first page of the online survey and then have the first question on the survey state something close to the following statement. As a research participant, I have read the Informed Consent Information and agree to participate in the research project as outlined by this statement. I am indicating my consent by responding yes to this question and by completing the project.

Informed Consent Document

Participation in a Research Project

Wesley College

Project Director (complete this). Phone No (complete this). E-mail (complete this).

Please read the following information:

1. This an invitation for you (as a student, teacher, etc.) to participate in a research project under the direction of the (complete this).

2. The project is titled (complete this).

3. The purpose of the project is to (complete this). (Tell them the area you are studying this in general, do not give away your hypothesis).

4. If you consent to participate, you will be involved in the following process, which will take about ____ minutes of your time: (complete this). Include the basic procedures here, and include where the project will take place, state what tasks they will do in the study. (E.g. You will be asked to complete a personality survey and answer questions about your food preferences. This will take approximately 15 minutes of your time.). But you need not say why, that is, you must tell them what you will have them to do, but you should not give away the hypothesis).

5. Participation in this project is voluntary. You have the right to withdraw at any time without penalty. If you chose to withdraw, it will not affect your future relationship with the researcher of your association with Wesley College in any way. If you have any questions, you may contact the project director at the phone number listed above. (Adjust this as needed to reflect the relationship of the researchers and the participant. The purpose of this section is to minimize even implied coercion. If the researcher and the participant have any professional or personal relationship this would assure them that it will not affect that relationship if they refuse to participate or withdraw at a later point).

6. There are no known risks to your participation in the study. (Or The risks are) (If questions are of a sensitive nature, you will need to indicate how you will handle someone becoming upset; e.g., referral to the Wellness Center.

7. There are no direct benefits to you as a participant. However, we hope that the results of this project will add to the body of knowledge in the area of (complete this) or (The benefits to you are )

8. There (is) (is no) compensation for your participation in this study. (If there is compensation of any type explain what it is and how much. If the participant must travel to the study site, you can include that there will be or will be no reimbursement for travel or parking.) If there is extra credit for a class indicate, how much and any alternatives that the student can do to receive the extra credit. You must have a non-research alternative if you are offering extra credit.

9. Your responses are strictly confidential. When the data and analysis are presented, no identifying items will link to the results of the study.

As a research participant, I have read the above and agree to participate in the research project. Upon request, I will receive a copy of this form for my information. If you have any questions regarding this study, you may contact the Project Director. If you have questions regarding your rights as a participant, you can contact the Wesley College IRB chair at [email protected].

The Wesley College Institutional Review Board has approved this project. IRB # _________

(This number should be added before presenting it to your participants).

Participant Consent Form or Child Assent Form This is the form that most studies will use but it was designed for adults who can give legal consent. If you are using an Adult population that is legally capable of giving legal consent this form should be used as is. However, if you are using participants under the age of 18 or those who may have cognitive deficits, it may need to be modified substantially. Participants, who cannot give legal consent, must give their assent as appropriate and then a legal guardian must provide Informed consent.

Informed Consent/Assent Form


Wesley College



1. This is an invitation for you (as a student, teacher, etc.) to participate in a research project under the direction of (complete this).


3. The purpose of the project is to (complete this). (Tell them the area you are studying in general, do not give away your hypothesis).

4. If you consent to participate, you will be involved in the following process, which will take about ____ minutes of your time: (complete this). Include the basic procedures here, and include where the project will take place, state what tasks they will do in the study. (E.g. You will be asked to complete a personality survey and answer questions about your food preferences. This will take approximately 15 minutes of your time.). However, you need not say why, that is, you must tell them what you will have them to do, but you should not give away the hypothesis).

5. Participation in this project is voluntary. You have the right to withdraw at any time without penalty. If you chose to withdraw, it will not affect your future relationship with the researcher of your association with Wesley College in any way. If you have any questions, you may contact the project director at the number listed above. (Adjust this as needed to reflect the relationship of the researchers and the participant. The purpose of this section is to minimize even implied coercion. If the researcher and the participant have any professional or personal relationship this would assure them that it will not affect that relationship if they refuse to participate or withdraw at a later point).

6. There are no known risks to your participation in the study. (Or The risks are ) (Asking questions that address sensitive issues or maybe socially embarrassing or have legal or financial repercussions are risks. If this is possible at all, state these and then indicate how you will minimize this risk. For example, say how you will keep it confidential. If questions are of a sensitive nature, you will need to indicate that some may become distressed when thinking about these issues and how you will handle someone becoming upset; i.e., referral to the Counseling Center or a therapist).

7. There are no direct benefits to you as a participant. However, we hope that the results of this project will add to the body of knowledge in the area of (complete this) or (The benefits to you are )

8. There is no (is) compensation for your participation in this study. (If there is compensation of any type explain what it is and how much. If the participant must travel to the study site, you can include there will be or will be no reimbursement for travel or parking.) If there is extra credit for a class indicate, how much and any alternatives that the student can do to receive the extra credit. You must have a non-research alternative if you are offering extra credit.

9. Your responses are strictly confidential. When the data and analysis are presented, no identifying items will link to the results of the study.

As a research participant, I have read the above, have had any questions answered, and agree to participate in the research project. Upon request, I will receive a copy of this form for my information. I also certify that I am at least 18 years of age and can legally consent to participate in this study.

Participant's Signature ______________________________ Date __________

Project Director's Signature __________________________ Date __________

If you have any questions regarding this study, you may contact the Project Director. If you have questions regarding your rights as a participant, you can contact the Wesley College IRB chair at [email protected]. The Wesley College Institutional Review Board has approved this project. IRB # _________

If you have participants who cannot give legal consent, please have their parent or legal guardian complete this form. Modify it as needed to fit the participants.

Parental or Legal Representative Consent Form


Wesley College



1. This is an invitation for your (child, ward, or fill in as appropriate) (as a student, group member, etc.) to participate in a research project under the direction of (complete this).


3. The purpose of the project is to (complete this). (Tell them the area you are studying in general, do not give away your hypothesis).

4. If you consent to participate, your (child, ward, or fill in as appropriate) will be involved in the following process, which will take about ____ minutes of his or her time: (complete this). Include the basic procedures here, and include where the project will take place, state what tasks they will do in the study. (E.g. He or she will be asked to complete a personality survey and answer questions about his or her food preferences. This will take approximately 15 minutes of his or her time.). However, you need not say why, that is, you must tell them what you will have them to do, but you should not give away the hypothesis).

5. Participation in this project is voluntary. Your (child, ward, or fill in as appropriate) has the right to withdraw at any time without penalty. If you chose to withdraw, it will not affect her or his future relationship with the researcher or her or his association with Wesley College in any way. If you have any questions, you may contact the project director at the number listed above. (Adjust this as needed to reflect the relationship of the researchers and the participant. The purpose of this section is to minimize even implied coercion. If the researcher and the participant have any professional or personal relationship this section should assure them that it will not affect that relationship if they refuse to participate or withdraw at a later point).

6. There are no known risks to your (childs, wards, or fill in as appropriate) participation in the study. (Or The risks are ) (Asking questions that address sensitive issues or maybe socially embarrassing or have legal or financial repercussions are risks. If this is possible at all, state these and then indicate how you will minimize this risk. For example, say how you will keep it confidential. If questions are of a sensitive nature, you will need to indicate how you will handle someone becoming upset; i.e., referral to the Counseling Center or a therapist).

7. There are no direct benefits to your (child, ward, or fill in as appropriate) as a participant. However, we hope that the results of this project will add to the body of knowledge in the area of (complete this) or (The benefits to you are )

8. There is no (is) compensation for your (childs, wards, or fill in as appropriate) participation in this study. (If there is compensation of any type. explain what it is and how much. If the participant must travel to the study site, you can include there will be or will be no reimbursement for travel or parking.) If there is extra credit for a class indicate, how much and any alternatives that the student can do to receive the extra credit. You must have a non-research alternative if you are offering extra credit.

9. Your (child, ward, or fill in as appropriate) responses are strictly confidential. When the data and analysis are presented, your (childs, wards or fill in as appropriate) will not be linked to the data by name, title or any other identifying item.

10. Your (child, ward, or fill in as appropriate) will be informed of all research activities and will be given the choice to participate. If your (child, ward, or fill in as appropriate) at any time indicates that participation in the project is causing stress or that participation is no longer voluntary, the project will immediately be terminated.

As the parent or legal representative of a research participant, I have read the above, have had any questions answered, and agree to allow my (child, ward, or fill in as appropriate) to participate in the research project. Upon request, I will receive a copy of this form for my information.

Parent's or Legal Representatives Signature ______________________________ Date __________

Project Director's Signature __________________________ Date __________

If you have any questions regarding this study, you may contact the Project Director. If you have questions regarding your rights as a participant, you can contact the Wesley College IRB chair at [email protected].

The Wesley College Institutional Review Board has approved this project. IRB # _________

Human Subjects Committee - Checklist

Wesley College

This form will be completed by the IRB representatives evaluating the project. However, please review it to ensure that you have provided all relevant information. INCLUDE THIS SHEET IN ALL SUBMISSIONS

Funding

___ Does the researcher report all funding sources.

___ If the research has federal funding has every researcher completed the online tutorial?

TITLE

___ Does the title of the study reflect the experience of the research participant?

Objectives and Hypotheses

___ Is the hypothesis and background explained in enough detail to do a cost benefit analysis on the project?

PROCEDURES

___ Is the explanation of procedures adequate?

___ Does it state amount of time the participant will be involved?

___ Are all documents associated with participant recruiting attached?

Methods

___ Are all study materials adequately described?

___ Are copies of the instruments provided?

BENEFITS

___ Is the statement of potential benefits complete?

COMPENSATION

___ Is the availability of compensation stated?

___ If there is extra credit offered is there a statement regarding extra credit for courses. In addition, is an alternative activity offered if they do not wish to participate in research?

RISKS

___ Is the description of the potential risks and discomforts complete?

___ Are methods of risk reduction in place? (e.g., referral in case of distress due to questions asked)

CONFIDENTIALITY

___ Is the assurance of confidentiality, when applicable clear and complete?

___ Has the participant had an opportunity to ask questions and they have been provided with contact information should they questions in the future?

___ Does it state that participants can receive a copy of the consent form if they request it?

GENERAL QUESTIONS

___ Is the investigator's name and phone number on the consent form

___ Is the consent form written in "lay language" that is appropriate to the participants?

___ If children or individuals who cannot give legal consent are included as subjects, is provision made for securing the assent of the child, the vulnerable adult, and the consent of the parent or legal represented?

___ Has permission been obtained from schools, agencies or other Non-Wesley site involved?

For use by the IRB committee only.

Feedback to the investigator: If you are recommending changes before approval please indicated these below. These comments will be communicated to the PI.

Feedback for the IRB Chair: Do you have any comments or feedback for the IRB Chair that will not be communicated to the PI?

Classification recommended to the IRB Chair.

_____ Expedited Review_____Full Committee Review

Revised February 2008

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