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Buena Vista University

Inspired by “Nuts and Bolts of CGU IRB procedures” written by Dean R. Gerstein, PhD, Vice Provost for Research and Krissyvan Khamvongsa, MA, Assistant Director of Research of Claremont Graduate University, February 6, 2009

Institutional Review Board and Institutional Animal Care and Use Committee

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The Purpose of IRB and IACUC Review The purpose is to assure compliance with defined federal

regulations (e.g., 45 CFR Part 46) and college policies. The IRB or IACUC did not author those policies but is responsible to implement them.

Specifically, the IRB is charged to 1) assure that faculty, staff, and students meet specific ethical standards

in all research that involves human (IRB) or animal participants (IACUC)

2) assure document compliance with federal regulations.

All such research must conform to the Belmont Principles for protection of human participants, as well as the Animal Welfare Act for the proper care and treatment of research animals.

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The IRB DNA: The Belmont Principles

http://ohsr.od.nih.gov/guidelines/index.html

Beneficence Do no harm Maximize benefits & minimize harm

Justice Equitable distribution of burden and

benefits Respect for persons

Individual autonomy is respected Persons with diminished autonomy

need extra protection (special populations)

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The Nuremberg Code plays a role as well

The voluntary consent of the human subject is absolutely essential. --that the person involved should have legal capacity to give consent; --should be so situated as to be able to exercise free power of choice, without

the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion;

--should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

--requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him/her the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

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Focus of IRB Reviews

Minimization of risks Risk-benefits relationship Equitable selection of participants Informed consent process Consent documentation Data monitoring Privacy and confidentiality Vulnerable populations Conflicts of interests

IACUC DNA: The Animal Welfare Act

The Animal Welfare Act was signed into law in 1966. It is the only Federal law in the United States that regulates the treatment of animals in research, exhibition, transport, and by dealers. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act as the minimum acceptable standard. The Act is enforced by the USDA, APHIS, Animal Care agency.

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http://awic.nal.usda.gov/government-and-professional-resources/federal-laws/animal-welfare-act

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Who Serves on BVU’s IRB and IACUC?

4 faculty, one of whom must be in science, one of whom must be a different gender (IRB can/should request review help from others when expertise is missing from board)

At least 1 community member unaffiliated with BVU An expert reviewer must be designated and available for

consultation we have a medical doctor for IRB protocols and a veterinarian for

IACUC protocols

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Information about BVU’s IRB and IACUC

We are on the website: www.bvu.edu/irb/ Basic information about research ethics, federal regulations,

and answers to FAQs. Proposal forms & examples of consent and debrief forms Resources (links to government and other organizations) This slide show is there

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Determining the Applicability of 45 CFR Part 46(do I need the IRB or IACUC)

Consider the following questions:

Does the activity involve Research? Research is “a systematic investigation designed to develop or contribute to generalizable knowledge.”

(The IRB can advise on issues for classroom activities but is not required to review them…research is held to a higher standard)

Does the activity involve Human Participants? Human participants are “living individuals, about whom an investigator obtains data through intervention or interaction with the individual or identifiable private information from some other sources.” If data come from nonliving people, living relatives also have rights.

Is there an animal involved? Any living or dead, warm blooded animal used for research, teaching,

testing, experimentation or exhibition purposes

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IRB Classifications for Review Classification is determined by the IRB Exempt. Studies to improve or evaluate standard practices in

educational institutions; fully anonymous non-sensitive surveys; analysis of pre-existing anonymous data; the participants are elected or appointed public officials or candidates for public office; other specific exemptions (e.g., classroom activities) Reviewed by chair or chair designee http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

Expedited. No more than minimal risk, no special populations such as pregnant women, prisoners, minors, mentally disabled. Reviewed by chair or chair designee http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

Full Board Review. Higher than minimal risks or studies of special populations, including members outside of Buena Vista University.

Human Subject Regulations Decision Charts: http://hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm

IACUC Classifications for Review

Designated member review The chair may designate a primary reviewer, who has the following options: Approve the protocol or amendment, if satisfied that approval criteria are met Request revisions to the protocol or amendment to secure approval, if

outstanding issues are present Request FCR, if further review of the protocol or amendment is warranted

Full Committee Review

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Who Submits to the IRB or IACUC?

In 2010-11, the IRB reviewed 118 proposals and approved 111 of them (73 expedited, 45 full board)

Humanities: 11

Social Studies: 62

Science: 34

Interdisc/staff: 11

Everyone!!!!!!!!(Who is doing research)

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Review Process

The IRB and IACUC accept written proposals to review specific study designs (“proposals”) from faculty, staff, or students via email to the chair of the committee.

The proposal form can be found on the IRB website. The chair expeditiously reviews all submissions, determines

their review status and follows the process of the designation. The IRB currently meets on the fourth Wednesday of the

month. To insure review, please submit at least one week prior.

The current forms must be used and directions followed or proposal will be returned for compliance.

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Review Process, continued The total elapsed time from receipt of proposal to approval can

be as little as one week, exempt designation or designated reviewer, but full board reviews may take up to 30 days.

However, there is wide variation in the time frame, mostly depending on how long the applicant takes to respond to questions and comments. Some proposals may require several revisions before approval is granted.

In full board reviews, the chair compiles comments and sends them to the researcher. Usually, but not always, the board seeks written clarification or revision of one or more elements of the proposal.

A research project may not continue without IRB or IACUC approval.

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Process for Submitting a Proposal

All on research team complete ethics training (includes mentors of student research projects)

Complete the proposal form as is (designated as 2014)

Attach consent forms and other materials – please submit as one complete file

Email file(s) to the chair with request for review.

Chair receives email, documents proposals on IRB storage server space, convenes the necessary board members to review proposal, & notifies principal investigator of outcome of the review. An approval letter is sent to designated PI.

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The Proposal: Form and Project Description To reiterate: Please use the current IRB or IACUC application

form:http://www.bvu.edu/irb

The project description should be written for an audience that includes non-scientists—minimize and clearly define all jargon.

Write clearly and concisely, and with ethics in mind—show awareness of issues related to IRB or IACUC concerns(If the researchers cannot articulate the purpose, procedures, and risks of the research, how can the board be sure they can articulate them to participants?)

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Responding to IRB Questions and Comments

IRB and IACUC responses are sent via email from the chair to the PI and/or faculty advisor

Responses to reviews should document changes made in the revision, and if appropriate, highlight changes in the revised documents. (i.e., use the model of “letter to the editor” of manuscript reviews; don’t just send a revision attachment without a letter to the chair).

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Aftermath: Modifications and Continuances

When to use the Modification form? For any changes to approved protocols, use the

modification form Key point – any change, no matter how trivial it appears,

must be officially requested and approved on a paper form. Paper trail is vital for everyone’s protection

How to request a time extension? Send an email to the chair that identifies the researchers,

project title, and date of the original, approved proposal. Explain the need for a time extension. This email documents the extension, and approval is given when there are no ethical concerns for continuance. Full board review will occur if the chair denies the extension.

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Pay Attention to: Documentation of informed consent Confidentiality (keeping it secret) Vs. Anonymity (no names

taken or learned in data acquisition and storage) Deception (Is it absolutely necessary?) Ethical issues clearly addressed Special populations/sensitivity issues Clarity and organization Grammar and spelling

Correcting mistakes or interpreting the intent of the proposal is not the purview of the IRB/IACUC and considerably burdens the process. Proposals may be returned –without review– for correction.

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Informed Consent

Age of Consent Participants over 18 years of age or parents of minors

Waiver of Signed Consent (rarely given)

(1) When the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.

(2) When the research presents no more than minimal risk to participants and involves no procedures for which written consent is normally required outside of the research context. In this case, documenting consent can be oral or witnessed by others.

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Informed Consent Follows the Nuremberg Code

1. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

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Informed Consent & the Nuremberg Code

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

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Informed Consent & the Nuremberg Code

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control

Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.

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Most Common Mistakes

Not documenting completion of ethics training Inadequate information on consent form Poorly written project descriptions Information on proposal form does not match project

description Inappropriate title for proposal Typos (especially on consent forms)

Attendance to detail matters because the quality of consent forms represent Buena Vista’s standing as a research institution, as well as a form of legal protection for all involved; the standards of research are considered higher than other documents produced for class.