Any research involving human subjects (this includes any and all surveys) is subject to review by the Wilmington College Institutional Review Board (IRB). Applications should be filed in the Office of Academic Affairs. The Academic Dean/Dean of the Faculty serves as the clerk of the IRB.
The Public Health Service Act (Title IV, Part G, Section 491 a) required the Department of Health and Human Services (DHHS) to issue regulations for the protection of subjects of research and to implement a program of instruction and guidance in ethical issues associated with such research. The regulations are codified as Title 45 Part 46 of the Code of Federal Regulations, Protection of Human Subjects (45 CFR 46), issued on June 18, 1991.
To address these regulations most colleges and universities have formed Institutional Review Boards (IRB's) or Human Subjects Review Boards (HSRB's) to review prospective research. Wilmington College needs to establish such a Board to comply with federal regulations.
Membership:
An IRB should have at least five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB members need to be sufficiently qualified through experience and expertise to promote respect for their advice and counsel in protecting the rights and welfare of human subjects. Consideration should be given to balance in terms of race, gender, cultural backgrounds, and sensitivity to community attitudes. Someone needs to be familiar with (or able to become familiar with) institutional commitments and applicable law. If campus research regularly involves children, prisoners, handicapped persons, pregnant women or mentally disabled persons, then a member of the IRB should be knowledgeable about and experienced in working with these groups.
The full committee is not used for exempted and expedited reviews (described later). In other cases, a majority of the membership must be present for a review and at least one person whose concerns are not primarily scientific should be present.
RESEARCH AND INSTITUTIONAL REVIEW AT WILMINGTON COLLEGE
- Exempted Review
Most research projects conducted at Wilmington College will be eligible for exempted review (which means they do not need review). Research that meets all the following criteria is exempt from review. If your project is exempt, a short description of the project should be filed with the committee. The description should clearly state that all criteria for exemption are met by the project. Class projects (even if there are individual variations by student or group) may be filed as a single project by the professor if all meet the criteria.
The description will be reviewed by the Clerk of the IRB or his/her designee within 2 working days. If all conditions are met, the research will be approved. Appendix A of this document is a copy of the “Request for Exempted Review” form.
CRITERIA FOR EXEMPTION- Research is conducted in an established or commonly accepted educational setting and involves normal educational practices. Examples include research on regular and special educational strategies or research on the effectiveness or the comparison among institutional techniques, curricula, or classroom management methods.
- Research involves use of educational tests, survey procedures, interview procedures or observation of public behavior and subjects cannot be identified individually, directly or through identifiers linked to the subjects. Disclosure of the human subject’s responses outside of the research cannot reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, or reputation.
- Research involves the use of educational tests, survey procedures, interview procedures or observation of public behavior not exempt under b. It is still exempt if the human subjects are elected or appointed officials or candidates for public office or if federal statutes require that confidentiality be maintained throughout the research and thereafter.
- Research involves collection or study of existing data, documents, records, pathological specimens or diagnostic specimens as long as subjects cannot be identified directly or through identifiers linked to the subjects.
- Research or demonstration projects which are conducted by or subject to approval of Department or Agency heads and which are designed to study, evaluate, or otherwise examine: a) public benefit or service programs, b) procedures for obtaining benefits or services under those programs, c) possible changes in or alternatives to those programs or procedures, or d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies: a) if wholesome foods without additives are consumed, or b) if a food is consumed that contains an ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
- The College has the right to further restrict research. Further restrictions will require committee approval and must be reexamined if questioned by a member of the College community.
- Expedited Review
Types of research that present only minimal risk to participants are eligible for expedited review. Criteria are given below. A list of materials that should be submitted for research in this category is also given below. The materials need to be reviewed by at least two members of the IRB. Approval of projects for expedited review should not require more than one week. Appendix B of this document is a copy of the “Request for Expedited Review” form.
CRITERIA- Research involves collections of hair, nail clippings, dental plaque and/or calculus, or teeth in a non-disfiguring manner, or bodily secretions.
- Research can involve collection of small (less than 450 ml. over an eight-week period and less than 2 samples per week) amounts of blood by venipuncture from subjects 18 years of age or older who are in good health and not pregnant.
- Research involves speech recordings made for research purposes such as the investigation of speech defects.
- Research involves moderate exercise by healthy volunteers.
- Study may involve use of existing data, documents, records, pathological specimens, or diagnostic specimens with possible identification of participant.
- Research may involve looking at individual or group behavior where the investigator does not manipulate subject’s behavior and the research will not involve stress to subjects.
- Research may involve work with drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
- Research must meet all the criteria.
- Full Review
A full review requires a majority of committee members, one of which must be a committee member whose concerns are not primarily scientific. Because of the need to call a meeting with up to three members present, this type of review may take several weeks. If your research does not fit all the criteria for either exempted or expedited review, you must request full review. An application for this type of review is in Appendix C of this document and needs to be submitted to the IRB.
- Other points to consider
If any part of your research is taking place at another facility, you will need to make sure that you have complied with that facilities IRB regulations as well as Wilmington College’s. In some cases, they will accept our approval if you provide written documentation. Wilmington College will approve projects approved by other organizations.
The Department of Health and Human Services has additional regulations for research involving children as subjects. If your research will involve children, please check the regulations to ensure that you are in compliance. The Clerk of the IRB should be able to assist you in interpretation of the regulations.
APPENDIX A
Request for Exempted Review Institutional Review Board
- Name of person submitting request
- Provide a short description of your project. (Attach)
- Verify that your project (or projects if class projects are being filed as one request) meets the following criteria by placing a check or N/A (not applicable) in the space when criterion is met or does not apply.
- The research will be conducted in an established or commonly accepted educational setting and involves normal educational practices.
- Any research that involves the use of educational tests, survey procedures, interview procedures or observation of public behavior and subjects is being conducted in such a way that individual cannot be identified.
- Disclosure of any human subject responses outside of the research cannot reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, or reputation.
- Research involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior not exempt under b. Research being conducted by the survey uses human subjects that are elected or appointed officials or candidates for public office or involves a situation for which federal statutes require that confidentiality be maintained throughout the research and thereafter.
- Any collection or study of existing data, documents, records, pathological specimens or diagnostic specimens is being done in such a way that subjects cannot be identified directly or through identifiers linked to the subjects.
- Research or demonstration projects which are conducted by or subject to approval of Department or Agency heads and which are designed to study, evaluate, or otherwise examine: a) public benefit or service programs, b) procedures for obtaining benefits or services under those programs, c) possible changes in or alternatives to those programs or procedures, or d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies: a) if wholesome foods without additives are consumed, or b) if a food is consumed that contains an ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
APPENDIX B
Request For Expedited Review
- Name of person submitting request
- Title of research
- Time frame for the research:
- Provide detailed description of the research with primary emphasis on the role of human subjects.
- Check any of the following criteria that pertain to your study. Indicate which criteria are not applicable to your study. (Note: If any criterion remains unchecked or is not marked N/A, then a full review needs to be requested instead of an expedited review.)
- Research involves collection of hair, nail clippings, dental plaque and/or calculus, or teeth in a non-disfiguring manner, or bodily secretions.
- Research involves collection of small (less than 450 ml. over an eight-week period and less than 2 samples per week) amounts of blood by venipuncture from subjects 18 years of age or older who are in good health and not pregnant.
- Research involves speech recordings made for research purposes such as the investigation of speech defects.
- Research involves moderate exercise by healthy volunteers.
- Study involves use of existing data, documents, records, pathological specimens, or diagnostic specimens with possible identification of participant.
- Research involves looking at individual or group behavior where the investigator does not manipulate subject’s behavior and the research will not involve stress to subjects.
- Research involves work with drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
- Attach a sample of the informed consent form that will be used with the research (samples can be found in Appendix D).
APPENDIX C
Full Review
APPLICATION FOR USE OF HUMAN SUBJECTS IN RESEARCH
Respond to each of the following items or questions. Provide enough detail so the reviewers will be able to judge how well your study protects human subjects. Your responses must be preceded by the exact question and typed in the original order. Normally, your response should not exceed five pages.
If any item listed below is NOT APPLICABLE for your study, type N/A beside the item number instead of leaving the item blank.
- Provide a brief description of the proposed study (i.e., purpose or problem to be investigated).
- What are your qualifications for conducting the study? (i.e., what is your experience with the procedures and instrumentation to be used in this study? If a student, what is your status, and which faculty member will supervise your research and what are his/her qualifications?)
- What are the requirements for and characteristics of the subject population? (i.e., what gender, age range, health or medical status, prisoners, institutionalized, adults, mentally handicapped, etc.)
- How will subjects be sampled, recruited, or otherwise enlisted as participants in the study?
- Describe in detail the methodology of your study. (i.e., how will the study be conducted from start to finish as far as human subjects are concerned? Be specific about the methods, instrumentation, and types of data collected, etc.)
- Describe the personnel, materials/equipment, or other resource requirements for the study. (Identify all personnel involved in the study, their role, their qualifications, and their access to the data.)
- How will you obtain the informed consent of the subjects? (i.e., how, where, and when will the study be explained to subjects? How will subjects indicate their consent?)
- What are the potential risks to the subjects, and what is the likelihood and seriousness of these risks? (Risks could be physical, psychological, social, legal, etc. and may result from your experimental procedures, or your methods of obtaining, handling, or reporting data.) Submit Electrical Equipment Safety Check form (Appendix E) if applicable.
- As applicable, for each risk identified in #8, describe other methods that were considered to reduce or eliminate these risks, and explain why they will not be used.
- What are the potential benefits to the individual subjects and/or society as a whole as a result of the proposed research?
- As applicable, describe how you will minimize or protect against potential risks to subjects throughout the study. (Describe emergency procedures, confidentiality safeguards, debriefing procedures, security measures for storing data, etc.)
- As applicable, provide the names and addresses of experts in your field (not including the investigators) with whom the committee members could communicate to discuss the potential risks of your procedures.
- If appropriate, provide references to any published materials that would help the committee make a judgment regarding your procedures for safeguarding the rights and safety of your subjects.
APPENDIX D
Sample Informed Consent Forms
Some sections may not apply to all projects and may be deleted as appropriate. When a signed consent document is used, a copy must be provided to subjects so each will have a record of their agreement to participate.
A written explanation of the study, which the subject may retain, is usually required for all studies, since it is considered to be an integral part of the process for obtaining informed consent. The investigator(s) should use an informed consent form that includes an explanation of the study at the beginning of the document. This format is preferred because it is more clear and concise than using a separate explanation of study and informed consent form. In those cases, for which a signed informed consent document will not be used (such as a mailed questionnaire study), the investigator(s) still must provide an explanation of the study and inform subjects of their rights. Usually this information is provided in a cover letter which accompanies the questionnaire and which the subject may retain.
Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all those facts, risks, and discomforts which might be expected to influence an individual's decision to willingly participate as a volunteer in a study.
Information required in your explanation is listed below. This information should include a "fair" explanation of procedures in language easily understood by lay people. If you are using a signed informed consent document, inform the subjects that these documents will be sealed in envelopes and stored permanently by the College.
Informed Consent Form Title of Investigation:
Investigator(s): (List faculty and students)
Purpose of Study: In situations where it is not possible to fully disclose the purpose of a study, the following statement is optional: "Because the validity of the results could be affected if the purpose of the study is fully divulged to me prior to my participation, I understand that the purpose of the study cannot be explained to me at this time. I understand that I will have an opportunity to receive a complete explanation of the study's purpose following my participation in the study."
Procedures: Tell subjects what will be expected of them and what they will be asked to do; what data will be collected and how it will be used; how confidentiality will be maintained, how the subjects (or you) may terminate their participation, etc.
Discomforts and Risks:
Alternate Procedures (if any): A disclosure of any appropriate alternative procedures that might be advantageous for the subject.
Potential Benefits: Of the investigation to the subject, or to society. In many investigations, direct benefits for the subjects may not exist.
Period of Time Required:
Contact Person: Invite the subject to contact you or another appropriate person if they have any questions, problems, or concerns about the study. Give the name, title, address, and phone number of the contact person.
Informed Consent Long Form
This is to certify that I, ______________________________, hereby agree to (give permission to have my child or legal dependent) participate as volunteer in a scientific investigation as an authorized part of the education and research program of Wilmington College under the supervision of .
The investigation and my part in the investigation (my child's or legal dependent's part in the investigation) have been defined and fully explained to me by the investigator(s), and I understand this explanation. A copy of the procedures of this investigation and a description of any risks and discomforts has been provided to me and has been discussed in detail with me.
I have been given an opportunity to ask whatever questions I may have had, and all such questions and inquiries have been answered to my satisfaction.
I understand that I am free to deny any answers to specific items or questions in interviews or medical history questionnaires.
I understand that any data or answers to questions will remain confidential with regard to my identity (my child's or legal dependent's identity).
I understand that, in the event of injury resulting from this investigation, neither financial compensation nor free medical treatment is provided for such an injury. (This statement is required for projects classified in either the expedited or full review category.)
I certify that to the best of my knowledge and belief, I have fully disclosed (my child or legal dependent has) any physical illness (or mental illness) or weakness that would increase the risk to me (him or her) from participation in this investigation. (This statement is required for projects classified in either the expedited or full review category.)
I further understand that i am free to withdraw my consent and terminate my (my child's or legal dependent's) participation at any time.
- Date ______________________________
- Date of Birth ______________________________
- Subject's Signature ______________________________
I hereby consent to the participation of ______________________________, my legal dependent, as a subject in the scientific investigation described. (This statement is required if minors or other legal dependents are involved in your investigation)
- Date ______________________________
- Signature of subject's parent or guardian ______________________________
I, the undersigned, have defined and fully explained the investigation to the above subject.
- Date ______________________________
- Investigator's Signature ______________________________
I was present when the study was explained to the subject(s) in detail and to my best knowledge and belief it was understood. (This statement is required for projects classified in either the expedited or full review category.)
- Date ______________________________
- Witness ______________________________
CONSENT FOR PHOTOGRAPHIC OR VOICE RECORDING
This is to certify that I, ______________________________, hereby give permission to (check all that apply):
- Photograph my (describe)
- Record my voice as an authorized part of the education and research program of Wilmington College.
I understand that permission to photograph includes any method of producing a visual image including still cameras, movie cameras or video cameras. Voice recordings may include conventional audiotaping or videotaping. I understand that all photographs or voice recordings will remain strictly confidential with regard to my name. Also, I understand that any photograph or voice recording may be used for research, classroom teaching, presentation at professional meetings, or publication in professional journals and books unless specified otherwise.
I have been given an opportunity to ask whatever questions I may have had, and all such questions and inquiries have been answered to my satisfaction. A copy of this form has been provided to me and has been discussed in detail with me.
I further understand that i am free to withdraw my consent for photographic or voice recording at any time prior to completion of the recording. After the recording, i may request that any individually recognizable photographic or voice recording not be shared with anyone but the investigator(s).
- Date ______________________________
- Date of Birth ______________________________
- Subject's Signature ______________________________
I hereby consent to the participation of ______________________________, my legal dependent, as a subject for photographic or voice recording. (This statement is required if minors or other legal dependents are involved)
- Date ______________________________
- Signature of Subject's Parent or Guardian ______________________________
I, the undersigned, have defined and fully explained the purpose of the photographic or voice recording to the subject.
- Date ______________________________
- Investigator's Signature ______________________________
I was present when the purpose of the photographic or voice recording was explained to the subject in detail and to my best knowledge and belief it was understood.
- Date ______________________________
- Witness ______________________________
APPENDIX E
This is a sample document that should be retyped on the letterhead of the company performing the electrical equipment safety check. A signed original of the memorandum must be sent to the compliance coordinator.
ELECTRICAL EQUIPMENT SAFETY CHECK MEMORANDUM DATE:
TO: IRB, Wilmington College
FROM: Technician’s Full Name
Name of Company
SUBJECT: Electrical safety check for research protocol <Insert Project Title>
I ______________________________, have inspected the items listed below and determined them to be electrically safe for use with human subjects.
- DESCRIPTION OF ITEM
- INSPECTION DATE
- REINSPECTION DATE