Human Subjects Review Committee Proposal Form

Date

MonthDayYear

Experimenter

First NameLast Name

Experimenter E-mail

Experimenter Phone

Area CodePhone Number

Institution(s) Affiliated

Title

Purpose - Please include a brief description of the purpose of the study; if multiple studies are part of the proposal, describe the purpose of each.

Method - Please describe your procedures exactly, including who your participants will be and how you will recruit them. If you are using any kind of questionnaire or survey, please attach your instrument(s).

Research in which a student is the principal investigator requires close faculty supervision.

Supervising Faculty

Date Faculty Completed IRB Training

MonthDayYear

How will close faculty supervision be accomplished in this study?

Please detail exactly how you will maintain participant confidentiality - this is especially difficult on a small campus so please consider what you will do when the researcher may know the participant.

Duration - How long will data collection last?

Benefits - Please describe the benefits provided by the study both to knowledge in general and particularly to the participants.

Risks - Please describe risks, both physical and psychological to the participants in your study. Make sure to consider age-specific risks, particularly when using minors as participants.

In accordance with federal guidelines, 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 allowable categories, may be reviewed by the IRB/HSRB through the expedited review procedure. The activities listed should not be deemed to be of minimal risk simply because they are included on the list. Inclusion on the 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.

If you would like your research project to be considered for expedited review, please answer the following questions.

1. The research activities present more than minimal risk to human participants.

YesNo

2. The research is classified.

YesNo

If any of the above answers are “Yes,” the research is NOT eligible for expedited review and you may submit this form without answering further questions. If the above answers are “No,” please finish the remaining questions and then submit your proposal for review.

3. Identification of the subjects and/or their responses reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation, or be stigmatizing.

YesNo

If yes, have reasonable and appropriate protections implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal?

YesNo (If No, the research is not eligible for expedited review.)

The research must involve only procedures listed in one or more of the following categories to be exempt from further IRB/HSRB review. Select the category(ies) that apply to the research study under review. If the research is eligible for expedited review, complete the remaining portion of the checklist at the end of this form.

Expedited Category 1. Clinical studies of medical devices only when the following condition is met. (a) 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.

YesNo

Expedited Category 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 not occur more frequently than 2 times per week; or (b) from other adults and children, 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.

YesNo

Expedited Category 3. Prospective collection of biological specimens for research purposes by noninvasive means.

YesNo

Expedited Category 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.

YesNo

Expedited Category 5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research 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 CFR46.101(b)(4)]. This listing refers only to research that is not exempt.)

YesNo

Expedited Category 6. Collection of data from voice, video, digital, or image recordings made for research purposes.

YesNo

Expedited Category 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.)

YesNo

Expedited Category 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.

YesNo

Expedited Category 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.

YesNo

To complete the process for submitting your information, please send the following to Dr. Sabrina Grondhuis:

your consent and debriefing forms
any instruments or measures you will use
the Primary Investigator (PI’s) and supervising faculty ethical training confirmation

Human Subjects Ethics Training is available on Course Connect.
After logging into Course Connect, access the training with the enrollment key Research (case-sensitive).

Procedures to Maintain Confidentiality and Anonymity