Exemptions and Not Human Subjects Research Human Investigation

Exemptions and Not Human Subjects Research Human Investigation Committee 2013

First of All Is It Research? Is It Human Subjects Research that requires IRB review?

What Does Exempt Mean? A federally designated category Describes certain kinds of research Means that the research is determined to be exempt from continuing IRB review

Who Decides? At Yale, the IRB decides whether or not a study qualifies for one of the exemption categories

The Categories Category 1 ◦ Research conducted in established or commonly accepted educational settings, involving normal educational practices Category 2 ◦ Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior

An Example or Two Category 1 ◦ An assessment of an educational technique, e. g. , you introduce a new model for teaching how to set broken bones. You have students complete a pre and post—model test of skill ◦ You survey all the medical schools in the Northeast to determine the amount of time spent teaching contraceptive techniques to residents ◦ Note: If you’re doing a study with a school system, there may be other regulatory requirements.

And more Category 2 ◦ You survey a group of adult mental health patients and family members to determine their basic understanding of available mental health services. You keep track of who attended, so you can contact them later. ◦ You then hold focus groups of some of the people you surveyed to identify their most common concerns regarding access to care.

Category 2 Caveats To qualify, the information collected has to be anonymous, or, if identifiers are kept, the information cannot pose a risk of criminal or civil liability or be potentially damaging to the participants’ financial standing, employability or reputation if the information is disclosed. If it’s particularly sensitive information the IRB may not grant exemption.

Category 2 Caveats Studies regulated by the FDA cannot qualify as exempt Even if it’s otherwise exempt, if it involves children (unless you meet the public behavior or the educational tests criteria), it doesn’t qualify.

Category 2 and HIPAA Example ◦ You’re identifying the group you will invite to your focus group from the medical records of the Eye Center. You yourself are part of the Cancer Center, so these are not your patients. ◦ You’ll need to request a Waiver of HIPAA Authorization

Categories, Redux Category 3 ◦ Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, or observation of public behavior that is not exempt under item (2) above; if the human subjects are elected or appointed public officials or candidates for public office; or federal statute(s) require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 4 45 CFR 46. 101(b)(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.

Category 4, The Caveats All the data or the specimens have to be existing at the time you request exemption You can’t record identifiers ◦ This means, you can’t decide that you’ll just record the medical record number for a while, until you match one set of information to another.

Category 4, The Caveats If this relates to an investigational drug or device, the study cannot be exempt, per FDA regulations. Cannot involve prisoners, cannot have been collected from individual while they were imprisoned or individual known to be currently imprisoned. A HIPAA waiver will be required if you don’t have a direct healthcare relationship to the potential subjects.

An Example You are going to search a medical records database for all subjects who had an allergic response to an anesthetic used in the OR from January 2011 through December 2011. You are going to record only: ◦ Their gender ◦ Their age ◦ Their treatment -- The type of surgery -- Their post-op LOS

Category 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 methods and procedures of public benefit or service programs.

Category 5 Example A community agency you know has received a grant from SAMHSA to initiate an innovative service model for its publically funded clients. Part of the SAMHSA grant requires an evaluation of the program.

Category 5 Caveats Has to deliver a public benefit (e. g. , Medicare) or a service (e. g. , example above) Has to be conducted pursuant to specific federal statutory authority Has to have no statutory requirement for IRB review Must not involve significant physical invasions or intrusions on the privacy of participants.

Category 5 Caveats Cannot propose to collect any data in addition to that which is necessary for the study, evaluation or examination of the program Cannot be regulated by the FDA Cannot involve prisoners.

Category 6 Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed, or a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or an agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the USDA.

Yale’s New Category 7 Research Involving Response to Non-Physically Invasive Stimuli Research that involves participant interaction including providing a response to a non-physically invasive stimulus such as: * reading/writing tasks * computer tasks * video games * viewing media * internet searches

Category 7 Caveats No more than minimal risk to subjects No federal funding No FDA regulated components No procedures that would be considered biomedically based No sponsor or other contractual restrictions No clinical interventions No prisoners as subjects No children as subjects No need for an NIH certificate of confidentiality

Note A study can qualify for more than one exemption category. For example, you might do a survey and also look at related data. This is a category 2 and 4 submission. But take care: you can have identifiable surveys, but if you’re then checking a medical record, you can’t record the identifiable information from the med record.

The Ethical Realities You still need to get consent ◦ But you won’t use an HIC validated consent form. You’ll use an information sheet, possibly coupled with language on the survey itself, for example. Or you may have written consent, but without an HIC validation box. You still need to tell subjects that this is research You still need to protect the subject’s privacy

What Do We Want From You? For all requests, fill out the HIC Request for Exemption form. DELETE the categories that do no apply to your request. Submit ONLY the request and the related documents. No extra copies.

What Related Documents? Any recruitment material you will use, for example, the email message. Or the flyer or poster If it’s a survey, the survey. If it’s a focus group, the questions you are planning to ask The information sheet or consent form

Not Human Subjects Research Is: obtaining data or specimens for research that ◦ Were not collected for the purpose of this study ◦ Are not identifiable ◦ If coded, this PI has no link to the code Can be retrospective or prospective

Kinds of Data Might be ◦ Data about health facilities, businesses or organizations that are not individuals ◦ Data on deceased persons ◦ Deidentified human data or specimens ◦ Data or specimens with limited HIPAA identifiers, such as dates and zip codes

NHSR and HIPAA For School of Medicine/School of Nursing research, if data or specimens included limited direct HIPAA identifiers, a Data Use Agreement must be in place.

Exemption #4 vs. NHSR Exemption 4 can never be prospective ◦ NHSR can be retrospective or prospective In Exemption 4, you are gathering the data ◦ In NHSR, the data is coming to you from another source.

NHSR Example You are getting 3, 000 de-identified data files from a national database that collects and then de-identifies the data. ◦ The files were collected for a broader reason than your study ◦ They have limited HIPAA identifiers, but you have a data use agreement in place with the national database.

Amendments (changes) to exempt studies should be submitted to the IRB for review Why? ◦ The change may make the research no longer exempt ◦ Example: An exemption was granted under Category 4 and the researchers now want to collect date of birth

Resources The HIC Exemption and Not Human Subjects applications The HRPP Procedure (100 PR 3) for Exemptions The HRPP Checklist for Exemption (100 GD 9) These are on the HRPP website, http: //www. yale. edu/hrpp/

You Can Also Call the HRPP main number ◦ 785 -4688 ◦ Or email us at hrpp@yale. edu; ysmhic@yale. edu; human. subjects@yale. edu