**PRIM&R 2005**

**Session A13**

**Writing 101 for IRB Administrators: Effective Written Communication in
Tough Situations**

Karen M. Smith, PhD

Regional Office Director

Midwestern Region, Office of Research oversight

Veterans Health Administration

**SOME COMMON FINDINGS AND CONCERNS**

> **[Minutes]{.underline}**

-   Do not describe the nature of amendments

-   Do not show how waivers of consent are justified

-   Do not show SR-NSR device determinations

-   Do not show required determinations for research involving children
    or prisoners

-   Unclear about modifications required by the IRB

-   Do not document discussion and/or IRB decisions about Serious
    Adverse Event reports

-   Unclear about IRB decisions

-   Unclear about substance and resolution of controverted issues

-   Do not identify the primary reviewer

-   Do not distinguish between abstentions and recusals

-   Confuse the non-scientific member with unaffiliated or "community"
    member when documenting quorum

-   Do not tracking the exit and entry of members during to meeting to
    demonstrate quorum was maintained

-   Do not consistently document the term of approval

> **[Letters]{.underline}**

-   Inconsistent with the facility's policies or procedures

-   Unclear about IRB requirements for changes

-   Unclear about the IRB's reasons for
    disapproval/suspension/termination

-   Boilerplate letters vague about expectations

**SOME REAL LIFE EXAMPLES**

**1. Entire minutes entry for a series of local site SAE's:**

> \(2\) \"Study XYZ\", P.I. Researcher, M.D.- The following adverse
> events concerns \[local site\] patients. The IRB reviewed adverse
> event report concerning patient A who expired on \[date\] at
> \[hospital\] His wife reports his death was caused by internal
> bleeding. An autopsy was not performed. The subject was enrolled on
> study \[date\] and was assigned study \# A. Patient B expired at home
> on \[date\]. The patient had a longtime history of cardiac problems.
> No autopsy was performed. The patient was assigned study number B.
> Patient C reported at x day follow-up that he had been hospitalized.
> The patient\'s wife was contacted on \[date\]. The patient woke up in
> the middle of the night complaining of his heart racing. His wife
> checked his heart rate which was 174 with a BP at 110/70. She
> subsequently called EMS and the patient was taken to a local hospital.
> The patient responded to medication IV and was stabilized. He
> underwent a cardiac catheterization on \[date\] in which 3 stents were
> placed. The patient has had no further problems since discharge on
> \[date\]. The patient was started on drug 1 and drug 2. The patient
> was x days post \[intervention\]. Patient D began to feel poorly x
> days post \[intervention\]. He developed \[symptom\] approx. \[date\]
> and saw his PMD. Urinalysis revealed gross hematuria with some wbc, dx
> \"prostatis\", Rx levoquin. He presented to ER 3/1 with cc: \"anuric\"
> and was admitted with creatinine \>11. The patient was acutely
> dialyzed and hyperkalemia controlled. Renal biopsy showed classic
> Goodpasture\'s Syndrome with 100% glomerular crescents, basement
> membrane immunofluorescence, IgBM 85(nl\<5).

**2. Minutes items on new proposals:**

> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> The IRB reviewed and approved the questionnaire that determines
> whether the caller meets eligibility criteria, the \"participants fact
> sheet\" that summarizes the research project for the potential
> participants, the introductory interviewer dialogue that will be used
> to obtain informed consent, the participant response booklet that the
> participant will use to facilitate answering the interview questions,
> and \"interviewer fact sheet\" that the interviewer will use as an
> information resource to respond to questions that potential
> participants may ask about the study. Final approval of the newspaper
> advertisement is dependent upon approval of the public relations
> officer. The consent form was approved contingent upon the following
> modifications:
>
> The consent form should:
>
> State the number of subjects to be enrolled
>
> Advise subjects that they will receive the medical care necessary to
> treat injury resulting from participation.
>
> Advise subjects that they will receive some compensation even if they
> withdraw during participation.
>
> Advise subjects of the approximate length of time it will take to
> receive compensation.
>
> The investigator will also be requested to provide some detail as to
> how the consent form will be administered. A minor modification was
> recommended in the administrator\'s script.
>
> The motion to approve the pilot test as redeveloped was seconded and
> approved unanimously. The total vote= 10. There were 10 votes in favor
> of the motion, 0 opposing and 0 abstentions.
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

1.  **[New Study:]{.underline} [PI:]{.underline}** Some Doctor, M.D.
    **[Study Title:]{.underline}** A Study. **[Items
    Submitted:]{.underline}** Project Checklist, Project Data Sheet,
    Budget, Conflict of interest forms, Complete Protocol, HCORP from,
    Informed Consent. **[Committee Action:]{.underline}** Dr Y.*,
    primary reviewer,* performed a detailed examination of this proposal
    as per HSC Informed Consent and Protocol Checklist (Appendix 2), and
    made a motion to **Approve the Study** contingent on: 1) Several
    changes to the Informed Consent Form, 2) PI does provide the 10% HSC
    fee as per policy. 3) Several changes to the Protocol. Dr. Y made
    the motion to approve the study for 12 months at minimal risk
    contingent upon full committee review of the above changes. The
    motion received a second from Dr. Z, and the committee voted to
    approve the study with the above contingencies.

> **TOTAL: \_9\_ For: \_9\_ Against: \_0\_ Abstained: \_0\_**
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

**3. Excerpts from minutes for an apparently controverted issue:**

> PROTOCOL QUESTIONS
>
> -\>Will parts of this study (surgery) take place at the \[University
> affiliate\] or exclusively at the VA?
>
> -\>Will VA patients be asked to sign \[university affiliate\] Consent
> Forms?
>
> -\>If parts of this study will take place at \[university affiliate\],
> then Dr. A must submit the \[university affiliate\] IRB approval
> letter and copies of the approved versions of the \[university
> affiliate\] Consent Forms
>
> ...\[some other stuff omitted\]...
>
> VA CONSENT FORM -- GENERAL COMMENTS
>
> -.The Committee agreed that there is a significant amount of jargon
> and scientific terminology used to describe each procedure.
>
> -\> Some members of the Committee noted that patients with paralysis
> are well informed in the medical descriptions of their condition and
> they should be able to understand the information in these consent
> forms.
>
> -\>Other members of the Committee felt that the 2 VA Consent Forms
> were far too long and too difficult for patients to understand. The
> documents were written as if everything will work as planned without
> any alternate possible outcomes. The consent forms should be rewritten
> at a 6^th^ grade reading level.
>
> After much discussion, the Committee agreed that many of the
> explanations should be simplified and the investigator should reduce
> the amount of scientific jargon.
>
> VA CONSENT FORM CORRECTIONS -- SCREENING CONSENT
>
> \[long list of specific corrections, none of which address the problem
> of jargon or reading level\]
>
> **ACTION TAKEN:**
>
> **APPROVED, New Study with 2 VA Consent Forms**
>
> *\*\*Pending submission of revised VA Consent Forms with the requested
> corrections (to be reviewed by Dr. C and two IRB members)*
>
> *\*\*Pending completion of the required training in Human Studies
> Research and Good Clinical Practice by Investigators X, Y, and Z.*
>
> RISK LEVEL=MODERATE (6 months)\\
>
> (5=for, 3=opposed, 0=abstain, 0=not present)

**4. A variety of justifications for waivers of consent**

> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> The IRB heard Dr. X\'s presentation and had no major concerns with the
> study. The Subcommittee waived the requirement for informed consent as
> the information required for the study is existing in \[local site\]
> databases.
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> This is a retrospective study of prostate cancer patients treated with
> a pattern of reducing treatment areas with increased dose. The data
> will be de-identified prior to the analysis.\
> \
> WAIVER APPLICATION FORM CORRECTIONS\
> -\>Item 1, the investigators must identify the specific PHI that will
> be accessed for this study within this form.\
> \
> **ACTION TAKEN:\
> APPROVED, New Project with Waiver of Informed Consent\
> ***Pending submission of revised Waiver Application Form with the
> requested correction\
> *[The risks are reasonable in relation to benefits to subjects and the
> importance of knowledge to be gained.\
> The risks of the study have been minimized to the extent possible.\
> ]{.underline}RISK LEVEL= MINIMAL (12 month approval)\
> (9=for, 0=opposed, 0=abstain, 1=not present)
>
> [A waiver of patient authorization for access to protected health
> information has been granted for this protocol.\
> ]{.underline}1. This waiver was reviewed and approved under normal VA
> IRB review procedures (38 CFR 16.108(d)).\
> 2. The approval is granted based on the IRB's determination that the
> risk to the privacy of individuals is minimal based on:\
> a) the investigator's plan to protect the identifiers from improper
> use or disclosure, and\
> b) the investigator's plan to destroy the identifiers at the earliest
> opportunity consistent with the research, and\
> c) the investigator's written assurance that the PHI identified below
> will not be reused or disclosed outside the VHA, except as detailed in
> the request for waiver of authorization.\
> 3. The VA IRB determined that the research could not be practicably
> conducted without this waiver of authorization or without the PHI
> identified below.\
> 4. The PHI that may be used or disclosed for this protocol is limited
> to: \[list of data to be collected\]
>
> \-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
>
> As applicable, the requirement to obtain informed consent for the
> studies listed in this section is waived per 45CFR 46.116(d) (1-4)
>
> **\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**
>
> The Board determined that this research meets the regulatory
> requirements for a waiver of informed consent under 45 CFR 16.116(d)
> for the retrospective chart review and the identification of subjects
> to be contacted directly. Specifically, this portion of the research
> involves minimal risks, does not affect the rights and welfare of the
> subjects, it is impracticable to obtain informed consent. The subjects
> will not be provided with information.
>
> **\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--**

**5. Entire minutes entry for an amendment:**

> **3. "Study Number and Title"**
>
> Amendment: Version 15 dated 7/18/03, revised consent (12/15/03)
>
> Approved with no changes (or no additional changes).
>
> Total Number Voting (5 ); Number voting for ( 5); Number voting
> against (0); Number abstaining (0 )

**6. Entire minutes entry for a new proposal:**

+----+-----------------+-----+-------------+--------------------------+
| 46 | Investigator A  | IRB | Minimal     | The Effectiveness of     |
| \. |                 | \#  |             | Drug X in Disease Y: A   |
|    | Researcher B    |     | Children    | Multi-center randomized  |
|    |                 |     |             | controlled trial         |
|    | Researcher C    |     |             |                          |
|    |                 |     |             |                          |
|    | Sponsor:        |     |             |                          |
|    |                 |     |             |                          |
|    | Federal Agency  |     |             |                          |
+----+-----------------+-----+-------------+--------------------------+

> This is such minimal risk, that it does not need discussion.