UNIVERSITY OF MARYLAND, COLLEGE PARK
HUMAN SUBJECTS REVIEW COMMITTEE (HSRC)
Departmental Application for Review of Research Using Human Subjects
Please check one:
Initial Application
Renewal Application
Name of Principal Investigator
or Project Faculty Advisor
(NOT a student or fellow; must be UMD employee)
Name of Co-Investigator
Tel. No.
Tel. No.
Administering Department of Project
E-Mail Address of P.I.
E-Mail Address of Co-I.
Where should IRB send approval letter?
Tel. No.
Name of Student Investigator
@
Student Identification No. & E-Mail Address
Name of Student’s Advisor (if different from above)
Signature of Student’s Advisor
Project Duration (mo/yr – mo/yr)
--
Project Title
Sponsored Project
Funding
ORAA Proposal
Data
Agency
ID Number
(PLEASE NOTE: Failure to include data above may result in delay of processing sponsored research award at ORAA.)
CONFLICT OF INTEREST: Investigators
do
MEMBERS OF HEALTH CENTER: Investigators
do not have a real or potential COI. See question #7 on page 2.
are
are not members of Health Center. See question #8 on page 2.
For initial application, please attach a copy of your responses to question 1 - 8 of the instructions on page 2 of this document,
including all related documents (such as questionnaires, interview questions, surveys).
OPTIONAL: Complete appropriate box below to indicate whether you are requesting an exemption from further human
subjects review and to list the number of any exemption categories (described on page 4 of this document) which you
believe applies to your project:
Exempt----List Exemption Category Numbers
Or
Non-Exempt
If exempt, please briefly describe the reason(s) for exemption. Your notation is simply a suggestion to the HSRC.
Date
Signature of Principal Investigator or Faculty Advisor (PLEASE NOTE: Person signing above accepts
responsibility for project, even when data collection is performed by other investigators)
Date
Signature of Co-Principal Investigator
Date
Signature of Student Investigator
Date
Signature of Human Subjects Review Committee Chairperson or Designee.
(Please also print name of person signing above)
(PLEASE NOTE: When HSRC Chairperson is also a project investigator or the Student Investigator’s
advisor, this line should be signed by another member of the HSRC.)
(rev 11/03)
* PLEASE ATTACH THIS COVER PAGE TO EACH SET OF COPIES*
* SEND (3) COPIES WITH ONE CONTAINING ORIGINAL SIGNATURES *
You may send e-mail to irb@deans.umd.edu to inquire about the status of applications delivered to the IRB.
Please return completed applications to the Chairperson of the Human Subjects Review Committee in your
academic department. Thank you
(Page 2 of 5)
Instructions for Completing the Initial Application
(Please provide the information indicated below in a form suitable for a general audience.)
1. Abstract: Provide an abstract (200 words) that describes the purpose of this research and summarizes the
strategies used to protect human subjects.
2. Subject selection:
a. Who will be the subjects, how will you persuade them to participate, and how many do you expect will
participate? If you plan to advertise for subjects, please include a copy of the advertisement.
b. Will the subjects be selected for any specific characteristics (e.g., age, sex, race, ethnic origin, religion, or
any social or economic qualifications)?
c. State why the selection will be made on the basis or bases given in 2(b).
3. Procedures: Describe in detail your methods and procedures, placing particular emphasis on what will be done
to subjects and what they will be asked to do. If you are using a questionnaire or handout, please include a copy in
each set of application documents.
4. Risks and Benefits: Are there any risks to the subjects? If so, what are these risks? What potential benefits will
accrue to justify taking these risks?
5. Confidentiality: Adequate provisions must be made to protect the privacy of subjects and to maintain
confidentiality of identifiable information. Explain how your procedures accomplish this objective,
including such information as the means of data storage, data location and duration, a description of
persons with access to the data, and method of destroying the data when completed.
6. Information and Consent Forms: State specifically what information will be provided to the subjects
about the investigation. Might any of this information be misunderstood by the subjects? State how the
informed consent of the subjects will be obtained and include the consent form that you will be using. .
Be sure to include a description of how data storage methods ensure confidentiality. THE IRB
STRONGLY SUGGESTS USING THE SAMPLE CONSENT FORM (PAGE 5 OF THIS
APPLICATION) AS A GUIDE. CONSENT FORMS SHOULD CONTAIN ALL OF THE
ELEMENTS OF INFORMED CONSENT PRESENTED ON THAT SAMPLE. When a consent
form requires more than one page, please include a space for the subject to initial and date at the top of
each page. [FOR EXAMPLE: Initials_____ Date___] Also, each page must display a page range (such
as, “Page 1 of 2,” then “Page 2 of 2.”) This step would confirm that the subject agreed to the entire
contents of the consent form. When appropriate, please review INFORMED CONSENT FOR
PROJECTS INVOLVING MINORS at: http://www.umresearch.umd.edu/IRB/IRBappprocess.html
7. Conflict of Interest: Describe the potential conflict of interest, including how such a conflict would affect the
level of risk to the study participants. Please consult the University of Maryland policy on conflict of interest, as
defined by the University of Maryland Policies and Procedures III-1.11(A) or III-1.11(A)(1). These may be
viewed at: http://www.usmh.usmd.edu/Leadership/BoardOfRegents/Bylaws/SectionIII/III111.html and
http://www.inform.umd.edu/CampusInfo/Departments/PRES/policies/iii111a.html.
8. HIPAA Compliance: State whether you are using protected health information or “PHI”. Currently, researchers
employed by the University of Maryland Center or who are working within or under the auspices of the
University Health Center are subject to specific HIPAA requirements regarding the creation, use, disclosure, or
access of PHI. Please consult the University of Maryland’s Summary of HIPAA’s Impact on University Research
at: http://www.umresearch.umd.edu/IRB/IRBhipaa.html.
Each copy of the application should include the Department HSRC application cover form, eight separate
sections that correspond to the areas indicated above, and all relevant supporting documents. Typical
supporting documents include: consent forms, letters sent to recruit participants, questionnaires
completed by participants, the ORAA Internal Routing Form for Proposals (if any), and any other material
germane to human subjects review. Please also include either: (1) a mailing label containing the address
where the IRB should send the approval memorandum and stamped consent forms (if any); or (2) a note
indicating the name, telephone number, and e-mail address of the person to be notified when the
application has been approved by the IRB.
(Page 3 of 5)
Instructions for Completing the Renewal Application
A renewal application is required when the continuance of the research project will involve any of the
following: obtaining data through intervention or interaction with human subjects; obtaining private
information from human subjects; or the analysis or manipulation of data previously collected from human
subjects in a way that increases the risk to those subjects beyond the level previously approved.
Non-exempt projects are approved for only one year; a renewal application should be submitted no later
than 30 days prior to the last day of that one-year approval period. (For example, an application approved on
June 30, 2000 would expire on June 30, 2001; a renewal application will be due at the IRB no later than June 1,
2001.) However, applications that are found to be exempt are approved for three years. A renewal application
should be submitted for an exempt project no later than 30 days prior to the last day of that three-year approval
period. (For example, an application approved on June 30, 2000 would expire on June 30, 2003; a renewal
application will be due at the IRB no later than June 1, 2003.) If you have any question about when or where to
submit a renewal application, please contact the Chairperson of the HSRC in the academic department where
your previous application was approved.
Contents of the Renewal Application
1. Present a description of the project that was proposed in the original application. If any
materials relevant to the use of human subjects have been or will be modified, please include a copy
of the proposed modifications. Include a final draft copy of the consent form(s), if applicable, for
review.
2. Indicate whether the project was undertaken and how many subjects have participated.
Summarize what you have learned thus far and provide a summary of relevant recent literature, if
any.
3. Indicate whether there have been any problems (such as adverse effects or complaints)
involving human subjects since the previous HSRC/IRB review. If there have been problems,
describe how they have been handled.
4. Indicate whether there will be any modifications in procedures using human subjects, types of
subjects, or the consent process. Please provide (i) a very detailed description of all such changes
and (ii) copies of any modified forms or instruments.
5. Indicate the specific location (building and room number) in which the official records of this
research project will be retained.
6. Please be sure to include: (1) copies of any consent forms containing the IRB approval stamp
which were sent to you when your previous application was approved; and (2) copies of unstamped
consent forms which you would like to use for future data collection.
7. Indicate whether any conflict of interest or HIPAA compliance issues exist that was not reported
on your initial application. For more information on what to report, please see numbers 7 and 8 on
page two of this application form.
Each copy of the renewal application should include the Department HSRC application cover form, seven separate sections
that correspond to the areas indicated above, and all relevant supporting documents. Typical supporting documents include:
consent forms, letters sent to recruit participants, questionnaires completed by participants, the ORAA Internal Routing Form
for Proposals (if any), HIPAA Authorization (if applicable) and any other material germane to human subjects review. Please
also include either: (1) a mailing label containing the address where the IRB should send the approval memorandum and
stamped consent forms (if any); or (2) a note indicating the name, telephone number, and e-mail address of the person to be
notified when the application has been approved by the IRB.
(Page 4 of 5)
Revised to comply with Federal Common Rule, August 19, 1991
EXEMPTION CATEGORIES
(PLEASE NOTE: Although exempt research is exempt from further review beyond the IRB CoChairpersons, it must still be approved by the IRB before data collection may begin.)
1.
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as (a) research on regular and special
education instructional strategies, or (b) research on the effectiveness or the comparison
among instructional techniques, curricula, or classroom management methods.
2.
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior, unless: (a) information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked to the subjects; and (b)
any disclosure of the human subjects’ responses outside the research could reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects’
financial standing, employability, or reputation.
3.
Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public
behavior that is not exempt under paragraph (2) if: (a) the human subjects are elected or
appointed public officials or candidates for public office; or(b) the research is
conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for
the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1,
which provide certain legal protections and requirements for confidentiality.
4.
Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects
cannot be identified, directly or through identifiers linked to the subjects.
5.
Research and demonstration projects which are conducted by or subject to the approval
of department or agency heads, and which are designed to study, evaluate, or otherwise
examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or
services under those programs; (c) possible changes in or alternatives to those programs
or procedures; or (d) possible changes in methods or levels of payment for benefits or
services under those programs.
6.
Taste and food quality evaluation and consumer acceptance studies, if (a) wholesome
foods without additives are consumed or (b) a food is consumed that contains a food
ingredient at or below the level and for a use found to be safe, or agricultural chemical
or environmental contaminant at or below the level found to be safe, by the Food and
Drug Administration or approved by the U.S. Environmental Protection Agency or the
Food Safety and Inspection Service of the U.S. Department of Agriculture.
NOTE: These exemption categories do not apply to research involving prisoners, fetuses, or pregnant
women. Exemption category #2 for research involving survey or interview procedures or observation of
public behavior, does not apply to research with children, except for research involving observations of
public behavior when the investigators do not participate in the activities being observed.
(SAMPLE -- Please model your consent form according to this format)
INFORMED CONSENT FORM
Page 5 of 5
Identification of Project/ Title
Statement of Age of Subject
(Please note: Parental
consent always needed
for minors.)
(Please note: Title of application and title above should be the same.)
I state that I am over 18 years of age and wish to participate in a program of
research being conducted by Insert Name of Principal Investigator in the
Department of ________________ at the University of Maryland, College
Park.
Purpose
The purpose of this research is to measure the effects of prolonged sleep loss.
Procedures
The procedures involve three sessions, four weeks apart, during which I will be
asked to go without sleep for periods of 24 to 48 hours. At various times during
the sleepless period, I will be asked to perform simple tasks and to respond to
sound by pushing a button.
Confidentiality
All information collected in this study is confidential to the extent permitted by
law. I understand that the data I provide will be grouped with data others
provide for reporting and presentation and that my name will not be used.
Risks
As a result of sleeplessness, I may experience extreme tiredness and sleep
disturbances over a short period of time. Normally, there are no long-term
effects associated with the periods of sleeplessness involved in this experiment.
Benefits, Freedom to
Withdraw, & Ability
to Ask Questions
The experiment is not designed to help me personally, but to help the
investigator learn more about sleep loss and the ability of persons to perform
tasks for the safe operation of machinery and cars. I am free to ask questions
or withdraw from participation at any time and without penalty.
Medical Care
The University of Maryland does not provide any medical or hospitalization
insurance for participants in this research study nor will the University of
Maryland provide any compensation for any injury sustained as a result of
participation in this research study, except as required by law.
(Include this section only when
appropriate for your project. If
included, please do not modify the
wording displayed at right)
Contact Information
Of Investigators
Provide name, address, telephone number, and (if appropriate) e-mail address
of principal investigator.
Contact Information of
Institutional Review Board
REQUIRED---Following statement must be included:
If you have questions about your rights as a research subject or wish to report a
research-related injury, please contact: Institutional Review Board Office,
University of Maryland, College Park, Maryland, 20742;
(e-mail) irb@deans.umd.edu; (telephone) 301-405-4212
Please add name, signature,
and date lines to the final page
of your consent form
NAME OF SUBJECT
SIGNATURE OF SUBJECT
DATE
****Please note: When a consent form requires more than one page, please include a space for the
subject to initial and date at the top of each page. [FOR EXAMPLE:
Initials_____ Date___]
Also, each page must display a page range (such as, “Page 1 of 2,” then “Page 2 of 2.”) This step
would confirm that the subject agreed to the entire contents of the consent form. ****