US Military Academy (USMA) Human Research Protection Program (HRPP)

Request for Determination instructions

Please read the instructions and the form carefully.

The form must be complete with all applicable attachments in order to be processed in a timely manner. The following guidelines are provided to help you complete the Exempt Determination form and to comply with all HRPP laws and regulations. If you have any questions, please contact Dr. Linda Mallory, EDO at or 845-938-7385.

  1. Please be thorough. In order for the EDO to make an informed decision, the PI must provide complete and comprehensive explanations of the proposed research.
  2. A complete package includes the exempt determination form, a resume or CV from the PI (or a transcript from cadet investigators); the CITI grade book results (with module quiz scores); any instrument(s) which are proposed, including surveys and interview/focus group questions; and a signed page 10.
  3. There are six categories for exemption as outlined in 32CDR219.All categories include the common requirement thatthe research poses no risk to the subjects for personal, professional, financial, or physical harm. If the research does not fall into one of the categories for exemption, the research cannot be exempted. These categories are:
  4. Evaluation, comparison, or assessment of instructional practice;
  5. Surveys, interviews, educational tests, or observation;
  6. Surveys, interviews, educational tests, or observation of public behavior of public officials or candidates for public office;
  7. Collection of existing data;
  8. Public benefit or service programs;
  9. Food quality evaluation and consumer acceptance studies
  10. The following types of research cannot be considered for exempt approval. Please refer to the EDO for an expedited or full IRB review form and instructions.
  11. Deception research;
  12. Research which is approved or unapproved FDA regulated items (including foods, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products);
  13. Research using prisoners or any incarcerated population as subjects;
  14. Research using prisoners of war as subjects;
  15. Any research which poses a personal, professional, financial, physical, or emotional risk that is greater than what the subject would encounter in routine life experiences
  16. Human research protection approval does not constitute command approval.
  17. Any research conducted on faculty/staff assigned to USMA must receive command approval for use of their time.
  18. Any research involving Cadets outside of class time must have approval from USCC.
  19. Any surveys conducted on active duty or civilians outside of USMA command including IMCOM (Garrison) or MEDDAC must have ARI approval.
  20. Contact the EDO for more information on command approvals.
  21. Active duty members (including cadets) may not be monetarily compensated for their participation in research
  22. Active duty members may receive token incentives for participation
  23. The incentives may not be sufficient to entice a subject to participate who may otherwise would not have done so, for example substantial extra time off or other big awards
  24. Subjects may withdraw from participating in research for any reason without consequence.
  25. Subjects may not be ordered, forced, coerced, or required to participate in research for any reason.
  26. “Exempt approval” means exempt from any further review (please see USMA 70-25), including continuing reviews or follow-up.
  27. Documented informed consent is not required, however subjects should be informed that the research is voluntary and the purpose and benefits of the research.
  28. For cadet research:
  29. The faculty sponsor is the principal investigator and is responsible for the conduct of the research.
  30. All cadets who will be handling the data must be listed on the protocol as associate investigators and complete appropriate CITI training.
  31. Generally, only exempt research will meet the timeframe for semester-level cadet research.
  32. The EDO will make an exempt determination within10 business days of receipt of a complete package.
  33. Any research which does not meet exempt criteriamust be submitted for review by the IRB in accordance with CAIRB SOP and USMA 70-25.
  34. Expedited approval may take up to 40 business days; a full review may take up to 60 business days.

EDO Project Control #: ______

US Military Academy (USMA) Human Research Protection Program (HRPP)

Request for Determination

(See USMA REG 70-25 for the use of this form,)

  1. Study Title:

  1. Proposed Start Date:
/ Proposed End Date:
  1. Principal Investigator (PI) Information

HumanResearch Training Completed

NOTE: Attach CITI Grade Report for the Research Investigators Module for all investigators

First Name: / Middle Initial: / Last Name:
Degree(s) & Field(s) of Study:
Job Title: / Military / Civilian
Department/Division/Branch: / Major Activity Directorate:
Work Address: / Affiliation:
USMA Faculty or Staff
Cadet
DoD Employee (Not USMA)
Contractor
Other, specify:
Work Phone: / Fax: / Email:

NOTE: For cadet research, the faculty sponsor is the PI.

  1. Associate Investigators Involved in Study (insert additional rows if needed)

Note: Associate investigators include all individuals responsible for the design or conduct of the study. For cadet research, include all of the cadets on the protocol who will have access to the data.

Name (First, Middle, Last)/Degree / Department/
DivisionorAffiliation / RoleIn Project
(indicate if cadet) / Training
Completed

NOTE: For all investigators, please enclose a resume, CV, or transcript (for cadets) to demonstrate research background and qualifications. For all investigators who are not assigned to USMA, you must have a separate data use agreement for each PI.

  1. Funding
  1. Is your project funded in whole or in part by an external agency? __Y__N

If yes, provide funding source.

Please be advised that all external funding studiesmust be cleared through IID. Please contact Dr. Elizabeth Velilla, Assistant Dean of Research Operations, at or 845-938-2764.

6. Study Information:

  1. Research Determination

(1)Study Objectives (Limit 800 words): Describe specific objectives of this study. What is the study designed to accomplish?

(2)Synopsis of the research (Limit to 800 words). Provide a brief description (in layman’s terms) of your research design and planned use of human participants. This is similar to an abstract of a research paper.

(3)Review of literature. Provide a brief summary of relevant literature to support the theoretical foundation of your study. There should be evidence that the research question is supported in scholarly literature.

(4)Does the investigator intend to publish the results or present the results in a public forum? Note: Intention to publishor present results does not necessarily define a project as research.

YES / NO

(5)Is learning something for the benefit of people, other than the participants, a major goal of this activity?

YES / NO

If “Yes”, specifically describe how the use of the results will benefit people or society.

  1. Human SubjectDetermination: Will investigators collect any information about the study participants (attitudes, opinions, characteristics, demographics, traits, actions/reactions, etc.)?

YES / NO / If “no” skip to Part C

(1)If investigators collect any information about the study participants,how will investigators collect the information?

iInteraction(Example: Surveys, Interviews, E-mail correspondence, etc.); or
iiIntervention(i.e. blood draw, electrodes, wearing or use of equipment, designed exposure to environmental conditions, etc.) ; or
iiiSecondary Data(data that have already been collected and aggregated)

(2)If investigators collect any information about the study participants,is any of the collected information individually identifiableprivate information?

YES / NO

(3)If the investigators collect any information about the study participants, what is the recruitment strategy)?

NOTE: HRPP approval is not the same as command approval. Use of faculty/staff time or cadet time outside of the classroom must have appropriate command level approval. Please see the instructions for guidance.

(4)Identify the population (subjects for which represent the results of the research) for the study.

(5)Provide the sampling strategy.

NOTE:Access to the entire Corps of Cadets can only be granted if clear and compelling reasons can be provided and only with permission from the Commandant of Cadets.

(6)Justification for this sample size (provide a power analysis or other statistical or scientific justification)

(7)Maximum number of subjects to be enrolled ______

  1. Does the subject population involve any vulnerable populations?(Mark all that apply.)

Cadets (Note: See Appendix E, USMA REG 70-25 for special procedures that apply when using cadets)
Pregnant Women or Fetuses (Note: More restrictive exemption criteria are required for research involving pregnant women or fetuses. See 45 CFR 46, Subpart B for more information.)
Prisoners (Note: Prisoners cannot be exempted research. See 45 CFR 46, Subpart C for more information. The involvement of prisoners of war as human subjects of research is prohibited [DoDD 3216.02, para. 4.4.2])
Children (Note: Research involving children has more restrictive exemption criteria. See 45 CFR 46, Subpart D for more information. Active duty and cadets are not considered “children” irrespective of age.)
Active Duty Military Members within USMA command
Active Duty Military Members outside of USMA command including IMCOM(Garrison) or MEDDAC
Employees of the principal or associate investigators
Students enrolled in a class taught by a principal or associate investigator
Cognitively impaired persons
Illiterate persons
Non-English-Speaking Persons
Other potentially vulnerable participants: Who?
  1. Does this research involve any approved or unapproved FDA regulated items (including foods, dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products.)

YES / NO

(Note: FDA-regulated research cannot be approved as exempt research.)

  1. Does this study involve the use of deception on one or more of the participants?

YES / NO

(Note: Deception studies cannot be approved as exempt research,)

  1. Foreseeable Risks. State any foreseeable risks this study may impose on human subjects. This includes personal, physical, emotional, economic, professional, and legal risks, as well as the risks of invasion of privacy and breach of confidentiality.
  1. Research Methodology. Provide a thorough description of how the data will be collected including the sampling strategy, how the data will be analyzed; and how the results will be reported.

7.CATEGORIES OF EXEMPTION

Check “Yes”and complete the corresponding section for each of the following six categories of exemption that apply. Leave all other categories unchecked. If none of the categories applies, you may need to complete a research protocol IAW USMA REG 70-25 and submit to the IRB Administrator for IRB review.

CHECK “YES” FOR AT LEAST ONE OF THE FOLLOWING:

A. 32 CFR 219.101(b)(1):

1. EVALUATION/COMPARISON OF INSTRUCTIONAL STRATEGIES/CURRICULA

YES

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as

(i) Research on regular and special education instructional strategies, or

(ii) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

  1. Educational Setting: Describe the educational setting in which you will the research. Include all geographical locations involved in the study.
  1. Educational Practices: Describe, in sufficient detail, the educational practices you are studying.

Note: FDA-regulated research does not qualify for this exemption.

B. 32 CFR 219.101(b)(2):

2. SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, OR OBSERVATION OF PUBLIC BEHAVIOR

YES

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

(ii) Any disclosure of the human subjects’ responses 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.

  1. Recording Procedures: Describe the procedures used to collect the data. Provide a detailed description that includes locations (physical locations or websites), instruments used to record (questionnaires, data collection sheets, etc.), methods used to record (audio, video, one-on-one interview, focus group interviews, etc), and who will be recording the information.
  1. Data Management: Describe how confidentiality will be maintained. In other words, how the data will be de-identified, stored, or disposed. Provide a detailed description that includes locations that the information will be stored, who will have access to the information, how long the information will be stored, if and how the data will be destroyed after use, if and how the data will be coded, etc..
  1. Attach all proposed research instruments (e.g. tests, questionnaires, surveys, interview outlines or scripts, data collection sheets, etc) to this application.
  2. Intended Dates of Data Collection (d-MMM-yy):

Start: / End:
  1. Will the investigator collect any informationthat may involve sensitive aspects, such as illegal conduct, illegal drug use, sexual behavior, hate mongering, or illegal use of alcohol?

YES / NO

(If “YES”, complete an IRBresearch protocol and submit to the IRB Administrator. Please see the instructions.)

  1. Before a test, survey, or interview begins, will you inform participants that their participation is voluntary and that they may withdraw from participation at any time without loss of benefits the subject is otherwise entitled?

YES / NO

Notes:

  • When the research involves children as subjects this exemption must be limited to educational tests (cognitive, diagnostic, aptitude, achievement) and observation of public behavior when the Investigators do not participate in the observed activities.
  • Research that involves observation of public behavior when the investigators participate in the observed activities cannot be granted an exemption.
  • “Public behavior” means any behavior that a subject would or could perform in public without any special devices or interventions.
  • FDA-regulated research does not qualify for this exemption.
  • Attach a copy of any instruments or questions that will be asked for educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures.

C. 32 CFR 219.101(b)(3):

3. SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, OR OBSERVATION OF PUBLIC BEHAVIOROF PUBLIC OFFICIALS OR CANDIDATES

FOR PUBLIC OFFICE

YES

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under the previous paragraph if:

(i) the human subjects are elected or appointed public officials or candidates for public office; or

(ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Explanation: Describe how subjects may be identified or are at risk, or state the federal statute that allows the confidentiality of the subject to be maintained throughout the research and thereafter.

D. 32 CFR 219.101(b)(4):

4. COLLECTION OR STUDY OF EXISTING DATA

YES

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are (mark all that apply):

publicly available; or

PublicSource(include agency/person and location/website):

if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (See paragraph 8 of this form.)

Recording Procedures: Describe how the data are collected, stored, and de-identified. Include the start date and end date of the data extraction.

Notes:

  • Enclose a description of all data variables to be collected and/or a copy of the data collection sheet.
  • To qualify for this exemption, the data, documents, records, or specimens must already exist.
  • FDA-regulated research does not qualify for this exemption.

E. 32 CFR 219.101(b)(5):

5. PUBLIC BENEFIT OR SERVICE PROGRAMS

YES

Research and 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:

(i) Public benefit or service programs;

(ii) Procedures for obtaining benefits or services under those programs;

(iii) Possible changes in or alternatives to those programs or procedures;

(iv) Possible changes in methods or levels of payment for benefits or services under those programs.

Proof of approval by Federal Department/Agency Head is attached.

YES / NO

Notes:

  • This exemption applies to federally funded projects only and requires authorization or concurrence from the funding agency.
  • This exemption category does not apply if there is a statutory requirement that this project be reviewed by an IRB or if the research involves physical invasion or intrusion upon the privacy of subjects.
  • FDA-regulated research does not qualify for this exemption.

F. 32 CFR 219.101(b)(6) and 21 CFR 56.104(d):

6. FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE STUDIES

YES

Taste and food quality evaluation and consumer acceptance studies,

(i) If wholesome food, without additives are consumed or

(ii) If a food is consumed that contains a food 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.

Explanation: Describe the type of food to be tasted or ingredient to be evaluated. State whether it is FDA-, EPA-, or USDA-approved.

8. Secondary Data Collection(see Appendix E, USMA REG 70-25). For an exemption, an investigator (with proper authorization) may inspect identifiable records, but may only record information in a non-identifiable manner.

Will existingPersonally Identifiable Information (PII) be accessed in the course of preparing for this research?

YES / NO

If “No”, skip to the Conflict of Interest Declaration(paragraph 9).

A. STATEMENT OF AFFIRMATION

If PII is accessed (used) in the course of preparing for this research the following 3 conditions must be metto allow for the access (use) of PII as “preparatory to research”: