Responsible Conduct in Research
Human Subjects Education Module
Copyright©2002 Winona State University, P.O. Box 5838, Winona, Minnesota, 55987
Welcome to the WSU Human Subjects Education Module.
Instructions
•
Documentation of successful completion of this program is required of all
WSU students, faculty and staff who conduct research involving human
participants on or off campus. It is also required of any individual not
associated with WSU who conducts research involving WSU students or
employees, or conducts research using records containing information on
WSU students or employees.
•
Reviewing the module takes about 20 minutes. Successful completion is
documented by scoring 80% on an online, 20-question multiple choice quiz.
The quiz is available on Desire to Learn (D2L)
https://winona.ims.mnscu.edu/.
•
See the next page for instructions on registering to complete the Human
Subjects Education Module and the Quiz.
Contents
Instructions
• You can self-register in the Human Subjects Education Module. Go
to the Desire to Learn (D2L) Home Page at
https://winona.ims.mnscu.edu/. Login and click Self-Registration on
the toolbar. Select Human Subjects Education Module. Click on
Register; click on Submit; Click Finish. A Registration Summary
will appear. If you click on the Go to Human Subjects Module, you
will go directly to the course. If you do not want to go to the course
immediately after enrolling, click on Done and you will go back to
your D2L Home Page. The next time you login to D2L, click on the +
sign to the left of the words No Semester to see a list of courses and
click on Human Subjects Education Module to go to the course.
• Call TLT Services via ext. 2900 if you have any problems enrolling in
or accessing the course.
Contents
Contents
– Rationale for the Education Requirement
– Definitions
– History
• The Nuremberg Code
• The Belmont Report
– The Belmont Principles and Applications
» Respect for Persons - Informed Consent
» Beneficence - Assessment of Risks & Benefits
» Justice - Selection of Subjects
Contents (Continued)
– Federal Regulations
– Principle Investigator (PI)
• General Responsibilities
• Request for Approval of Protocol
• Informed Consent Form
• Informed Consent Process
Contents (Continued)
– Institutional Review Board (IRB)
• Members
• General Responsibilities
• Authority
• Purpose of the Review
• Content of the Review
• Financial Conflict of Interest
• Types of Review
– Exempt Research
– Expedited Review
– Full Committee Review
• Complaints and Investigations
– Quiz
Rationale for the Education Requirement
– As of October 1, 2000, grant applicants to the U.S. Department of
Health and Human Services (HHS) National Institutes of Health
(NIH) must certify that all key personnel named in a research
proposal have completed an education program in the protection of
human subjects.
– Other agencies are expected to adopt similar policies, just as, in
1991, sixteen agencies adopted the HHS human subjects protection
regulations as their “common rule.” In addition, the U.S. Congress
is considering extending all federal regulatory provisions to all
research, regardless of the sources of funding. The state of
Maryland has already passed such a statute with respect to the use
of human subjects in research.
Contents
Rationale for the Education Requirement (Cont)
– HHS strongly recommends institutions follow the federal
regulations regarding protection of human subjects regardless of
the source of research sponsorship.
– WSU has filed a Federal wide Assurance with HHS affirming it
will apply all federal research-related regulatory requirements to
all research conducted under its auspices, regardless of source of
financial support, if any. Hence, all persons submitting a Request
for Approval of Protocol to the WSU IRB must include
documentation that they have successfully completed this
instruction module.
Contents
Definitions - What is “Human Subjects” Research?
– Research is “a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge.” (45 CFR 46.102)
– Research may involve direct interactions or interventions, such as
obtaining data through surveys, interviews, observation, taking
medical histories, obtaining blood samples, urine sampling,
diagnostic procedures, or treating patients at least in part for the
purpose of gaining generalizable information. Research may also
be indirect, such as analysis of specimens or data. (Hint: The
intent to publish or present the results of an activity usually, but
not always, implies the activities involve research.)
Contents
Definitions - What is Human Subjects
Research? (Continued)
– Research (as defined previously) that involves human participants
may be “human subjects research” if the subjects meet the
following definition.
– A human subject is a living individual about whom an
investigator conducting research obtains either data through
intervention or interaction with the individual; or identifiable
private information from a confidential source.
– Key to the human subjects definition are the phrases “about
whom” and “identifiable.” Collecting information FROM
individuals is not necessarily human subjects research, but
collecting identifiable information ABOUT individuals usually is.
Contents
History: The Nuremberg Code
– The U.S. government believes it has an ethical and legal
responsibility to protect the rights of citizens who agree to
participate in research studies.
– The principles underlying the protection of human subjects have
their seeds in events following World War II. In 1947, the
Nuremberg Military Tribunal developed a code of standards to be
used in judging physicians accused of conducting research
atrocities in Nazi concentration camps.
Contents
History - The Nuremberg Code (Continued)
– Key to the Nuremberg Code was the principle that the voluntary
consent of individuals who were research subjects was absolutely
essential. Such consent could be judged by three criteria:
• Capacity to consent
• Freedom from coercion
• Comprehension of the risks and benefits involved
Contents
History - The Belmont Report
– In 1979, the Department of Health, Education and Welfare issued
the Belmont Report on the “Ethical Principles and Guidelines for
the Protection of Human Subjects of Research,” developed by the
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (available at
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm)
– The Belmont Report expanded upon the Nuremberg Code,
establishing three ethical principles and accompanying applications
for the protection of human subjects.
Contents
The Belmont Principles and Applications
– Practical applications of the ethical principles set forth in the
Belmont Report are:
Ethical Principles
Applications
1. Respect for Persons
Informed Consent
2. Beneficence
Assessment of risks and benefits
3. Justice
Selection of subjects
Contents
Respect for Persons - Informed Consent
– Respect for Persons - Researchers must respect individual
participants’ autonomy and protect those with reduced autonomy.
Persons must be given all the information and time they need to
make an informed decision as to whether or not to participate in a
study and must freely volunteer to do so.
– There must be freedom from coercion, either directly or
indirectly. Subjects should not feel any pressure to participate,
including unintended pressure that may be created by the
researcher and subjects’ non-research related relationships.
– Extra care must be taken with individuals who may have a limited
capacity to consent, such as children, the elderly and the mentally
ill. Their legal guardians (for children) or legal representatives (if
appointed) must participate in the decision-making process.
Contents
Respect for Persons - Informed Consent
(Continued)
– Informed Consent - Before agreeing to participate in a research
project, human subjects must be given a clear description of the
proposed research and must understand what the research will
entail, including any risks associated with their participation.
They must be assured participation is voluntary and that they may
withdraw from a study, without prejudice, at any time. In short,
subjects have a right to be “informed” and must freely “consent” to
participate.
– Securing subjects’ informed consent is generally confirmed
through subjects (and/or their legal representatives) receiving and
signing a copy of a form including the above information.
Contents
Respect for Persons - Informed Consent
(Continued)
– In the case of anonymous surveys, informed consent may be
obtained by including a statement on the instrument indicating that
by completing the survey the subject is giving his/her consent.
The statement must include the elements required to obtain
informed consent, but the human subjects’ signatures are not
required.
– Informed consent waivers may be only be requested in unusual
circumstances, generally in cases where the only record linking the
subject to the research would be the consent form and there is
potential harm from a breach of confidentiality .
Contents
Beneficence - Assessment of Risks & Benefits
– Beneficence - The Belmont Report stated research should
“maximize possible benefits and minimize possible harms.” The
researcher must balance the obligation to protect the well-being of
the individual human subjects who agree to participate in her/his
study with the possible benefits the research may offer society.
– The ultimate benefits of any research must outweigh any and all of
the risks to human subjects participating in the project.
Contents
Beneficence - Assessment of Risks & Benefits
(Continued)
– Assessment of Risks and Benefits - Risks must not only be
disclosed in the informed consent process, they must be
minimized in the research plan. Researchers must consider
physical, psychological, social and economic risks in designing
their research.
– Researchers must also offer protections against invasion of
privacy (access to information about a person’s body or behavior
without her/his consent) and ensure the confidentiality of any data
collected (safeguarding of information voluntarily given by one
person to another). Personal information gathered about human
subjects in the course of a study -- data that can be directly linked
to a specific individual -- must not be accessible by any individual
without the subject’s knowledge and consent.
Contents
Justice - Selection of Subjects
– Justice - An “equitable distribution of research burdens and
benefits” is required. This means selection of participants must not
be based on the “favor” or “disfavor” of the researcher, nor the
social status or “vulnerability” of the subjects. The past practice of
recruiting subjects from “captive,” manipulatable populations
(poor patients in public institutions, prisoners, soldiers, students)
led to abuses, as well as faulty research results.
– In recent years, National Institutes of Health have placed
increasing restrictions on research that does not select sample
populations reflecting the appropriate numbers of minorities,
women and children. NIH has also established special provisions
for reviewing protocols involving prisoners.
Contents
Justice - Selection of Subjects (Continued)
– Selection of Subjects - Subjects should not be selected based on
class, socioeconomic status or race unless the study objectives
require such selectivity. Women in their child-bearing years must
be included unless there is specific scientific evidence of risk. The
use or non-use of children must be justifiable. If prisoners are
involved, a prisoner representative must serve on the IRB.
– Counselor-client, employer-employee and teacher-student
relationships are potentially coercive, and extra precautions should
be taken to guard against any such perception. For example,
faculty awarding extra credit for students participating in a study
should offer an alternative, comparable method of earning extra
credit for those students who choose not to participate.
Contents
Federal Regulations
• The following regulations and laws apply to human subjects research:
– Code of Federal Regulations dealing with the Protection of Human
Subjects (45CFR46) & Public Health Service (PHS) Policy http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
– Health Research Extension Act of 1985 (Public Law 99-158) as
amended by the National Institutes of Health (NIH) Revitalization
Act of 1993 (P.L. 103-43) http://www.hhs.gov/ohrp/humansubjects/guidance/statute.htm
– (Note: The Food and Drug Administration (FDA) also has
regulations that apply if the research involves a product regulated
by the FDA. Protection of Human Subjects and informed consent
requirements are prescribed in 21 CFR 50 and Standards for
Institutional Review Boards appear in 21 CFR 56).
Contents
Federal Regulations (Continued)
– The 1991 Federal Policy for the Protection of Human Subjects Institutions engaged in research supported by any of 16 agencies
must file an assurance agreeing 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.”
– Participating agencies include: The U.S. Departments of
Agriculture, Energy, Commerce, Housing and Urban
Development, Justice, Defense, Education, Transportation and
Health and Human Services; and Veterans Affairs, the National
Science Foundation, NASA, EPA, AID, Social Security
Administration, CIA and Consumer Product Safety Commission.
(Again, the Food and Drug Administration follows separate, but
similar regulations.)
Contents
Principle Investigator (PI) - General
Responsibilities
– Researchers must adhere to the ethical guidelines and legal
regulations covering human subjects research. They are
responsible for:
• Design of the study and preparation of the research plan
• Submission of all required forms/information to the designated
Institutional Review Board (IRB)
• Conduct of the research, including reporting any unanticipated
problems involving risks to subjects or others, or unexpected
serious harm to subjects, to the IRB
• Compliance with IRB decisions, stipulations and data requests
• Submitting proposed amendments to previously approved
research
Contents
PI General Responsibilities (Continued)
– Three key documents must be submitted by the Investigator to
secure IRB approval:
• Protocol Request for WSU IRB Approval form
• Informed consent form or statement or consent waiver request
• Documentation of completion of this Human Subjects
Education Module
Contents
PI - Request for Approval of Protocol
The Request for Approval of Protocol Form includes descriptions of:
• the proposed research activity
• the scientific rationale for the proposed research activity
• the risks to subjects
• any procedures that are experimental
• anticipated benefits to subjects, if any
• subject selection, recruitment procedures and the anticipated
number of subjects
• the proposed consent document and process to be used
• safeguards to be taken if vulnerable subjects are involved
• steps to be taken to ensure confidentiality of data
Contents
PI - Informed Consent Form
– The proposed informed consent form must be submitted with the
Request for Approval of Protocol. Elements to be included in the
form are specifically spelled out in federal regulations.
– There are 12 basic elements and 6 possible additional elements.
Contents
PI - Informed Consent Form (Continued)
1.
2.
3.
4.
5.
6.
A statement of the proposed research
An explanation of the purposes of the research
The expected duration of the subject’s participation
A description of the procedures to be followed
Identification of any procedures which are experimental
A description of any reasonably foreseeable risks or discomforts
to the subject
7. A description of any benefits to the subject or others which may
reasonably be expected to result
8. A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject
9. A statement describing the extent, if any, to which confidentiality
of records identifying the subject will be maintained
Contents
PI - Informed Consent Form (Continued)
10. For research involving more than minimal risk, an explanation as
to whether any compensation, and an explanation as to whether
any medical treatments are available, if injury occurs and, if so,
what they consist of, or where further information may be
obtained
11. 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
12. A statement that participation is voluntary, refusal to participate
will involve no penalty or loss of benefits to which the subject is
otherwise entitled, and the subject may discontinue participation
at any time without penalty or loss of benefits, to which the
subject is otherwise entitled
Contents
PI - Informed Consent Form (Continued)
– The 6 additional elements that should be added, as appropriate,
are:
1. A statement that the particular treatment or procedures may
involve risks to the subject (or embryo or fetus, if the subject
is or may become pregnant), which are currently unforeseen
2. Anticipated circumstances under which the subject’s
participation may be terminated by the investigator without
the subject’s consent
3. Any additional costs to the subject that may result from
participation
Contents
PI - Informed Consent Form (Continued)
4. The consequences of a subject’s decision to withdraw from
the research and procedures for orderly termination
5. A statement that significant new findings developed during
the course of the research which may be related to the
subject’s willingness to continue participation, will be
provided to the subject
6. The approximate number of subjects in the study
Contents
PI - Informed Consent Process
– Simply having a signed, acceptable form is not sufficient evidence
that informed consent has been secured. Subjects must understand
what the form says. They must have been given a reasonable
amount of time to read the form and an opportunity to ask
questions about the proposed research. In short, informed consent
is actually an on-going process, which is documented through use
of an informed consent form.
– It is recommended consent forms be written at no more than an 8th
grade reading level. In some cases, due to language barriers or
other circumstances, the elements of informed consent may be
presented orally. In those cases, the IRB must receive a written
summary of what is to be communicated orally and a witness must
be present at the oral presentation. The subject may then sign a
“short” consent form.
Contents
PI - Informed Consent Process (Continued)
– If the subject is potentially “vulnerable,” (elderly, cognitively
impaired, or economically or educationally disadvantaged), extra
care must be taken to be sure they are truly giving their informed
consent. There are additional regulatory requirements if research
involves women, human fetuses, neonates, prisoners or children. .
– If the subjects have legal guardians or legal representatives, those
representatives must participate in the informed consent process
and their signatures also must be secured. Subjects (and their
representatives) should be given a copy of the signed form.
Contents
Respect for Persons - Informed Consent
(Continued)
– In the case of anonymous surveys, informed consent may be
obtained by including a statement on the instrument indicating that
by completing the survey the subject is giving his/her consent.
The statement must include the elements required to obtain
informed consent, but the human subjects’ signatures are not
required.
– In some cases, the IRB may allow for alterations to the normal
consent form elements or waive the the consent form requirements.
However, the IRB can grant waivers only under special
circumstances and it is not required to do so.
Contents
Institutional Review Board (IRB) - Members
– Requests for Approval of Protocols and informed consent forms
are reviewed by an institution’s Institutional Review Board (IRB).
– The 1971 federal regulations required institutions to create IRBs
with specific membership qualifications and representation.
– Large research institutions may have multiple IRBs, each one of
which reviews protocols involving specific types of research. At
smaller institutions, an IRB may invite individuals with
competence in special areas to assist them as needed.
Contents
IRB - Members (Continued)
– IRBs must include:
• at least five members representing a diversity of individuals
• members with expertise in research and knowledge about
regulations and professional conduct
• both men and women
• members of more than one profession
• at least one member whose primary concerns are scientific and
at least one member whose primary concerns are nonscientific
• at least one member who is not affiliated with the institution
Contents
IRB - General Responsibilities
– IRBs
• review, approve, require modifications in, or disapprove all
research activities involving human participants
• review and require or waive documentation of informed consent
• maintain written records of all correspondence, meetings,
proposals reviewed, reviews, decisions concerning reviews,
progress reports from investigators and reports of injuries
• conduct continuing review of research at least once a year
• investigate complaints that researchers have failed to obtain
needed approval or mistreated, coerced or deceived subjects
• suspend or terminate research that is not conducted in accord
with requirements or has been associated with serious harm to
subjects
Contents
IRB - Authority
– The IRB has the authority to approve, require modifications in, or
disapprove all research activities involving human subjects
conducted by WSU students and/or employees or by individuals
accessing records on WSU students and/or employees.
– Research that has been reviewed and approved by an IRB may be
reviewed and disapproved by officials of the institution. However,
those officials may not approve research if it has been disapproved
by the IRB.
Contents
IRB - Purpose of the Review
– The IRB reviews protocols to insure the design of the study is
consistent with sound scientific principles, ethical guidelines, and
legal requirements.
– The IRB’s paramount responsibility is to protect the rights and
welfare of human research subjects. As such, it reviews requests
in terms of the impact of proposed research activities on the human
participants. The academic quality of proposed research is
reviewed in that context. The research plan, design and
methodology are reviewed as they are related to the protection of
human subjects.
– For example, a protocol would not be disapproved solely because
the request for approval was poorly written, but it could be
disapproved because a poorly written document might not provide
the IRB the appropriate information needed to approve the request
Contents
IRB - Content of the Review
– In reviewing requests to conduct research, the IRB determines:
• risks to subjects are minimized
• risks to subjects are reasonable in relation to anticipated
benefits
• selection of subjects is equitable
• informed consent will be sought from each prospective subject
and appropriately documented
• the research plan makes adequate provision for monitoring the
data collected to ensure
– the safety of the subjects
– the privacy of the subjects
– the confidentiality of data
Contents
IRB - Financial Conflict of Interest
– IRB’s may also consider a researcher’s possible financial conflict
of interest as it may be related to the protection of human subjects.
– A financial interest is anything of monetary value, including, but
not limited to, salary or other payments for services, equity
interests, and intellectual property rights. Conflict of financial
interests involves situations in which the findings secured through
research conducted by the principle investigator could result in
personal gain or give improper advantage to themselves, coapplicants, or their spouses or dependents.
– Questions on possible conflicts of interest are included on the
Request for Approval of Protocol form.
Contents
IRB - Types of Review
– Some activities are excluded from review by the IRB: For
example: teaching/training, diagnostic evaluations, therapeutic
procedures, clinical training (but not research training).
– Assessment activities and randomly distributed, anonymous
customer satisfaction surveys are examples of excluded activities.
They do not fall under the definition for “research” on “human
subjects.”
– All other research proposals involving human participants fall
under one of three types of review categories:
• Eligible to be Exempt
• Eligible for Expedited review
• Full Committee review required
Contents
Types of Review - Exempt Research
– The term “exempt” is something of a misnomer, because it does
not mean a researcher is exempt from submitting a request to the
IRB. Researchers cannot make self-determinations that their
proposed research is exempt.
– The Belmont principles of respect for persons, beneficence and
justice still apply to “exempt” research. In addition, under PHS
regulations, not all exemptions apply to all categories of human
subjects. Many professional societies also encourage following
informed consent procedures for exempt research. (The FDA does
not allow for any waivers of informed consent.)
– Hence, individuals conducting exempt research at WSU must
request an exemption by submitting a Request for Approval of
Protocol Form with an informed consent form to the IRB. .
Contents
Types of Review - Exempt Research (Continued)
– The Chair or a designee reviews the request to confirm it does have
exempt status and that appropriate documentation of the informed
consent process is on file.
– The Chair or designee is authorized to grant an exemption on
behalf of the full IRB. A denial of an exempt proposal must be
voted on by the full IRB.
– The federal regulations identify 6 categories of exempt research.
Periodically, these category descriptions are modified to reflect
changes in certain fields of research. Abbreviated descriptions of
the current categories follow:
Contents
Types of Review - Exempt Research (Continued)
1. research conducted in commonly accepted educational
settings, involving normal educational practices, such as
research on instructional strategies, techniques, curricula or
classroom management
2. educational tests, surveys, interviews or observation of public
behavior, unless information is recorded in such a manner
that the human subjects could be identified and linked to the
subjects and place them at risk
3. educational tests, surveys, interviews or observation of public
behavior (not exempt above), if the subjects are public
officials or candidates for public office or federal statutes
require confidentiality
Contents
Types of Review - Exempt Research (Continued)
4. the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if the data
is publicly available and recorded so subjects are
unidentifiable
5. research conducted by official agency or department heads on
public benefit programs, procedures for obtaining such
benefits, or possible changes to such programs or benefits
6. taste and food quality evaluation and consumer acceptance
studies of wholesome food or foods containing an ingredient
that has been identified as safe by the Food and Drug
Administration or the Environmental Protection Agency or
the U.S. Department of Agriculture
Contents
Types of Review - Expedited Research
– Two types of research are eligible for expedited review.
1. Projects involving “minimal risk” as identified by the federal
government and published in the Federal Register. Minimal
risk means the odds of harm are no more than one might
expect to encounter in daily life or during routine medical or
psychological examinations
2. Projects involving minor changes in previously approved
research
– The federal regulations identify 8 categories of “minimal risk”
activities. Abbreviated descriptions of the current categories
follow:
Contents
Types of Review - Expedited Research (Continued)
1. clinical studies of drugs (for which a new drug application is not
required) and medical devices (for which an exemption is not
required and/or the device is approved for marketing)
2. collection of blood samples in accord with specific federal criteria
3. collection of specific biological specimens by noninvasive means
4. collection of data through noninvasive procedures routinely
employed in clinical practice (excluding x-rays or microwaves)
5. research on materials collected for non-research purposes
6. collection of data in audio or visual format
7. research on group characteristics or behavior employing survey,
interview, oral history, focus groups, program evaluation, human
factors evaluation or quality assurance methodologies
8. continuing review of research previously approved by the IRB
Contents
Types of Review - Full Committee Review
– All other research involving human participants is subject to full
IRB review. The Protocol and informed consent form must be
approved by a majority of the IRB members.
– During the course of any research approved by the IRB, any
changes made in the research plan and/or any problems
encountered must be reported to the IRB. At least a yearly review
is conducted, however the IRB may request more frequent reviews.
– Rejected protocols may be revised and resubmitted. However,
research disproved by the IRB may not be conducted at or in
association with WSU. An IRB decision to disapprove research
cannot be appealed.
Contents
IRB - Complaints and Investigations
– The IRB is authorized to investigate any complaints received from
human subjects participating in a research study or from other
interested persons who have concerns about the conduct of a
research study. If warranted, the IRB may require previously
approved research be discontinued.
– Reports of research being conducted without IRB approval also
warrant investigation by the IRB. The IRB will require any such
unauthorized research to be stopped immediately until proper
approval is secured.
Contents
Quiz
–
Successful completion (a score of 80%) of a 20-question multiple choice
quiz is required of all WSU students, faculty and staff who intend to
conduct research involving human participants on or off campus.
–
If you are already “enrolled” and are reviewing this material in D2L,
click on the Module Quiz link to your left. Then click on Start Quiz. If
you don’t see a Module Quiz link, simply return to the Contents page and
access the quiz through that page.
–
If you have not yet enrolled, please see the Instructions at the beginning
of this module. If you prefer to complete a hard copy version, contact the
G&SP Office.
–
See the next page for instructions on completing the quiz.
Contents
Quiz (Continued)
– Each question has an individual save button. At the bottom of the
quiz, there's also a Save All Responses button. If you decide to
change any responses, remember to re-save them.
– SAVING YOUR RESPONSES DOES NOT SUBMIT THE
QUIZ.
– To submit the quiz, at the bottom of the quiz, go the far right side
of the screen and click on the Go to Submit Quiz icon. You will
be asked if you are sure you want to submit the quiz. Click
Submit Quiz. A dialog box will ask if you are sure you want to
submit the quiz. Click OK. Your results, along with the correct
answers for any incorrect responses, will appear. Click on
Submissions for a copy of just your grade, download the page
and submit it with your IRB Protocol Request as documentation
of successful completion of the course.
Quiz (Continued)
– If you need a copy of the quiz at a later date, Login to D2L. You
will find a link to the course under Course list for No Semester.
Click on the + sign to the left of the word No semester to see a list
of courses and click on Human Subjects Education Module to go
to the course. Click Grades.
– To save an image of the screen to a file:
• On a PC, click and hold the ctrl button and the print screen
button. Open up a blank word document and click paste. Save
the document to a file. on your computer.
• On a MAC, click and hold the shift, command and 3 buttons.
Open up a blank word document and hit paste. Save the
document to a file on your computer.
–
Quiz (Continued)
– If you want to save your grade as a pdf file instead, click print.
Choose the option to save the file as a pdf file on your computer.
Click print. The document will open. Save the file on your
computer. (Note: If you do not have a pdf prompt when you
click print, you may need to install Adobe Professional on your
computer. This is available for installation on your computer. Go
to Start, Control Panel, Add or Remove Programs. In Add New
Program, select Adobe Acrobat Professional 9. Click Add.)
– You may re-take the quiz at any time. Only your highest score
will be recorded in the G&SP Office. The G&SP Office may
certify the results upon the request of the IRB.
– If you have any questions, contact the G&SP Office at ext. 5519
or npeterson@winona.edu.
Contents