Attach5_OHSRP_Form

REQUEST FORM: OHSRP DETERMINATION FORSURVEYS, INTERVIEW PROCEDURES, PROGRAM EVALUATION, EDUCATIONAL TESTING AND RESEARCH

INSTRUCTIONS

Use this form to request a determination for activities that involve prospective collection of data only, including:

• Use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior¹

• Educational Research: conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.²

• Program evaluation or demonstration project designed to study, evaluate, or otherwise examine:

• Public benefit or service programs;

• procedures for obtaining benefits or services under those programs;

• possible changes in or alternatives to those programs or procedures; or

• possible changes in methods or levels of payment for benefits or services under those programs,

• Quality assurance activities

Please attach the survey, questionnaire, interview script or test to the completed form together with the consent language that will be administered before the subject participates in the activity.

For assistance completing the form, call OHSRP at (301) 402-3444. Submit a PDF of the completed form with required signatures and attachments to:

PDF and E-mail: ohsr_nih_ddir@od.nih.gov

Fax: 301-402-3443 Interoffice mail: Building 10, Room 2C146

Date of Request: __________________

Requestor’s name: __________________ e-mail: ______________________________

Role: __Administrative support __Investigator __Other, explain: ________________

Name of NIH Senior Investigator: ___________________________________________

(The investigator must be an NIH employee)

IC _____________ Laboratory/Branch _______________________________________

Building & Room No. _________ Tel. No. __________ FAX No. ___________________

Is the NIH Senior Investigator an NIH employee(FTE)? _____Yes _______No

Senior Investigator Signature: _____________________________________________

(Signature of Investigator who will conduct research)

Supervisor Signature: ____________________________________________________

(Signature of official for IC, e.g., Lab/Branch Chief)

Name of NIH investigator conducting research if not the NIH Senior Investigator: (i.e, junior investigator, contractor investigator, fellow, student)

________________________________________________________________________

Please provide the name and e-mail of any others who should receive a copy of the OHSRP determination: ____________________________________________________

1. What role will the NIH investigator(s) have in this research project? (check all that apply)

__ Conduct research activity

__ Analyze samples/data only

__ Consultant/advisor to collaborator(s)

__ Author on publication(s)/manuscript(s) pertaining to this research

__ Other, please describe: ______________________________________________

2. Title: __________________________________________________________

(Provide a short title to distinguish this activity from other projects that you may have)

3. Describe in lay terms the research activity that will be performed:

_______________________________________________________________________

4. Proposed start date ___/___/_____ Proposed completion date ___/___/_____

5. Specify the nature of the data: (select all that apply)

__ Interview procedure

__ Survey

__ Educational Testing

__ Educational Research

__ Research on public benefit or service programs

__ Other, describe: __________________________________________

6. What kind of human data (e.g., private information, responses to questionnaires, test results, recordings) will be collected in your research?

________________________________________________________________________

7. Will human data be? (select all that apply)

Collected Yes__ No__

Received Yes__ No__

Sent Yes__ No__

8. If receiving or sending, list the collaborating investigator(s):

Name Institution/IC Address/e-mail FWA number*

________________________________________________________________________

9. Where are the subjects of this research activity located? (Provide a general description or complete the institutional information below)

Institution: _____________________ Contact Name: _______________________

Address: __________________________________ Phone: _______________________

10. Will NIH investigator(s) have direct contact or intervention with the subjects of the study? (For example, by interviewing, surveying or recording the subjects?)

Yes__ No__

If yes, what is the age range of subjects involved in the research?

___ Children aged < 18 years

___ Adults aged > 18 years

11. Who will collect the data or information?

(a) ___ NIH Investigator

(b) ___ non-NIH Collaborator

(c) ___ NIH Contractor

(d) ___ Other, specify__________________________________________

If b or c, will an Honest Broker or data use agreement be used? Yes__ No__

If yes, complete and attach the Honest Broker Assurance or data-use agreement to this submission; e-mail ohsr_nih_ddir@od.nih.gov to request a form.

12. Select the best description that applies to the human data or information:

__ Data or information will not contain any identifiable information, nor can it be linked to individual subjects by you or your collaborators.

__ Data or information will be recorded in such a manner that subjects can be identified directly or through identifiers linked to the subjects

13. Per NIH guidance, are all conflicts of interest by NIH employees (sender or receiver), if any, resolved? _____Yes _____No**

*A Federalwide Assurance (FWA) is issued by the U.S. Department of Health and Human Services (DHHS)/ Office of Human Research Protections (OHRP) to institutions which receive Federal funds/support to conduct human subjects research. To search for the FWA# for domestic or international institutions go to http://ohrp.cit.nih.gov/search/fwasearch.aspx?styp=bsc

**If the answer is “No”, note that OHSRP will be unable to make a determination and research may not proceed until all conflicts are resolved. For more information, see the October 2011, A Guide to Preventing Financial and Non-Financial Conflict of Interest in Human Subjects Research at NIH. For assistance review the list of Ethics Coordinators and find the contact for your IC: http://ethics.od.nih.gov/coord.pdf

1 The following activities involving educational tests, survey, interviews or observation of public behavior are not eligible for exemption and must be reviewed by an IRB if:

• the information obtained is recorded such that human subjects can be identified, directly or through identifiers linked to the subjects; and

• any disclosure of the 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; or

• the research involves children, unless it involves observation of public behavior and the investigator will not participate in the activities being involved.

2 Note that educational research may include children and use identifiable information, however other local or federal regulations may apply such as The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) and/or The Protection of Pupil Rights Amendment (PPRA) (20 U.S.C. § 1232h; 34 CFR Part 98); however OHSRP cannot provide advice on these regulations.

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