irb member education the irb review process & membership responsibilities

IRB Member EducationThe IRB Review Process & Membership

Responsibilities

v06/01/2010IRB Member Education

Before you begin…

Have you completed the required CITI modules?

• You should complete the required CITI modules for IRB Members before you read this presentation

• Specified modules provide an overview of IRB regulations and ethical principles, as well as specific information about the role of an IRB member

• Please visit http://researchadmin.iu.edu/REEP/reep_citi.html to log-in

Please also visit the IRB Member Education Site at https://www.sharepoint.iu.edu/sites/iu-ora/in-rca/irbeducation

/default.aspx for links to important IRB policies & procedures.


Contents

• About the IRBs• IRB Membership• Conflicts of Interest• Review by the Convened IRB• Expedited Review• Special Topics in IRB Review• Questions

Please click on a topic to skip to that section


About the IRBs

What is an IRB?

An Institutional Review Board (IRB) is a committee mandated by law to protect the rights and welfare of human research subjects participating in research

activities.

• IU has seven IRBs which review research:– Social/Behavioral IRBs: IUB, IRB-01– Biomedical IRBs (IUPUI): IRB-02, IRB-03, IRB-04, IRB-05– Emergency IRB: IRB-07


About the IRBs

IRB Purpose and Authority• Responsible for reviewing and approving all research studies that

involve human subjects and are conducted at or on behalf of IU and its affiliates, including:

– Clarian Health Partners/Indiana University Health

– Health & Hospital Corporation (Wishard)

– Roudebush Veterans Affairs Medical Center

• Responsible for reviewing applications for non-human subjects research and some student projects

• Must comply with federal regulations and institutional policies governing research activities with human subjects

• Each IRB is qualified and established to review several specific types of research


About the IRBs

IRB Purpose and Authority• IRB actions include:

– Final approval: No changes needed in study. Investigator may proceed with research.

– Provisional approval: Minor revisions need to be made and specific revisions requiring simple concurrence by the investigator can be stipulated. After revisions, final approval may be granted by IRB Chair or Board member. If the event of extensive changes or protocol questions, reviewers may request subsequent review.

– Tabled : Major study concerns exist impacting the protection of human subjects, or clarifications or modifications regarding the protocol or informed consent document that are directly relevant to the determinations required by the IRB are necessary. The investigator’s response must be reviewed by the convened IRB at a subsequent meeting

– Disapproved: Significant study concerns exist such that the Board does not feel the project can be conducted as currently proposed. Specific reasons for disapproval will be included in meeting minutes and communicated to the investigator in writing. The study cannot be resubmitted in the same format.

– Suspension: Temporary cessation of some or all research activities in a protocol– Termination: Determination to permanently withdraw IRB approval for some or all

research activities in a protocol


IRB Membership

• IRB members are appointed to two- or three-year terms • Members may be appointed for an unlimited number of terms• Membership must meet the following criteria:

– Sufficiently qualified through experience, expertise, and diversity

– At least five members

– Mix of men and women and individuals representing differing professions

– At least one member from a nonscientific discipline

– At least one member not affiliated with the institution

– Qualified to review research involving vulnerable subjects

– No conflict of interest


IRB Membership

Regular Members• Review general information items, major amendments, continuing

reviews, new and tabled studies at monthly IRB meetings. • Also serve as weekly reviewers (~3 times a year) to review items via the

expedited process.

Alternate Members• Assume the responsibilities of an absent regular IRB member at the

monthly IRB meetings.

Consultants• Requested to attend IRB meetings as needed to supplement the

knowledge of the IRB • Provide review and necessary expertise, but are not considered members

and are not eligible to vote on or approve IRB business.


IRB Membership

Community Representatives• Review study documentation from the potential research subject

perspective (i.e., as a subject’s advocate)– Generally focus on the readability and understandability of the

informed consent/assent documents• Serve as secondary or tertiary reviewers on new studies• May review other items as appropriate

Prisoner Representatives• Review studies involving prisoners as a subject population• Serve as secondary reviewers on new studies, continuing reviews,

amendments, general information, etc.


IU Human Subjects Office

• Serves as support staff to the IRBs• Responsible for the administration of Board activities• Authorized by the IRBs to:

– conduct preliminary review of all materials submitted to the IRB to ensure submissions are acceptable

– accept applications for exempt studies– review and accept applications for non-human subjects

research and student projects


Member Responsibilities

Conflicts of Interest

• The IUP SOP on IRB Operations requires IRB members to disclose potential conflicts of interest

– Initial disclosure is made via the IRB Member Information Sheet at time of appointment – If you identify additional conflicts during your appointment term, please notify the IU

Human Subjects Office staff as soon as possible• If you have a conflict of interest with a study or item to be reviewed at a meeting, you will be

excluded from the discussion of and voting upon that agenda item except to provide any information that may be requested by the IRB.

• If it is determined that you have a conflict of interest which requires that you absent yourself from the room during discussion and voting, you will:

– Not be counted towards the maintenance of a quorum during your absence from the room.

– Be recorded in the meeting minutes as being absent during the discussion and voting of that item.



Conflicts of Interest

• Identifying conflicts of interest: – Refer to the IUP SOP on IRB Operations for a definition of conflicts of interest

– Disclose any potential conflicts to staff

– In some cases, staff members may have already indicated on the agenda that have a conflict with the particular study or item under review:

• You are listed as a co-investigator on a particular study. • You have disclosed a financial conflict of interest which relates to the study.

– In other cases, staff will not know in advance whether you feel that you have any sort of conflict of interest regarding a particular item or items listed on the agenda (e.g., such as a financial conflict of interest). In this case, you should identify for the Chair and staff that you have a conflict of interest with a particular agenda item or items during the Call for Conflicts portion of the meeting.

• The IU SOPs and AAHRPP standards require a formal evaluation process for IRB chairs and members.

• The IRB chair will annually evaluate each IRB member and provide feedback in face-to-face meetings.

• IRB chairs and vice chairs will be evaluated by the Assistant Vice President for Research Compliance, in collaboration with the Associate Directors for the Human Subjects Offices. Feedback will be provided in face-to-face meetings.

• Evaluations and feedback will be given at the end of the fiscal year to coincide with member appointment cycles.



Annual Evaluation

Review by the Convened IRB

Review Process



Reviewer Responsibilities

• Prior to each IRB meeting, you will be assigned to review items which require review by the convened IRB

– Assignments are based on specialty– General information items, amendments, and continuing reviews are each assigned

to one primary reviewer– New and tabled studies are assigned to three reviewers, including a nonscientist

reviewer. Primary reviewers make the initial report to the Board and additional reviewers add comments.

• The agenda and applicable study documents for all items to be reviewed are posted to an internal SharePoint site approximately one week before the meeting.

– Review the agenda and any to be prepared for discussion at the meeting.– Notify the staff if any materials are missing or additional information is needed for

your review.




• Before the meeting, conduct an in-depth review of all materials to which you have been assigned.

• Complete a Reviewer Checklist (RVC) for all items to which you have been assigned – Provides specific questions to consider during your review– Also includes information from staff reviewers:

• Any additional instructions or information about the item

• Requested provisions to be returned to the investigator

– Reviewers are encouraged to use the RVC to provide their own comments back to staff, and to note minor provisions so that only substantive comments that concern the protection of human subjects need to be discussed at the meeting. Please be as specific as possible.

– All provisions included on the RVC will appear in the minutes and will be forwarded to investigators. Completed RVCs should be posted to SharePoint, emailed to staff, or printed and given to staff at the IRB meeting




• For all materials assigned to you, notify the Human Subjects Office staff immediately if you have a conflict of interest or if you feel that the material you’ve been asked to review does not fall under your expertise. – When issues arise which prohibit you from reviewing the materials,

Human Subjects Office staff will identify another appropriate IRB member or consultant to review the item. In some cases, staff may ask you or the IRB Chair for advice in terms of identifying a suitable individual to review the item.




• During the meeting:– You will be asked to present items to the Board, including:

• Summary of the study• Summary of the item• Any questions or concerns you have identified

– All IRB members may ask questions or provide additional comments, if necessary

– After discussion by the Board, primary reviewers should make a motion for appropriate IRB action (e.g. approval, provisional approval, table, disapproval) on which the Board will vote


The IRB Meeting

Maintaining Quorum

• The federal regulations require that an IRB meeting cannot be held without the established quorum of members being present.– Specific guidelines exist which help staff determine whether a

quorum will be present at each meeting. – Quorum requires a majority of voting members, a nonscientist, and

appropriate expertise for the items being reviewed• Staff depend upon IRB members to confirm their attendance at each

meeting to ensure that quorum will be maintained throughout the meeting and to make alternate arrangements in case quorum might be threatened.

• If you will arrive late or leave early from the meeting, please let staff know as soon as possible.


The IRB Meeting

Available Resources

• Human Subjects Office staff members are available to answer questions regarding any issues related to meeting process, study file documentation, regulatory requirements, etc.

• Study documents relevant to items for review are available during the meeting via projector

• Full study files are available upon request for any agenda item scheduled for discussion. – Study files can be made available for your review during the

meeting, even if you are not assigned as a reviewer for the specific item.

– If you would like to see or review a study file, please ask staff for assistance.


The IRB Meeting

The Agenda

• Call to Order• Review of Minutes• Call for Conflicts • General Information• Major Amendments• Continuing Reviews –

Ongoing• Tabled Studies• New Studies


The IRB Meeting

General Information Items

• Reports of information which may or may not require additional action unless there is concern and/or clarification needed regarding the information submitted– Items may include: notification of unanticipated

problems involving risks to subjects, reports or allegations of noncompliance, notification of study suspensions, special requests from an investigator, etc.


The IRB Meeting

General Information Items

• Investigators submit Noncompliance Form or Prompt Reporting Form, as well as any supplemental information (e.g., memo from sponsor, report from data safety monitoring board, etc)

• When appropriate, investigators provide corrective/preventative action plans for acceptance by the Board

• Some reports require specific determinations by the Board; determinations are noted in the agenda and often highlighted.


The IRB Meeting

Major Amendments

• Changes to a study that are considered to potentially increase risk to subjects– IRB provides guidelines to investigators on its website regarding

whether amendments should be considered major or minor• Review by the convened is required • Investigators submit the Amendment Form and all affected documents

which may include supporting materials, informed consent documents, Summary Safeguard Statement, protocol, etc.


The IRB Meeting

Continuing Reviews – Ongoing • Ongoing studies that:

– were originally reviewed by the convened IRB,– the investigator wishes to continue, and– the information provided by the investigator in Section I of the continuing

review form indicates that at least one subject remains active or is in long-term follow-up.

• Review by the convened IRB is required• Investigators submit Continuing Review form, current informed consent and

assent (if applicable), Summary Safeguard Statement, HIPAA authorization (if applicable), recruitment materials, any relevant multi-center trial reports, audit reports, copies of materials of all activity with the study since the last review.


The IRB Meeting

Continuing Reviews – Ongoing

• Reviewers should include a motion regarding how frequently the study should be reviewed – Studies must be reviewed at least annually, but may be reviewed more

frequently depending upon the degree of risk– Protocols using a test article that involves greater than minimal risk and has

never been used in humans, protocols presenting a high probability of serious risk to subjects, with minimal probability of benefit, and protocols led by an investigator who has been found to be in serious or continuing noncompliance within the past year must be reviewed more frequently than annually, unless adequate oversight and/or data safety monitoring exists such that more frequent review is not warranted.

• If there are any significant new findings that may relate to the participant’s willingness to continue participation in the research, it should be requested that such information be provided to participants. Also, the currently approved consent/assent statements should be reviewed to determine that it is still accurate and complete.

acthurst

Is this still applicable?


The IRB Meeting

Tabled Studies

• Studies reviewed at a previous meeting• Board identified major study concerns which impact the protection of

human subjects, or requested clarifications or modifications regarding the protocol or informed consent document that are directly relevant to the determinations required by the IRB

• Provisions are returned to investigator for response and resubmission, which review by the convened IRB


The IRB Meeting

Tabled Studies

• The investigator’s response is assigned to the same reviewers who reviewed the new study during the IRB’s initial review of the study

• The Board is provided with the minutes from the previous meeting, the investigator’s response, and any supporting documents. The initial submission is also available.


The IRB Meeting

New Studies

• Board is provided with all documents submitted by the investigator • Reviewers use the RVC to review the new study and determine

whether it meets the criteria for approval of research• Studies which involve approved or investigational drugs are

reviewed by a pharmacy representative. In general, the pharmacy representative would serve as a secondary reviewer on such a study.


The IRB Meeting

New Studies: Important Considerations

• Members of the IRB should only be concerned about research design or scientific merit as it impacts the protection of human subjects; however, the design and sample size should be adequate to answer the questions posed.

• The IU SOPs for Research with Human Subjects reflect both federal and IU policy. Using these as additional resources will help avoid asking for revisions which may be in conflict with such policies.

• Close scrutiny of the entire proposal is necessary to avoid asking the investigator questions that are already answered in the protocol or for the inclusion of statements which may already be included.

• Investigators may request waivers of the informed consent or authorization requirements. In such cases, refer to the SSS and the IU SOPs for more information.

– Typically, the IRB’s granting of such waivers must be voted upon by the Board and documented in meeting minutes or study records.

– The purpose of the Summary Safeguard Statement (SSS) is to provide an overview (i.e., brief summary) of the research study in lay terms.


The IRB Meeting


• IRB members should be able to ascertain the acceptability of proposed research studies in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

• IRB members should be knowledgeable about the local research context in terms of where it is proposed that the research will be conducted.

– If you are assigned a new study for review and believe that additional information should be provided either by the investigator or a consultant regarding the local context of a proposed research study, please contact IRB staff as soon as possible so that appropriate arrangements can be made.


The IRB Meeting


• Are the principles of the Belmont Report adequately addressed (e.g., respect for persons, beneficence, justice)?

• Are the regulatory criteria met for the approval of the project?• Are privacy protections appropriate?

– Privacy refers to individuals and to their interest in controlling access of others to themselves.

– Individuals have an interest in:• Controlling the time, place, and nature of the information they give to others, and

• controlling the information or experiences that are proffered to them

– Privacy considerations can be affected by: gender, ethnicity, age, socio-economic status, education, ability level, health status, relationship to researcher, legal status, etc.

Information adapted from a presentation on “Privacy and Confidentiality” by Joan Sieber, California State University, Hayward


The IRB Meeting


• Are confidentiality protections appropriate?– Confidentiality refers to data (e.g., identifiable information about a person)

and about agreements and procedures for limiting the access of others to that data

– Methods to protect confidentiality should be described both to the IRB (via the study application) and to subjects (via the informed consent process)

– There can be many different methods employed to protect confidentiality, including making efforts to store and dispose of data securely, sharing data appropriately, obtaining Certificates of Confidentiality, etc.

– Confidentiality expectations may differ for quantitative vs. qualitative research.

Information adapted from a presentation on “Privacy and Confidentiality” by Joan Sieber, California State University, Hayward

Expedited Review

Review Process


The Expedited Review Process

Expedited Review

• Not all IRB submissions require review by the convened IRB and are reviewed via the expedited review process

• Expedited items are reviewed by IRB members who serve as weekly reviewers– Weekly reviewers are experienced members designated by

the Chair to review items which qualify for expedited review procedures.

– A member is designated as experienced after either service for at least one year on a full IRB or after the review of 20 study actions at a full IRB meeting whereby the Board serves as a mentor to the new member.



Expedited Review

• Expedited reviewers may not disapprove an item• If an expedited reviewers feels that the item

cannot be approved, the item is forwarded to the convened IRB for review– The expedited reviewer’s comments are

provided to the convened IRB



Eligible Submissions

• Specific minimal risk research:– New expedited studies: fall into one of seven categories

determined to be minimal risk and eligible for expedited review by the federal regulations

• All ongoing review (continuing review, closeout, amendments) of expedited studies may be conducted via the expedited process

– New exempt studies: fall into one of six categories of research determined to be exempt from IRB review



Eligible Submissions

• Specific actions for studies previously reviewed by the convened IRB:– General information items which do not represent a potential risk to subjects– Minor amendments: changes to a study that do not potentially increase risk to

subjects– Continuing reviews if no subjects have been enrolled or study is permanently

closed to subject enrollment with no active subjects– Provisional approvals: items previously reviewed by the convened IRB and

approved pending response to specific conditions; expedited members review the responses and provide final approval if appropriate

– Closeouts: studies which have been completed, will not be initiated, or are closing prior to completion

• Study cannot be closed if data is still being collected or subjects are still in follow-up



Reporting to the IRB

• The IRB must be notified of approval of items reviewed via the expedited process

• Expedited items approved since the last IRB meeting are reported in the Expedited Items Report and posted to SharePoint for the Board’s review

• No discussion or vote is required• Please notify IRB staff if you have any questions or

concerns about an item on the Expedited Items Report

Special Topics in IRB Review


Special Topics

Informed Consent

• Is the consent process outlined in the SSS acceptable, in terms of the timing, any waiting periods, and the setting?

• Will informed consent be sought from each prospective subject or legally authorized representative?

• Is the consent process legally effective?

• Did the investigator provide sufficient opportunity to the subject in considering participation?

• Has the possibility of coercion or undue influence been minimized?

• If vulnerable populations are involved, is the process adequate?

– For research involving cognitively impaired individuals, is the proposed plan for assessment of capacity to consent adequate?

– For research involving pregnant women and fetuses, is the proposed plan for obtaining the father’s permission adequate?

– For research involving minors, is the assent process and plan to obtain consent from parents/guardians appropriate?


Special Topics

Children

• The SSS solicits information from the investigator to discern whether children be a targeted population for enrollment. If so, the investigator must complete a special request form.

• For studies that involve children as a subject population, OHRP allows the IRB to approve only research which falls into one of 4 categories (45 CFR 46.403). The IRB must carefully consider this determination.

• The initial category determination is made by the investigator; however, the IRB must ultimately determine and subsequently vote on the appropriate category in which the research belongs.


Special Topics

Children

• Category 1: research that does not involve greater than minimal risk to children • Category 2:

– research involving greater than minimal risk – but presenting the prospect of direct benefit to the individual child-subject (anticipated

benefit justifies the risk and anticipated benefit is at least as favorable as that of alternative approaches)

• Category 3: – research involving greater than minimal risk – and no prospect of benefit to the individual child-subject

• research represents no more than a minor increase over minimal risk; • the intervention or procedure presents experiences to the child-subjects that are reasonably

commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations;

• and the intervention or procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is a vital importance for understanding or amelioration of the disorder or condition

• Category 4: research not otherwise approvable under one of the above categories – the study presents a reasonable opportunity to further the understanding, prevention, or

alleviation of a serious problem affecting the health or welfare of children; Secretary of HHS must approve, after consultation with a panel of experts following publication and public comment


Special Topics

Children

• IRB must consider the investigator’s plans for soliciting the permission (parental/guardian informed consent) of the parents or guardians. These determinations are documented in the meeting minutes.

• Although the regulations require the permission of each parent or guardian, there are circumstances in which the IRB may determine that permission from only one parent or guardian is sufficient.

– The regulations allow permission of only one parent or guardian for research involving children which falls into categories 1 or 2; however, the IRB must determine that the permission of one parent or guardian is sufficient. That the research falls into category 1 or 2 is not sufficient.

• For example: it may be inappropriate to allow permission of only one parent or guardian in a standard therapeutic trial for childhood cancer where one has time to sit down and obtain permission from both parents (unless one is deceased, unknown, incompetent, or not reasonably available, or when only one parent or guardian has legal responsibility), just because the research falls into category 2.

– For research involving children which falls into categories 3 or 4, both parents or guardians must provide permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent or guardian has legal responsibility for the care and custody of the child


Special Topics

Children• IRB must determine that adequate provisions are made for soliciting the assent of children when, in

the judgment of the IRB, the children are capable of providing assent. Assent is typically required for children ages 7 and older, but may be appropriate for younger children depending on their aptitude/ability.

– Assent can be documented by the child’s signature on the consent form OR the child’s signature on a separate assent form

• For children ages 7-17, consider the use of an assent statement.– Represents a child’s affirmative agreement to participate in a research project.– Explains the nature of the study, what the child will be asked to do, risks/benefits, etc. in simple

terms (i.e., terms understandable by children of the targeted age-group).– Signed by the child

• The IRB may determine that assent is not necessary if:– The capability of some or all of the children is so limited that they cannot be reasonably

consulted (taking into account the age, maturity, and psychological state of the child)– The intervention or procedure involved in the research holds out a prospect of direct benefit

that is important to the health or well being of the children and is available only in the context of the research

– The research meets the required regulatory criteria for waiver of consent• Refer to the SOP on Vulnerable Populations for more information.


Special Topics

Cognitively Impaired Subjects

• In instances where the subject is cognitively impaired, the IRB must consider whether adequate provisions are made for soliciting the assent of the subject when in the judgment of the IRB, the subject is capable of providing assent.

• In addition, the IRB will consider the procedures proposed for evaluating:– The mental status of prospective subjects– whether the subjects’ mental status may change during the course of the study– how investigators will identify persons authorized to give legally valid consent on

behalf of individuals judged incapable of consenting on their own behalf

• For some subjects, decision-making capacity may fluctuate during the course of the research, requiring consideration of a possible re-consenting process.


Special Topics

Cognitively Impaired Subjects

• The IRB may only approve research involving cognitively-impaired subjects when the following three conditions apply:

– Only incompetent persons or persons with impaired decision making capacity are suitable as research subjects,

– The proposed research entails no significant risks, tangible or intangible, or if the research presents some probability of harm, there must be at least a greater probability of direct benefit to the subject, and

– Procedures have been devised to ensure that the subject’s representatives are well informed regarding their roles and obligations to protect incompetent subjects or persons with impaired decision making capacity.

• A special request form prompts the investigator to provide information to the IRB such that this evaluation can be made. Please pay close attention to the investigator’s responses and consider whether the investigator has made adequate provisions.

• Refer to the SOP on Vulnerable Populations for more information.


Special Topics

Pregnant Women, Human Fetuses, and Neonates

• Research involving women who are or may become pregnant should receive special attention from the IRB due to additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus.

• The fetus deserves special protection as well because the it is the most vulnerable research subject.

• The SSS solicits information from the investigator to discern whether this will be a targeted population for enrollment. If so, the investigator must complete a special request form.



Special Topics

Prisoners

• A prisoner is “any individual involuntarily confined or detained in a penal institution.”

• Additional subject protections must be in place for biomedical or behavioral research involving prisoners (45 CFR 46, Subpart C) and a prisoner representative must be present for review and discussion of all items involving prisoners.

• These protections must not only be considered for studies in which prisoners are the prospectively targeted subject population, but also for studies in which research subjects become prisoners after the research has commenced.


Special Topics

Prisoners

• For prisoner studies, the investigator is required to submit additional documentation to the IRB regarding 7 protocol-specific findings. – The IRB must concur with the investigator’s response to these findings. If

the IRB does not concur, the investigator must be asked to make revisions such that concurrence will be obtained.

• The IRB must determine in which of 4 categories of prisoner research the proposed project falls.

• If a new study involving prisones is conducted or supported by HHS, additional findings and documentation are required. In addition, the IRB may be asked to carry out such other duties as may be assigned by the Secretary of Health and Human Services.



Special Topics

Unanticipated Problems Involving Risks to Subjects or Others & Noncompliance

• Unanticipated Problems Involving Risks to Subjects or Others: In general, includes any incident, experience, or outcome that meets all of the following criteria:

– unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

– related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

– suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

• Noncompliance: Any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations, requirements of VHA Handbook 1200.5, or institutional policies governing human subjects research or the requirements or determinations of the IRB.


Special Topics

Unanticipated Problems Involving Risks to Subjects or Others & Noncompliance

• IRB will review allegations or reports of these events as general information items – Based upon these allegations or reports, the IRB may

require that additional actions be taken.

• Refer to the SOP on Unanticipated Problems and Noncompliance for more information.


Special Topics

HIPAA

• Also referred to as The Privacy Rule – effective April 14, 2003• Written in response to public concern over potential abuses of the

privacy of health information• Establishes a category of health information (protected health

information or PHI) which may be used or disclosed to others only in certain circumstances or under certain conditions

• The IRB serves as the Privacy Board for studies under its jurisdiction and must consider HIPAA issues in its review of research studies


Special Topics

HIPAA

• Applies to research activities conducted by covered entities and involving PHI

• In general, subjects must sign an authorization at the time of enrollment to allow the use or disclosure of their health information for research purposes.

• In limited circumstances (which must be prospectively approved by the IRB), an authorization may not need to be obtained from subjects at the time of enrollment (i.e., a waiver of authorization).

• Recruitment procedures must also be reviewed to determine whether an authorization must be signed by subjects prior to determining whether subjects can enroll in a research study.


Special Topics

Investigational Devices

• For studies involving investigational devices, the IRB must determine whether the device represents a significant risk or nonsignificant risk device, in accordance with FDA guidelines

– Significant risk device: presents a potential for serious risk to the health, safety, or welfare of a subject and

• is intended as an implant, • is used in supporting or sustaining human life, • is of substantial importance in diagnosing, curing, mitigating, or treating disease, or or otherwise prevents

impairment of human health, or• Otherwise present a potential for serious risk to the health, safety, or welfare of a participant

– Nonsignificant risk device: does not meet the definition of a significant risk device

• The initial risk determination is made by the investigator; however, the IRB must ultimately determine and subsequently vote on the type of risk for the investigational device.

• For additional information, see the IU SOP on Investigational Device Accountability

acthurst

Official SOP name


Special Topics

Undue Influence

• IRB members have occasionally reported that individuals have made efforts to unduly influence them in relation to IRB review of protocols or research-related issues. – For example, an investigator may discuss a particular protocol with an IRB

member and make some attempt to exert pressure on that member to produce a desired outcome in the IRB review.

• Such efforts to influence IRB members should be reported to an IU Human Subjects Office Director immediately – Directors may work to resolve the issue either by contacting the affected

individual directly or by contacting an IRB Chair or Vice-Chair, other University official (e.g., Department Chair) for further resolution.

– The appropriate University officials will be notified of such reports in order to ensure that members are not being unduly influenced by investigators or other institutional personnel.


Special Topics

Planned Emergency Research


Questions

IU Human Subjects Office – Indianapolis (317) 274-8289

[email protected] http://researchadmin.iu.edu/HumanSubjects/IUPUI/hs_home.html

IU Human Subjects Office – Bloomington(812) 856-4242

[email protected] http://researchadmin.iu.edu/HumanSubjects/IUB/hs_home.html

IRB Member Education site:

https://www.sharepoint.iu.edu/sites/iu-ora/in-rca/irbeducation/default.aspx


Thank You

We appreciate your time commitment to the Indiana University IRB review process. Your participation in the IRB process is a very important contribution toward the University’s efforts to comply with federal regulations.

Best wishes on your future IRB involvement.

irb member education the irb review process & membership responsibilities

Documents