Running Head: GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
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Group 1 Academic Research Site Risk Mitigation Paper
Medical Product Regulatory Affairs
Name:
Section Content:
Other contributions:
Todd Ficeto
Conflict of Interest
References
Lisa Hines
Regulatory Documents
Tables/graphics
Isabel
Manring
SOP for Consent Process
Wrote the introduction and determined the
order of the paper
Angela Sow
Documentation
Assembled the first draft and distributed it for
review
Nicole Vrettos
Informed Consent
Compiled draft comments and distributed the
final copy
Kristin Zhong
Research Training
Cover page
GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
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Group 1 Academic Research Site Risk Mitigation Paper
Medical Product Regulatory Affairs
Clinical research is a very important component for the discovery and validation of new
and improved medical treatments across the United States and worldwide. Academic research
sites can offer world renowned researchers, physicians, and students many exclusive possibilities
that foster collaboration and provide an ideal environment to conduct new and innovative clinical
trials. Large academic medical centers
such as the Ohio State University offer
large patient populations, numerous
core laboratory facilities, as well as
administrative support such as the
multiple Institutional Review Boards
(IRBs) and the Clinical Scientific
Review Committee (CSRC) that make
it an ideal place to safely and
efficiently conduct human research trials (The Ohio State University, 2014). Continued
regulatory compliance with all federal and state regulations and guidelines is of the utmost
importance for an academic research site. The above graphic illustrates the relationship among
these regulations and guidelines (York, 2011). Preventing scientific misconduct of any kind is
essential (Jones, 2014a). Some of the most common errors occurring at an academic research
site involve mismanagement of regulatory documents, improper consenting procedures, veiled
conflicts of interests, inadequate training of researchers and staff, and insufficient study specific
documentation. This paper will focus on these selected regulatory risks and potential mitigation
procedures as well as provide a Standard Operating Procedure (SOP) for proper consenting at an
GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
academic research site. The regulations associated with these risk categories are summarized in
appendix A.
Regulatory Documents
Maintaining regulatory documents during clinical research is an important step in
demonstrating compliance with appropriate standards to provide safety and protection of human
subjects. The International Conference on Harmonisation (ICH) Guideline for Good Clinical
Practice (GCP) defines these essential papers as “documents that individually and collectively
permit evaluation of the conduct of a trial and the quality of the data produced” which “serve to
demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP
and with all applicable regulatory requirements” (International Conference on Harmonisation
(ICH), 1996). A complete list of essential documents is listed in the ICH GCP document under
section 8 and is grouped by the stages of research occurring before, during, or after the trial. An
explanation of purpose and who should maintain the files is also included. Examples of these
documents are provided in the figure below (Jones, 2014b).
These combined official papers form an overall picture to the regulatory agencies that the study
protects the human subjects and is ethical. It is a way to document that the staff are trained and
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qualified to do the study and that the IRB and sponsor are monitoring the study activities as well
as the investigator’s oversight. Accurate data and source documentation and ongoing adherence
to GCPs also help validate the integrity of the study (Jones, 2014b).
To avoid lapses in essential document requirements, a trial master file is compiled when a
new study is initiated (OSU Center for Clinical and Translational Science, 2012). A tracking
system should be established to organize documents and monitor expiration dates. Smaller
studies conducted at a single location can utilize a spreadsheet program such as Microsoft
Excel® to track documents. However, larger studies across multiple sites may choose a
computerized regulatory document management (RDM) system to allow more efficient
organization (Zhao et al., 2010). Some facilities use legal counsel to help create checklists for
more accurate maintenance (Slocum & Barnett, 2006).
Internal and external compliance monitoring is crucial throughout the project. Each
study should have a quality management program that specifies how and when audits will occur.
Sponsors will hire a contract research organization (CRO) to validate the regulatory documents
and the research data. The academic research site may also perform internal reviews of trials.
This can occur by the facility’s Office of Responsible Research Practices (ORRP) through
quality improvement programs or assessments by the Office of Research. The facility’s legal
office may also want to inspect and/or approve trial specific regulatory documents. In addition,
the FDA can conduct either announced or unannounced visits at any time during a research trial
to verify data and ensure compliance with regulations. This can be a routine inspection or due to
a specific complaint (U.S. Food and Drug Administration, 2010). If noncompliance is
discovered during the inspection the FDA presents the findings to the organization on a 483
form, “Notice of Observations” (U.S. Food and Drug Administration, 2014a). Significant
GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
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violations are communicated to the facility via a FDA Warning Letter, which outlines the actions
required and specifies a timeframe for completion (U.S. Food and Drug Administration, 2012).
To avoid these FDA sanctions and other violations, a focus on both completeness and quality of
essential regulatory documents is crucial.
Informed Consent
When conducting clinical research, informed consent plays a large role in the ethics of
the trial and the protection of human subjects. As stated in the Nuremberg Code, “the voluntary
consent of the human subject is absolutely essential” (as cited in Coleman, Menikoff, Goldner, &
Dubler, 2005, p. 311). Inadequate consenting cannot only impact the integrity of the data, but it
can also compromise the rights and welfare of the research participants. The Code of Federal
Regulations (CFR) Title 21 Part 50 Subpart B and the ICH GCP Part 4.8 outline the regulations
that one must abide to when consenting prospective participants to a clinical trial. Failure to
adhere to these regulations can result in a significant compliance risk for the academic research
site. To avoid improper consenting, researchers must develop a plan for preventing, monitoring
and managing the risk.
The consent process is ongoing; it begins when a subject is first informed of the trial and
continues until the subject completes the study (Coleman et al. 2005). To prevent inadequate
consenting, one must ensure that qualified personnel are conducting the consent discussion with
the prospective subject or their legally authorized representative (LAR) at an appropriate time for
the subject. This includes staff who are properly trained on the protocol and are delegated the
task of obtaining informed consent on the delegation log. As discussed in ICH 4.8.7 and 21 CFR
50.20, the subject/LAR need to be given adequate time to review the consent form and ask
questions, prior to deciding whether or not they want to participate in the trial (International
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Conference on Harmonisation, 1996; U.S. Food and Drug Administration, 2014b). Consent
should not be obtained during a stressful time such as in labor or any other situation that could
cause the participant to not be able to properly consent. If possible, the subject/LAR should be
given the opportunity to take the informed consent form home to review and discuss it with
whomever they choose. During the consent discussion, the researcher must explain all of the
essential consent elements to the subject/LAR and ensure that they understand them prior to
signing the consent form; the majority of lawsuits over improper informed consenting result
from inadequate explanations of the risks and benefits of the study (International Conference on
Harmonisation, 1996; Kulakowski & Chronister, 2006; U.S. Food and Drug Administration,
2014b). Abiding to these processes can help ensure that the participants make an informed and
voluntary decision regarding participation. This can prevent ethical violations and harm that can
stem from enrolling patients who are not fully informed.
Additional preventative measures need to be taken when consenting vulnerable subjects.
This includes: children, prisoners, handicapped persons, pregnant women, economically or
educationally disadvantaged persons, and mentally disabled persons (U.S. Food and Drug
Administration, 2014c). Researchers must ensure that LAR’s are signing the consent form when
appropriate and that the correct consent process is taken for patients who are illiterate. Proper
training of research staff and frequently updated and implemented SOPs can help with these
processes.
After informed consent is obtained, it is important that routine monitoring occurs to
verify that the consent process was conducted appropriately. A double review system is one
method of monitoring that can be used. In this method, the researcher conducting the consent
discussion reviews the document for errors. Following the initial review, another staff member
GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
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also reviews the document to verify that it was accurately completed. In addition to the double
review system, monitoring can also include routine internal audits. Having a colleague
periodically review the documents can serve as a method of additional oversight. It can help
determine if the consent process was documented appropriately, if the process was carried out
adequately and whether or not the correct consent version was used. Documentation is crucial
when it comes to the informed consent process. Without proper documentation, there is no
evidence that the process occurred. Effective monitoring throughout the entire trial can help
identify documentation errors and can lead to the development of a management plan.
When a risk occurs, it is imperative that it is addressed quickly and is managed to prevent
reoccurrence. Management of improper consenting can include additional staff training on the
protocol and/or consenting process, and the development of SOPs or checklists. The SOPs and
checklists can serve as a guide for the researcher conducting the consent discussion. They can
help ensure that the process was conducted appropriately and that nothing was left out. An SOP
for Informed Consent is included in appendix B. If a risk is identified, one must report the risk
to the appropriate authorities. This can include internal management, the IRB and the sponsor.
Through proper reporting and the development of action plans, the risk can be managed and the
likelihood of it occurring again can be reduced.
Conflict of Interest
Keeping academic institutions’ research free from bias is of extreme importance to
maintain credibility and integrity of the outcomes and results of scientific research. Conflict of
interest (COI), or competition of interests, often distorts presentation and interpretation of
research data in biomedical publications, and its non-disclosure is perceived as a misconduct
with serious consequences for trustworthiness of science communication (Markovitch et al.,
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2010). The declaration of all relevant financial conflicts of interest (FCOIs) and non-financial
COIs by authors of research papers and/or investigators is simple and remains the most important
step toward the validity and acceptance of academic research (Markovitch et al., 2010). The
federal codes that govern COIs are 21 CFR 54, 42 CFR Part 50 F, which covers grants and
cooperative agreements, and 45 CFR Part 94, which deals with contracts. Although not all
conflicts are necessarily financial related, the most overt and blatant forms of COI usually exist
when the institution or investigator has a monetary interest in the outcome of a particular study.
The current policy under the Public Health Services (PHS) is that institutions receiving federal
grant money must review all significant financial interests of investigators prior to the
commencement of research. The PHS defines a Significant Financial Interest as anything of
monetary value, including but not limited to salary or other payment for services (e.g., consulting
fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and
intellectual property rights (e.g., patents, copyrights, and royalties from such rights), (Coleman et
al., 2005). Included in appendix C is a table that summarizes the COI policies at the 10 medical
schools receiving the largest amount of funding from the National Institute of Health.
The best safeguard to ensure the integrity of the academic institution and its research is to
implement a Conflict of Interest Committee. This committee sets the guidelines that will
eliminate financial conflicts per the NIH. The committee will draft, maintain and make
publically available a written policy and procedures manual that mirrors and complies with all
federal COI regulations. All investigator disclosures of COI must be maintained for a period of
three years or longer per 45 CFR 74.53b and 92.42b, as well as retain any actions taken (Office
of Population Affairs, 1999). The committee will also certify compliance of all regulations and
conduct regular training education seminars for investigators regarding internal policy and
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industry regulation every four years, or upon policy revision that affects the investigator, new
investigators, and discovery of a violation.
Other responsibilities include both institutional and internal reporting. Internal reports
will contain the basic elements of the Institution’s standard FCOI report (i.e., grant number,
name of investigator, type and dollar amount of FCOI). Internal files will also contain
investigator agreements, documentation of compliance and a review on how the plan ensures
research objectivity. On the institutional side, reports will include disclosures of occurrences of
FCOI (within 60 days of discovery), use of NIH funds, and annual report of ongoing cases of
FCOI and change to internal policy.
Transparency is another key element of public disclosure of FCOI. The primary methods
of making the Institution’s policy available would be by posting it on a publicly available
website. If the Institution does not have any current presence on a publicly accessible web site
(and only in those cases), the Institution needs to make its written policy available to any
requestor within five business days of a request (National Institute of Health, 2014).
Retrospective reviews upon occurrence of non-disclosure of FCOI (within 120 of
discovery) must be reported to the NIH. Key elements of the retrospective review should
include: (1) project number, (2) project title, (3) Program Director/ Principal Investigator (PD/PI)
or contact PD/PI if a multiple PD/PI model is used, (4) name of the Investigator with the FCOI,
(5) name of the entity with which the Investigator has a financial conflict of interest, (6) reason
for the retrospective review, (7) detailed methodology used for the retrospective review (e.g.,
methodology of the review process, composition of the review panel, documents reviewed), (8)
findings of the review and (9) conclusions of the review (Policy of Medicine, 2014).
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The mitigation report is the last necessary disclosure to the NIH once a violation has been
found in a retrospective review. The mitigation report is a statement of how the institution is
going to manage the FCOI that has been discovered. The mitigation report must include, at a
minimum: (1) the key elements documented in the retrospective review above, (2) a description
of the impact of the bias on the research project, (3) the Institution's plan of action or actions
taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of
harm done, including any qualitative and quantitative data to support any actual or future harm;
analysis of whether the research project is salvageable) (Policy of Medicine, 2014).
Conflicts of interest can be devastating to an academic institution if gone undetected.
The Institution’s reputation and credibility could be severely diminished as in the Jesse
Gelsinger/University of Pennsylvania Case. The penalties for FCOI violations include censure,
suspension of grants and of IRB approval of studies, nonrenewal of appointment, and dismissal
(Lo, Wolf, & Berkeley, 2000). Putting the proper policy and procedures in place is the best way
to protect the integrity of the academic research institution, although temptations for conflicts are
high. The "publish or perish" principle dominates researchers' and authors' behavior, and
modifying this behavior will require widely accepted policies and adequate training and
mentoring and incentives other than just publication as an academic reward (Relman, 1977).
Research Training
Bioethical practices are becoming more complex as technological advances are made
which involve expertise from multiple different fields (Whitmore, 2012). There is a need for
clinical and translational scientists who move bench or laboratory science into the bedside or
health care practices (Whitmore, 2012). With clinical research becoming more complex, there is
a substantial risk of inadequate training practices. There are several ways to mitigate this
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significant risk. Mitigation can be achieved by increasing the educational requirements for
clinical research professionals, implementing a quality control program, and enhancing the
researchers' knowledge through regular open seminars and staff meetings.
Increasing the educational requirements to go into a clinical research career is a way to
prevent inadequate training practices. This trend has been observed in many healthcare
professions such as physician assistants being required to have a master's degree and physical
therapists with a doctorate. For clinical research, certification through the Society of Clinical
Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) is
one way to promote adequate training. The SOCRA website states, “SOCRA developed the
Certified Clinical Research Professional Certification program to evaluate a CRP's knowledge,
understanding, and application of the conduct of clinical investigations involving humans”
(2014). The ACRP website states, “ACRP Certification is the formal recognition of clinical
research professionals who have demonstrated the knowledge, skills, and abilities to perform
ethical and responsible clinical research by passing one of three role-specific certification exams
based on international standards” (2014). Another method of preventing inadequate training is to
have clinical research professionals attain at least a master's degree in clinical research. A
graduate level degree would allow for specialization in a field of clinical research. It would also
cover the fundamentals of clinical research such as the regulatory requirements, bioethical
considerations, research design and methods, and the science involved.
A way to monitor ineffectual training practices includes a quality control program. This
is one method of ensuring quality. Pfizer states that the quality process is:
Creating, implementing, and upholding standard operating procedures (SOPs) for trial
execution, a quality scientific and medical design of the protocol, clinical investigator and
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site pre-assessment and selection, regulatory agency and ethics committee approval,
developing and providing appropriate informed consent (language, transparency of
benefits and risks) and obtaining ethics committee approval of the informed consent
process, investigator meetings and training, adequate recording and reporting of data,
periodic monitoring, and audits. (2009)
Quality practices must be implemented throughout the entire clinical research study and not just
on testing and oversight (Pfizer, 2009). It can be enforced through the quality assurance visit.
The quality assurance team should conduct separate interviews for the principal investigator and
sub-investigator asking questions such as how the protocol has been implemented (Pfizer, 2009).
They should also interview the study monitor asking questions such as how the monitor activities
occurred and specific questions on data abnormalities (Pfizer, 2009).
Incompetent training practices can be managed by requiring research staff to attend
seminars and staff meetings, and develop and review a clinical study report. The purpose of
seminars is to advance the attendee's knowledge regarding important subjects in clinical research
as well as provide updates on the most recent developments and guideline changes. Seminars
offer the opportunity to obtain new scientific knowledge about potential new research areas.
Regular staff meetings would allow employees to share concerns and address issues that can be
mitigated under the guidance of a supervisor. In addition, the supervisors could comment on
departmental strengths and weaknesses. If a risk is identified, the employees could manage it by
developing a clinical study report. The report would include the identified risk as well as a plan
to prevent recurrence. Having employees review this report could promote awareness of the
mistake, decreasing the likelihood of it occurring again. The clinical study report could also
provide an overview of the clinical data that may have been compromised due to the identified
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risk; this could aid in the statistical analysis. Questionable data would be removed from the data
analysis portion of the paper with a proper explanation. The study analysis with and without the
questionable data could be given to regulators for a better understanding of the ethics involved in
the study (Pfizer, 2009). Incorporating all of these practices into one’s standard routine could
help mitigate the risks associated with inadequate training.
Documentation
It is paramount for an academic clinical research institution to exhibit good
documentation practices in advance, during, and after conducting a clinical research trial. Valid,
reliable, and uniform documentation demonstrates an effort to uphold adequate protections of
human subjects and is necessary for the submission of information to the sponsor, institutional
review board, auditors, and any federal, state, or local regulatory entity. Ultimately, it is the site
principal investigator (PI) that is responsible for ensuring good documentation practices despite
the fact that there may be a number of personnel contributing to various aspects of the trial.
Thus, the PI and research staff must be familiar with the FDA 21 CFR, ICH E6 GCP, and other
relevant guidelines that are essential to academic clinical research institutions.
As mentioned in previous sections, the academic site must maintain and store all
documents related to regulatory affairs, informed consents, potential conflicts of interests, and
training in accordance with ICH E6 GCP. In addition, an academic research institution must keep
all participants’ original records or certified copies that are needed for reconstruction or
evaluation of the clinical trial. This is known as source data (International Conference on
Harmonisation (ICH), 1996). Source documentation is defined as original documents, data, and
records (International Conference on Harmonisation (ICH), 1996). In the event of a dispute with
regulatory agencies, an abundance of source documentation can be a valuable source of evidence
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that the academic site is vested in conducting quality human subject research. The responsibility
for possessing source documents lies with the academic site PI.
The PI must govern all research practices to ensure information such as case histories,
study visits, and observations, is accurate, thorough, and is correctly transcribed onto case report
forms (U.S. Food and Drug Administration, 2014d). A Case report form is defined in ICH GCP
1.11 as a printed, optical, or electronic document in which all procedures required by the
protocol are recorded. Electronic Data Capture (EDC) systems are becoming more popular as it
is a convenient method to facilitate clinical research data collection. Increasingly, many medical
records that pertain to research participants are established in, maintained, and retrieved from an
electronic system. Depending on the type of information, an electronic record may be accessible
from open or closed systems (U.S. Food and Drug Administration, 1997). These systems must
be validated, secure, and have restricted access. Regardless of the system used, the principal
investigator must be proficient in the system and able to assess accuracy and consistency with
case report forms.
All records should be kept for a minimum of two years following study completion, post
marketing application approval, or the when the sponsor discontinues all studies under the
relevant IND. These records can be stored within the academic site or at an off-site facility so
long as the environment is conducive to integrity preservation. Proper record retention and
documentation practices pose a serious risk to credible research conducted at an academic
research site. The first step in reducing this risk would be to prevent malpractice by sufficiently
training all professionals that are delegated authorities in the research trial. Source
documentation should be monitored periodically by a sponsor’s representative in accordance
with ICH GCP 5.18 and terms negotiated in the Clinical Trial Agreement (CTA). This monitor
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should be proficient in the protocol, possess a reasonable amount of knowledge regarding the
disease and investigational therapy, as well as be familiar with the site clinical record systems. If
the latter is not true, the study coordinator or PI should train the monitor how to navigate the
electronic record system. The monitor’s responsibility is to verify accuracy, consistency, and
that the research is conducted in a manner that is compliant with GCP and federal and state
research regulations. In addition to having external monitoring visits, internal monitoring is a
great way to do quality control and implement quality improvement plans. The PI should
provide guidance to research staff as to when these internal monitoring visits should occur (i.e.
prior to each external monitoring visit or after a set number of consecutive enrollments). Should
any discrepancies be discovered via internal or external monitoring visits, the matter should be
discussed thoroughly, a prevention plan developed, and if warranted; the FDA, IRB, or other
relevant regulatory agencies should be notified. An additional risk mitigation plan would be
establishing a Data Safety Monitoring Board (DSMB). A DSMB is an external committee
whose purpose is to monitor the safety, efficacy, and progress of the trial. It is a committee of
experts that are knowledgeable in the particular field of research. The DSMB offers critical
feedback in addition to monitoring records and study status.
In conclusion, there are many ways to implement and mitigate common regulatory risks
involved in clinical research at an academic research site. Perpetual compliance with federal and
state clinical research regulations can be obtained by frequent, open communication with
regulatory agencies and continued training. Maintaining this symbiotic relationship between
researchers at academic sites and clinical research regulatory entities is essential in successfully
conducting clinical trials that do not compromise human subject protections for the advancement
of science. The result is innovative therapies and new discoveries that have profound
GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
implications for target populations that are the product of sound clinical research performed at
academic research sites.
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References
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Appendix A
Applicable Regulatory Requirements
Content
Informed Consent
Conflict of Interest
Research Training
Federal
21 CFR 50 Subpart B
45 CFR 46.116-117
21 CFR 54
21 CFR 312.53
42 CFR 50.603-606
45 CFR 94
21 CFR 312.50-53 Subpart D
21 CFR 54
Data/Source
Management
21 CFR 312.62
21 CFR 11
Regulatory
Documents
21 CFR 312.62
ICH
ICH E6 GCP 4.8
--ICH E6 GCP 4.2.3
ICH E6 GCP 4.2.4
ICH E6 GCP 1.11
ICH E6 GCP 1.51
ICH E6 GCP 1.52
ICH E6 GCP 5.18
ICH E6 GCP 8
Standard Operating Procedure – Consenting Process for Adult Research Subjects
22
Appendix B
Standard Operating Procedure-Consenting Process for Adult Research Subjects
1. Background:
Federal regulations and guidelines exist that define the proper consenting procedures. These are based on
the Belmont Report and written into law and upheld by the institution in order to maintain the federal wide
assurance with the FDA and other federal entities.
2. Guidelines and Regulations
a.
21 CFR 50 – Protection of Human Subjects Research
b.
21 CFR 54 – Financial Disclosure by Clinical Investigators
c.
21 CFR 56 – Institutional Review Boards
d.
21 CFR 312 – Investigational New Drugs (Drugs for Human Use)
e.
21 CFR 812 – Investigational Device Exceptions
f.
45 CFR 46 – Protection of Human Subjects
g.
ICH E6 – Good Clinical Practice
3. Terms and Definition:
a.
IRB – The Institutional Review Board is designed according to 45 CFR 46 and performs the tasks
established in the same policy to ensure ethical human subjects research.
b.
Legally Authorized Representative (LAR) – The legally authorized representative is an individual
who is authorized under judicial or other applicable law to consent on behalf of a prospective
subject.
c.
Human Subject: A human subject is a living individual with whom an investigator conducts a
research study and obtains data through either intervention or interaction with the individual or
identifiable private information according to 46 CFR 46.
d.
Short Form – A short form may be used in appropriate situations in which all required elements
of the consent will be presented orally to the subject or the subjects legally authorized
Approved 11/24/14-IRB Policy Committee
Standard Operating Procedure – Consenting Process for Adult Research Subjects
23
representative. A written summary of the oral content of the consent has to be approved by the
IRB and given to the subject or the subject’s legally authorized representative.
e.
Long Form – The long form is the official IRB-approved consent document that describes the
elements set forth by federal guidelines and regulations about the study and must be signed by the
subjects or the subjects legally authorized representative.
4. Procedure:
a.
Required Conditions:
i. Consent has to be acquired under circumstances that enable the potential participant or
their legally authorized representative sufficient time to consider participation in the
study. No coercion or undue influence or language may be used in the process.
ii. The consent must be acquired by designated impartial party that has thorough knowledge
of the study and who has received proper training regarding the federal and state
guidelines regarding human subject’s research.
b.
Consenting process (initial):
i. The potential study subject is provided with general information about the study for
which they may be eligible for. Any advertising or information used must be approved by
the institution’s IRB.
ii. The potential study subject indicates interest in the study.
iii. The consenting process will involve the designated medical center study personnel and
the potential study subject. The person obtaining the initial consent must possess
knowledge regarding the study and the IRB process. For vulnerable subjects, an
additional impartial witness or authorized representative may be required.
iv. During the consenting process, the IRB approved consent form will be discussed so that
the potential subject can give voluntary consent to participate. The following elements
need to be addressed:
1.
Explanation of the purposes of the research, including name and sponsor of the
study, PI and contact information
Approved 11/24/14-IRB Policy Committee
Standard Operating Procedure – Consenting Process for Adult Research Subjects
2.
Description of the procedures involved in the study
3.
Expected duration of participation including number of visits and time
24
commitment for each
a.
4.
Identify which procedures are experimental
Descriptions of reasonable risks and benefits to the study participant, disclosure
of alternative treatments
5.
Description of how confidentiality will be maintained and who has access to
records
6.
Description of any necessary audio and video/photo recording that will be
conducted in the study and access to these recordings, a separate signature line
to consent for this is required (if applicable)
7.
Explanation regarding any compensation that may be given
8.
Information regarding withdrawing consent such as contact information and any
written procedures
9.
Contact information regarding any suspected research-related injury to the
participant
a.
Including information regarding medical treatments for these injuries,
payments, and any other additional information
10. Statement that the participation is voluntary and that any refusal will not have
any loss of benefits the participant is otherwise entitled to. This applies also if
the participant withdraws consent at any time in the future.
11. Statement that participant will receive a copy of the consent form.
v. Time to ask any remaining questions regarding the study or consider participation must
be given.
vi. The study personnel must ensure that all information given has been understood by the
potential participant or their legally authorized representative.
Approved 11/24/14-IRB Policy Committee
Standard Operating Procedure – Consenting Process for Adult Research Subjects
25
vii. If the potential subject or legally authorized representative agrees to take part on the
study, he/she signs the consent document to acknowledge their willingness to participate
in the study. The person obtaining consent will also sign the form and make sure it is
dated and a copy is given to the participant or legally authorized representative.
viii. Any study related calendars or materials may be given to the subject at this time.
ix. No person can be involved in any study until proper consent is acquired and documented.
c.
Consenting process (continuing):
i. After the initial consent is acquired, the consent is maintained through an ongoing
exchange of information between the protocol PI and the participant until the study is
complete or the participant withdraws consent.
ii. It may be necessary to re-consent subjects throughout the trial as new information
become available and the initial consent form is amended.
d.
Documentation of consenting process
i. The consent process must be documented in the subject’s medical record/source
documentation. The following items should be recorded:
1.
Details of consent discussion including:
a.
Who was present (e.g. family members, other research staff, clinical
staff, etc.)
b.
Where discussion took place (e.g. privacy)
c.
Opportunity and amount of time given for questions and review
d.
That no coercion occurred
e.
Version of consent and HIPAA authorization discussed
2.
Mental status of subject (.e.g. oriented, alert, sedated, etc.)
3.
Who signed and dated the consent form (subject or LAR, study staff)
4.
Subject and/or LAR verbalized understanding of items listed in consent form
5.
Consent was signed prior to conduction of any study activities
6.
Copy of signed forms were given to the subject/LAR
Approved 11/24/14-IRB Policy Committee
Standard Operating Procedure – Consenting Process for Adult Research Subjects
7.
Where original forms are filed
5. Documents:
a.
Written consent form (long form) that has been approved by the IRB and is current
i. Written in the language of anticipated study subjects (if applicable)
b.
HIPAA authorization form approved by the IRB
c.
Consent short form (if applicable)
d.
Written summary script (if applicable)
Approved 11/24/14-IRB Policy Committee
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GROUP 1 ACADEMIC RESEARCH SITE RISK MITIGATION PAPER
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Appendix C
Conflict of Interest Policies at the 10 Medical Schools Receiving the Largest Amount of Funding
from the National Institute of Health
(Lo, Wolf, & Berkeley, 2000)