OSP – HS – 01

Not Applicable

Exempt

Expedited Approval
Full IRB Review

Approved

Disapproved

Other Action:
By:
By:
By:
By:
By:
For IRB Use Only Protocol #: HS ____________
Date:
Date:
Date:
Date:
Date:
Last Name:
Museum/Center:
Project Title:
First Name:
Date of Submission:
Request for:
☐ Confirmation that this project is Exempt as defined by SD 606
☐ Expedited Review as defined by SD 606
☐ Full Review as defined by SD 606
This Application is:
☐ for a new project
☐ a revision for a new project
☐ a renewal for a previously approved protocol, with changes
☐ for changes to an approved protocol
Instructions:
If you’re planning a project (a defined study with a topic of inquiry involving a circumscribed group of people) to conduct research involving human subjects, you must complete this form and submit it to the Smithsonian’s Institutional Review Board (IRB) through the Office of Sponsored Projects.
Required Documents (please include with completed application):
Copy of the consent to be used in your research (may be unnecessary for Exempt research)
Copy of any surveys, questionnaires or tests to be administered
Copy of certificate(s) evidencing completion of training in human subject research for all employees and affiliated persons working on project. Training must have been completed less than 24 months prior to date of application.
* Project Investigators must be Smithsonian employees or affiliated persons
†
who must secure the significant involvement and approval of a Smithsonian employee (sponsor) to conduct human subject research on Smithsonian premises.
†
Affiliated persons refer to the following categories of individuals who are not Smithsonian employees but who operate on
Smithsonian property: contractors embedded with Smithsonian employees; volunteers, including Regents and advisory board members; interns and Fellows; Friends of the National Zoo (FONZ) employees and Smithsonian Early Enrichment Center
(SEEC) employees; visiting researchers, scientists, scholars, and students; research associates, regardless of working title; and Federal agency or non-profit employees located at a Smithsonian facility.
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Human Subject Research is defined as obtaining data through interaction or intervention or identifiable private information from a living human individual in a systematic investigation designed to contribute to generalizable knowledge, including study, development, testing and evaluation. Research includes such activities as the measuring, taking or testing of a subject’s bodily tissue, psychological testing, formal interviews, focus groups, questionnaires, interactive or non-interactive observations of public behavior that obtain personal information, using either electronic or visual tracking and related activities that produce a body of study data, with the intent to draw statistically, quantitatively- or qualitatively-based conclusions.
Human Subject Research does not include interviews used to provide quotes or illustrative statements, such as those used in journalism; collection of oral histories and cultural expressions to document a specific historical event or the experience of individuals without intent to draw statistically or quantitatively-based conclusions or generalizations, except when subjects are part of a vulnerable population; gathering of information from a person to elucidate a particular item(s) in a museum collection; gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance; or interview procedures, focus groups, questionnaires, interactive or non-interactive observations of public behavior that obtain personal information, using either electronic or visual tracking, that are conducted for Smithsonian internal purposes only , the results of which will not be published or presented in a public setting (e.g. conferences or professional meetings).
Even if your project does not need IRB approval you are still responsible for assuring the rights and
welfare of all human participants in the activity.
If you are unsure whether you need to submit this form, please contact the IRB Administrator in the Office of Sponsored Projects at 202-633-7110 or
OSPCompliance@si.edu for further guidance.
If your project does meet the definition of human subject research in SD 606, please return the completed form as an attachment to OSPCompliance@si.edu or mail to: Office of Sponsored
Projects, Smithsonian Institution, P.O. Box 37012, MRC 1205, Washington, DC 20013, phone (202)
633-7110 and fax (202) 312-1981.
Note:
If your project does not meet the technical definition of research involving human subjects, you do not have to submit this application (See SD 606).
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Investigator Information
First Name: Last Name:
Museum/ Center:
Phone:
Discipline:
Date of HS certification and course taken (OSP, CITI, NIH):
Email:
Highest Degree: Year Completed:
If you are a Smithsonian affiliated person, rather than SI staff,, please provide the following:
Type of affiliation: ☐ Fellow ☐ Research Associate ☐ Visiting Researcher ☐ Other:
Email: Name of Smithsonian
Sponsor:
Phone:
Sponsor’s HS certification and course taken (OSP, CITI, NIH):
Project/ Study Information
Project Title:
Anticipated Funding Source (s):
Anticipated Start Date: Anticipated End Date:
Designated Code or Proposal ID (OSP project)
Time Period for Approval Request (Maximum one year unless Exempt):
Will others conduct or assist with the research project: ☐ YES ☐ NO
If yes, please provide the name, phone number, and email of each person and a brief description of his/her role as it relates to the Smithsonian Institution. Please provide certification of human subjects training, the training date, and provider (e.g., OSP, NIH, CITI). Any individual who will interact with subjects (recruiting, interviewing, answering questions, or distributing surveys) or who will have access to personal information contained in the collected data must provide evidence of training.
1.1 Attach a brief project summary of the purpose of the research in non-technical language. Include a statement of the research problem, the data to be collected, and main data collection methods. Include any materials to be used in the study.
1.2
Will the living human subjects, from whom data will be collected, be any of the following?
☐ YES ☐ NO
☐ patients ☐ children (under 18 years of age) ☐ persons under duress or coercion
☐ prisoners ☐ persons with mental disabilities ☐ persons unable to give informed consent
If yes, you must fill out Part 2
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1.3
Please describe the subjects to be recruited for the research (age, ethnicity, gender, health, etc.).
1.4
Describe briefly how subjects are to be recruited.
1.5
Will you ask human subjects for consent to participate in the research?
☐ YES, in writing ☐ YES, recorded in audio or video ☐ YES, orally only ☐ NO
Unless you are seeking an Exempt determination, if the answer is NO, or if the language of obtaining consent is not spoken or understood by the subject(s), you must fill out Part 2.
1.6 What information is gathered from subjects (including name or other identifying info)?
1.7
Please indicate the research methods or techniques involved (indicate all that apply).
☐ taking, testing, or measuring human tissue
☐ injections, the ingestion of pills, or other physical interventions
☐ inducement of psychological stress in subject
☐ deception of human subjects
☐ seeking personally embarrassing or sensitive information
☐ voice, video, digital, or image recording of human subjects
☐ none of the above
If any of the above are indicated, except “none of the above”, you must fill out Part 2.
1.8
Please indicate what procedures you will use to safeguard collected data (indicate all that apply).
☐ human subjects will not be identified at all by name or other identifiable information
☐ data on human subjects will be identified only by a code
☐ data will be in the possession of the researcher and/or Smithsonian with appropriate restrictions
☐ data containing private information will be restricted from public access
☐ all data is already in the public domain
☐ other, please specify:
☐ no safeguards will be used
If there are no safeguards for private information and that information is not already in the public domain, you must fill out Part 2.
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1.9
Please indicate the procedure to be used to safeguard personally identifiable private information in research publication (indicate all that apply).
☐ any and all human subjects will remain anonymous (pseudonyms where necessary will be used)
☐ no personally identifiable private information will be published
☐ identifiable private information is already in the public domain
☐ for public figures and cultural exemplars, as well as for sources, the information to be revealed
 conforms to the generally accepted standards of the research discipline
☐ other, please specify:
☐ no safeguards will be used
If there are no safeguards indicated for preserving anonymity or the confidentiality of private information, you must fill out Part 2.
1.10
Please indicate if the research may involve any of the following risks for human subjects (indicate all that apply).
☐ bodily harm ☐ disease ☐ social censure ☐ persecution
☐ deception ☐ psychological distress ☐ embarrassment ☐ incarceration
If any of the above are indicated, you must fill out Part 2.
Fill out Part 2 if need be; otherwise go directly to the CERTIFICATION portion of the application.
If a question is not applicable, indicate so by entering “NA”. Otherwise, answer each question
completely. Provide additional material as appropriate. Answer blocks expand as needed.
Section 1: Vulnerable Subjects
2.1.1. How many subjects will be recruited for the research?
2.1.2. Why is the inclusion of these subjects necessary for the research?
2.1.3. What, if any, is the institutional affiliation(s) of the subjects? If permission has been obtained from cooperating institutions (school, hospital, corporation, prions, or other relevant organization), append documentation of the approval (letter, email, etc.).
2.1.4. Is the approval of other research compliance committees or another Institutional Review Board required? If so, what are they? If approval has been obtained, append documentation of the approval.
Section 2: Recruitment and Informed Consent
2.2.1. Is an incentive offered? ☐ NO ☐ YES, please explain below
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2.2.2 Is there any language barrier that could affect the consent process (your explanation of the research and the subject’s agreement to participate)? If so, please provide details, such as plans for use of translators or translated documents. ☐ NO language barrier ☐ YES, please explain below
2.2.3. Explain how you will inform subjects about your research and then obtain their consent. (For an explanation of elements of informed consent please visit http://www.hhs.gov/ohrp). Subjects must be told that participation is voluntary, and that they may stop at any time. Be sure you address where, when, and by whom consent will be obtained, how the assent of children (under 18 years of age), mentally infirm, or otherwise legally incompetent subjects will be obtained, particularly if someone else is to consent on their behalf. If you will not inform subjects that they are participating in research you must justify the lack of informed consent – see “Requesting a Waiver of Informed Consent” (OSP-HS-06).
2.2.4. If subjects are vulnerable due to their legal status, economic status, economic status, illiteracy or other circumstances, describe steps to minimize the risk of coercion or undue influence. Include in your description of how you ensure subjects understand that their participation is voluntary.
2.2.5. Do subjects sign a written consent form and receive a copy for their records? If not, do they receive an information sheet that provides what they need to know before deciding to participate? (Attach a copy of consent form, information sheet, or script for oral explanation to subjects). If you are requesting a waiver of documentation of informed consent, please follow the instructions in “Requesting a Waiver of
Written Informed Consent” (OSP – HS – 05).
Include translated consent form for research conducted in languages other than English.
Section 3: Intrusive and/or Stressful Data Collection Techniques
2.3.1. What do subjects do, or what is done to them, or what information is gathered? (Attach copies of instructions, interview guides, tests, questionnaires, surveys or clinical protocols to be used. Include translated documents for research conducted in languages other than English.)
2.3.2. How many times will observations, tests, etc. be conducted and over what period of time? How long will the average subject data gathering encounter be? What is the likely range of such encounters?
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2.3.3. Are subjects to be deliberately deceived in any way? If so, what is the nature of the deception? Is it likely to be significant to subjects? Is there any other way to conduct the research that would not involve deception, and if so, why have you not chosen that alternative? What is the explanation for the deception given to subjects following their participation?
Section 4: Care of Data
2.4.1. How are confidentiality and/or anonymity assured where appropriate? Will identifiers be removed from data? If so, at what point, and if not, please explain why the identifiers must be retained and how the data will be protected.
2.4.2. Will research data (written or otherwise recorded) be destroyed at the end of the study? If not, where and in what format and for how long will the data be stored?
Section 5: Subjects Protection in Publication
2.5.1. To what uses – research, demonstration, public performance, archiving- might research data be put in the future? How will subjects’ permission for further use of their data be obtained?
2.5.2. Does the type of data to be collected involve expressions protected under intellectual property rights regimes (written work, artistic work, songs and music, stories, inventions, etc.)? If so, how will the intellectual property rights of the human subjects be protected? Indicate and provide examples of permission forms and/or agreements to be signed by subjects.
2.5.3. How will the desire of some subjects to remain anonymous and the desire of other to be cited in publication be handled?
Section 6: Risks and Benefits
2.6.1. Explain possible risks of physical, psychological, legal, and social harm to participants in the research.
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2.6.2. Are the risks necessary, and why?
2.6.3. What steps will be taken to minimize the risk? Should a subject experience significant distress or otherwise be harmed, what are your plans for addressing the problem (e.g., emergency care training for research staff if physical harm is a risk; referral for evaluation or treatment if there are significant psychological risks)?
2.6.4. How will participation in this research benefit subjects? Will subjects be “debriefed” or receive information about the research project following its conclusion? If there are no direct benefits to the subject, what are the benefits of the research to society and/or the field of research that justify the risks or inconvenience to the subjects?
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Smithsonian Institution policy requires formal training in human subject research. Before determination or approval will be granted by the IRB, all Smithsonian employees and affiliated persons proposing, conducting or assisting with the research project must have completed training (typically on-line) offered by the National Institutes of Health (available at http://phrp.nihtraining.com/users/login.php
) or the CITI
Program in the Protection of Human Subjects (available at http://www.citiprogram.org/ ), or equivalent program within the past 24 months and obtained a certificate of completion.
If training in human subject research has been completed, please provide certificate(s) with your application.
All Smithsonian employees and affiliated persons participating in this project, listed on page 3, have completed human subject research training within the past 24 months. ☐ YES ☐ NO
Neither I nor any of my associates in this research project, to my knowledge, has a real or apparent conflict of interest that would lead me or my associates to misrepresent the research, the treatment of human subjects, and the facts contained in this application.
☐ This is correct ☐ This is not correct (please explain below)
By submitting this application, I certify that the research has been adequately designed to protect human subjects and all of the information contained in this application is accurate and complete.
______________________________________
Applicant’s Signature
_________________
Date
If the applicant is a Smithsonian “affiliated person”.
______________________________________
Smithsonian Sponsor’s Signature
_________________
Date
Note: Sponsor’s signature indicates your active interest and/or involvement in the proposed project.
Approval of Unit Director (for all applicants):
______________________________________
Signature of Museum/Research Center Director
_________________
Date
______________________________________ ( Printed name of Director )
Director’s signature indicates approval of the proposed activity to be undertaken on your premises and/or in the name of the Smithsonian and your unit/center.
The IRB will advise you of its determination/approval or request for additional information as soon as possible. You must not begin your research until you have received IRB approval or an Exempt
determination.
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