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Purdue University
Committee on the Use of Human Research Subjects
Institutional Review Board (IRB)

• Expedited Review
• Full Committee Review
• Instructions for Application Form and Narrative
• Application Form

1. EXPEDITED REVIEW
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   The Application Form to use human subjects in research is available on our website under "Forms". The Application Form is to be used for protocols undergoing Expedited or Full Committee review. This information will assist you in determining which of these two reviews you should apply for.

   1. Research activities that: (a) 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 Committee 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.
   3. The categories in this list apply regardless of the age of the subjects, except as noted.
   4. 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.
   5. The expedited review procedure may not be used for classified research involving human subjects.
   6. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review.
   EXPEDITED CATEGORIES:

   Items 1-7 below are the categories for which research may qualify for expedited review. STUDIES INVOLVING PRISONERS OR INDIVIDUALS UNDER THE JURISDICTION OF THE CRIMINAL JUSTICE SYSTEM AS SUBJECTS WILL NOT BE ACCEPTED FOR EXPEDITED REVIEW
   

   1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      1. 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).
      2. 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:
      1. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts withdrawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week;
      2. 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.
   3. Prospective collection of biological specimens for research purposes by noninvasive means. Some examples are:
      1. Hair and nail clippings in a nondisfiguring manner;
      2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
      3. Permanent teeth if routine patient care indicates a need for extraction;
      4. Excreta and external secretions (including sweat);
      5. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax by applying a dilute citric solution to the tongue;
      6. Placenta removed at delivery;
      7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
      8. 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;
      9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
      10. 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. Some examples are:
      1. 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;
      2. Weighing or testing sensory acuity;
      3. Magnetic resonance imaging;
      4. Electrocardiography, electroencephalography, thermography detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
      5. Moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.

      However, studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

   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 Exempt.
2. FULL COMMITTEE REVIEW
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   Research which does not qualify for Exempt or Expedited Review must be reviewed by the Full Committee at its monthly meeting. This includes research that involves more than minimal risk; is not listed in the regulations as qualifying for exempt or expedited review; and any research which involves fetuses, pregnant women, prisoners, or groups who may have diminished capacity to provide consent or who may be at high risk.

3. INSTRUCTIONS FOR APPLICATION FORM AND NARRATIVE
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   The Application Form to use human subjects in research is available on our website under "Forms". The same forms are completed for Expedited and Full Review. If the investigator requests Expedited Review and the Committee reviewers determine that the protocol requires Full Review, the application will be referred to Full Review. This document includes line-by-line instructions for completing the Application Form and Narrative.

   Application Form for Expedited and Full Committee Review

   1. Project Title. Please use the project title that is used in the application for funding. Please remain consistent in your use of the project title. A future change in the project title will require a completed Revision Form.
   2. Type of Review. Please mark if you are requesting Full Review or Expedited Review. You can determine which type of review your application requires by reading the Expedited Review Categories.
   3. Funding Source. All sources of funding should be listed. Please note whether funding is pending. If you have submitted a federal grant application for Federal funding for this project, a copy of the grant application must be attached to the original of the submitted application.
   4. Principal Investigators. The principal investigator (PI) must be a Purdue faculty member or investigator authorized by the Vice Provost for Research. For further information about being an authorized PI, please see Policy on Eligibility to Serve as a Principal Investigator for Research Involving Human Subjects. Please provide the PI's name, position with the University, Department, Campus address and telephone, fax, and e-mail address. Much of the Committee's contact with the PI will be through e-mail. As such, it is important that the information be legible.
   5. Other Personnel. Please list and provide title and contact information for all collaborators, visiting investigators, graduate students, and other investigators who are participating in this research.
   6. Principal Investigator Signature. By signing the Application Form the PI attests that s/he agrees to conduct the project as described in the application and adhere to the Committee's reporting requirements regarding project changes, unanticipated problems, risks and termination of her/his association with the University. The investigator also attests s/he has access to the Committee's Federal-Wide Assurance (FWA) and federal regulations and reports.
   7. Department Head's Signature. The signature of the PI's Department Head indicates s/he has read and approved the application. Additionally, s/he will maintain the project records for three (3) years upon completion of the project if the investigator terminates her/his University association.
   8. Project Location. Please disclose the location(s) where the research will be conducted. This specifically refers to data collection. If the data collection is taking place at another institution with their own IRB, the Committee requires investigators obtain review from the other institution first before submitting the application to our office. In these cases, be certain to submit a copy of the other institution's IRB approval with your application.
   9. Subject Types. Investigators must indicate the types of subjects to be recruited. Of the listed options, please check all that apply to your research project. "Normal Volunteers" refers to adults 18 - 65 years old who are not institutionalized, prisoners, under the jurisdiction of the court system, disabled and/or incapable of giving consent.
   10. Investigational New Drug. You must indicate if your project includes the use of a pharmaceutical that is classified as an Investigational New Drug (IND) by the Food and Drug Administration (FDA) or if the project includes the use of a drug for which it has not been approved by the Food and Drug Administration (FDA). If this is the case please state the name of the drug, the IND number and company manufacturing the drug. Any application using an IND must be reviewed by the Full Committee.
   11. Investigational Medical Device. You must indicate if your project includes the use of a pharmaceutical that is classified as an Investigational Medical Device (IMD) by the Food and Drug Administration (FDA) or if the project includes the use of a device for which it has not been approved by the Food and Drug Administration (FDA). If this is the case please state the name of the device, the IMD number and company manufacturing the device. Any application using an IMD must be reviewed by the Full Committee.
   12. Radiation and Radioisotopes. If the application uses radiation or radioisotopes in any form, the application will be reviewed by the Full Committee. Additionally, the application will be reviewed by Radiological and Environmental Management and/or the Radiation Safety Officer
   13. Additional Issues. Various issues help us determine the type of review that the application requires. For example, applications wishing to waive informed consent requirements or using VO2 Max testing will require Full Committee review. Answer this section by indicating all items that apply to your application.
   14. Copies. For investigators requesting Expedited Review, submit the original application (Application Form plus Application Narrative with all supporting documents). An investigator requesting Full Review should submit the original application PLUS nineteen (19) complete copies.
   Application Narrative for Expedited and Full Review.

   The Committee is responsible for assuring that appropriate safeguards exist to protect the rights and welfare of human research subjects. The Committee relies on your Application Narrative in executing this responsibility. Incomplete narrative sections will delay the Committee's review of your Application.

   Your Application Narrative should include all of the following sections, clearly marked and titled. Page numbers should also be included.

   1. Proposed Research Rationale (one page or less)
      Please state why you wish to do the proposed research. Include your hypothesis, if any, and the contribution the study is expected to offer to a generalized body of knowledge.
   2. Specific Procedures to be Followed
      This section should stand on its own, without reference to appendices, grant applications, or articles in press or published. It must set out clearly, and completely, in two or less pages, the design of the study and the protocol for implementing the research. The Committee carefully reviews this section of the application to determine the potential risks to subjects. Because members of the Committee may be unfamiliar with your study area, please describe procedures in a manner that can be easily understood by persons unfamiliar with your field.
   3. Subjects to be Employed
      Set forth the criteria for inclusion and exclusion of subjects for the proposed study. Your study may require that subjects possess particular characteristics, such as physical fitness, particular health status, race, sex, age, or personal experience. This section should describe the qualities that are required to be a subject in your study, and what steps, if any, you will take to ensure that these characteristics are present in the subjects.

      If you are using restricted or special populations, please state why.

      Federal regulations require that selection of subjects be equitable across gender, racial and ethnic groups, and the Committee is required to assess this. Minorities and women are to be included in all human subjects research so that findings can benefit all. Convincing rationale must be presented to justify the exclusion of specific groups.

      Children are to be included in research unless it is inappropriate. Children may be excluded from human subject research when there are scientific or ethical reasons for doing so. The following are justifications for excluding children:

      • Research topic is irrelevant to children,
      • Laws or regulations bar the inclusion of children in the research,
      • Knowledge being sought in the research is already available for children or will be obtained from another ongoing study and an additional study will be redundant,
      • A separate, age-specific study in children is warranted and preferable,
      • Insufficient data are available in adults to judge potential risk in children,
      • Study designs aimed at collecting additional data on pre-enrolled adult study participants, or
      • Other special cases justified by the investigator and found acceptable to the Committee.
      The Committee will assess the proposed subject population to determine if:
      • The subject population is appropriate,
      • Minority and ethnic representation is planned, if appropriate, and
      • There is a balance between those who will reap the benefits of the research and those who carry the burden of the research. It would be inappropriate to target one sub-group for a study that would benefit the wider population. The ethical concern is that one group cannot share a greater percent of the burden than is appropriate.
      Additionally, please describe the criteria the investigator will use to terminate a subject's participation in the study. For example, an adverse reaction to some aspect of the protocol or failure to comply with stated activities would be appropriate criteria for terminating a subject's participation. Please remember that the participation of each subject is voluntary, and s/he can halt participation in the study at any time.
   4. Recruitment of Subjects

      Please explain how, where, and by whom subjects will be recruited. Attach all recruitment materials (letters, advertisements, etc.) to this application.

      Things to consider in recruitment practices:

      1. How will you be contacting potential subjects?
      2. Is the confidentiality and privacy of the potential subjects protected?

         When soliciting potential subjects through a third party (e.g., a physician releasing names of patients to a researcher), the procedures should be carefully reviewed to protect the potential subjects' privacy and ensure that participation is voluntary (free of coercion).

      3. Who will be doing the recruitment and are they trained in human subject protection?

         The principal investigator is responsible for ensuring that all parties who assist with recruitment follow approved procedures and that no undue pressure is applied on individuals to participate.

      4. Advertisements for Subjects

         Recruitment of subjects is part of the Informed Consent process and must be reviewed by the Committee. Additionally, advertisements and solicitation letters must be reviewed by the Committee. Subject recruitment and advertising may NOT be initiated prior to review and approval by the Committee.

         If you plan to advertise for subjects, please include the following in the advertisement:

         1. The name and address of the clinical investigator;
         2. Disclosure that recruitment is for a research study;
         3. A summary of the purpose of the research and subject eligibility criteria;
         4. A simple and clear description of the risk to subjects involved in the study; and
         5. The person to contact for further information.

      5. Students as Subjects

         If you are using students as subjects, neither recruitment nor data collection may take place during class time if the activities are not actually part of the curriculum. Non-curriculum activities may occur prior to the start of class, or after class has ended, so that those students who do not choose to participate will be free to leave. Additionally, a student's grade may not be influenced by his/her participation, or lack of participation, in a study. For further information see Classroom Research.

      6. Procedures to Obtain Informed Consent

         How will informed consent be obtained? "Informed Consent" means the knowing consent of an individual or his legally authorized representative. S/he must be able to exercise the power of choice without undue inducement or any element of force, fraud, deceit, duress, constraint, or coercion. Please describe the typical circumstances for discussing the research, the consent process and obtaining the subject's permission for enrollment in the research.

         1. Capacity To Consent.
            Will any or all of the subjects lack the capacity to participate fully in the process of informed consent? If yes, describe plans for assessing the capacity to consent. People who lack the capacity to consent are considered to be vulnerable. Provisions must be made to secure consent from a legal representative.
         2. Describe What Will Be Said To The Subjects To Explain The Research. The complexity of the study will dictate the specific procedures used to explain the study. Provide an outline of how the research will be explained to potential subjects. Include any illustrations that will be used to explain the research. Will subjects be shown the experimental apparatus? Include any information that will be useful to the Committee in assessing this process. For example, approximately how much time will be spent explaining the study? Will the research be explained by one person, followed by clarification by the principal investigator? A verbatim script is required for telephone surveys.
         3. How Will Subject's Understanding Be Assessed?
            It is expected that the investigator will assess the subject's understanding of the research. What activities are planned to assess understanding? What questions will be asked to assess understanding? Formal tests of understanding are not required, but investigators are expected to establish reasonable and practical plans to verify that subjects understand what they will be doing if they volunteer to participate in the research.
   5. Procedures for Payment of Subjects
      Some projects will provide payment for subjects. The payment schedule, and the procedure for partial payment of subjects who do not complete the entire study, must be stated explicitly. If compensation is to be given to subjects, it must be reasonable and non-coercive. The Committee must approve subject compensation amounts and payment increments. Any changes to the approved compensation schedule requires a Revision of Protocol Form.

      If research subjects are paid from University funds, IRS regulations and University Policies require the University to document individuals receiving compensation. As such, investigators will provide the subjects' names and social security numbers to their business office. (See University Guidelines on Paying Human Subjects). Therefore, if research subjects are to be paid for participating, a statement must be placed in the Consent Form stating that while the information provided by the subject is confidential, the business office will document their name and social security number. Thus, the fact that the subject participated in a study is subject to the Open Records Act.

      Raffles are subject to state law. Therefore, raffles, drawings, and door prizes may not be used without the approval of the Assistant Vice Provost for Research Compliance, .

      Regarding the use of extra credit as compensation, please see the Department of Communication Research Policy on Using Extra Credit as Compensation for Participation in Research.

   6. Confidentiality
      Confidentiality and privacy are important to people. Please describe the procedures you will use to protect the subject's privacy. Include where and how records will be maintained. Be certain to include a description of how identifying information will be stored, and for how long. Also state who will have access to the data and how restricted access will be guaranteed. Please provide specific details on the procedures you plan to follow, including how and when data, tapes, etc. will be destroyed.

      If a subject's participation and/or data will not be kept confidential, please discuss why disclosure is essential to the study, and the steps you will take to gain a waiver of confidentiality by each subject. Also, please discuss any reasonable limits on confidentiality. If your study involves illegal drug use of mental health issues, your may want to consider obtaining a Certificate of Confidentiality.

      If there is a chance that information will be disclosed which must be reported, please include a statement similar to the following:

      Indiana State law requires that evidence of (1) child/elder abuse or neglect, or (2) the intent to seriously harm one's self or others, be reported to appropriate officials. Should information of this nature emerge as a result of the proposed study, authorities will be notified immediately.

   7. Potential Risks To Subjects
      Clearly explain reasonable risks that may be experienced by participants in this research. Risks can be psychological, physical, social, economic or legal. Describe in detail all precautions that will be taken to minimize risk. Precautions might include monitoring of untoward effects. Be specific and describe who, what, when, where, why and how the data will be monitored. When psychological risks are involved, describe where subjects will be referred for follow-up when needed.

      When deception is used in the research, explain how you will debrief the subject, including what subjects will be told about the research, the nature of the deception and the necessity of the deception. Correct all misinformation that was given during the research, e.g., if subjects were told the experiment was about one thing and it was actually about something else, or false feedback was given.

   8. Benefits To Be Gained By the Individual and/or Society
      Potential benefits to the subjects or society must be stated clearly. Compensation is not considered a "benefit" to a subject, but rather remuneration for a subject's time and inconvenience. If the risks are minimal, and there is demonstrated benefit to society, the research may not need to provide individual benefit to a particular research subject.
   9. Investigator's Evaluation of the Risk-Benefit Ratio
      Straightforward assessment of the risks and benefits is necessary. If the researcher ignores risks or exaggerates benefits, the protection of the human subject is not being adequately managed. In assessing the risks and benefits, consider the anticipated frequency, severity, average duration and reversibility of the possible risk.
   10. Written Informed Consent Form
       The Consent Form template must be used for competent subjects over 16-years of age. The Consent Form must be modified for youth, seriously ill, learning disabled and other special populations. The Consent Form must give the subject a clear and concise explanation of the research to be conducted, the procedures to be employed, and any foreseeable risk to the subject. It must be written in plain language appropriate for the targeted subject population, and explicitly state that participation is voluntary.

       For further details see Informed Consent.

       In the event the written informed consent is inappropriate for your study, or study population, please review Waiver of Informed Consent. If your subjects are under age 16 or not legally competent, please review the guidelines for obtaining the Assent of minors. If your subjects are non-English speakers, please provide both an English version and a foreign language version of the consent form.

   11. Supporting Documents
       Attach any letters of cooperation from other organizations, institutional review board approvals from other institutions, copies of questionnaires or tests to be given to the subjects, advertisements, etc., which support the Application. If you are applying to federal agencies for funding, provide one (1) copy of the grant application.