remedies for the top 10 stalls in the irb new protocol submission process university of indianapolis...

Remedies for the Top 10 Stalls in the IRB New Protocol Submission Process

University of Indianapolis IRB

February 24-25, 2010

University of Indianapolis IRB Members

Dr. Donna Konradi, IRB Chair (Nursing)

Dr. Matthew Beekley (Kinesiology)

Cory Clasemann, Human Protections Administrator

Dr. Lucinda Dale (Occupational Therapy)

Tracy Marschall (Social Sciences)

Dr. Fred May (Nursing)

Dr. Peter Rundquist (Physical Therapy)

Dr. John Somers (Teacher Education)

Dr. Jacqueline Wall (Psychology)

Alan Witchey (Community Member)

*Greg Manship

*Alternate member for Cory Clasemann)

UIndy IRB, February 24-25, 2010

IRB Review

• The purpose of IRB review is to maximize research participant benefit and minimize risk.

• Using the information in the protocol submission documents, the IRB reviewers weigh the benefits of participation against research-related risks for the prospective research subjects.


The Purpose of the Forum….

• Describe common problems that lead to “stalls” and delays in the IRB approval process

• Describe remedies for resolving common problems

• Provide resources from the Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) and other Federal Agencies regarding the criteria for IRB approval & the scope of the IRB’s obligations & responsibilities.


10 Stalls

1. Incomplete protocol submission

2. Clarity issues

3. Incomplete &/or missing requests for waivers

4. Information inconsistencies

5. Inability to determine based on the information provided if the research related activities are consistent with Uindy Policies and Procedures

6. Concerns about data security measures

7. Research team member roles and responsibilities are not clearly described.

8. Concerns about the research design

9. Research related activities are not clearly described

10. Submitted documents are not “research-ready.”


#1: The Incomplete Submission

• When required information is missing from the initial protocol submission, the IRB staff will contact the researcher with requests for additional pieces of information. The IRB will not distribute an incomplete protocol to committee members for review.

• Carefully review your institution’s submission checklist and make sure that all required elements are included with the protocol submission

a) Description of the informed consent process

b) Letters of informed consent / assent

c) Letters of cooperation / agreement

d) Recruitment materials

e) Verification of Human Subjects’ Protections Training

f) Data collection tools


a) Informed Consent / Assent Process Elements

WHO will be responsible for obtaining the informed consents?

WHO will answer the prospective participants questions about the research study?

WHERE will informed consent take place?

WHAT information will be provided to each participant?

HOW will participants receive information about the study?

HOW will the members of the research team verify that participants understand the essential informed consent elements?

WHEN will the participants provide their informed consent.?


b) Informed Consent Document Elements

Include all of the required elements on the informed consent document.

Provide the IRB with an exact copy of all consent / assent documents. After the IRB has approved the protocol, any & all changes to the letter of informed consent must be submitted as a project “revision” for approval.

Develop the Informed Consent document on institutional letterhead.


Resources for Developing the Informed Consent Document

Institutional Review Board Guidebook Chapter 3, Basic IRB Review (Section B Informed Consent). United States Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP)

General Requirement for Informed Consent, Protection of Human Subjects Title 45 Code of Federal Regulations §46.116

OHRP Informed Consent Frequently Asked Questions, United States Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP)


http://www.hhs.gov/ohrp/irb/irb_chapter3.htm#e2

http://www.hhs.gov/ohrp/irb/irb_chapter3.htm#e2

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116

http://www.hhs.gov/ohrp/informconsfaq.html

c) Letters of Agreement / Cooperation

Include with the protocol submission signed letter(s) of agreement or cooperation.

Each letter should include:• Name, position, and scope of authority for the individual

granting the research team access to the recruitment &/or data collection site and/or study sample.

• Language affirming that the signatory understands the nature of the research, understands any site responsibilities and agrees to provide access.

• The dates of facility involvement in the research


d) Recruitment Materials

Provide the IRB with exact copies for all recruitment documents & scripts (e-mails, phone scripts, announcement postings, in-person announcement scripts, etc).

Provide the IRB with detailed information about your recruitment procedures and strategies.


d) Required Recruitment Elements

1. Name and address of the researchers and the research facility

2. Purpose of the research

3. Eligibility criteria for participation

4. Anticipated participant benefits (if any)

5. Time or other commitments required of the participant

6. Location of the research

7. Individual to contact for additional information

Resource Recruiting Study Subjects, United States Food and Drug Administration (FDA).


http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm116329.htm

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm116329.htm

e) Human Subjects’ Protections Training

Provide the IRB with verification of human subjects protections training for all members of the research team.

Resource OHRP Investigator Responsibility Frequently Asked Questions, United States Department of Health and Human Services (DHHS).


http://www.hhs.gov/ohrp/investigatefaq.html

http://www.hhs.gov/ohrp/investigatefaq.html

f) Data Collection Tools & Measures

• Provide the IRB with all study-related tools, measures, surveys, and data recording forms. The IRB must receive these tools and measures in the exact form that they will be used in the research and distributed to the research participants.

• If participants will be accessing a survey or other measures electronically (ie. from an online survey hosting service), provide the IRB with a live link to the online survey.


Stall #2: The Confusing Submission

The protocol does not include a clear explanation &/or description of all research process elements

When the information provided by the researcher is confusing or unclear, the IRB will contact the researcher with requests for clarifications.

• Significant and distracting grammar errors that result in unclear communication

• Spelling errors and lack of precision with “word choice” • Missing, confusing &/or inaccurate information • Use of jargon


Stall #3: Incomplete &/or Missing Requests for Waivers

IF….• Federal waiver criteria are met but a waiver has not been

specifically requested by the researcher OR• A waiver is requested by the researcher but the Federal waiver

criteria have not been met

THEN…..• The IRB will ask the researcher to add or revise the Request for

Waiver documentation. The IRB can not approve a protocol unless requests for waivers meet the criteria described in the Federal Guidelines.


Stall #3: Requests for Waivers

Types of waivers• Waiver of documentation of informed consent

§46.117c• Waiver of informed consent §46.116c, §46.116d

The IRB will review all waiver requests based on evaluation of the criteria for waiver or alteration, and will approve, modify or deny each request.

The Waiver of Informed Consent document is available from the UIndy IRB website


http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=45&PART=46&SECTION=117&TYPE=TEXT

Resources for Additional Information about Waivers

Code of Federal Regulations Title 45 Public Welfare Department of Health and Human Services Part 46 Protection of Human Subjects §46.116 & §46.117

Protecting Personal Health Information in Research: Understanding the HIPPA Privacy Rule. Department of Health and Human Services (DHHS), National Institutes of Health (NIH)

Instructions for Waiver of Authorization or Altered Authorization: When may an application for IRB Waiver of Authorization or Altered Authorization be Approved by an IRB under HIPAA privacy rules? HIPAA Privacy Rule Research Guidance, Frequently Asked Questions

Institutional Review Boards and the HIPPA Privacy Rule, Department of Health and Human Services (DHHS), National Institutes of Health (NIH).


Stall #4: Protocol Inconsistencies

The description provided for participant research related activities is not consistent across all protocol documents

– Protocol description of research activities– Informed consent document(s)– Protocol description of informed consent processes– Recruitment materials– Letter of cooperation/agreement

When the information provided in the protocol is contradictory &/or inconsistent, the IRB is unable to evaluate participant risks and benefits.


Stall #4: Common Inconsistencies

The amount of time required for study participation is not the same on all study-related documents. Example: Identifies in the protocol that the focus groups will meet for 90 minutes; identified in the letter of consent that the focus groups will meet for 60 minutes.

The number of individuals needed for research study participation is not the same on all study documents. Example: Identifies a projected sample size of 50 participants in the protocol; identifies a projected sample size of 65 on the letter of informed consent.



• The words anonymous and confidential are used interchangeably. – Anonymous means that there is no link between the

participants and the data they provide. – Confidential means that there is a link between participants

and the data they provide.

Example: Describes a procedure for coding data that includes using a key to link individual participants to the information they provide on a survey document; States on the letter of informed consent that the method of data collection is anonymous.



Once involved in the research process, participants are asked to provide personal information beyond the scope of what was described during the recruitment process or during informed consent processes. Example: Participants are informed that they will be completing a functional assessment tool for range of motion. After signing the letter of informed consent, participants are asked to provide information about their workman’s compensation status.


Suggestions for Identifying and Resolving Inconsistencies

• If the protocol is developed by a group, then a final meeting should be scheduled to reconcile all parts of the protocol prior to submission.

• Content expert review• Peer review• Reasonable person standard: Review by a

reasonably intelligent individual who is not content expert


Stall #5: Unable to Verify if Research Procedures are Consistent with UIndy Policies

Based on the information provided in the protocol submission documents, the IRB is unable to determine if the research procedures will be consistent with appropriate UIndy policies related to research and data access.


Policy and Procedure Documents

1. Policy on Medical Emergencies and Accidents Incurred by Individuals Participating in University of Indianapolis Research Projects on Campus

2. Use of Professional Research Methods in the Classroom

3. University of Indianapolis Students as Research Participants

4. Procedures & Guidelines for access to the SOPS Research Pool


Stall 6: Data Security Concerns

Data security measures (or the explanation of data security measures) are insufficient and/or not adequate based on the type of data collected.

According to the NIH Policy for Data and Safety Monitoring:

1. Monitoring & data security should be commensurate with risks

2. Monitoring & data security should be commensurate with project size and complexity

Resource: NIH Policy for Data and Safety Monitoring, NIH Guide (July 10, 1998). National Institutes of Health.


Stall #6: Data Security Concerns

Specific IRB Concerns • Data security measures are insufficient for the type of data

collected.• Procedures for data storage, retention, and security are not

described. • Procedures for data storage, retention and security are not

appropriate for the type or format of the data.• Procedures for data coding are not addressed or insufficiently

described.• Does not correctly differentiate between de-identified, coded and

anonymous data.• Does not include sufficient data security strategies for protecting

the data “key” (the information that matches the participant identifiers to the coded data).


Stall #7: Research Team Member Responsibilities & Qualifications

To ensure that participant risks are minimized, investigators must provide evidence that they are sufficiently qualified to perform their research-related tasks and responsibilities.

If information about the researchers’ qualifications &/or credentials is unclear, the IRB will ask the investigators to provide this data.


Stall #8: Scientific DesignExamples of Design-Related Problems

• The relationship between the current study and previous research is not established.

• The links between the research questions (hypotheses statements); the research design; the specific types of data collected; the data collection tools or measures, and the data analysis procedures are unclear, inconsistent, &/or inaccurate.

• The link between the type of qualitative methodology (grounded theory, ethnography, focus group, etc) and specific research procedures is not clearly described.

• The researcher does not differentiate between inclusion criteria and research-related interventions.


Stall #8: Scientific DesignExamples of Design-Related Problems

• Rationale for collecting specific pieces of personal information is not provided.

• Rational for sample size is not provided.


Considerations of Research DesignIRB Guidebook, Chapter 4

• The value of research depends upon the integrity of study results. One of the ethical justifications for research involving human subjects is the social value of advancing scientific understanding and promoting human welfare by improving health care. But if a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even to inconvenience them through participation in such a study.

• One question that every IRB member asks is "To what degree is it our responsibility to review the underlying science of the proposed research?" Clearly, if it is not good science, it is not ethical.



• The federal regulations under which IRBs operate, however, do not clearly call for IRB review of the scientific validity of the research design. Nonetheless, they do require that IRBs determine whether "[r]isks to subjects are reasonable in relation to...the importance of the knowledge that may reasonably be expected to result" [Federal Policy §___.111(a)(2)]. If the underlying science is no good, then surely no important knowledge may reasonably be expected to result.



• Left without clear direction on this point, most IRBs appear to take the following approach, which has been described approvingly by Robert Levine (1986, p. 21): Where the investigator conducting the research under review is seeking funding from the federal government or other extramural funding agency, rigorous review of the science is left to the agency's peer review process. The IRB provides a less detailed examination to satisfy itself that there are no obvious flaws that would place subjects at unnecessary risk.



• Where the protocol will not receive such detailed scientific review, IRBs review the research design with much more care, perhaps with the assistance of consultants, if the IRB itself does not possess sufficient expertise to perform such a review. Levine suggests that IRBs should establish their authority to criticize the scientific merits of protocols and to exercise that authority to require that investigators correct design flaws identified by the IRB before receiving IRB approval, but that IRBs should recognize their limits in this regard as well. [See also Commentary by Levine following McLarty (1987), p. 3.



• Benjamin Freedman suggests that research must be both valid and of value [Freedman (1987b)]. Although IRB members do not need to be experts in scientific methodology or statistics, they should understand the basic features of experimental design, and they should not hesitate to consult experts when aspects of research design seem to pose a significant problem.

• The purpose of this chapter of the Guidebook is to provide some basic background information on scientific research design, some of the research techniques used by scientists, and some ethical considerations raised by these designs and techniques.

Resource: Institutional Review Board Guidebook Chapter 4, Considerations of Research Design, United States Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP).


Biomedical and Behavioral ResearchIRB Guidebook, Chapter 5

• Most behavioral research involves no physical intervention and no physical risk. However, some studies do present a risk of social harm (e.g., harm to a subject's reputation, which is sometimes a danger if confidentiality is not maintained) or psychological harm, which may occur if the research involves deception or provides subjects with unwelcome and disturbing information about themselves. When deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects will be debriefed. (Debriefing may be inappropriate, for example, when the debriefing itself may present an unreasonable risk of harm without a counterveiling benefit.) The IRB should also make sure that the proposed subject population is suitable. [See Guidebook Chapter 3, Section A, "Risk/Benefit Analysis.“]


Biomedical and Behavioral ResearchIRB Guidebook, Chapter 5

• Some studies involve the possibility of a moral wrong, which is what some commentators have labeled the ethical problems posed by deception of subjects or invasions of their privacy.

• IRBs need to determine whether any deception or invasion of privacy involved in a research protocol is justified.

Resource: Institutional Review Board Guidebook Chapter 5, Biomedical and Behavioral Research: An Overview, United States Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP).


Stall 9: Insufficient Description of the Research Activities

If insufficient or unclear information is provided about the research-related activities or interventions, the IRB is unable to evaluate participant risk.

If the description of the research activities is insufficient or unclear, the IRB will ask the researcher to provide additional clarifying information.


Clearly Describe All Research-Related Activities

Where will the research be conducted?

Which members of the research team are involved in each procedure?

What will each participant in the research study do?

How long will each research-related activity take?

What are the risks associated with each activity?

What are the specific participant benefits associated with each activity?


Clearly Describe Compensation Procedures (if appropriate)

IRBs must attempt to make sure that prospective subjects realize that their participation is voluntary, and that choosing not to participate will not adversely affect their relationship with the institution or its staff in any way. To make this determination, IRBs should know who the subjects will be, what incentives are being offered, and the conditions under which the offer will be made.

IRB Guidebook Chapter 3, Basic IRB Review Section G, Incentives for Participation


Clearly Describe Compensation Procedures (if appropriate)

What type of compensation will be provided (money, gift card, other tangible “benefit”)?

When will participants receive their compensation?

What activities do participants need to complete to be eligible for compensation?

How will the participant receive compensation?

How much compensation will be provided?

Who will receive compensation for participation? If all participants are not compensated equally, how will the researcher(s) determine who receives what level of compensation?


Stall 10: Research-Ready Documents

• Documents must be research-ready: If post-IRB approval changes to the letters of informed consent/assent and/or recruitment materials are needed, a “Request for Revisions” must be submitted to the IRB for approval before these documents can be used in the research process.

• Active links to electronic surveys.• Appropriate documents on letterhead.• If survey data collection is anonymous or if there is an

intention to code the survey data, remove from the survey documents requests for the participants’ names and significant identifying information.


IRB Resources

The standards for IRB review are derived from Code of Federal Regulations Title 45 Public Welfare Part 46 Protection of Human Subjects (45 CFR 46).

A good resource for information about the IRB review process standards is the Office for Human Research Protections (OHRP) IRB Guidebook

IRB Guidebook Chapter 3, Basic IRB Review: Includes information about informed consent, selection of subjects, privacy, & incentives.

IRB Guidebook Chapter 4, Considerations of Research Design

IRB Guidebook Chapter 5, Biomedical and Behavioral Research

A comprehensive source of information about IRB guidelines and processes: Bankert, E. & Amdur, R. (2005). Institutional Review Board: Management and Function, Jones & Bartlett.


remedies for the top 10 stalls in the irb new protocol submission process university of indianapolis...

Documents

irb staff

irb reviewers

irb approval process

purpose of irb review

cory clasemann uindy

irb chair nursing

research study

research design