The IRB: An Invitation to the Research Realm Anne Marie Hobson, BSN JD Director, Office Research Affairs Lankenau Institute for Medical Research

Agenda History IRB Description IRB Submission Process

Historical Perspective The National Research Act of 1974 established the modern Institutional Review Board (IRB) system for regulating research involving human subjects. The Department of Human Health Services (DHHS) promulgated the main IRB regulations in 1981 in Title 45, Part 46 of the Federal Code of Regulations (45CFR46) (continues to undergo revisions) In federal agencies adopted the HHS regulations, now referred to as the Common Rule The FDA has not adopted the common rule - similar regulations codified under Title 21, Part 50, 54 & 56 apply to the IRB and human subject research

Principles of the Belmont Report Respect for Persons treat individuals as autonomous agents Beneficence risk/benefit analysis Justice distribute the risks and potential benefits

What is the IRB? “The IRB is a committee whose primary responsibility is to protect the rights and welfare of research subjects and to function as a kind of ethics committee focusing on what is right or wrong and what is desirable or undesirable. The IRB is thus required to make judgments about what individuals and groups ought to do and how they ought to do it.”* * Amdur, R.J, The Institutional Review Board Handbook

What Is the IRB? Not secretive - it’s not a star chamber By regulation made of at least 5 members A scientist A non-scientist A non-affiliated member A consultant can be used to assist in a review

Main Line Hospital IRB Composed of three subcommittees at Bryn Mawr, Lankenau and Paoli Also serves the research community at Riddle Memorial Hospital and Bryn Mawr Rehabilitation Hospital Committee meetings are monthly schedule posted on the web

Is it research? Activity defined as “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” “Systematic” = research methods are employed to test a hypothesis and draw conclusions “Generalizable” = to disseminate or intend to disseminate findings to a scientific or other professional audience

Does it involve “human subjects”? Human subject = a living individual about whom an investigator (whether professional or student) conducting research obtains: –DATA by intervention or interaction with the individual Or – IDENTIFIABLE PRIVATE INFORMATION (where the identity of the subject can be or may be readily ascertained by the investigator, or where the identity of the subject is associated with the information)

Educational Requirement Collaborative Institutional Training Initiative (CITI) Web based introduction to research The BASIC training courses are valid for 3 years. After 3 years, you are required to re- certify by taking an online REFRESHER Course

How does the IRB review research? May judge activity not to be research if it doesn’t involve human subjects May decide to exempt the research May decide to expedite the research Otherwise, will conduct full board review

Exempt Human Research Research conducted as part of an established or commonly accepted educational practice Surveys, interviews or observations of public behavior, unless: –Information is recorded in such a way that human subjects can be identified directly or through identifiers linked to the subjects AND –Any disclosure of the information outside the research study could reasonably place a subjects at risk of criminal or civil liability, or be damaging to financial standing, employability or reputation

Exempt Human Research 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 in such a manner that the subjects can not be identified, directly or through identifiers linked to the subjects

Expedited Review Collection of –Small amounts of blood by venipuncture, finger, heel or ear stick –Biological specimens by noninvasive means –Data collected by noninvasive procedures routinely employed in clinical practice –Data composed of voice, video, digital or other image Research involving –Data, documents, records or specimens collected (or to be collected) solely for non-research purposes (e.g. medical treatment or diagnosis) –Individual or group characteristics of behavior that does not qualify for exempted research

Expedited Review Must still be submitted to the IRB Reviewed internally Approved by the Chair (Dr. Keshgegian) One year approval WITH annual continuing review Once approved, the Principal Investigator receives a letter from the Office of Research Affairs signed by the IRB Chair with IRB Stamped Approved Consent for use with research subjects.

Full Board Review Any study determined to be greater than minimal risk = all clinical trials Or A study determined to be minimal risk but does not fit an expedited category Any biopsies or blood draws over the regulatory allowable limits Any radiation exposure for research purposes, or MRI with sedation

The Protocol Purpose Subject Recruitment/Selection Location Background Research Design Risks/Benefits Confidentiality

The Informed Consent Document Background/Purpose Procedures Risks and Side Effects Alternative Treatments Benefits Compensation Questions/Contact Persons Confidentiality

MLH IRB Protocol Review Pre-review by ORA staff to check for completeness of protocol Assigned to 2 Primary Reviewers Information packets containing the protocol, the informed consent document, and any additional materials (such as the investigator brochure) is sent ~10 days before the meeting to all IRB members

Criteria for IRB Review and Approval of a Study Risks are minimized Risks are reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may be reasonably expected to accumulate Subject selection is equitable Informed Consent will be sought from each prospective subject or from the subject’s authorized representative Informed consent will be documented

Other Criteria for IRB Review and Approval of a Study Where applicable, the research plan makes adequate provision for: Monitoring the data collected to ensure the safety of the human subjects Protecting data privacy and confidentiality Safeguarding vulnerable populations

At the meeting… Primary reviewers present the protocol, providing a brief synopsis Discussion is open to all members Questions may be posed by any member The PI is invited to the meeting to provide additional information, explanation or to answer any outstanding IRB questions The IRB votes on approval of the protocol

IRB Full Board Decisions* Approval Withheld Approval Tabled Disapproved * In all instances the Principal Investigator receives a letter from the Office of Research Affairs signed by the IRB Chair. Once approved, the Principal Investigator receives a final approval letter signed by the IRB Chair with IRB Stamped Approved Consent for use with research subjects.

Protocol Amendments ANY change to the protocol or the informed consent document requires submission of an amendment Some amendments can be expedited; others require full board review Formal approval and IRB stamped consent form will be issued as with a new study

Continuing Review All expedited or full board approved studies must be reviewed at least yearly PI submits a continuing review form Form basically serves as a snapshot of the research (what happened in the last year) Depending on the study, continuing review may be expedited, but most initial full board approved studies will require full board continuing review Formal approval and IRB stamped consent form will be issued as with a new study

Where to start? Familiarize yourself with our Website at: From the ORA website: –Complete IRB Training Requirements –Review flow diagram “How to Apply for IRB Review” –Prepare documents as outlined in “Requirements for IRB Submissions/Applications” A research mentor is an excellent resource!

Contact Information Lankenau Institute for Medical Research Suite G-44, NEB Alia Dudley, Analyst Theresa Greaves, Manager Nancy Havens, Administrative Assistant Anne Marie Hobson, JD, Director Albert A. Keshgegian, MD, Ph.D., IRB Chair