department: may 2013 policy no.: sw-cr-100 policy and ... · sjh recognizes and accepts...

DEPARTMENT: DATE LAST REVISED: DATE LAST REVIEWED DATE ADOPTED: PAGE NUMBER: POLICY NO.: APPROVED BY:

Clinical Research May 2013 May 2013 May 2013 1 SW-CR-100 Executive Council

POLICY AND PROCEDURE

Institutional Review Board (IRB) Policy

Table of Contents

Section Topic Page

1.0 PURPOSE 1

2.0 DEFINITION OF TERMS 2

3.0 POLICY 3

3.1 Responsibility and Functions 4

3.2 Composition of Membership 7

3.3 Review and Approval of Proposed Research Projects 9

3.4 Unresponsiveness to Information/Modification Requests 10

3.5 IRB Authority to Suspend or Terminate Research 11

3.6 IRB Requirement for Cooperative Research 11

3.7 Records 11

4.0 PROCEDURE 12

4.1 IRB Review of Research 12

4.2 Review of Investigational Device Studies 16

4.3 Continuing Review and Completed Studies 17

4.4 Modification/Amendment 19

4.5 Reporting Unanticipated Problems and Serious or Continuing Noncompliance

19

4.6 Emergency Use of a Test Article 23

4.7 Non-Emergent Expanded Access of an Unapproved Test Article 25

4.8 Informed Consent 26

4.9 HIPAA 36

4.10 Experimental Subject’s Bill of Rights 42

4.11 Surrogate Consent for Research 43

4.12 Other Institutional Policies 45

5.0 REFERENCES AND RESOURCES 46

6.0 POLICY/PROCEDURE HISTORY 46

1.0 PURPOSE

The modern history of human subject protections begins with the standards established in the Nuremberg Code. These standards were used by the Nuremberg Military Tribunal to judge the human experimentation conducted by the Nazis. The Nuremberg Code captures much of what we now take for granted to be basic principles governing the ethical conduct of research involving human subjects. In September of 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted the Belmont Report that sets forth three basic ethical principles: respect for persons, beneficence, and justice. These





basic ethical principles provide the ethical foundation for Institutional Review Board (IRB) review. Saint Joseph Health (SJH) policy requires that all research involving human subjects be reviewed and approved by a duly constituted, federally recognized IRB. This policy establishes the SJH IRB Organization as the administrative body responsible for protecting the rights and welfare of human subjects choosing to participate in research activities conducted under the auspices of SJH.

2.0 DEFINITION OF TERMS

Assent means the child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Children are defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction in which the research will be conducted.

Co-Investigator (Co-I) is an individual involved with the Principal Investigator (PI) in the scientific development or execution of a project. The designation of a Co-I, if applicable, does not affect the PI’s roles and responsibilities as specified in this policy. Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Individually Identifiable Health Information is a subset of health information, including demographic information collected from an individual, and (1) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual and





that identifies the individual or with respect to which there is reasonable basis to believe the information can be used to identify the individual. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Principal Investigator (PI) is the individual with absolute responsibility for the overall conduct of the research study. The PI must ensure that the research study is carried out in compliance with the policies of SJH. Research means a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute research for the purposes of this policy, whether or not they are supported under a program which is considered research for other purposes. Sponsor means a person or entity that takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

3.0 POLICY

All research protocols involving human subjects SJH entities shall be reviewed by the SJH Institutional Review Board, unless otherwise noted in this policy, in relation to the entity’s mission statement, values and other guidelines. This review serves to ensure the protection of human subjects in research as required under the Federal Policy (Common Rule) for the Protection of Human Subjects, FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56) and applicable California and Texas state and local laws. It is the policy of SJH that the regulations of the Department of Health and Human Services (DHHS), set forth in 45 Code of Federal Regulations Part 46, are applicable to all research involving human subjects, as defined by these regulations, for which SJH is responsible, regardless of the source of funding or whether the research is funded. In the case of conflict between regulations of the funding or regulatory agency and DHHS, the more restrictive regulations shall prevail.





It is also SJH’s policy to obligate and adhere to the regulations of the Food and Drug Administration (FDA) set forth in 21 Code of Federal Regulations Parts 50, 56, 312, 600, and 812 governing projects involving investigational new drugs or devices and the State of California Protection of Human Subjects in Medical Experimentation Act (Health and Safety Code: Section 24170-24179.5). Included in this policy is SJH’s commitment to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. SJH recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human subjects fulfills these ethical principles. 3.1 Responsibility and Functions

A. SJH has agreed to protect the welfare of all human subjects involved in

research, whether or not the research is conducted or supported by a federal department or agency. Therefore, the designated IRB has jurisdiction over all human subjects research involving SJH patients, staff, and/or conducted at SJH facilities, and does not routinely authorize any exceptions. SJH IRB may also serve as the IRB of record for research studies conducted by individuals credentialed as a SJH site Medical Staff member regardless of whether the study takes place in a SJH entity’s facility or in the researcher’s office, and whether or not SJH entity’s patients are involved in the study.

The IRB follows the Ethical and Religious Directives for Catholic Health Care Services in reviewing research proposals.

Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of SJH or the individual entity. However, these officials may not approve research if it has not been approved by the IRB.

The IRB has the following responsibilities:

1. The IRB shall ensure that all human subject research, regardless

of funding, complies with the Federal Policy (Common Rule) for the Protection of Human Subjects and FDA regulations at Title





21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56). All human subject research supported by the Department of Health and Human Services (DHHS) shall comply with all Subparts of DHHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46). All Federally supported human subject research shall also comply with any additional human subject regulations and policies of the supporting Department or Agency as well as with California and Texas state and local laws. The IRB shall ensure that the research is reviewed according to the controlling standards identified by federal law, agency policy and/or regulation.

2. Except for research exempted or waived under Section 56.104 or 56.105 of Title 21 (FDA regulations) and/or Section 101(b) or 101 (i) of Title 45 (DHHS regulations), all research for which the governing IRB is responsible shall be reviewed, prospectively approved, and subject to continuing oversight by that IRB. The governing IRB shall have the authority to approve, require modifications in, or disapprove the research for which it is responsible.

3. Except where specifically waived or altered by the governing IRB under Sections 50.23, 50.24, or 56.109(c) of the FDA regulations and/or Sections 101 (c), 116 (c) and (d), or 117 (c) of the Federal Policy, all research for which the governing IRB is responsible shall require written informed consent, in non-exculpatory language understandable to the subject (or the subject’s legally authorized representative), including the following basic elements per Sections 50.25(a) and (b) of the FDA regulations and Sections 46.116 (a) and (b) of the DHHS regulations:

a. Identification as research; purposes, duration, and

procedures; procedures which are experimental. b. Reasonably foreseeable risks or discomforts; c. Reasonably expected benefits to the subject or others; d. Alternative procedures or treatments, if any, that might be

advantageous to the subject; e. Extent of confidentiality to be maintained; f. Whether compensation or medical treatment are available

if injury occurs (if more than minimal risk); g. Whom to contact for answers to questions about the

research, subjects’ rights, and research-related injury;





h. Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is otherwise entitled; and

i. When appropriate, additional elements per Section 50.25(b) of the FDA regulations and Section 46.116(b) of the DHHS regulations.

The IRB shall require that information be given to subjects as a part of informed consent. The IRB may require that information in addition to that specifically mentioned above be given to the subjects when, in the IRB’s judgment, the information would be meaningful and add to the protection of the rights and welfare of subjects. The IRB shall require the documentation of informed consent or may waive documentation in accordance with current DHHS and FDA policies.

4. The governing IRB shall ensure that it has appropriate knowledge

of the local context in which research for which it is responsible will be conducted.

For multisite research, the IRB will consult with an IRB member or consultant representative of the local community, to identify and address local context issues.

5. The IRB shall ensure the existence of adequate continuing

education and oversight mechanisms (appropriate to the nature and volume of the research being conducted) to verify that investigators, IRB members and staff, and other relevant personnel maintain continuing knowledge of, and comply with, relevant Federal regulations, Office for Human Research Protections (OHRP) guidance, other applicable guidance, California and Texas state and local law, and IRB determinations and policies for the protection of human subjects.

The IRB Chairperson, IRB members, IRB staff, research pharmacists and human subjects research investigators and staff shall complete appropriate education related to the protection of human subjects before reviewing or conducting human subject research and shall maintain documentation of completion of on-





going training. SJH requires the completion of the web-based Collaborative Institutional Training Initiative (CITI) program.

6. The IRB has established written policies and guidance as

contained herein for:

a. conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution;

b. determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no changes have occurred;

c. ensuring that changes in approved research are reported promptly to the IRB and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and

d. ensuring prompt reporting to the IRB, institutional officials, the FDA, OHRP and/or other applicable government agencies, of any:

i. unanticipated problems involving risks to subjects or others in any covered research;

ii. serious or continuing noncompliance with Federal, Institutional, or IRB requirements; and

iii. suspension or termination of IRB approval of research.

3.2 Composition of IRB Membership

FDA and Department of Health and Human Services (DHHS) regulations specify IRB membership requirements as follows:

A. The IRB shall have at least five members, with varying backgrounds, to promote complete and adequate review of research activities commonly conducted by the entity.

B. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.





C. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas.

D. When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled person, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence, the IRB shall require, as appropriate, additional safeguards in the study to protect the rights and welfare of the subjects. Research involving these subject groups may be subject to specific Federal and/or State regulations. Those provisions are not incorporated or described in this policy. If an investigator is contemplating performing research involving any of these groups, s/he should consult with the Human Research Protection Program (HRPP) Office before submitting the research for IRB review.

E. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

F. The Chair of the IRB presides over the meeting and has such duties as are identified in this policy. The Chair will be appointed by the SJH Institutional Official for Research and must have demonstrated knowledge of the regulations governing human subjects research, awareness of the ethical considerations raised by such research, and a commitment to the highest standards of research integrity and human subjects protection. The Institutional Official may appoint one or more Vice-Chairs who will be responsible for and/or assist the Chair in the performance of his or her duties including presiding over the meeting.

G. Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas.

H. Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

I. No IRB may have a member vote on the IRB's initial or continuing review of any project in which the member has a conflicting interest;





however, an IRB member with a conflicting interest may still provide information requested by the IRB.

J. An IRB may, at its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. A motion to involve a consultant may be made by any member in attendance at the IRB meeting. The decision to involve a consultant must be made by majority vote of the members present.

K. Designated alternates may be appointed and used. To ensure appropriate review of studies, the alternate’s qualifications should be comparable to the member for whom he or she is acting as an alternate. The IRB minutes must document when an alternate replaces a member.

The SJH Institutional Official for Research shall appoint new members in consultation with the Chairperson(s) and IRB Manager. The initial term of appointment is two years and subject to reappointment. At the conclusion of a term of service, a member may be appointed for an additional term and may serve successive additional terms without limitation. Each permanent member will be expected to attend a majority of the scheduled meetings.

3.3 Review and Approval of Proposed Research Projects

A. The IRB is vested with the authority and is responsible for approving, disapproving, and when necessary, requiring the principal investigator to modify research involving human subjects at convened meetings at which a majority of the designated members are present, including at least one member whose primary concerns are in non-scientific areas. Expedited review procedures involving research with minimal risk are to be in compliance with current DHHS and FDA requirements. Research activities which are exempt from IRB review under the DHHS regulations are specified in Section 46.101(b), 45 CFR Part 46, Subpart A; Research activities which are exempt from IRB review under FDA regulations are specified in Section 56.104, 21 CFR Part 56. The IRB will adhere to Federal guidelines in considering exempt research.

B. The IRB is responsible for notifying investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the proposed research activity is disapproved, the IRB shall include in its written notification a rationale for the disapproval; the investigator then





has the opportunity to respond to the IRB’s decision in person or in writing.

C. The IRB shall require documentation of informed consent or may waive documentation in accordance with current DHHS and FDA regulations.

D. The IRB is responsible for conducting continuing review of research covered by SJH policy and DHHS and FDA regulations appropriate to the degree of risk, but no less than annually, and shall have authority to observe or have a third party observe the consent process and the research as appropriate.

3.4 Unresponsiveness to Information / Modification Requests

A. Initial Application

If a response to an IRB request to secure IRB approval of a proposed research project during the course of an application for exemption, expedited review or full review is not received within 90 days of the date of the request, the project may be designated “inactive or withdrawn”. When clarifications or modifications are not submitted within sixty (60) days, a reminder will be sent to the investigator with an additional thirty (30) day deadline. The IRB may, at its discretion, grant an extension if the investigator provides acceptable justification for a delay. If the IRB does not receive any communication from the investigator, the protocol application will be administratively withdrawn. Administrative withdrawal will require the resubmission of a new protocol application, and the PI may be required to attend a full IRB review of the protocol.

B. Continuing Review

If a response to an IRB request for information is not received within 90 days of the date of the request, approval of the protocol may be rescinded. When clarifications or modifications are not submitted within sixty (60) days, a reminder will be sent to the investigator with an additional thirty (30) day deadline. The IRB may, at its discretion, grant an extension if the investigator provides acceptable justification for a delay. Unresponsiveness can result in further disciplinary action up to and including suspension of all protocols for which the investigator is responsible. Where applicable and/or under current law the suspension will be reported to the appropriate oversight agency.





3.5 IRB Authority to Suspend or Terminate Research

The IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected or serious harm to subjects. The IRB's action of suspension or termination shall be reported promptly to the investigators, appropriate institutional officials, and if applicable under current law, to the appropriate oversight agencies.

3.6 IRB Requirement for Cooperative Research When SJH contracts or subcontracts research to a cooperating institution, SJH as a grantee or prime contractor is committed to and remains responsible for safeguarding the rights and welfare of human subjects. SJH may use joint review, seek reliance upon the review of the qualified IRB at the cooperating institution, or undertake other appropriate arrangements aimed at protecting the rights of human subjects in research.

3.7 IRB Records

A. Records Retention

In accordance with the provisions under current DHHS regulations, SJH keeps and maintains systems of records and documentation which may be electronic or paper based (i.e., minutes, correspondence, approved consent documents, et al) of IRB activities. The IRB will prepare and maintain for at least 3 years after completion of the research, adequate documentation of IRB activities, including the following: 1. Copies of all protocols reviewed (including the most recent master

protocol) and their accompanying documentation, approved consent documents, progress reports submitted by investigators, and reports of injuries to subjects.

2. Minutes of the IRB meetings in sufficient detail to show attendance at the meetings; the names of those not present at the meeting; actions taken by the IRB; the vote on these actions including the number of members for, against, and abstaining on each agenda item; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution.





3. Records of continuing review activities. 4. A list of IRB members identified by name; earned degrees;

representative capacity; indication of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to the IRB’s deliberations; and any employment or relationship between each member and SJH.

5. The HRPP Office is responsible for maintaining a file pertaining to each IRB Member. Each IRB member file must consist of the members’ letter of appointment by the Institutional Official, the member’s resume, education compliance, conflict of interest statement and any other relevant correspondence relating to the member’s service on the IRB. The HRPP Office is responsible for obtaining an updated resume from each member upon the occasion of the member’s reappointment for an additional term and an updated education compliance and conflict of interest statement.

6. The IRB’s written policies and procedures, forms and other instructions.

7. Statements of significant new findings provided to subjects. 8. Copies of all correspondence between the IRB and investigators.

B. Records Inspection

The IRB records under federally funded or regulated projects shall be accessible for inspection and copying by authorized representatives of DHHS, FDA and the Federal sponsor at reasonable times and in a reasonable manner. In the case of projects funded by non-Federal sponsors, IRB records shall be retained and be accessible for inspection and copying by the sponsor in accordance with contractual obligations, applicable laws and SJH policy.

4.0 PROCEDURE

4.1 IRB Review of Research

A. Criteria for IRB Approval

Applications must meet the following criteria for IRB approval: 1. Risks to subjects are minimized by using procedures which: 1) are

consistent with sound research design; 2) do not unnecessarily expose





subjects to risk; and 3) whenever appropriate, utilize procedures already being performed on the subjects for diagnostic or treatment purposes.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance to society of the knowledge that may reasonably be expected to result.

3. Selection of subjects is equitable. The IRB will consider the purposes of the research, the setting in which research will be conducted, and the population from which subjects will be recruited including special problems or research involving vulnerable populations such as pregnant women, children, mentally disabled persons, or economically or educationally disadvantaged persons.

4. IRB approved consent forms must be used for the consent. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative in accordance with current federal rules on the protection of human subjects.

5. Where appropriate, the research plan makes adequate provision for regular monitoring of the data collected to ensure the safety of the subjects. NOTE: For blinded or multi-centered studies, studies in which mortality or morbidity from underlying disease (e.g., cancer or AIDS) may be high, and phase I or II studies of potentially dangerous drugs or procedures, continuous centralized monitoring of outcomes may be necessary. This may be accomplished by a data safety monitoring board (DSMB) or un-blinded Co-investigator. Specific rules for overwhelming evidence of efficacy or sufficient evidence of toxicity to require changes in protocol may be required.

6. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

7. Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with severe physical disabilities or mental illness, appropriate safeguards have been included in the study to protect the rights and welfare of these subjects.

8. Where children are subjects, the additional findings required under 45 CFR 46 Subpart D.

9. Where prisoners, pregnant women or fetuses are subjects, additional requirements as specified in applicable laws and regulations will be required.





B. IRB Decisions

1. The primary concern of the IRB is the protection of the rights and welfare of human subjects in research. The efforts of the IRB during initial review of a proposed research project are directed at: a. identification of risks; b. evaluation of risks (i.e., a determination of whether or not the

risk/benefit ratio is acceptable/appropriate); c. evaluation of procedures to minimize risk; and d. evaluation of the informed consent document to ensure that all

required elements are present. 2. The responsibilities and functions of the IRB are to be consistent

with current applicable State, and DHHS and FDA requirements. The IRB shall review and have authority to approve, require modifications (to secure approval), or disapprove all research activities covered by the regulations.

C. Appeal of IRB Decisions

Investigators are encouraged to communicate with the HRPP Office to clarify the reasons for deferral (IRB requiring additional information in order to make a determination) or disapproval of applications. If formal written responses to IRB inquiries fail to resolve disputed issues, investigators may request an appointment to attend an IRB meeting to present their views.

D. Expedited Review

1. Expedited review procedures are described in 45 CFR 46.110 of DHHS regulations and 21 CFR 56.110 of the FDA regulations. In short, the IRB Chair or one or more experienced reviewers designated by the Chair from among members of the IRB, reviews the research and approves it or refers it to the full IRB for further discussion and/or action.

DHHS and FDA publish a shared list of activities that may be reviewed through expedited review procedures.

2. To qualify for expedited review, an activity must: (1) present no more than minimal risk AND involve only procedures listed in one or





more of the categories authorized by 45 CFR 46.110 and 21 CFR 56.110; OR (2) be a minor change in previously approved research during the period of 1 year or less for which approval is authorized by the IRB.

3. Consultants may assist the IRB Chair in making decisions in expedited review, but expedited review cannot be performed solely by persons who are not members of the IRB. In conducting expedited review, the IRB reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research. If an IRB reviewer feels that an expedited approval is not appropriate, the research activity will be referred to a full IRB meeting for review in accordance with the ordinary, non-expedited procedure set forth in the DHHS and FDA regulations.

4. All research protocols approved through expedited review will be documented in the meeting minutes to advise all IRB members of research proposals which have been approved under the procedure.

E. Research Exempt from IRB Review

1. Research activities involving human subjects that are exempt from IRB review are identified under 45 CFR 46.101(b)(1) – (6) of the DHHS regulations and 21 CFR 56.104 (a) – (d) of the FDA regulations for exemptions from IRB requirement. Institutions and IRBs may not create new categories of exempt research under 45 CFR Part 46.

2. No human subject research can be initiated at SJH until the research study has been approved by the IRB or determined to be exempt under applicable federal regulations. The HRPP Office will determine if the research project meets the eligibility requirements for exemption from IRB review. At its discretion, the HRPP Office may choose to consult with IRB members when determining whether an exemption applies. Research investigators CANNOT make the determination of exemption from IRB review for their own studies. Only the HRPP Office can designate an activity as exempt. As a matter of Federal policy, SJH is responsible for all human subjects research conducted within its borders and should know about all research that is occurring whether it is approved by an IRB or designated as exempt by the HRPP Office.

3. Proposed human subjects research which may qualify for exemption, or changes to ongoing human subject research which has been





granted an exemption, shall be communicated in writing to the HRPP Office for its review and determination.

4.2 Review of Investigational Device Studies

The IRB will review clinical investigations undertaken to develop safety and effectiveness data for Medical Devices according to the requirements of the Investigational Device Exemptions (IDE) regulations (21 CFR 812). A determination of Significant Risk (SR) and Nonsignificant Risk (NSR) for an investigational device must be made prior to consideration of approval of the medical device study, except when the study is exempt from IDE regulations. FDA considers all SR device studies to present more than minimal risk, and thus, full IRB review is necessary. Generally, IRB review at a convened meeting is also required when reviewing NSR studies. However, some NSR studies may qualify as minimal risk under 21 CFR 56.102(i), and the IRB may choose to review those studies under its expedited review procedure. Informed Consent must be obtained for either type of studies. The IRB will document its SR or NSR determination in the meeting minutes.

A. Definitions

Medical Device: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

1. Recognized in the official national Formulary, or the United

States Pharmacopeia, or any supplement to them, 2. Intended for use in the diagnosis of disease or other conditions,

or in the cure, mitigation, treatment, or prevention of disease, in man or other animals or

3. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.





Investigational Device: Is a medical device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. Significant Risk Device: An Investigational Device that:

1. Is intended as an implant and presents a potential for serious risk

to the health, safety, or welfare of a subject; 2. Is purported or represented to be for a use in supporting or

sustaining human life and present a potential for serious risk to the health, safety, or welfare of a subject;

3. Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Nonsignificant Risk Device: An Investigational Device that does not meet the definition for a Significant Risk Device (21CFR 812.2(b)).

Exempt from IDE Regulations: A medical device which does not require an Investigational Device Exemption from FDA prior to clinical use. The IRB does not need to decide whether devices exempt from IDE Regulations pose a significant or nonsignificant risk. IRB approval is still required before the investigation may begin.

4.3 Continuing Review and Completed Studies

A. Continuing Review

1. IRB review: The SJH IRB is responsible for conducting continuing review of research covered by DHHS and FDA regulations appropriate to the degree of risk, but no less than annually. The frequency of continuing review will be determined at the time of initial review and at each subsequent review. The review will be in accordance with federal regulation using either a convened review process or an expedited review process.





The IRB will review each study at a regularly convened meeting, unless the study qualifies for expedited review in accordance with DHHS and FDA regulations. At the time of each continuing review the IRB will determine if the study should be terminated, amended, or allowed to continue. The criteria for IRB approval are the same during continuing review as they are in initial review.

2. Determining frequent review: Follow-up for some protocols may

be more frequent. This will be determined by the IRB when the initial review or a report from an ongoing study shows high risks to the subjects. Other factors such as multiple requests to amend, the occurrence of unanticipated problems, or other evidence of problems or risk can trigger more frequent and intensive review. When appropriate, the IRB may require continuing review after a predetermined number of subjects have been treated with the test article. This more intensive monitoring can also result in auditing of research and patient records. When necessary, the IRB can request verification of facts and verification that no material changes have occurred since the previous IRB review, from sources other than the investigators.

3. Lapse in IRB Approval: If any project activity occurs or continues

after the expiration date, the investigator is deemed to be out of compliance with both Federal regulations and SJH policy. No new subjects may be enrolled after the expiration date. If subjects remain active in a study after the expiration date, the IRB should be notified immediately and permission may be obtained to continue only where necessary to eliminate apparent immediate hazard to the subject.

B. Notification of Completed Study

1. FDA and OHRP require under 45 CFR 46.103 (b)(4) and 21 CFR

56.108 (a) that the IRB shall be notified promptly of any changes in research activity. This includes notification that research activity has ended. SJH requires that all investigators notify the IRB in writing when a study is completed. For investigator-initiated studies, a final results report, if applicable, must also be submitted by the investigator for review by the IRB.





4.4 Modification/Amendment

A. All modifications/amendments to an approved protocol and/or consent form must be received and approved by the IRB before the changes are initiated except where necessary to eliminate apparent immediate hazard to the subject. Requests for approval of modifications may be submitted at any time.

B. Major modifications/amendments are reviewed through the full IRB review process, minor modification requests are reviewed through the expedited process.

C. Changes in study sites or investigators or the addition of a study site or investigator must also be reported in writing to the HRPP Office. In the case of a change in the principal investigator, both the current principal investigator and the replacing principal investigator must sign the form requesting the change.

4.5 Reporting Unanticipated Problems and Serious or Continuing Non-Compliance

A. Authority

OHRP, under the regulations at 45 CFR 46.103(a) and (b)(5)(i), and FDA, under regulations at 21 CFR 56.108 (b)(1)and (2), require written procedures for ensuring prompt reporting to the IRB, appropriate Institutional Officials, and the Department or Agency head of any instance of unanticipated problems involving risks to human subjects or others, or any serious or continuing noncompliance with these regulations or the requirements or determinations of the IRB.

B. Requirement

The IRB must be notified in writing of any Unanticipated Problems or serious or continuing noncompliance, which includes (i) Adverse Events or non-adverse event incidents (ii) Protocol Deviations and Violations, and (iii) updated safety information, as defined below. The IRB has the authority to suspend or terminate approval of research that, among other things, has been associated with unexpected serious harm to subjects [45 CFR 46.113]. In order for the IRB to exercise this important authority in a timely manner, it must be informed promptly of unanticipated problems and serious or continuing noncompliance [45 CFR 46.103(b)(5)] and [21 CFR 56.108 (b)].





C. Definitions

Adverse Event: any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research.

External Adverse Event: An event or outcome that is experienced by subjects enrolled at study site(s) (e.g. multicenter clinical trial) under the jurisdiction of other IRBs.

Internal Adverse Event: An event or outcome that is experienced by subjects enrolled at study site(s) under the jurisdiction of the SJH IRB (IRB of record).

Incident (Non Adverse Event): An undesirable and unintended, although not necessarily unexpected, event or outcome involving any aspects of the research study that is not an adverse event.

Non-Compliance: Failure to comply with federal regulations, state laws, St. Joseph Health policies, and/or the policies, requirements or determinations of the Institutional Review Board, or provisions of the approved research study. It is not noncompliance when there is a need to deviate from the approved protocol in order to protect the welfare of research participants.

Protocol Deviation: Any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator’s control and that has not been approved by the IRB, and does not affect the participant’s safety, rights, or welfare and/or the completeness, accuracy and integrity of the study data. This term, though sometimes used interchangeably with the term “violation,” is most often used when the variance is intended for the safety of one or more research participants or an unintended change that is not considered as serious as a violation, is considered minor or administrative, and may involve no more than minimal risk to participants or others.





Protocol Violation: Any protocol deviation that may affect the subject’s rights, safety, or welfare, and/or the completeness, accuracy and integrity of the study data. This term though sometimes used interchangeably with “deviation” is often considered a major, more serious, variance from an approved protocol than a deviation.

Safety Information: Information that addresses the risks or potential benefits of the research study.

Serious Adverse Event: any adverse event that results in death; is life-threatening (places the subject at immediate risk of death from the event as it occurred); results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; or based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. The occurrence of a serious adverse event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

Unanticipated Problems: any incident, experience, or outcome that meets all three of the following criteria:

It is unexpected (in terms of nature, severity, or frequency) given (a) the

research procedures described in the protocol-related documents,

such as the IRB-approved research protocol (or within the general

investigational plan), the investigator’s brochure or the informed

consent documents; and (b) the characteristics of the subject

population being studied; and

It is related or possibly related to participation in the research (meaning

that there is a reasonable possibility that the incident, experience, or

outcome may have been caused by the procedures involved in the

research); and

It places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized





D. Investigator Reporting Responsibilities

1. Any Unanticipated Problems involving risks to subjects or others and any serious or continuing noncompliance including (i) adverse events or non-adverse event incidents, (ii) protocol violations, and (iii) updated safety information, must be reported to the governing IRB.

2. The Principal Investigator is responsible for submitting to the governing IRB ongoing reports of events that are unanticipated problems or serious or continuing noncompliance and that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research.

3. For studies under the jurisdiction of the SJH IRB, the PI must report events that constitute unanticipated problems or serious or continuing noncompliance to the SJH IRB.

a. If an Adverse Event is unexpected, related or possibly related to

participation in the research, and places subjects or others at a greater risk of harm than was previously known or recognized, then the adverse event is an unanticipated problem and must be reported to the IRB.

i. Unanticipated study-related deaths or life-threatening

events are to be reported to the HRPP Office within 24 hours after awareness by email, and within 5 business days.

ii. All other reportable adverse events as defined in this policy are to be reported within 5 business days to the IRB.

iii. Serious adverse events that do not meet the criteria listed above must be reported to the IRB at the time of continuing review only if the study is not overseen by a central Safety Monitoring committee.

b. If an Incident (Non Adverse Event) is unexpected, related or

possibly related to participation in the research, and places subjects or others at a greater risk of harm than was previously known or recognized, then the adverse event is an unanticipated problem and must be reported to the IRB.





i. All reportable incidents as defined in this policy are to be

reported within 5 business days to the IRB.

c. If there is Updated Study Information that addresses the risks or potential benefits of the research, it should be reported to the IRB if it affects the safety and welfare of subjects.

i. Reportable updated safety information must be reported

to the IRB within 5 business days. ii. All other updated safety information that does not meet

the criteria above should be submitted within a reasonable timeframe to the IRB, or as required by the sponsor.

d. All Protocol Violations must be reported to the IRB within 5

business days. e. All Protocol Deviations must be reported to the IRB at the

time of continuing review.

4. For studies under the jurisdiction of the NCI CIRB, the PI must report events that constitute an unanticipated problem or serious or continuing noncompliance to the NCI CIRB.

E. IRB Responsibilities

The IRB will promptly report any unanticipated problems involving risks to subjects or others, or any serious or continuing noncompliance to the appropriate Institutional Officials and Regulatory Agencies, if the IRB determines an incident meets the criteria for reporting.

4.6 Emergency Use of a Test Article (Any drug, biological product, or medical

device)

A. Emergency Use is defined as the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21CFR 56.102(d)].

Life-threatening includes both life-threatening and severely debilitating:





Life-threatening: Diseases or conditions where likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened IRB meeting is feasible.

Severely debilitating: Diseases or conditions that cause major irreversible morbidity e.g, blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.

B. Informed Consent

Informed consent must be obtained from the subject (or the legally authorized representative), unless the requirements of an exception from the informed consent requirement [21 CFR 50.23(a)] are satisfied. FDA regulations [21 CFR 50.23] permit emergency use of a test article without informed consent where the investigator and an independent physician, who is not otherwise participating in the clinical investigation, certify in writing the determination of exception from informed consent requirement.

If, in the investigator’s opinion, immediate use of the test article is required and time is not sufficient to obtain the independent determination, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. This documentation shall be submitted to the IRB within 5 working days after the use of the test article. [21 CFR 50.23(b) and 21 CFR 50.23 (c)]. A copy of the signed informed consent or the clinical investigator’s annotation of exemption from informed consent shall be a part of the patient’s chart.

C. Exemption from Prior IRB Approval

Emergency Use of a test article is exempt from prior IRB review and approval provided that such emergency use is reported to the IRB in





writing within 5 working days after its use. Expedited IRB approval is not permitted in emergency use.

D. One Emergency Use per Test Article

The FDA regulation [21 CFR 56.104(c)] allows for one emergency use of a test article at an institution. Any subsequent use of the investigational product at the institution is subject to prospective IRB review and approval. However, the FDA acknowledges that it would be inappropriate to deny emergency treatment to a second individual if the only obstacle is that the IRB has not had sufficient time to convene a meeting to review the issue. Data collected from an emergency use situation cannot be utilized for research purposes because use of test articles under these circumstances are not considered research.

4.7 Non-Emergent Expanded Access of an Unapproved Test Article

There are some non-emergent instances in which an unapproved test article may be used under the Food, Drug and Cosmetic Act’s “Expanded Access to Unapproved Therapies and Diagnostics” (Section 561). Use of test articles under these exceptional circumstances are not considered research.

A. Single Patient or Small Group Access

FDA allows access for patients who do not meet the requirements for inclusion in a clinical trial but whom the treating physician believes the unapproved investigational drug, biologics, or device may provide a benefit in treating and/or diagnosing their disease or condition under the following circumstances:

1. The patient or patients have a serious disease or condition. 2. There is no comparable or satisfactory alternative therapy to

diagnose, monitor or treat the disease or condition, and there is sufficient evidence of safety and effectiveness to support the use;

3. Potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated; and

4. Providing the investigational drug or device for the requested use will not interfere with the initiation, conduct, or completion of a clinical trial that could support marketing approval of the





expanded access use or otherwise compromise the potential development of the expanded access use.

The Principal Investigator must receive authorization by the sponsor, concurrence from the FDA, and concurrence from the IRB chair or designee prior to use of the test article for expanded access.

4.8 Informed Consent

A. Definition

Informed consent is the knowing consent of an individual or his/her authorized representative, which is obtained without inducement or element of force, fraud, deceit, duress, or other forms of constraint or coercion. An informed consent form documents informed consent. The consent form should be a statement addressed to the subject and should read as such. It must be in a language the subject or the representative can understand (avoid or define technical terminology, adjust for educational background and ages, provide translations in other languages when subjects do not understand English). Separate forms may be required for different subject groups (parents, children, etc.), as well as for release of particular kinds of information (photographs, audiotapes, videotapes). When experimental drugs are used, California Health and Safety Code Section 111530 requires that if the subject is a minor, consent shall be provided by a parent or legal guardian of the subject and shall also be provided by the subject if the subject is seven years of age or older. The consent of minors will be referenced as the Assent from here on in this policy.

B. Obtaining Informed Consent

1. Responsibility for Process:

Investigators are responsible for obtaining the subject’s informed consent to participate in the research and for ensuring that no human subjects will be involved in the research prior to obtaining their consent.





2. Consent for Participation in a Treatment Study:

It is SJH’s policy that the Principal Investigator (PI) or a Co-Investigator (Co-I) must be actively involved in obtaining informed consent from potential participants in treatment studies. The PI or Co-I must discuss the study with the research subject and document this activity by signing the consent form as “Study Investigator who obtained consent” for participation in the study. The research coordinator may further review the form with the patient, but the PI or Co-I is expected to take a significant role in the process. For treatment studies, the PI, Co-I or other research staff member designated by the PI may obtain the patient’s signature on the form. This activity is documented by signing the informed consent form as “Other research staff who participated in the consent process” on the informed consent form.

3. Consent for Participation in a Non-Treatment Study (Data Collection, Registry or Nursing Study, e.g.):

For studies in which the research subject will not be receiving medical treatment as a part of the study, non-MD co-investigator may obtain informed consent from a potential research subject. This activity should be documented by signing the consent form as “Study Investigator who obtained consent” for participation in the study. Individuals designated by the PI to participate in the consent process for each study must be identified to the IRB prior to conducting those activities.

4. Required Procedures:

As authorized by the IRB, investigators are responsible for ensuring that legally effective informed consent shall: a. Be obtained from the subject or the subject’s legally

authorized representative; b. Be in language understandable to the subject or the

representative;





c. Be under circumstances that provide a sufficient opportunity to consider whether or not to participate that minimizes the possibility of coercion or undue influence;

d. Not contain exculpatory language through which the subject or to the subject’s representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the research investigator, the sponsor, the institution or its agents from liability for negligence.

5. Elements of Consent

a. Required Elements of Consent In seeking informed consent the following basic elements of informed consent shall be provided to each subject: i. A statement that the study involves research, an

explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

ii. A description of any reasonable foreseeable risks or discomforts to the subject.

iii. A description of any benefits to the subject or others which may reasonably be expected from the research.

iv. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

v. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA, DHHS, SJH IRB, and the study sponsor(s) may inspect the records, as applicable.

vi. For research involving more than minimal risk, an explanation as to whether any compensation for injury is provided (details must be included) and whether medical treatments are available if injury occurs and if so, what they consist of or whether further information may be obtained. A contact for further information must also be listed.





vii. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research-related injury to the subject.

viii. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject are otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

b. Additional Elements of Informed Consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

i. A statement that the particular treatment or procedure

may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

ii. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.

iii. Any additional costs to the subject that may result from participation in the research.

iv. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

v. A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.

vi. The approximate number of subjects involved in the study.

c. Clinical Trials Website

When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical





trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description of this clinical trial will be available onhttp://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

C. Waiver or Alteration of Informed Consent

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent according to current DHHS regulations provided the IRB finds and documents the following conditions: 1. The research involves no more than minimal risk to the subjects; 2. The waiver or alteration will not adversely affect the rights and

welfare of the subjects; 3. The research could not practicably be carried out without the waiver

or alteration; AND 4. Whenever appropriate, the subjects will be provided with additional

pertinent information after participation. OR 1. The research or demonstration project is to be conducted by or

subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

2. The research could not practicably be carried out without the waiver or alteration.





D. Witness

1. The IRB requires that study personnel obtain a witness signature on all consent form documents as indicated on the templates. The IRB encourages the person signing as witness to observe the entire consenting process; understanding that this is not always feasible, at a minimum the requirement in that the person signing as witness observes and verifies as the participant signs and dates the document.

2. The witness should be a member of the health care team who is not associated with the study. If such a witness is not available at the time, a member of the study team who is not the person consenting, such as the study coordinator, may serve as the witness. A research subject’s family member is not an acceptable witness for the consent process.

3. If the signature of a witness is not obtainable at the time of consent, a Deviation Report Form must be filed explaining the circumstances that prevented study personnel from identifying a suitable witness for signature.

E. Documentation of Informed Consent

1. Types of Consent Documents

The consent form may be (1) a written document that contains the required elements of informed consent, to be read by the subject or the subject’s representative or by the investigator to the subject or subject’s representative; or (2) a short written form stating that the basic elements of informed consent have been presented orally to the subject or legal representative. Under SJH, option (2) is allowable ONLY in circumstances where the subject speaks a language other than English and a bilingual interpreter is utilized to orally translate required elements of consent specific to the study. a. Written Consent Document

When a written document is used, investigators shall be responsible for ensuring that informed consent is documented by the use of a written consent form approved by the IRB and signed by the subject or the subject’s legally authorized representative, unless this requirement is specifically waived by





the IRB. Each subject or legally authorized representative signing the written consent form must be given a copy of that form.

The IRB may approve a process for a particular study that allows the informed consent document to be delivered by mail or facsimile to the potential subject or the subject’s legally authorized representative. The consent interview would be conducted by telephone to discuss the document. The subject or legally authorized representative and witness would sign, date and return the document to the investigator, the remaining signatures would be obtained, and a copy of the fully executed consent document would be returned to the subject by mail.

b. Short Form Consent When a short form written consent document is used: i. All required elements of consent shall be presented orally to

the subject or the subject’s legally authorized representative in a language that is understandable to the subject or the subject’s representative. The person conducting the informed consent discussion shall read the entire English version of the consent to the patient, pausing at frequent intervals to allow the interpreter to orally translate the words he/she has spoken;

ii. The written summary of what is to be said to the subject or the representative shall receive the prior approval of the IRB; the full English version of the consent form is the equivalent of a written summary and must be presented to the subject in its entirety if an alternative written summary has not been approved by the IRB;

iii. A witness fluent in the language spoken shall be present at the oral presentation and at the time the research subject signs the informed consent form; The subject or representative shall sign the short form; The witness shall sign both the short form and the written summary;

iv. The person obtaining the consent shall sign the written summary;

v. A copy of the short form and the written summary shall be given to the subject or the subject’s representative;





vi. The translated version of the short form shall be submitted to the IRB with each new study; and

vii. If the research participant is greater than 7 but less than 12 years of age, the IRB approved, written Pediatric Assent document shall also be orally presented.

c. SJH policy requires and the IRB recognizes that only SJH

ministry interpreters, approved SJH telephone interpretation services, or other individuals who have been competency-tested and specifically cleared by the SJH ministry may serve as oral translators of written consent. A witness fluent in the subject’s language must sign and date the ICF that has been orally translated into the subject’s language and approved by the IRB.

d. This policy must be followed for all research consents administered to subjects at any SJH site. When consents are obtained in medical offices or other non SJH sites, researchers are expected to demonstrate that they are in compliance with this policy. They may arrange to use a certified telephone interpretation service or may have a staff member competency tested and approved by a SJH ministry.

e. The IRB strongly encourages the full written translation of consent forms in all possible situations. The short form is only intended for use in situations where consent of a non-English speaking person is anticipated to be a rare event.

2. Translated Informed Consent Document

The IRB-approved Informed Consent Document is written in English may be translated into other languages. The IRB reserves the right to require the consent form to be translated if they determine it to be necessary. The translated consent document must be submitted to the IRB for approval. The IRB shall accept only certified translations of the informed consent. All translated submissions must be accompanied by a certification of translation.

3. Waiver of Documentation of Informed Consent Under the following conditions, the IRB can waive the requirement

that the subject sign the consent form. However, waiver of





documentation of signed informed consent does not constitute waiver of informed consent:

a. The research in its entirety involves no more than minimal risk

and involves no procedures for which written consent is normally required outside the research context; OR

b. The only record linking the participant and the research would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality.

The IRB may waive the requirement to obtain a signed consent form for some parts of the study or the entire study in accordance with DHHS and FDA requirements.

F. Retention of Signed Consent Documents

Signed consent forms must be maintained as confidential and stored so as to be available upon IRB request. If subjects are patients, signed consents become a part of, and must be included in their medical records. SJH patient medical records are maintained according to each SJH entity’s policy for Medical Records Retention. For subjects who are not patients, consent forms are to be stored in departmental files. In instances where this is not feasible, they may be stored in the Principal Investigator’s files, but procedures must ensure that the department can gain physical control over consent forms when necessary.

G. Confidentiality

1. Confidentiality

In the informed consent procedure, subjects are often given assurances that the confidentiality of records identifying the subjects will be maintained. Loss of confidentiality may occur, however, when court orders that research files or information be submitted as evidence in a legal matter or where other legal compulsion (e.g., subpoena) requires the release of such information. The court decides who has access to the files and what information may be required to be provided.





Unless there are no identifiers on project materials and subject lists are not maintained, complete confidentiality of records identifying the subjects may be assured only to extent that disclosure is not compelled by court order. When FDA regulated products are being studied or the study is funded by a governmental agency, the informed consent document should state that the FDA or other governmental agency might review and copy the subject’s medical records and, if necessary, obtain the identity of the subject.

2. Inadvertent Disclosure

Security in storage, limitation of access, and coding constitute the best measures to minimize risk of inadvertent disclosure to unauthorized parties. Measures to prevent this problem should be described in protocols for studies in which the data collected is sensitive.

3. Certificate of Confidentiality

Under section 301(d) of the Public Health Service Act (42 U.S.C.241(d)) the Secretary of Health and Human Services may authorize persons engaged in biomedical, behavioral, clinical, or other research to protect the privacy of individuals who are the subjects of that research. This authority had been delegated to the National Institutes of health (NIH). Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. Certificates allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. A Certificate of Confidentiality can be used for research that is sensitive and where the protection is judged necessary to achieve the research objectives. Sensitive means that disclosure of identifying information could have adverse consequences for subjects or damage their financial standing, employability, insurability, or reputation.





4.9 HIPAA

A. Policy Statement

It is the policy of the IRB to facilitate compliance with applicable laws and regulations that govern use or disclosure of health information for research by SJH affiliated investigators and their Sponsors. In particular, all research using information created, received or maintained by or on behalf of SJH regarding its patients shall be conducted in accordance with applicable requirements of federal health privacy standards promulgated by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (the “Privacy Rule”) and analogous state laws and regulations.

B. Procedures for Implementation:

All investigators whose research proposals are reviewed by the IRB (whether under full or expedited review), as well as those whose exempt research is cleared by the HRPP Office, shall be informed of their obligations to meet the requirements of the HIPAA Privacy Rule where they propose to use SJH records containing Protected Health Information (PHI), or to enroll research participants and collect data containing PHI. The IRB will provide researchers with forms and consultation regarding what the researcher needs to do to comply with applicable standards of the Privacy Rule. 1. HIPAA Authorization and Informed Consent:

For all research where informed consent will be obtained from research participants who are SJH patients, investigators also must obtain authorization to use and disclose PHI using the HIPAA Authorization Form. The HIPAA Authorization Form specifies the uses and disclosures of the PHI that SJH may make in preparing and transmitting data to the IRB, Investigator and/or Sponsor, while the informed consent specifies the uses and disclosures that the Investigator and Sponsor may make of the research data set that has been disclosed by SJH.

The HIPAA Authorization Form may be included at the end of the consent document approved by the IRB.





2. Circumstances in which HIPAA Authorization is not Required

Under certain circumstances, the IRB may determine that HIPAA Authorization is not required. These situations include the following: a. The IRB may approve a waiver or alteration of the HIPAA

Authorization requirement, in whole or in part, only if it determines that:

i. The use or disclosure of PHI involves no more than minimal risk

to participants’ privacy, based on the presence of at least the following elements:

1) There is an adequate plan to protect the identifiers from

improper use and disclosure; and 2) There is an adequate plan to destroy the identifiers at the

earliest opportunity consistent with the conduct of the research (unless there is a health or research justification for retaining the identifiers, or if retention is otherwise required by law); and

3) There is an adequate written assurances that the PHI will not be reused or disclosed to another person or entity except as required by law, for authorized oversight of the research, or for other research for which the use or disclosure would be permitted by the Privacy Rule; and

ii. The research could not practicably be conducted without the

waiver or alteration; and iii. The research could not practicably be conducted without access

to and use of the PHI.

b. Subject Recruiting and Records Review Preparatory to Research:

The Privacy Rule imposes limitations on the use and disclosure of protected health information for the purpose of identifying and contacting prospective research participants. Similar limitations are imposed when a prospective researcher or Sponsor seeks to examine existing SJH data for purposes of protocol development or





evaluation of the suitability of SJH as a site for future research. The IRB will approve proposals only if they respect these limitations. i. Reviewing medical records to identify potential participants or to

evaluate SJH as a research site:

Requests to review medical records to identify potential participants should be made in writing and submitted to the HRPP Office. Investigator requests will be reviewed by the HRPP Office and officially cleared by the IRB Chair.

ii. Contacting Prospective Participants: The only persons who may be approved to use PHI maintained by or on behalf of SJH and/or may contact a current or former patient about a research opportunity are: (i) members of SJH’s workforce; and (ii) health care providers with admitting privileges at SJH entities. Except as provided in (3) below, the IRB will not approve a research protocol that relies on other persons to contact prospective study participants.

iii. Recruiting Exception: The IRB may grant a partial waiver of patient HIPAA Authorization that permits SJH to disclose PHI to an individual or organization outside of the covered entity for the limited purpose of contacting patients about a research opportunity. A decision by the IRB to grant a partial waiver of HIPAA Authorization will be made in accordan