REQUEST FOR EXEMPT RESEARCH DETERMINATION

Submit a copy of this form, any surveys/questionnaires that will be used

and a copy of the information you will provide to subjects about the research, if applicable.

Date:

Principal Investigator (PI): Department: Division:

Mentor (if PI is not MSSM Faculty):

Phone Number:

Funding Source: (If externally funded, submit copy of research plan)

Project Title:

Location where research will be carried out:

Summary of Research (or attach research proposal/plan):

Number of Subjects to be enrolled, or number of charts to be reviewed:

NOTE: No prisoners can be involved in exempt research. Typically, no interactions with minors can occur in exempt research.

NOTE: If you are accessing PHI, even if you are not recording identifiers, HIPAA regulations may apply.

In some cases, a request for Waiver of HIPAA authorization or Alteration of HIPAA may be granted.

Please check all that apply, and briefly explain how each point will be addressed:

Selection of participants is equitable:

Medical Center data security policies will be adhered to for any data handled during the conduct of this study:

There are interactions with subjects and the Research Information Sheet (E3.26.14) will be provided to potential subjects.

Indicate the method of recruitment by selecting one of the following:in-person, email, postal mailing, website, community center or public space

I have attached a copy of any survey or data collection instrument that will be used. There are surveys for this research.

The subject’s privacy will be protected:

No interaction with subjects will occur:

If you are not sure if you need to use the research information sheet, or you would like to make significant changes to the document, please contact the PPHS Office for guidance.

Exemption Categories:

These categories do not apply if your project is FDA regulated or if the research involves prisoners:

Check which category you are seeking for this exemption:

(1) 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.

(2) 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. Does not apply to interviews, surveys or interactions with children as subjects. SUBMIT A COPY OF ANY SURVEY INSTRUMENTS YOU WILL USE.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or 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.

GUIDANCE on this category:

  • Existing means previously collected and in existence at the time of submission of this form.
  • Publicly available means completely unrestricted access for anyone, and no requirements or approval process needed to access the data (an example is census data)
  • Identifiers linked to the participants means the data is coded and the researcher or collaborator has the ability use the code (subject ID#) to go back to identifiers.

Application must include listing of all information (variables) to be obtained, how data/specimens will be labeled, and the source. Submit a copy of the data collection form.

(3) 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 paragraph (2) of this section, 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.

(5) Research and demonstration projects which are conducted by or subject to the 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; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

By submitting this form the PI agrees to follow all relevant institutional policies. PPHS education requirements must be met by the PI.

It is the PI’s responsibility to ensure all members of the research team are adequately trained.

This submission does not relieve you of responsibilities to submit to FCOIR (x44075) or GCO (x58300)

Version: 9.2.14

ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI AND THE MOUNT SINAI HOSPITAL

RESEARCH INFORMATION SHEET

Study ID #: Form Version Date:

Title:

Researcher: Name, Degree

local contact address

local telephone number

The purpose of this research study is to see <discuss in a sentence or two the purpose of this study>. You are being asked to take part in a research study because you <indicate basic inclusion criteria>.

Being in a research study is completely voluntary. You can choose not to be in this research study. You can also say yes now, and change your mind later. If the subject population is, or may be, part of Mount Sinai’s patient population, insert the following:Deciding not to be in the research study, now or later, will not affect your ability to receive medical care at Mount Sinai Medical Center.

If you agree to take part in this research, you will be asked to <describe research procedures to be followed>. Your participation in this study will take about <insert length of time/duration of study participation. If there are more than one interactions, such as a follow-up survey, please indicate both how long each research activity will take and over what period of time>. We expect that <insert expected number of total subjects> people will take part in this research study.

If this is a survey study, insert: You can choose not to answer any question you do not wish to answer. You can also choose to stop taking the survey at any time. (This means that the survey needs to be designed to include the possibility of skipping questions and cannot force someone to answer a question to continue.)You must be at least 18 years old to participate. If you are younger than 18 years old, please stop now.

The possible risks to you in taking part in this research are:

  • <insert possible risks or discomforts, including feeling uncomfortable, or having someone else find out that you were in a research study. Include potential loss of confidentiality of data.>.

The possible benefits to you for taking part in this research are:

  • <insert possible benefits, if any to the research subject or others. IF NONE, delete this sentence. >.

To protect your identity as a research subject, <choose which method applies: no identifiable information will be collected, the research data will not be stored with your name, the researcher(s) will not share your information with anyone. In any publication about this research, your name or other private information will not be used>.

If you have any questions about this research, please contact the Researcher at < Insert local phone number or relevant way of contacting the researcher>. You can also call the Program for the Protection of Human Subjects Office at 212-824-8200.

This project was determined to be exempt from federal human subjects research regulations.

Version: E9.2.14