Use of Human Subjects in Research
Approval Form
To complete this form you will need the following:
A brief overview of the purpose of your study.
A complete and accurate description of what will happen to participants in your study.
- You must include a copy of all materials you will provide participants, including surveys, interview questions, e-mails used to recruit participants, and so on.
A copy of any recruitment materials you will use such as emails, advertisements, or scripts of what you will say at class visits or over the phone.
A completed informed consent form or an explanation of why you will not seek written informed consent.
- (There is a template for an informed consent form at the end of the document. You may use it or create your own. Be sure to cover all the points listed in the template if you create your own informed consent form.)
A description of how you will maintain participant anonymity or the confidentiality of data collected for your study.
- (If you are conducting a survey using Institutional Research survey software, the survey is considered to be anonymous since you will not have access to any identifying information when you receive the survey data from Institutional Research.)
Type of review requested:
- Exempt—There will be minimal risk[1] to participants and all participants are 18-years-old or older.
- Expedited—There is more than minimal risk to participants and all participants are 18-years-old or older.
- Full—There is substantial risk to participants and/or participants are younger than 18-years-old or members of a protected group (pregnant women, prisoners, economically disadvantaged, etc.)
Instructions: Click in any gray area and you can enter the information requested. (You can also move from gray box to gray box by pressing the tab key. Please be sure to save a copy of the form you are completing under a different name. Use the Save As command under the File menu to do this. Questions? Call AndySkelton at 245-1309 or email him .
Project Title: Enter Title Here
Principal Investigator: Enter Name Hereemail: enter email address
Type of Project: (check one and provide any additional information required)
Student research to fulfill a course requirement
Instructor’s name Enter instructor's name here
Course name Enter course name here
(This form must be reviewed by your faculty supervisor or instructor)
I certify that my faculty supervisor has reviewed this form
“Furnishing false information to any College official or faculty member at any time…” violates the Student Code of Conduct and may result in and F for a course, and possible suspension from the College.
Independent Student Research
Faculty Supervisor name: Enter faculty supervisor's name here
(This form must be reviewed by your faculty supervisor or instructor)
I certify that my faculty supervisor has reviewed this form
“Furnishing false information to any College official or faculty member at any time…” violates the Student Code of Conduct and may result in and F for a course, and possible suspension from the College.
Faculty Research
Other (including non-Dickinson researchers) Describe
Anticipated starting date: (write as month/day/year—it will be converted into day/month/year)
Anticipated ending date: (write as month/day/year—it will be converted into day/month/year)
Whom will you ask to participate in your research? (Check all that apply):
Adults
Minors (anyone under 18 years of age)
Vulnerable individuals (children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.)
Individuals with special characteristics or skills. Describe the particular skills or characteristics you seek. For example, you want to left-handed female long-distance runners, or only sorority members, etc.
Estimated number of participants:
How will participants be recruited? (check all that apply)
Class visits Advertisements (including posters) email blasts Word of mouth
Other Please describe
As part of your materials, you must include a copy of any recruitment materials you use such as emails, advertisements, or scripts of what you’ll say at class visits or over the phone.
Will you offer any inducements (e.g., course credit, money)? Yes No
If you checked yes, describe any inducements (e.g., money) you will offer individuals for their participation? Describe inducements
Project Description & Procedures
Describe your research project and explain why it is of interest.
This information is important in weighing the benefits of the research against any risks that might be incurred by the subjects in the study.
Enter your project description here. Use as much space as you need.
Describe the procedures that will be used in your study.
Describe the procedures as a participant would experience them. Your description should include what will be said to subjects, particularly any statements that will be misleading or deceptive, as well as statements during the debriefing period and all written materials, including questionnaires, surveys, or tests, to be given to subjects during the course of the study. Include a copy of the script and any written materials to be used in the study to this form.
Describe procedures here. Use as much space as you need.
RISKS
Will you deceive people about what you plan to do? Yes No
If yes, then describe how and why you plan to deceive participants.
Describe deception here
Will you use any materials or engage in social interactions that participants might consider offensive, threatening, or degrading? Yes No
Describe materials or interactions here
Will participant be at psychological, social, physical or legal risk? Yes No
Describe risks here
Will you collect any personal or sensitive information from participants? Yes No
Describe sensitive information here
Describe how you will minimize any risks you have identified in your research.
Enter your description here.
VOLUNTARY PARTICIPATION/INFORMED CONSENT
(NOTE: The questions in this section do not apply to unobtrusive observation of public behavior).
Before someone can consent to take part in research, that person must understand what will happen to him or him, and the risks and benefits of participating. This information should be provided in clear, non-technical language. Also, there should be minimal possibility of coercion or undue influence by the researcher that makes someone think she or he must participate. The Institituional Review Board (IRB) needs the following information to decide if people are participating voluntarily. We prefer a written and signed consent form, but will waive this requirement (e.g., no signature) to ensure confidentiality.
Will a written consent form be used? Yes No Explain why you will not use a written consent form
If yes, either complete the model informed consent form at the end of this document or include a copy of a consent form you designed.
Are any participants minors (under 18)? Yes No
If yes, either complete the model assent form at the end of this document or include a copy of an assent form you designed.
If research involves participant observation, what is the researcher’s “cover story?”
Describe the cover story here.
CONFIDENTIALITY
There is a difference between confidentiality and anonymity. Consider survey research. If you do not know who returned a survey (there is no information you have, at any time, that would allow you to connect a survey with an individual) then you are conducting an anonymous survey. If you can connect a survey to a particular individual (even if only temporarily) then the survey respondent would usually expect you to treat her or his responses confidentially.
What steps will be taken to insure confidentiality of personal data? Be specific. How will research personnel (including students) be informed of their responsibilities in maintaining confidentiality? How will confidentiality be preserved as data are collected, stored, analyzed and published? When will data identifying individual subjects be destroyed?
Enter a description of the procedures you will use to ensure confidentiality. Make certain you answer the questions asked above.
If data will be collected that identifies individuals or is recorded in a way that allows observations to be linked to individuals then please describe the information, who will have access to it, and how it will be used. (This includes information taken from non-public institutional files or archives.)
Enter your answer to the question above.
BEFORE YOU SUBMIT THIS FORM
In orde to submit this form electronically you will need to check that you agree or disagree with the following statement. If you disagree with the statement then we cannot process the approval form electronically, in which case you should contact AndySkelton (x1309).
I hereby certify that I am the primary investigator and that the preceding information is accurate, complete, true and correct to best of my knowledge, information and belief.
I agree with the preceding statement
I do not agree with the preceding statement
IRB Form Revised 12/20101
Consent Form
Enter your name and departmentEnter a phone number at which you can be reached
Enter the names of any co-investigatorsEnter a phone number at which they can be reached
ENTER THE TITLE OF YOUR STUDY
INVITATION TO PARTICIPATE: You are being asked to participate in a research study because Explain why you chose them. Use as much space as you need.
PURPOSE: The purpose of the study should be expressed in lay language and should clearly state the nature of the research project.
PROCEDURES: The subject must be informed exactly what his/her participation will involve in chronological order. This may include the length and frequency of interviews, types and number of tests, randomization, questionnaires, video-taping, follow-up studies, etc.
RISKS: Describe in lay language any potential risks to subjects associated with this study. Avoid percentages and ratios. Rather, state how many individuals out of some number might be at risk (e.g., 1 in a 1000, 1 in 1,000,000, etc.)
BENEFITS: Describe in lay language any potential benefits, accruing either directly to the subject, or to society. If there is no direct benefit to the subject, a statement reflecting this fact must be included.
COMPENSATION: Describe any fees (dollar amount), extra credit in a course, etc, to be paid to the subject for participation, describe partial payment or no payment for early termination or bonus for completion.
If no payment will be given, use the following statement: There will be no financial compensation.
CONFIDENTIALITY
You understand that every attempt will be made by the investigators to maintain all information collected in this study strictly confidential. Authorized representatives of the Dickinson College Institutional Review Board (IRB), a board charged with protecting the rights and welfare of research subjects, may be provided access to research records that identify you by name. If any publication or presentations results from this research, you will not be identified by name.
Describe the procedures you will use to maintain confidentiality.
ADDITIONAL INFORMATION: A statement that any significant new findings developed during the course of the study that may relate to the subject’s willingness to continue his or her participation will be provided to the subject.
(The investigator must provide the subject and the IRB with a written statement concerning any significant finding(s) that may potentially influence a subject’s decision to continue participating in the study. In this circumstance the investigator must re
WITHDRAWAL:
You understand that your participation in this study is completely voluntary and that you have the right to refuse to participate, as well as to withdraw at any time. For Dickinson College students participating in this research, you understand that your right to refuse to participate or to withdraw will not prejudice your standing within Dickinson College or within your course.
SUBJECT RIGHTS: You have been given the opportunity to ask questions and have had them answered to your satisfaction.
CONCLUSION: You have read and understand the consent form. You agree to participate in this research study. Upon signing below, you will receive a copy of the consent form.
Please report any concerns or problems during this research project to the Chair of the Dickinson College IRB, Andy Skelton.He may be reached at 717-245-1309 ().
Name of SubjectSignature of SubjectDate
Name of InvestigatorSignature of InvestigatorDate
Name of WitnessSignature of WitnessDate
(The signature of an independent witness is optional, but is advisable if it can be obtained without undue interference with the research.)
IRB Form Revised 12/20101
Additional Materials
Cut and paste or use the Insert File command to add additional materials starting on this page.
IRB Form Revised 12/20101
[1]"Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 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."[§46.102.i]