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IRB Form 2

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Application for Review of Human Subjects Research at Swarthmore College

Before performing Human Subjects Research at Swarthmore you must read and understand Swarthmore's Guidelines for Human Subjects Research.

Please submit 2 copies of the following to the Human Protections Administrator

• A copy of this document with the information about the principal investigator and research project  filled out and the check lists completed.
• A brief description of your research project.
• A description of the aspects of the research involving Human Subjects.
• A copy of any consent forms.  These forms must have an expiration date of no more than one year from the beginning of the project.

If the project goes on for more than one year, a new application must be submitted.

If this is student research it requires a faculty or staff sponsor.

Complete the following checklists to determine if you believe that your research should qualify for expedited review:  

This research does qualify for expedited review ____

This research does not qualify for expedited review ____

Part A (all items must apply) Put a check mark near all items that apply to your research.

__ 1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.

__ 2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.

__ 3. The research does not involve the collection of information regarding sensitive aspects ofthe subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

__ 4. The procedures of this research present no more than minimal risk to the subject. ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) 

Part B (at least one item should apply) Put a check mark near all items that apply to your research.

__ 1. Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected prior to the research for a purpose other than the proposed research. [NB: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]

__ 2. Collection of data through use of the following procedures: a) non-invasive procedures routinely employed in clinical practice and not involving exposure to electromagnetic exposure to electromagnetic radiation outside the visible range (i.e., not involving x-rays, microwaves, etc); b) 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; c) weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler blood flow, and echocardiography; d) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing involving healthy subjects.

__ 3. Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

__ 4. Research on individual or group characteristics or behavior (including but not limited to research involving perception, cognition, surveys, interviews, and focus groups) as follows:

a) Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation;

b) Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members.

__ 5. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. [NB: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]

__ 6. Research that involves deception. [NB: Deception must be scientifically justified and de-briefing procedures must be outlined in detail.]

__ 7. Prospective collection for research purposes of biological specimens; research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.

__ 8. Research previously approved by the 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 the research remains active only for the purposes of data analysis; or (c) where the IRB has determined that the research involves no greater than minimal risk and and no additional risks have been identified; (d) where no subjects have been enrolled and no additional risks have been identified.

If ANY of these apply.  Put a check mark near all items that apply to your research.

__ 1. The research involves prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects. 

__ 2. The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

__ 3. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).

__ 4. The procedures of the research involve more than minimal risk to the subject (where "more than minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).

__ 5. Any research which does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status. 

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