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T A B L E O F C O N T E N T S GUIDELINES FOR PROPOSAL DEVELOPMENT AND REVIEW SUMMARY DESCRIPTION OF TYPES OF HSR PROPOSALS HSR BOARD GUIDELINES FOR INFORMED CONSENT FORM
GUIDELINES FOR PROPOSAL DEVELOPMENT AND REVIEW These Guidelines are meant for the use of members of the Ithaca College
community who, as a function of their position with the College, plan
and conduct research projects using human subjects. It contains definitions,
instructions, and procedures for use in preparing proposals and research
protocols that minimize the potential for risk to human subjects. These
Guidelines are also meant to facilitate research by faculty, staff,
and students in compliance with federal and state laws. The mission of Ithaca College to provide professional education within
a liberal arts context is enhanced by the conduct of research where
faculty and students share in projects which question and expand the
body of knowledge in their fields. In order to study how humans react
or respond to stimuli, it is often necessary to involve them as subjects
in research projects. When human subjects are used, great care must
be exercised to assure that all risks are minimized. The College supports a very comprehensive and inclusive concept of risk as it applies to the potential harm to human subjects. Any risk, physical or psychological, is weighed carefully to assure that it has been minimized as much as possible in the project protocol and that appropriately qualified supervision will be available throughout the subject's participation and afterwards, if needed. Review and approval by the All-College Review Board for Human Subjects Research (HSR) is meant to aid both the subjects and the investigators by bringing scrutiny to projects by a group of peers who can objectively assess the potential for risk and accommodations made to minimize it. SUMMARY DESCRIPTION OF TYPES OF HSR PROPOSALS There are three types of HSR proposals: standard, expedited, and delegated.
These types of proposals are detailed below. Standard Review - required when the research involves more than minimal risk to the subject (see operational definintion). Expedited Review - may be used for replication of a previously approved study, a study that involves minimal risk, or an anonymous written or Web survey. Delegated Review - may only be used for course projects (Class IV) that require only an anonymous written survey. In this type of review, the HSR Board holds the course instructor responsible for reviewing student projects. In delegated review, student protocols are designed in accordance with a protocol template provided by the course instructor. It is the protocol template that the instructor must gain approval from HSR to distribute to students as a guide for protocol development (see example of protocol template). Once the instructor has HSR approval of the protocol template, it may be distributed for use by students in the class. IT IS THE RESPONSIBILITY OF THE INSTRUCTOR TO REVIEW AND APPROVE ALL STUDENT PROTOCOLS IN ACCORDANCE WITH THE PROTOCOL TEMPLATE, PRIOR TO CONDUCT OF THE STUDENT STUDIES. Upon completion of the student sudies, the isntructor must send a copy of all approved student protocols with survey/questionnaires to the HSR Board. See details of the Delegated Review. Please review the following detailed descriptions to determine the appropriate review procedure for your proposal. Submission of an inappropriate proposal will result in rejection by the HSR Board.
The mechanism for protection of human subjects is prescribed by federal
and state law and includes the establishment of an Institutional Review
Board for Human Subjects Research. At Ithaca College this body is the
All-College Review Board for Human Subjects Research and is appointed
by the Provost and Vice President for Academic Affairs. "HSR," as it
is commonly known, has the responsibility for fulfilling all federal
and state regulations pertaining to human subjects research and
for assuring that in projects involving human subjects which fall outside
the scope of those regulations the subjects are also accorded proper
and adequate protection. Statutory responsibility of HSR can be found in the Code of Federal
Regulations, PL 99-158 and PL 103-43, Title 45, Part 46 Protection of
Human Subjects and in the New York State Public Health Law, Article
24-A. These statutory regulations must be met for any human subjects
research for which external funds are sought. The Provost and Vice
President for Academic Affairs extends this statutory responsibility
to encompass all research involving human subjects, regardless
of the source of support. Further, the Provost and Vice President for
Academic Affairs has charged all faculty to rigorously scrutinize
all projects involving human subjects to ensure that the subjects
are properly protected. Membership of the All-College Review Board for Human Subjects Research
shall be:
Members are appointed for two-year terms and, at the discretion of
the Provost and Vice President for Academic Affairs, may be reappointed.
Members will recommend a chairperson to the Provost and Vice President
for Academic Affairs. Below is a list of Board members for the academic year 1999-2000: Betsy Keller, Department of Exercise and Sport Sciences, 274-1683, keller@ithaca.edu Wendy Robertson, Hammond Health Center, 274-3177, wroberts@ithaca.edu Cynthia Scheibe, Department of Psychology, 274-1324, scheibe@ithaca.edu Chairperson, Jill Swenson, Department of Television/Radio, 274-3632, swenson@ithaca.edu Donald Simmons, Department of Business Administration, 274-1127, dsimmons@ithaca.edu Hector Velez, Department of Sociology, 274-1259, velez@ithaca.edu Community Board Member, Eileen Wright, 1342 Danby Road, Ithaca, NY 14850 TBA, Department of Physical Therapy or Occupational Therapy
CATEGORIES OF HUMAN SUBJECTS PROJECTS At Ithaca College, projects involving human subjects are divided into five categories. Generally projects conducted for publication in peer review journals will require HSR review. For Categories I, II, and III below, the responsibility for review lies within the department or administrative unit. See additional explanation on next page.
I. Clinical procedures that are administered to a patient by a qualified staff member or a student(s), under the supervision of qualified faculty, for the purpose of diagnosis, prevention or treatment of a medical condition and which may directly benefit the patient.
II. Projects that are entirely contained within regularly scheduled classroom or laboratory instructional process and are designed to instruct students in technique, methodology, or procedure. Included are projects that bring in persons from outside the class or institution for demonstration purposes.
III. Non-academic projects that involve subjects' responses to written surveys collected by methods that assure confidentiality. Examples are opinion polls, administrative surveys, and alumni follow-up studies. Categories IV and V require HSR review.
IV. Projects which are components of a scheduled course but are
conducted outside of the classroom, laboratory, studio, etc. and use
subjects not enrolled in the course for collection of information/data,
and/or depend on subjects answering questions of a sensitive nature.
For example:
V. Individual or collaborative research by faculty, administrators, or staff for professional or institutional purposes. This is any project an individual carries out in affiliation with Ithaca College or using Ithaca College facilities. All projects involving human subjects must be rigorously scrutinized by the investigator(s) responsible to assure that human subjects are properly protected. Although the need to safeguard academic freedom is recognized, primary accountability must be for the safety and protection of human subjects. Rigorous review procedures are necessary to evaluate all projects involving
human subjects. It is expected that all faculty members doing research
that involves the use of human subjects will determine which category
their research falls within. Once again, for Categories I, II, and
III above, the responsibility for review lies within the department
or administrative unit. However, if a project which would normally fall into Category I, II,
or III is of an unusual or sensitive nature, involves more than "minimal
risk" (see Operational Definitions) or needs more extensive scrutiny
than Categories I, II and III would ordinarily warrant, it should be
handled as if it were in Categories IV and V. Projects falling into Categories IV and V require review by the
All-College Review Board for Human Subjects Research. Review Procedures for Categories I, II, and III Notice of any breach of the approved supervising procedures shall be
sent to the dean. (For projects falling within the purview of the Health
Center, substitute "Vice President of Student Affairs and Campus Life"
for "dean.") The dean will be responsible for ascertaining the cause of the breach
and for assuring that the situation is corrected. At the discretion
of the dean, the project in question shall be discontinued until effective
safeguards have been restored. The dean will notify HSR of any such breach and the action taken to
correct it. Review Procedures for Categories IV and V The researcher(s) must submit a description of the proposed project
to HSR using the appropriate format described herein (see Types of HSR
Proposals). HSR will review the proposal to assess the risk to human
subjects. If risk is involved, HSR will determine if the aspects of
risk are necessary to successfully complete the study, and if the risks
to the subjects significantly outweigh the benefits to the subjects
and the importance of the knowledge to be gained. In making this assessment,
HSR must assure that the rights and welfare of each human subject are
adequately protected, that voluntary and legally effective informed
consent will be obtained in an appropriate manner, and that the person(s)
who will be conducting the research is appropriately competent and qualified.
If HSR finds more than minimal risk is involved, but approves the activity,
it will review the conduct of the activity at timely intervals. The
process for this review will be determined on an individual basis to
meet the unique needs of the project. Approval will be given only for
the specific research plans contained in the proposal and for the time
period stated in the proposal. Changes in the nature of the research
must not be undertaken without express approval of HSR and extension
of time beyond the approved period, should be requested of HSR by letter.
A researcher must immediately suspend a project if an adverse change
in the health or behavior of a subject is observed which is, or may
be, attributable to the research. The researcher should promptly report
the matter to HSR, and no part of the project shall be resumed without
the specific approval of HSR after notification by the Provost and Vice
President for Academic Affairs. HSR is responsible for monitoring projects involving the use of human
subjects in research. Any breach of safety measures on approved procedures
will result in suspension of the project by HSR, and notice of the breach
will be sent immediately to the Provost and Vice President for Academic
Affairs. The Provost and Vice President for Academic Affairs may report
any violation to the New York State Commissioner of Health or the Department
of Health. HSR will maintain a record of all projects it reviews and the decision
made on each project. Where approval is not given, the record must include
the reasons for the negative decision. If the project is approved, the
records will be maintained for a minimum of six years after the project
is complete. Rejected proposals will be maintained for a minimum of
one academic year after rejection. In determining the nature of the risks and the extent to which the
benefits of the study justify exposing the subjects to risk, HSR will
be considering the following issues. Identification and Reduction of Risks Informed Consent Federal Law stipulates that a person must be 18 years or older in order
to give legal consent for his/her own participation in research. Subjects
under the age of 18 may participate in research only with the signature
of their parent or legal guardian in addition to their own signature.
This also applies to the completion of anonymous questionnaires since
persons under 18 are not permitted legally to make the informed choice
to participate. Children should have the information about participation
in the research explained to them in language they can understand (by
their parent), and, if possible, they should also sign their consent. In cases where members of a team, class or organized group are being
recruited for a study and participation could affect the performance
of the team, class or group as a whole, the informed consent of the
coach, instructor or group leader is also required. Details about the format and types of information that should be included
in an informed consent form include the following (also see sample format
of informed consent form). Deception - In some types of research it is necessary to withhold
information from the subject or even to purposely deceive the subject
about the nature of the study to ensure that the subject does not purposely
alter behavior while being observed. If deception is used in a study,
an additional section entitled "Debriefing" (see description below)
must be included on the informed consent form. In general, withholding
information about the purpose of the study is more acceptable than actively
misleading subjects. In all cases the subjects must be told (at least
in a general way) about how long their participation will take, what
types of activities they will be asked to do, and any possible risks
resulting from participation. Inducement to Participate - Subjects are frequently offered
some form of incentive or reward for their participation (e.g., earning
extra credit points from their professor, small gifts or prizes, a chance
to win money in a lottery). In general, such inducements are allowable
as long as they are minimal and are not more attractive to some subjects
than to others. The primary ethical issue involves the extent to which
an inducement might be sufficiently large enough to cloud the person's
judgment about whether or not participation in the study is in their
own best interest. In cases where students may earn extra credit points
from their professor, other options to earn extra credit besides research
participation must be available. A second issue involves the extent
to which subjects can reasonably choose not to participate, especially
in cases where subjects are approached in a large group (e.g., a class)
and asked to participate en masse. In such cases, potential subjects
may feel that they cannot refuse to participate without standing apart
from their peers. This is particularly a problem if participation involves
a sensitive issue. For example, if the study focuses on AIDS and a person
chooses not to participate, it might be interpreted that the person
has AIDS. In such cases, the researcher/recruiter would need to demonstrate
that this concern has been recognized and addressed (e.g., by providing
a means for all potential subjects to appear as if they are participating
even if they are not). Confidentiality/Anonymity - In all research involving human
subjects, it is important to assure the subjects of the confidentiality
of their responses. This is especially important in cases where the
study involves asking the subjects personal questions about themselves
or obtaining other information that might put the subject psychologically
at risk if the information was made public. Total anonymity (i.e., where
the subject's name or face is never associated with his/her responses,
even to the researcher) is preferable, especially in the case of extremely
sensitive or personal information. This generally means that the subject
must be able to provide information in complete privacy and to submit
the information in such a way that it is mixed up with other subjects'
data before it is retrieved by the researcher (e.g., putting a questionnaire
into a "drop box"). In cases where it is necessary to have the subject's
names or an identification number associated with his/her responses
(e.g., in order to collate several sets of responses by the same subject),
the subjects need to be told who will see their data and specifically
how this information will be kept confidential. Videotaping/Audiotaping - If subjects are to be videotaped and/or audiotaped, they need to be informed of the following: 1. how and where the tapes will be stored; In all cases, subjects must give separate consent to be taped. This
can be accomplished by means of a statement and additional
signature line at the end of the Informed Consent Form. Defriefing - In most cases, it is desirable for subjects to
be debriefed after their participation in the study (i.e., told the
purpose of the study and given a chance to ask questions). There
are three cases in which debriefing is required: First, when there has
been deception involved in the study. Second, when subjects may
be left with a misleading or potentially harmful perception or
inaccurate information. And, third, when compensatory treatment
or follow-up is indicated. In some cases, such debriefing may not be possible immediately after
the study due to concern about other potential subjects finding out
about a deceptive aspect of the study which would preclude further data
collection. In these cases, debriefing statements or descriptions could
be offered to the subjects at a later date through the mail or other
means. In rare cases, debriefing may in itself pose a social or psychological
risk to the subject (e.g., it might make them aware of an extremely
embarrassing or negative behavior on their part), in which case it may
be more desirable to forego the debriefing procedure. This should be
explained in the proposal. Compensatory Follow-up - In cases where some physical or psychological
harm might result from the subjects' participation, plans for compensatory
treatment or follow-up counseling should be provided. Only subjects
who are from the Ithaca College community should be directed to contact
the Ithaca College Counseling or Health Centers. This is only necessary
if there is potential for physical and/or psychological risks as a result
of participation in a study.
GUIDELINES FOR INFORMED CONSENT FORM The Informed Consent Form must include the following (see the sample format for an Informed Consent Form).
1) A brief statement of the purpose of the study. 2) A brief description of the benefits of the study, both for the subjects
and for the broader community (e.g., other individuals, the scientific
field, etc.). 3) An explanation of what the subjects will be asked to do, including
the amount of time that their participation will take and a description
of the tasks they will be asked to do. Also include exclusionary criteria,
such as criteria to determine who is not suitable for participation
in your study. For example, criteria that excludes participation in
an exercise study may include cardiovascular disease risk factors. These
factors could be identified by completion of a medical history form.
In this case, the medical history form should be included in the HSR
proposal appendix. 4) A clear explanation of any discomfort or risks (physical and/or
psychological) that may occur as a result of their participation. In
the case biomedical or behavioral research that may result in physical
injury, an explanation should be given as to the availability of compensatory
medical treatment if physical injury occurs, and what that treatment
would likely be. In the case of social or psychological research that
may result in emotional distress, an explanation should be provided
as to the availability of compensatory counseling and how to receive
it. In addition, the following guidelines should be kept in mind.
1) There must not be any exculpatory language (e.g., "I agree
not to hold Ithaca College liable for any injuries."). 2) The language and terminology used must be easily understood by
the general population, and geared to the specific subject population
used (e.g., children). 3) If the consent form is more than one page in length, there must
be a place for subjects to put their initials on the bottom of each
page prior to the final one. 4) If the study involves subjects under the age of 18, the child's
parent or legal guardian must also sign the informed consent form. If
the child is old enough (i.e., more than five years old), there should
also be a place for the child to sign the form. 5) Subjects should be given a copy of the informed consent form. For
anonymous paper and pencil surveys a separate Informed Consent Form
is not necessary. There should be an introduction/recruitment face-page
which can be torn off and given to the subject. Additional Guidelines for E-mail Survey
Please type a response after the statement below. A "YES" response indicates that you understand the statement and are at least 18 years of age and you agree to participate. If you respond "NO", your response to this study will not be used. I understand the potential risks associated with participation in this study. I also realize that while the researcher will keep responses confidential, e-mail surveys are not secure. Furthermore, I realize that I may omit any question(s), and that I am free to withdraw at any time without penalty. I am at least 18 years of age or older. YES/NO: If the subject responds "No" to this statement, any data received from the subject may not be included in the study. Each September the Office of the Provost and Vice President for Academic
Affairs distributes a calendar of Human Subjects Research meetings and
proposal deadlines. Proposals submitted for the HSR standard review
and delegated review cycles must be in the Office of the Provost and
Vice President for Academic Affairs seven working days before the scheduled
HSR meeting. Proposals for expedited review may be submitted at any
time. A description of each type follows. Standard Review An agenda and copies of all proposals to be considered at the full
HSR meeting are sent to HSR members at least seven days before the meeting.
All members review all proposals prior to the meeting. If a proposal is found during pre-meeting review by members, to be
generally sound but needing clarification prior to approval, the principal
investigator may be invited to appear to speak to the proposal and answer
questions during the HSR meeting. This process is meant to expedite
the process for some applications, but should not be expected to eliminate
all follow-up questions or stipulations because the discussion of proposals
at the HSR meeting often brings to light questions and concerns that
were not recognized in advance. At the meeting, the chair places each proposal, in turn, on the floor
for discussion. Discussion is summarized for the minutes and for letters
to be sent to investigators stating: A. the disposition of the proposal into one of the four categories:
1. approved B. the reasons for the action above with stipulations specified, if applicable; and C. consultative comments and suggestions. Regarding item C above, in a spirit of collegiality and peer review
from time to time the HSR provides comments and suggestions which
are intended to strengthen and improve the methodology and outcomes
of projects. There is no requirement that investigators comply with
these suggestions as they will not affect the safety of human subjects.
Members of HSR are experienced researchers and/or reviewers who believe
that peer review and interaction is one of the most significant advantages
of membership in an academic community. HSR members represent various
disciplines of the academic community and can bring to proposal review
objective and fresh viewpoints. It would be unfortunate for an investigator
not to have the benefit of their observations. Following HSR meetings, letters of notification from the Associate
Provost are sent to the investigator with a copy to the faculty advisor,
if the investigator is a student and the advisor is specified. Every
attempt is made to get letters out within one week of the meeting. Revisions of the proposals that have been approved or tabled with stipulations
should be sent to the Associate Provost. The Associate Provost will,
in clear-cut revision, approve implementation of the project. In some
cases, where revisions required were substantive in nature, the HSR
Chair and another member of HSR will be polled for agreement before
approval is ratified. If a tabled proposal is revised, it must go back to the full HSR for
review. If a proposal has been rejected, a revised proposal may be submitted
without prejudice after it has been modified to eliminate the concerns
of HSR related to safety of human subjects. Expedited Review A. the disposition of the proposal into one of the five categories:
1. approved B. the reasons for the action above with stipulations specified, if
applicable; and C. consultative comments and suggestions. Regarding item No. C above, in a spirit of collegiality and peer review
from time to time the HSR provides comments and suggestions which are
intended to strengthen and improve the methodology and outcomes of projects.
There is no requirement that investigators comply with these suggestions
as they will not affect the safety of human subjects. Members of HSR
are experienced researchers and/or reviewers who believe that peer review
and interaction is one of the most significant advantages of membership
in an academic community. HSR members represent various disciplines
of the academic community and can bring to proposal review objective
and fresh viewpoints. It would be unfortunate for an investigator not
to have the benefit of their observations. If a standard review is required, the researcher will need to follow
the procedure for such review. Please recognize that the HSR Board is composed of individuals from
many different disciplines, and any interpretation of no or minimal
risk should be made cautiously and explained very clearly. If in doubt
about the nature of the risk or the appropriateness of the study for
Expedited Review, please consult with a member of the HSR Board before
submitting a proposal. The Expedited Review process is meant to help
investigators who are resubmitting or when there is a time constraint
for a minimal risk study. It is not intended as a way to by-pass the
full HSR Board. Guidelines for Standard and Expedited Proposal Submission The Informed Consent Form should be written in language that is geared
to the specific subject population. For example, more technical information
may be given to subjects who are upper-level majors in that field. When
the subjects are children, on the other hand, the language used in informed
consent forms must be written so that the child can understand it. The pages of the proposal should be numbered and must include the following
information. For Expedited Review submit the original plus two (2) copies.
For standard review submit the original plus ten (10) copies. Following
the structural Guidelines given below with proposals that are complete
and concise is appreciated. Structure of the Proposal Checklist 1. General Information about the Study b) Location. Where will the study be conducted? c) Time Period. When do the researchers plan to begin the study? When will the study be completed? d) Expected Outcomes. How will results of the study be disseminated (e.g., course project, course assignment, thesis, publication, conference presentation, etc.)? 2.Related Experience of the Researcher(s) 3. Benefits of the Study 4. Description of Subjects 5. Description of Subject Participation 6. Ethical Issues - Description b) Informed Consent. Attach a copy of the Informed Consent Form
to be used. If an Informed Consent Form will not be used, briefly
explain why one is not necessary for this type of study. Anonymous paper and pencil surveys with an introduction/recruitment
tear-off face page do not require a separate Informed Consent Form.
The tear-off page should include: 1) a brief statement of the purpose of the study, 7. Recruitment of Subjects b) Inducement to Participate. Are the subjects offered or given any
inducement for their participation in the study (e.g., extra credit
points from their course instructor, gifts, money, etc.)? If subjects
will earn extra-credit points for their participation, then students
in the course must be given other opportunities to earn extra-credit
points besides participating in research studies. Researchers must not
do the recruiting in their own classes (although they may have one of
their colleagues or research students recruit for the study in their
own classes), nor should their names be associated with the recruitment
procedures if recruitment will take place in their own classes. This
guards against the students' perception that they may be expected to
participate in a study that their own professor is conducting in order
to stay on good terms with that professor. 8. Confidentiality/Anonymity of Responses. Briefly describe the procedures that will be used to ensure the anonymity or confidentiality of the subjects' responses. If the subjects' names or other identifying information (social security number or ID number) must be associated with their responses (e.g., for collating several sets of data from the same person), then such identifying information should be removed from the data set after collation. See also the related section under Informed Consent for further information. 9. Debriefing. Briefly describe what the subjects will be told after their participation in the study, and attach a copy of the Debriefing Statement (if any). 10. Compensatory Follow-up (if appropriate). If there are foreseeable negative physical and/or psychological outcomes due to participation in the study (e.g., muscle soreness, emotional distress, anxiety about a social issue), briefly describe what type of compensatory treatment or counseling will be made available to or recommended to the subjects. Summary of Required Appendices for Standard and Expedited Proposals A. subject recruitment statement, letter or flyer Delegated Review In delegated review, student protocols are designed in accordance with a protocol template provided by the course instructor. It is the protocol template that the instructor must gain approval from HSR to distribute to students as a guide for protocol development (see example of protocol template). Once the instructor has HSR approval of the protocol template, it may be distributed for use by students in the class. IT IS THE RESPONSIBILITY OF THE INSTRUCTOR TO REVIEW AND APPROVE ALL STUDENT PROTOCOLS IN ACCORDANCE WITH THE PROTOCOL TEMPLATE, PRIOR TO CONDUCT OF THE STUDENT STUDIES. Upon completion of the student studies, the instructor must send a copy of all approved student protocols with survey/questionnaires to the HSR Board. To establish a delegated review, the following procedure should be
followed: 1. The faculty member teaching the course should review the Guidelines
for Human Subjects Research. Faculty choosing to use this process are
responsible for assuring the student projects meet these Guidelines.
2. The faculty member devises a protocol that each student or team
of students must complete for each project prior to collection
of data. (Note: This faculty member may simply adopt the Sample Protocol
included in these Guidelines for use by the students.) 3. The faculty member initiates contact with HSR to discuss the protocol
he/she wishes to implement and its compliance with the Guidelines. 4. The faculty member submits ten copies of the protocol to HSR for
review, following the published calendar for submission and review at
a regular HSR meeting. 5. HSR will communicate its approval or request for revision to the faculty member in a timely manner. 6. Upon HSR approval, the instructor will distribute the protocol to students for use in the development of their own proposals. 7. The faculty member will be responsible for reviewing all student protocols before they are conducted, to assure that they comply with the HSR-approved protocol template.
NOTE: FACULTY ARE RESPONSIBLE FOR ASSURING THAT THEIR STUDENTS UNDERSTAND
THE DISTINCTION BETWEEN ANONYMITY AND CONFIDENTIALITY. THE DELEGATED
REVIEW PROCESS MAY BE USED ONLY FOR PROJECTS USING ANONYMOUS
SURVEYS/ QUESTIONNAIRES AND CANNOT INVOLVE MANIPULATIONS OF SUBJECTS
OR THE INTRODUCTION OF ANY VARIABLES. The following sample protocol template has been approved by HSR for
Delegated Review and may be used with appropriate modifications if desired.
If the sample protocol is used exactly as shown (except for revision
in class name and number), it can be submitted for expedited review.
If any additional modifications are made, the revised protocol must
be submitted to the entire Board for standard review. (Note: In either
case, all that gets submitted is the two-page protocol template and
a cover letter.) Sample Protocol Template for Delegated Review Quantitative Mass Media Research Methods (221-26000) Protocol for Protection of On-Campus Human Subjects Participating in Paper and Pencil Surveys Please answer all of the following questions as they relate to your
proposed study. Use the heading above, and follow the format below exactly
(including numbering and subject headings.) 1. Topic/Research Question: What is the topic of your research? What is your research question? 2. General Information: Where (give specific locations on campus) and when (give specific dates) will your study be conducted? 3. Ethics/Risks: What potential risks or discomfort (i.e., physical, emotional, and/or social) might subjects experience by participating in your study? Does your topic deal with a sensitive issue? Could your subjects be embarrassed? Could your subjects recall any emotionally disturbing experiences? Does your survey ask subjects to admit to engaging in illegal activities? If there are risks, how will they be minimized? (One way risks are minimized is to provide subjects with the Counseling Center phone number: 274-3136.) 4. Subjects: Who are your subjects? What demographic characteristics will they possess? (NOTE: SUBJECTS MUST BE AT LEAST 18 YEARS OLD.) 5. Selection of Subjects: How will you choose your subjects? Where will they be recruited? 6.Anonymity: You should not include any identifying information (i.e., subjects' names, ID numbers, code numbers, etc.) on the questionnaires. (Subjects should be instructed NOT to put their names on the survey.) How will questionnaires be returned to you so that neither you nor anyone else will know which subject filled out which questionnaire? You should not let anyone else (including the professor) see any subject's questionnaire. 7.Recruiting of Subjects: What will you say to people when you ask them to participate? You should include an explanation of the purpose of your study and advise them of any potentially sensitive topics to be addressed. You should tell them that their anonymity and confidentiality will be assured. In addition, you should tell them that they can refuse to answer any questions and that they may withdraw from the study at any time. You should also inform them that they must be at least 18 years of age or older to participate. 8.Introduction: You must attach a tear-off cover page to your survey explaining all of the following:
1. that this is a class project; 9.Expected Outcomes: How will results of the study be disseminated (e.g., course project, course assignment, thesis, publication, conference presentation, etc.)? Samples of Introductions/Tear-off Cover Page for Delegated Review Alcohol Advertising We are Jane Doe and John Noe and as part of a project for our Quantitative
Mass Media Research Methods course (221-26000), we are conducting a
survey of Ithaca College students to find out about their attitudes
toward and experiences with alcohol advertising. Some of the questions
ask about your consumption of alcoholic beverages. You should feel free
to leave any questions blank and/or to stop filling out this survey
at any time. If you find any of the issues discussed in this survey
to be disturbing, please call the Counseling Center (274-3136) for assistance. When you have completed the survey, please place it in the drop box
marked "Advertising Survey" in the back of the room. Feel free to return
a blank or incomplete survey in the drop box. DO NOT WRITE YOUR NAME
ANYWHERE ON THIS SURVEY. PLEASE DO NOT FILL OUT THIS SURVEY IF YOU ARE NOT AT LEAST 18 YEARS
OLD. Please tear off this cover page and keep for your records. Thank you for helping us with our project! ----------------------- Television Viewing Behaviors As part of our research project in Quantitative Mass Media Research Methods (221-26000), we are studying the television viewing behaviors of Ithaca College students. We are asking you to fill out the attached anonymous survey ONLY IF YOU ARE AT LEAST 18 YEARS OLD. This survey asks you to respond to questions about how much television you view, where and when you view television, and which specific programs you typically watch. You can skip any questions that you do not want to answer and may withdraw from this study at any time. When you have finished the survey please return it in the attached pre-addressed campus mail envelope by (deadline). DO NOT WRITE YOUR NAME ANYWHERE ON THIS SURVEY OR THE ATTACHED RETURN ENVELOPE.
----------------------- 9. Survey: All teams must have the final version of their survey approved by the instructor before collecting any data. The final version of the survey will be attached to the approved protocol. ONCE THE SURVEY AND PROTOCOL HAVE BEEN APPROVED, EACH TEAM MUST GIVE THE INSTRUCTOR TWO COPIES OF EACH. Anonymity: An assurance that no identifiable private information is being gathered, i.e., the investigator will not be able to identify subject. Confidentiality: An assurance that all-identifiable private information will be kept secret and not be made available to anyone other than the investigator to whom it was entrusted. Consultative Comments and Suggestions: Statements made by Human Subject Research (HSR) to investigators following HSR review are intended to strengthen and improve the methodology or outcomes of a project. There is no requirement that investigators adhere to these statements as they have no bearing on the safety of human subjects. Debriefing: Immediately following data collection, subjects should be given clarification for any misconceptions that may have arisen. Subjects should be told the general nature of responses and told who (when and where) to contact if any follow-up is needed, e.g., counseling. Human Subject: A person about whom an investigator/researcher obtains data or identifiable private information through intervention or interaction with the individual. Informed Consent: Potential subjects are informed in language appropriate for their level of understanding about all features of the research that may affect their willingness to participate; their questions should be answered; and they should be free to choose to participate or not, and to discontinue participation at any time. Interaction: Communication or interpersonal contact between investigator and subject. Intervention: Physical procedures by which data are gathered through manipulations of the subject or environment that are performed for research purposes. Identifiable Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and the information provided for a specific purpose considered to be private. Individuals must be individually identifiable by the investigator to constitute their consideration as subjects falling under these Guidelines. Minimal Risk: Risks of harm anticipated in the project are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Sensitive Issues/Topics: Issues or topics that a reasonable person would consider emotionally charged or have the potential for causing substantial anxiety. Essential conditions or requirements that must be met in order to receive approval from Human Subjects Research committee to implement the project. American Psychological Association (1973). Ethical Principles in
the Conduct of Research with Human Participants. Washington, DC:
American Psychological Association. Cook, S.W. (1976). Ethical issues in the conduct of research in social
relations. In C. Selltiz, L.S. Wrightsman & S.W. Cook (Eds.), Research
Methods in Social Relations. (pp. 199-249) New York: Holt, Rinehart
& Winston. New York State Public Health Law, Article 24-A. OPRR Reports, Code of Federal Regulations, PL 99-158 and PL 103-43,
Title 45, Part 46 Protection of Human Subjects, Department of Health
and Human Services, NIH, OPRR, Revised March, 1983. Reynolds, P.D. (1982). Ethics and Social Science Research. Englewood
Cliffs, NJ: Prentice-Hall, Inc. Rheingold, H. (1982). Ethics as an integral part of research in child
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