Basic of the IRB Application Sam Bruton, PhD Director of the Office of Research Integrity Jennifer Downey, MA, CIP Special Assistant to the Vice President for Research April. 11, 2018

Guiding Ethical Principles Participant Autonomy (informed consent) ”Beneficence” – reasonable balance between risks and possible benefits. Justice (participant sample is fair). Guiding Ethical Principles

What has to be Reviewed: Projects that both: 1) involve human subjects 2) are research

Human Subjects: “a living individual[s] about whom an investigator... conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information.” (Note: ‘archival data’ is problematic b/c ambiguous.) (Also, ‘identifiable’ includes by investigator, even if kept confidential) Research involving secondary use of data: Projects that use data on human subjects gathered in earlier projects and in which individual identifiers are present require IRB review OHRP does not consider research involving only coded private information or specimens to involve human subjects as defined under 45 CFR 46.102(f) if the following conditions are both met: (1) the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and (2) the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain. From Hosman: It depends on the secondary data set. There are some that require an IRB approval. On one case I am familiar with, it would be possible to disaggregate the data such that you know who a respondent was. The people controlling the data wanted an IRB review in which the PI acknowledged that they would not disaggregate the data.

Research: research is “a systematic investigation...designed to develop or contribute to generalizable knowledge.” Excludes, e.g. institutional assessment/quality control studies; class assignments, typically. Concept is not precisely coextensive with “publishable” or “intent to publish”. Evaluation vs. Research

Special Populations Subpart B – Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects Subpart D – Additional Protections for Children Involved as Subjects in Research Subpart E – Registration of Institutional Review Boards The ethical principles for research involving human subjects described in the Belmont Report are codified in the Code of Federal Regulations, 45 CFR 46. Subpart A – Basic HHS Policy for Protection of Human Research Subjects, also called “The Common Rule,” Subparts B, C, and D describe additional protections for some of the populations that are considered particularly vulnerable: Subpart B Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects-- Research must be directly relevant to prisons or prisoners (e.g. the effects of incarceration, criminal behavior, prison infrastructures, etc.). Completion of the CITI Research with Prisoners Module is also required. Subpart D Additional Protections for Children Involved as Subjects in Research Subparts B, C and D define the specific categories of research in which pregnant women, human fetuses and neonates, prisoners, or children respectively may be involved. The subparts describe additional requirements for informed consent, and may specify additional responsibilities for the Institutional Review Board (IRB) when reviewing research involving these populations, and list the requirements for research that need additional levels of review and approval. Other vulnerable populations include, but are not limited to, mentally disabled persons and economically and/or educationally disadvantaged persons. While the regulations do not specify what additional protections are necessary for these groups, the HHS regulations (45 CFR 46.111) do require that investigators include additional safeguards in the study to protect the rights and welfare of these individuals “when some or all of the subjects are likely to be vulnerable to coercion or undue influence.”

Categories: Exempt Expedited Full Review CAVEAT!!: Category determinations are not within authority of investigators; only IRB

What slows down an IRB review? The IRB application does a good job of leading you through the information that an IRB reviewer will need in order to conduct his/her review. The application asks for certain narrative responses and also includes yes/no formatted questions and lists of items to be checked if they apply to your study. But here are some warnings about frequently occurring problems that the reviewers encounter:

Failing to attach documents properly. On the last page of the application form, item 42 lists documents that must be attached to the application: CITI Course Research proposal approval from Dissertation or Master's Thesis Committee Study recruitment documents Research Instrument ETC. Instructions for Attaching Documents: 1) Place the cursor where you want the attachment to appear. 2) Select the “Insert” tab at the top of MS Word. 3) Select “Object,” located on the far right of the tool bar (PC) or the bottom of the list (MAC) 4) Select the “Create from File” tab and check the box that states “Display as Icon.” Note: Do not check the box that says "link to file." 5) Browse to the location of your document, and double click on it. 6) Repeat these steps for each document to be attached. Note for Mac Users: Word for Mac is unable to attach .pdf files, so Mac users will have to first save the Citi certificates or any other .pdf files as .doc or .rtf files before attaching them. There are several ways to accomplish this. You may use Adobe to open the file and then select “File” and “Save as” and change the file type to an .rtf or .doc format. Alternatively, you may also download or create your own .pdf to .doc application or simply save the application and then open the file on a PC to attach as instructed above.

A Recent Example

Leading to….

And…

2. Failing to attach required current CITI training course certificates (Common Course and IRB) for both researchers and advisors (if applicable). CITI Common and Human Subject Research Courses are required for all co-investigators as well as the principal investigator. The following documents must be attached to this form: CITI Common Course Certificate (mandatory for all USM investigators and student advisors) CITI Human Subjects Course Certificate (mandatory for all USM investigators and student advisors) Both CITI certificates or alternative documentation of research ethics training for all non-USM investigators

3. Use of Outdated Forms: http://www. usm 3. Use of Outdated Forms: http://www.usm.edu/research/institution al-review-board Research proposal approval from Dissertation or Master's Thesis Committee (if applicable) Study recruitment documents (if applicable) Research Instrument (if applicable) Assent form for minors (if applicable) Consent forms (long or short) and any related documents Letter to parents (if applicable)

4. Failing to have appropriate external agency permission documents attached. On letterhead and SIGNED If agency requires IRB approval prior to providing the letter of permission, then you must have the agency write the letter saying, “Upon approval by the USM IRB, our agency will allow the recruitment of subjects…”

5. Failing to include all relevant information and attach relevant supplemental documents (survey instruments, consent forms, and recruitment materials). Research proposal approval from Dissertation or Master's Thesis Committee (if applicable) Study recruitment documents (if applicable) Research Instrument (if applicable) Assent form for minors (if applicable) Consent forms (long or short) and any related documents Letter to parents (if applicable)

Failure to appropriately modify consent template language. Especially

6. Researchers sending in applications directly, rather than having them sent in by department chair or unit head. Researcher Chair IRB Note: Receiving IRB applications directly from the department chair or unit head is the IRB’s way of verifying that the relevant supervisor knows of the project and approves. The applicant types in their name and date as primary investigator Graduate students should email the form to their advisors, who should REVIEW the completed form (and hopefully work with the student to make sure the application is as complete as possible). Advisors should provide a digital signature where indicated. Then the form should be sent by the advisor to the department chair for REVIEW. Department chairs should add their name and send the finalized form with all required names to irb@usm.edu. MUST BE SUBMITTED ELECTRONICALLY—NO HARD COPIES ACCEPTED. Instructions for Digital Signatures: By typing my name below, I acknowledge that I have read, understood, and approve of the information contained herein.

Not sending to irb@usm.edu Relatedly:

7. Typos and inconsistencies

8. Confusing anonymity with confidentiality. Does your research involve non-anonymous surveys (lot of confusion about anonymous vs. confidential) ‘Anonymous’ means that research data cannot be identified with individual subjects. Electronic surveys must be conducted via websites that do not link responses to e-mail addresses or other identifiers. Personal interviews are not anonymous.

9. Confusion about “disposition of data” -- not sufficient to say merely “stored in password-protected computer.” Does your research involve non-anonymous surveys (lot of confusion about anonymous vs. confidential) ‘Anonymous’ means that research data cannot be identified with individual subjects. Electronic surveys must be conducted via websites that do not link responses to e-mail addresses or other identifiers. Personal interviews are not anonymous.

10. Failing to explain research procedures and purpose of the research clearly and in sufficient detail. If I can’t clearly understand the purpose of your research, I can’t determine the merit of the research. Without understanding the merit of the research, I can’t with good conscience, approve of ANY risk or even inconvenience to the human subjects. Provide enough detail to help me understand the purpose of the research and the procedures to be followed.

Failing to describe previous research experience. Especially:

11. Confusing different consent procedures and forms

12. Misunderstanding about when a waiver of informed consent is permissible The HHS regulations (45 CFR 46.116(c)) allow IRBs to waive or alter some or all of the required elements of informed consent if all of the following conditions are met: “The research involves no more than minimal risk to the subjects. The waiver or alteration will not adversely affect the rights and welfare of the subjects The research could not practicably be carried out without the waiver or alteration. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.”

13. Consent forms contain jargon or are written at too high a level.

14. Failing to respond adequately to revisions requested by the reviewer. If the reviewer requests that you fix x, y, z, and you do not do so, you should not expect the reviewer to approve of your revision.

15. Knowing to submit modifications Requires approval before implemented (unless to eliminate safety issue) Will be evaluating the impact of change including the risk/benefit assessment “Minor” changes may undergo expedited review

16. Understanding renewals Investigators are responsible for monitoring the approvals for their studies. Must be done no less than annually for ongoing studies More frequent review may be necessary for some research studies

Questions?

Director of Office of Research Integrity Contact Info Dr. Sam Bruton Director of Office of Research Integrity Samuel.Bruton@usm.edu 266-6756 IC 418 Jo Ann Johnson IRB Manager Joann.johnson@usm.edu 266-5997 IC 417 Striking – most people say they understand