IRB Cheat Sheet - Feinstein Institute for Medical ?· IRB Cheat Sheet . Office of the IRB. 3333 New…

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  • Page 1 of 12

    IRB Cheat Sheet

    Office of the IRB 3333 New Hyde Park Road New Hyde Park, NY, 11042

    Phone: 516-321-2100 www.feinsteininstitute.org/hrpp

    irb@northwell.edu CASE MANAGERS: Richard D. Ramdeo, CIP Phone: 516-321-2118 rramdeo1@northwell.edu

    Lenox Hill Hospital-All Departments Emergency Medicine Radiation Oncology Radiology Otolaryngology Physical Medicine and Rehabilitation

    Dorean Flores, CIP Phone: 516-321-2112 dflores1@northwell.edu

    Feinstein Institute/Translational Research Neurology Neuroscience Psychiatry Urology

    Haemar Kin, MHA Phone: (516) 321-2117 hkin@northwell.edu

    Anesthesiology Dentistry Corporate/Health Services/Outcomes OB-GYN Orthopedic Surgery Pediatrics Pharmacy Surgery

    Khadijah Holley, BA Phone: (516) 321-2111 kholley@northwell.edu

    Medicine (excluding adult hematology/oncology) Staten Island University Hospital-All Departments Huntington Hospital-All Departments Neurosurgery Ophthalmology

    Alison Powell, LAT Phone: (516) 321-2115 apowell6@northwell.edu

    Division of Adult Hematology/Oncology Northern Westchester Hospital Phelps Memorial Hospital Pathology/Laboratory Medicine Nursing Population Health

    http://www.feinsteininstitute.org/hrppmailto:irb@northwell.edu

  • Page 2 of 12

    Does the activity qualify as research with human subjects and does it have to be submitted to the IRB?

    No STOP DO NOT SUBMIT

    STOP DO NOT SUBMIT

    Is the activity a systematic investigation designed to develop

    or contribute to generalizable knowledge?

    Activity is not research

    Yes

    The activity is research. Does the research involve obtaining

    information about individuals?

    Yes

    Does the research involve intervention or interaction with

    the individuals?

    No Activity is not research involving human subjects

    No Is the information individually

    identifiable (i.e., the identity of the subject is or may readily be ascertained by the

    investigator or associated with the information)?

    Yes

    No

    Yes

    Activity is research involving human subjects. Submit protocol to the IRB.

    Examples of studies that do not qualify as human subject research and would therefore not require IRB review and approval: A review of published literature, publicly

    available information, or previously collected data that contains no link or code to subject identity that is breakable by the investigator receiving and utilizing/analyzing the data.

    The analysis/use of discarded or commercially available human tissue where there is no link to subject identity or protected health information.

    The analysis/use of human tissue where there is no link or code to subject identity that is breakable by the investigator receiving and analyzing the tissue.

    Developed from Human Subject Decision Charts available at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

    For further guidance, click on: FAQs about Research Using Human Specimens, Cell Lines or Data on the Office of Extramural Research website.

    http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.htmlhttp://grants.nih.gov/grants/policy/hs/faqs_specimens.htmhttp://grants.nih.gov/grants/policy/hs/faqs_specimens.htmhttp://grants.nih.gov/grants/policy/hs/faqs_specimens.htm

  • Page 3 of 12

    Types of IRB Review If you have determined that your study is human subjects research, there are essentially three types of IRB new study submissions you can apply for:

    1) Exempt New Study 2) Expedited New Study 3) Full Board New Study

    If you are not sure what type of study you have, the best route is to call the IRB office. You can call or email your case manager directly. Also, you can visit the submission guidance section of the HRPP website: www.feinsteininstitute.org/hrpp/submissions for specific instructions on how to complete each type of submission.

    http://www.feinsteininstitute.org/hrpp/submissions

  • Page 4 of 12

    EXEMPT NEW STUDY 45 CFR 46.101(b) Categories of Exempt Human Subjects Research*

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

    a. research on regular and special education instructional strategies or b. 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:

    a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and

    b. 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.

    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 category # 2 (above) if:

    a. the human subjects are elected or appointed public officials or candidates for public office, or

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

    4) Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.

    5) Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which are designed to study, evaluate or otherwise examine:

    a. public benefit or service programs, b. procedures for obtaining benefits or services under those programs, c. possible changes in or alternatives to those programs or procedures or d. 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, if: a. wholesome foods without additives are consumed or b. 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.

    *Important Notes:. "Existing" means at the time the research is proposed. These exemptions do not apply to research involving prisoners (45 CFR Part 46 Subpart C). Exempt, Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the researcher(s) do not participate in the activities being observed.

  • Page 5 of 12

    DOCUMENTS REQUIRED FOR EXEMPT RESEARCH STUDIES:

    1) IRB Application for Exemption (will serve as the protocol) 2) Any documents that will be given to or presented to subjects 3) If you are doing a data review study, you must also submit a blank data collection sheet 4) If you are doing an educational test, survey, or interview, you will need to submit a copy of this

    document, as well as an information sheet that will be provided to the subjects. This information sheet will serve as informed consent. The template can be found online.

    Examples of Exempt Category 1: An investigator investigates whether their new PowerPoint presentation on hand sanitizing is better than the standard hand sanitizing education at decreasing the number of hospital related infections. The presentation is done during a nurses training seminar. Category 2: An investigator anonymously surveys patients before and after laparoscopic surgery to determine if their diets have changed because of the surgery. Category 3: An investigator anonymously surveys a senator regarding a concentration of cancer patients in a region with known water pollution. Category 4: An investigator reviews medical charts to determine if hepatitis B is related to tuberculosis. The investigator does not record any of the 18 protected health identifiers. Category 5: An investigator, on behalf of the FDA, examines whether West Nile spraying has an effect on lung conditions in people. Category 6: An investigator examines which flavor of two wholesome and additive-free foods are preferred by patients in the hospital during recovery, An exempt study can consist of multiple exempt categories. Under category 4: If information about patients is being collected from multiple sources, a temporary link is allowed in order to correctly account to whom the information belongs; however, this link must be destroyed immediately after data collection and prior to any data analysis occurring.

  • Page 6 of 12

    EXPEDITED NEW STUDY: 45 CFR 46.110 Categories of Expedited Human Subjects Research*

    (1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met. (a) 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 dec