RISKS TO SUBJECTS ARE MININMIZED
Researchers are asked ensure that the potential research-related risks to research subjects are minimized. That is, if there are any risks involved in participating in the research, the researcher should take all reasonable steps to minimize those risks. Risks include physical risks (such as the possibility of having an allergic reaction), psychological risks (such as the possibility emotional distress), social risks (such as the possibility of embarrassment or ridicule by peers), legal risks (such as the possibility of being sued because of information shared with the researcher), and economic risks (such as the possibility of being fired from one’s job for sharing information with the researcher).
RISK/BENEFIT RELATIONSHIP
Researchers should demonstrate that the risks to the subject are reasonable relative to the anticipated benefits to the subject, and relative to the importance of the knowledge that may be reasonably expected to result. That is, if the research has minimal benefits to the subject and to society, then it should have only minimal risks. Higher risk-levels are acceptable only when there are greater potential benefits (such as in cancer research).
SELECTION OF SUBJECTS
Researchers should take steps to make the selection of subjects as equitable as possible. That is, researchers should take steps to ensure that people of a certain gender, race, religion, economic classes, etc., are not systematically excluded or included as research subjects, without research related reasons. The committee is to ensure that the selection of subjects is fair, so that one group of people does not undergo an unfair portion of the risks or benefits of the research. Clearly, no selection of subjects will be perfectly equitable (with representatives from every ethnicity, age-group, economic class, etc). Thus, researchers are only required to show that they have taken steps to increase the diversity of their research subjects and to minimize inequities.
CONFIDENTIALITY
Researchers need to show that they have a clear plan for how they will protect the confidentiality of the subjects, where appropriate. If names will be connected to the data in any way (including on informed consent forms), researchers should take steps to protect the confidentiality of subjects. One way to do this is to create a “key” linking names to letters or numbers. The researcher should replace names with the letter or number on data that will be made public. The key, or any other paperwork connecting names with data should be placed somewhere secure, such as a locked file cabinet. The exact procedures for confidentiality should be explained clearly to the research subjects.
INFORMED CONSENT
Researchers need to show that they will seek informed consent for each prospective subject. That is, researchers need to make sure adequate explanation of the research process, including the potential risks and benefits, are given to the subjects and that, with that information, the subject freely consent to participating in the research. Usually, though not necessarily, this is demonstrated by preparing a written informed consent form.
Researchers should demonstrate that attention has been paid to special problems that may arise when research involves vulnerable populations, such as children, pregnant women, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons.
The IRB would like to emphasize that this is not a complete or even uncontroversial list of ethical issues involved in research on human subjects. Rather, it is intended as a starting point for discussion. The IRB would like to act, not as an ethical dictator, but as a facilitator of a campus-wide conversation about research ethics.
The Off ice of Human Subjects Research at the National Institutes for Health has an online program on the protection of human subjects of research (a valuable two-hour tutorial). Go to http://phrp.nihtraining.com/index.php
Categories of Research that May be Reviewed by the Institutional Review Board (IRB)
Through an Expedited Review Process
(referenced at 45 CFR 46.110), Revised 6/23/05
Applicability
(A) Research activities that
(1) present no more than minimal risk to human subjects, and
(2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of reviewexpedited or conveneutilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB review
Research Categories
1. Clinical studies of drugs and medical devices only when condition
(a) or (b) is met. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may no occur more frequently than 2 times per week; or
(b) From other adults and children1[1] [LB1] considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples:
(a) hair and nail clippings in a nondisfiguring manner;
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
(c) permanent teeth if routine patient care indicates a need for extraction;
(d) excreta and external secretions (including sweat);
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
(f) placenta removed at delivery;
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
(j) sputum collected after saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical devise are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples:
(a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
(b) weighing or testing sensory acuity;
(c) magnetic resonance imaging;
(d) electrocardiography; electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
(e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a). In Colorado a child is under age 18.
Click here to download and save a blank application to complete and submit. This should be submitted as an attachment to IRB@fortlewis.edu by the PRIMARY INVESTIGATOR (faculty). A complete and thorough application expedites the process!
Fort Lewis College Institutional Review Board
Application to Use Human Subjects in Research
{Click here to download and save a blank application to complete and submit.}
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I believe this research qualifies for a : Full Review ________ Expedited Review - Category_____ (see page 5)
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Research Project Title
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Principal Investigator (must be a faculty member):
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Department:
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Telephone: |
E-mail: |
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Brief description of PI’s background relevant to research (particularly with regard to specialized procedures):
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Co-Principal Investigator (student researcher):
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Department:
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Telephone: |
E-mail: |
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Date project activity to begin:
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Site of Research:
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Other Institutions/Non-Institutional Investigators (describe collaboration or use of records):
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Will this project be supported by funds? ? Yes ? No Funding Agency:
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As the investigator submitting this proposed research and signing below, I agree to conduct the research involving human subjects as presented in the protocol or modifications to it and as approved by the Department and the Institutional Review Board; to obtain and document informed consent and provide a copy of the consent form to each subject unless this is waived by the IRB; to present any proposed modifications in the research to the IRB for review and approval prior to implementation; to retain records for the mandated lengths of time; and to report to the IRB any problems or injuries to subjects.
PI Signature: _________________________________________Date: ____________
Co-PI Signature: _______________________________________ Date: _____________
Please type your answers to the questions directly below the questions. Please enter your answers in bold, a different font or color in order to make reading your application easier
- 1. Succinctly (in approximately fifty words or less) describe the purpose and methods of the research. Include a brief description of all procedures to be conducted and any instruments (surveys, etc) that will be used. If you are submitting a FULL REVIEW Application please attach a full proposal. No full review will be considered without the complete proposal.
- 2. Describe the risks and benefits this research has for research subjects (include physical, psychological, social, legal and economic risks). If there appears to be no risks, write “no known risks.” Describe any measures taken to minimize risks. Explain how the risks are reasonable relative to the benefits. See page 3 of this application packet for further explanation of what the IRB is seeking with this question.
- 3. Describe if and how confidentiality will be maintained. (Be specific: Will names be attached to the data in any form? How will the data with names be stored?) See page 3 of this application packet for a full explanation of how the IRB considers the role of confidentiality in reviewing your research.
- 4. What are the characteristics of the subjects you are choosing? Offer some justification for selecting subjects with these characteristics.
- 5. A selection of subjects is equitable if it does not systematically exclude or include people of a certain gender, race, age, religion, economic class or educational level, etc. See page 3 of this application packet for a full discussion of equitable selection of subjects. Although the selection of subjects will never be perfectly equitable given the parameters of experimental design, explain what steps you will take to increase the diversity of the subjects and to minimize inequities. Describe your recruitment procedures (use of flyers, newspaper advertisements, etc.) and explain how these procedures will help to increase diversity.
- 6. Do research subjects include any of following: minors, incarcerated persons ), in vitro Fertilization, fetuses/fetal tissue, economically/educational disadvantaged, pregnant women, persons unable to give valid informed consent due to physical or mental condition, or does it target specific ethnic/cultural groups? If any of the vulnerable categories listed above are involved, address rationale, any additional safeguards for their protection, and explain why the research is minimal risk for those subjects.
- 7. Will subjects be compensated? How?
- 8. Will a written informed consent form be used and signed by participants?
- a. If yes, attach the informed consent form (see below)
- b. If no, explain how the research meets each of the following criteria such that the research qualifies for a waiver of informed consent:
- i. Research involves no more than minimal risk to subjects;
- ii. Waiver will not adversely affect the rights and welfare of subjects;
- iii. Research could not be conducted practicably without the waiver or alteration; and
- iv. Subjects will be provided with pertinent information in some other format.
Basic Elements of Informed Consent (from 45 CFR 46.116)
In seeking informed consent, the following information shall be provided to each subject:
- (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject. (NOTE: This includes any information about procedures that might make a subject hesitant to participate.)
- (3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
- (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
- (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
- (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
- (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Click here to download and save a blank template (if necessary). This should be submitted as an attachment to IRB@fortlewis.edu by the PRIMARY INVESTIGATOR (faculty). A complete and thorough application expedites the process!
FORT LEWIS COLLEGE INFORMED CONSENT TO PARTICIPATE IN A RESEARCH PROJECT
[You are encouraged to model your consent form after this consent form. If you choose not to use this format, your consent form must at a minimum include the same elements as this model. Before using this model, delete all text in brackets. Consent documents should be written in simple language and address directly to the participant (in second person), so that they may be understood easily by people with all levels of education]
TITLE OF PROJECT:
NAME OF PRINCIPAL INVESTIGATOR: [Faculty Member, if this is a student research project]
NAME OF CO-INVESTIGATOR: [Student, if this is a student research project]
CONTACT NAME AND PHONE NUMBER FOR QUESTIONS\PROBLEMS ABOUT RESEARCH:
CONTACT NAME AND PHONE NUMBER FOR QUESTIONS\PROBLEMS ABOUT RESEARCH-RELATED HEALTH PROBLEMS:
CONTACT NAME AND PHONE NUMBER FOR QUESTIONS\PROBLEMS ABOUT PARTICIPANT RIGHTS OR ETHICAL CONSIDERATIONS: [IRB representative: Mary Ann Erickson 247-7694]
SPONSOR OF THE PROJECT: [FUNDING AGENCY OR COMPANY]
PURPOSE OF THE RESEARCH [Explain that the study involves research and describe its purpose]
PROCEDURES/METHODS TO BE USED: [Use lay language so participants clearly understand how the study will be conducted and what will be expected of them. Explain the techniques and procedures that participants will experience. Identify and describe any experimental or non-standard procedures, methods, drugs, or devices. Tell them if they will be videotaped or audiotaped.]
RISKS INHERENT IN THE PROCDURES [Describe any reasonably foreseeable risks of discomforts to the participants. Include any physical, psychological, social, economic, or legal risks. If the research involves physical risks, include a statement informing the subject that if she is or may become pregnant, the particular research may involve risks to the subject or embryo, which are currently unforeseeable. State “There are no known risks” if there are none. ALSO include the following statement: It is not possible to identify all potential risks in an experimental procedure, but the researcher(s) have taken reasonable safeguards to minimize any known and potential, but unknown risks.]
BENEFITS [Describe any benefits to the participants or to others that may reasonably be expected for the research. Monetary compensation should not be categorized as a benefit.]
ALTERNATIVE PROCEDURES: [If relevant, inform the participant of any alternative ways to achieve the same benefits that may or may not involve the same risks]
COSTS/COMPENSATION: [Tell the participants if they will receive remuneration for participation and under what conditions. Inform participants of any costs to them that may result from participation in the study.]
CONFIDENTIALITY: [Describe how confidentiality or records identifying the participants will be maintained. When individual names will not be recorded except on the informed consent form, and those names will not appear on the final document, please consider using this standard statement: While one cannot ever guarantee complete confidentiality, steps will be taken to prevent anyone from associating your name with the data gathered. Your name will not appear on any of the papers on which the data are recorded, nor will it appear in the final research document. The only place your name will appear is on this signed informed consent form. The consent forms will be stored separately from the data. In addition to the researchers, the federal research regulatory bodies and the Fort Lewis College Institutional Review Board may have access to the research records.]
OTHER CONSIDERATIONS: [List any other considerations that may affect a person’s willingness to participate. Inform the participant if the investigator or sponsor has a significant financial interest in the outcome of this particular study or research. Inform the participants that there may be research procedures that conflict with the participant’s beliefs or values.]
LIABILITY: [The following statement must be included on the form:] The Colorado Governmental Immunity Act determines and may limit Fort Lewis College’s legal responsibility if an injury happens because of this study. Claims against the College must be filed within 180 days of the injury.
PARTICIPATION: [Include these paragraphs with minimal modification. Do not have signatures appear on a page without this text.]
Your participation in the research is voluntary. If you decide to participate in the study, you may withdraw your consent and stop participating at any time without penalty or loss of benefits to which you are otherwise entitled. If at some point during the research, there are new findings that may affect your willingness to participate in the study, you will be informed of those findings.
[Include a description of circumstances in which the subject’s participation may be terminated by the investigator without the subject’s consent.] Your signature acknowledges that you have read or have had read to you the information stated and willingly sign this consent form. Your signature also acknowledges that you have received, on the date signed, a copy of this document containing 2 pages.
_________________________________________________________
Participant's Name (printed)
___________________________________________ ______________
Participant's Signature and Date
___________________________________________ ______________
Investigator or co-investigator Signature and Date
Use the following block only if parental\guardian consent is required. Include the text explaining to what the parents are agreeing.
FOR MINOR
As parent of guardian you authorize_______________________________ (print name) to become a participant for the described research.
The nature and general purpose of the project have been satisfactorily explained to you by ________________________________ and you are satisfied that proper precautions will be observed.
Minor’s date of birth:
______________________________________
Parent\Guardian name (printed):
______________________________________
Parent\Guardian Signature and Date:
_____________________________________ _______________
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