|
|
 |
|
|
|
| |
Application Form for the College of the Atlantic
Ethical Research Review Board
Note: There are two versions of the ERRB application form.
The first, which is provided here below, is the Conventional Application Form. It is similar to that used by institutional research boards at schools aiming simply to insure compliance with Federal Law regulating "research" that is done "on human subjects" in the technical senses of those terms. If you answered Yes to the Part A question and at least one of the questions on Part B on the Optional or Required Checklist then you must either fill out this form or include the information it asks for in an application that uses the second General Application Form provided below.
The second version is a General Application Form intended for anyone interested in looking at ethical issues of any kind which might arise in their work and who wants some help considering them -- even if they are not required by law to seek approval for their project because it does not involve, in the technical sense, "research" that is done "on human subjects."
-----------------------------------------------------------------
The Conventional Application Form
(designed to insure compliance with Federal Law on "research on human subjects", modelled on the Carleton College IRB materials -- see reference at end of page)
1. Contact Information
Name:
email:
Research Supervisor(s):
2. Project Description
Type of Project (e. g. senior project?):
Title:
Brief Description of the project including:
What questions you hope to answer?
What your basic research plan is?
What disciplines and methods form part of the project?
What will be the final products and forms of presentation for your project?
3. Relevant Ethical Guidelines and their Application in your Project
4. Estimated duration of total project (note: approvals are granted for no more than 1 year from the date of review):
5. Subjects:
- Estimated total number of subjects (including control subjects):
- Age range of subjects:
- Sex of subjects:
- Where will this study be conducted?:
(For example: on campus, in elementary schools, on MDI and New York, etc.)
- Source of subjects:
Please note: Investigators are discouraged from enrolling subjects with status relationships with the investigators (e.g. faculty-students; student advisees of faculty-students). Approval may be granted with a compelling justification or employment of a mechanism ensuring anonymity of participation.
6. Support:
Grant Support (if any) for Project:
Commercial Support (if any) for Project:
7. Background:
Provide a brief historical background of the project with reference to the investigator's personal experience and to pertinent scientific literature.
8. Plan of study:
(A) State the hypothesis or research question you intend to answer. Describe the research design, methods, interventions, and procedures (including standard or commonly used interventions or procedures) to be used in the research. Specifically, identify any interventions, procedures, or equipment that are innovative, unusual, or experimental.
(B) Describe any deception procedures employed in this study, if applicable. Please explain why deception is necessary. Examples of deception used for research purposes: withholding relevant information, use of a confederate (someone who poses as someone they're not), false performance feedback, offering fictitious information about the true purpose of the study, etc.
9. Possible risks:
(A) Indicate what you consider to be the possible risks (or inconveniences) to subjects and indicate the precautions to be taken to minimize or eliminate these risks. If any data monitoring procedures are needed to ensure the safety of subjects, describe them.
(B) If deception is used, please explain possible risks and precautions to be taken to minimize or eliminate these risks.
10. Selection of Subjects and the Informed Consent Process:
Indicate whether this project involves any of the following subject populations:
* Minors
* Prisoners
* Pregnant women
* Cognitively impaired or mentally disabled subjects
* Economically or educationally disadvantaged subjects
NOTE: If you indicated any of the above, additional safeguards will need to be implemented in order to protect these populations from excessive risk, coercion or undue influence. Please describe the precautions that you will take to minimize all possible risks given the unique setting or circumstance faced by these individuals. See federal guidelines at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
11. Describe how subjects will be recruited and how informed consent will be sought from subjects or from the subjects' legally authorized representative. If children are subjects, discuss whether their assent will be sought and how the permission of their parents or legal guardians will be obtained. Use additional sheets as needed.
12. Will your subjects receive any compensation for participation in cash or in kind? If so, please describe the amount or kind of compensation.
13. Will your subjects receive course credit (either extra credit or fulfillment of a course requirement?). Note: Students must be offered an equally desirable, non-research option for receiving the same amount of course credit. If so, please describe the amount or kind of credit received for research participation. AND please describe the optional procedure for receiving credit.
14. Privacy and Confidentiality of Data and Records: Will identifiable, private, or sensitive information be obtained about the subjects or other living individuals? Whether or not such information is obtained, describe the provisions to protect the privacy of subjects and to maintain the confidentiality of data.
15. Investigator's Pledge
I certify that the information furnished concerning the procedures to be taken for the protection of human subjects is correct. I will seek and obtain prior approval for any modification in the project design or informed consent document and will report promptly any unexpected or otherwise significant adverse effects encountered in the course of this study. I certify that all individuals named as consultants or co-investigators have agreed to participate in this study.
Certification is recorded by emailing this form via your own COA email account to errb@coa.edu.
16. Certification of Supervisor
Supervisor's Certification (in case of student applications)
I certify that I have read this application in full and that I have discussed with the project investigator(s) the ethical treatment of the human subjects who will participate in this project, as well as the procedures to protect the privacy of the subjects and the confidentiality of data generated. Certification is recorded by emailing this form via your own COA email account to errb@coa.edu.
17. Attachments
Please attach the following items in order for the ERRB to review your research.
* A copy of the informed consent document NOTE: Carleton College provides one useful website for designing such forms for Conventional applications at: http://apps.carleton.edu/governance/institutional_review_board/forms/consent/
* Any recruitment notices or advertisements
* Debriefing statement in the case of research involving deception.
* Any survey instruments, psychological tests (other than standard, commercially available instruments), interview forms, or oral-interview scripts to be used in the research.
* Certificate of completion of education in the protection of human research subjects, if you have one
* Formal research protocol, if available
* Senior project proposal or grant application, if applicable
* * * * * * * *
(It should be noted that this form has been patterned after the Institutional Review Board model at Carleton College. Carleton also provides a useful manual covering ethical codes and issues and guidelines relevant for conventional applications such as those doing traditional research projects in medicine or psychology at: http://apps.carleton.edu/governance/institutional_review_board/forms/manual/)
You may also direct further questions to:
errb@coa.edu or Gray Cox, chair of the ERRB
Optional or Required? | ERRB Application Process | Useful Resources | Glossary | ERRB Policy
|
|
|
|
|
|
|
