Not research, Exempt research, and Expedited research

Bob Craig, Ph.D.

Director, Research Compliance 2008

First, is what you are doing research?

 There are Federal guidelines that define research and “human participant research”  Some studies that are sent to Office of Research Compliance are clearly not research. If this is the case, they do not require IRB or ORC input.

Not research in BRAAN II

 Question in BRAAN II (Second required category), Human Subject Research  There are three questions. All three must be answered “yes”

Questions

 First, does the protocol meet the federal definition of “Research”  The federal definition is provided in the “help” icon and is  “a systematic investigation designed to develop or contribute to generalizeable knowledge”  Additional information in “help” icon.

Questions

 If the first question is answered “Yes”, two additional questions appear. They must also be answered “yes” for the project to be considered Human subject research.

Questions

 First question: Does the research involve living persons? Yes or No  Second question: Are you collecting private information as part of this research? This does not refer to Protected Health Information (PHI).

Is it research?

 Most case reports and most oral histories are not generalizable and, therefore, not research.

 Many classroom projects, if not intended to be published, are also not research.

Is it research?

 Many quality improvement projects are not research.

 Many program evaluation projects are not research.

Is it human subject research?

 Is the information about a living individual?

 If the answer is no, it is not human subject research.

However, if the study involves the collection of protected health information (PHI), even if the patients have died, a HIPAA waiver may be required and will need to be processed by the IRB as research.

If not human subject research

 If the investigator knows the project is not human subject research, it is not necessary to send to the Office of Research Compliance.

 However, the PI may go to BRAAN II and answer first three questions, if desired.

 The Office of Research Compliance will issue a form indicating that what you want to do is not human subject research.

 Sometimes required by funding agencies.

Exempt research

 Assume three questions have been answered “yes”

What is “Exempt Research”?

 Some human subject research is exempt from the necessity for IRB review by 21 CFR §56.104 and 45 CFR §46.101(b)(2).  If it is judged to qualify as exempt, research must still be reviewed and must be conducted in accordance with WVU policies, the Federalwide Assurance, federal guidelines and the ethical principles stated in the Belmont Report.

Who evaluates exempt research?

 The Research Compliance Office (Barb White) since the advent of BRAAN II.

Categories

  There are 6 distinct categories for exemptions. There are some that we don’t receive.

 Information on these, seldom used, categories and additional information on ones discussed here, can be obtained at the WVU Research Compliance website (Document 210r) or the appropriate Federal Regulations.

Category 1

 Research conducted in established or commonly accepted educational settings involving normal educational practices.

 It would include research on educational strategies, comparison among instructional techniques, or classroom management methods.

Category 2

 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if human subjects cannot be identified directly or through identifiers

Category 2, cont’d

 When survey procedures involve sensitive questions, there should be provisions to make sure that the procedure provides anonymity. If anonymity is promised, there must be a clear explanation of how this will be accomplished.

 Also, must provide information on where to go for counseling (i.e., Carruth Center or other)

Category 3

 Research involving the use of educational tests (same as category 2), but the human subjects are elected or appointed public officials, or candidates for public office.

Category 4

 The research involves the collection of existing data, documents, records, pathological specimens, or diagnostic specimens. 

The reviewed materials must currently exist and may not be collected after the protocol is approved.



The data to be collected and recorded must be described. A complete list of variables to be collected, must be submitted.

Category 4 (part II)

 The information to be collected or studied: Must be publicly available or, Information is recorded by the investigator in such a manner that participants cannot be identified either directly or through identifiers linked to them.

Category 5

 The project is a research or demonstration project or  The project is conducted by or subject to the approval of a particular Federal Department or Agency head.

 Consist of study, evaluation, or examination a public benefit program

Category 6

 The research involves taste and food quality evaluations and consumer acceptance studies.

Reviewers action

 1. Determine that the project is human subject research.

 2. If it is, determine that it fits a particular category for exempt acknowledgment.

 3. Check additional 12 points on checklist (Document 210r)  4. Notify investigator that research qualifies as exempt and under which category.

Additional requirements for exemption

 The procedures must be adequately described.

 There must be no more than minimal risk; this needs to be adequately explained.

 The selection of participants must be equitable, and this must be explained.

 If investigator interacts or intervenes, it cannot be exempt.

Additional points.

 If medical records are accessed, the nature of the data to be recorded must be explained in detail.

 If identifiable PHI is to be collected from medical records, a HIPAA waiver of authorization is required.

 The need for HIPAA waiver must be justified and explained.

Additional points

 The research does not involve prisoners as participants  There are copies of all advertisements, surveys, scripts, cover letters, and letter of permission.

 If incentives are provided (extra credit, coupons, vouchers), they must be justified and explained.

Coercion and undue influence

 Care must be taken to ensure that there is no coercion or undue influence placed on potential subjects. For example, if faculty member wants to use his/her own students as subjects, it must be made clear that there are no penalties for not participating. Same for employer/employees, coach/players, etc.

Cover letter

 If a cover letter is used in conjunction with a survey or questionnaire to explain the study, the first item must be a statement, “This is research”

Cover letter

A statement that explains the reason for the research (dissertation project, course requirement, etc) A statement explaining what the study is designed to show.

A statement that subjects’ response will be kept anonymous or confidential and explain how this is to be accomplished.

Cover letter

 If audio taping, inform subject and explain storage and disposal of tape.

 A statement that not all questions need answered.

 A statement that class standing, job, grades, etc. will not be affected if subjects does not participate.

 A statement that participation is voluntary.

 If sensitive questions are asked, provide counseling information.

HIPAA waiver

 Use or disclosure of PHI must involve no more than minimal risk to privacy.

  Must be a plan to protect the identifiers from improper use Must have a plan to destroy identifiers at earliest opportunity.

 Must be written assurances that PHI will not be reused or disclosed, except as required by law.

 Must be statement explaining why research could not practicably be conducted without waiver and why it could not practicably be conducted without access to the PHI.

Exempt research and children

 Children can be subjects of exempt research

unless

the research involves the use of survey procedures or interview procedures.

 Observation of public behavior involving children can be exempt if the investigator(s)

does not

participate in the activities being observed.

Still more and summary

 A study cannot be exempt if:  A consent form is used  There is intervention with subjects  The study involves focus groups  The research is subject to FDA regulations.

Research reviewed under expedited procedures

 Research that fits these categories must be reviewed by the IRB.

Expedited Research

 Requires one or more experienced IRB reviewers, but does not require a convened IRB.

 There must be no more than minimal risk to subjects.

 The identification of participants will not place them at risk of criminal or civil liability or be otherwise damaging

Expedited

 The research must fit into one of several specific categories.

Category 1

 Research on medical devices in which an IDE is not required or if the device is approved for marketing and it is used in accordance with its labeling.

Category 2

 Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy non-pregnant adult where  Participants weigh more than 110 lbs and  Amounts drawn will not exceed 550 ml in 8 wk period and  No more frequently than 2/week.

Category 3

 Prospective collection of biological specimens for research purposes by noninvasive means.

Category 4

 Collection of data through noninvasive procedures routinely employed in clinical practice where:  No general anesthesia or sedation  Do not involve x-rays or microwaves  If medical devices are employed, they are approved for marketing.

Category 5

 Research involving materials (data, documents, records, or specimens that have been collected; OR  Research involving materials that will be selected solely for non-research purposes (medical treatment or diagnosis).

Category 6

 Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7

 Research on individual or group characteristics or behavior (including research on perception, cognition, motivation, identify, language, cultural beliefs, social behavior, etc.)

Category 8a

 The research is permanently closed to enrollment of new participants

and

 All participants have completed all research-related interventions

and

 The research remains active only for long-term follow-up of participants.

Category 8b

 The research is permanently closed to enrollment of new participants

and

 No participants have been enrolled and no additional risks have been identified.

Category 8c

 The research is permanently closed to enrollment of new participants

and

 The remaining research activities are limited to data analysis.

Category 9

 Medical Device research.

 The research is not conducted under an IDE

and

the IRB has determined that  The research involves no greater than minimal risk.

Summary

 Try to fit a research project into an exempt or expedited category if it can be done without compromising the study.

 It will save time and effort.