rRev.. 6/ 09/02095/123/10/03 PI’s Last Name:
BOSTON COLLEGE
Institutional Review Board (IRB)
INSTRUCTIONS FOR INVESTIGATORS
This form has been revised in order to ensure that all research conducted at Boston College is in compliance with all federal requirements and consistent with our ethical standard of conduct.
If you are planning to conduct a study involving human participants, please note the following:
· For externally funded research, please wait until you have been notified that your project will be funded before submitting a protocol application to the IRB. Submit documentation of funding status with the protocol application.
· Please refer to the BC Consent Guide for the required format for Consent and Assent Forms.
· Each investigator listed on the IRB protocol must complete either the web-based human participant protection tutorial or a program approved in advanced by the BC IRB. The web-based tutorial may be found at http://cme.nci.nih.gov. Please submit copies of the certificates of completion with the IRB application.
· All Principal Investigators who will be working with health information must complete the “Statement on HIPAA PHI Use.” [add hyperlink]Submit this form with the IRB application, as applicable.
· Questions about submissions should be directed to Rachel Krebs (Administrative Director, Office for Human Research Participant Protection, 552-4778)Pruchno (IRB Chair, 552-1594) or Stephen Erickson (Director, Research Compliance and Intellectual Property Management,
· 552-3345). Advance consultation can facilitate the process of review. Protocols should be submitted to Rachel KrebsStephen Erickson in the Lower Campus Office Building, 5510.
· Please provide complete responses to all questions. This will help speed the review process.
· For student research projects, please note that the student’s advisor is required to sign the application by which he or she is certifying that he or she will oversee the project in its entirety.
· Incomplete protocols will be returned to the principal investigator, resulting in delays in protocol approval.
· Submit the correct number of copies of the Application for Review of Research Proposal Involving Human Participants and related documents (see checklist, last page). Be sure to keep a complete copy of all materials for your records.
· Please provide complete responses to all questions. This will help speed the review process. Incomplete protocols will be returned to the principal investigator, resulting in delays in protocol approval.
· Questions about submissions should be directed to Rachel Krebs (Administrative Director, Office for Human Research Participant Protection, 552-4778). Advance consultation can facilitate the process of review. Protocols should be submitted to Rachel Krebs, Office for Human Research Participant Protection, 21 Campanella Way, Rm. 551.
See the checklist matrix at the end of the form for complete documentation requirements.
BOSTON COLLEGE
Institutional Review Board (IRB)
INSTRUCTIONS FOR INVESTIGATORS
This form has been revised in order to ensure that all research conducted at Boston College is in compliance with all federal requirements and consistent with our ethical standard of conduct.
If you are planning to conduct a study involving human subjects, please note the following:
· Each investigator listed on the IRB protocol must complete the web-based human subject protection tutorial. The tutorial may be found at http//cme.nci.nih.gov.
Questions about submissions should be directed to Joanne Scibilia (Office for Sponsored Programs; 552-8405) or Rachel Pruchno (IRB Chair, 552-1594)
· Please provide complete responses to all questions. This will help speed the review process.
· Incomplete protocols will be returned to the principal investigator, resulting in delays in protocol approval.
· Submit the correct number of copies of the Human Research Protocol and related documents (see checklist, last page). Be sure to keep a complete copy of all materials for your records.
· See checklist on Page 9 for complete documentation requirements.
A. Does this research qualify for exempt status? If so, all of the following must be true:
· Minimal risk (The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).
· No identifiers (Information will be recorded such that it is impossible for the investigator to link the data to any individual subject).
· No medical treatments are involved.
v Additionally, exempt research must fall into one of the following categories. §46.101(b) Unless otherwise required by Department or Agency heads.
CATEGORY 1 – Research in Educational Settings Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
CATEGORY 2 – Educational Testing Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
CATEGORY 3 – Research involving Public Officials 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) of this section. If: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
CATEGORY 4 – Existing Data 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.
* Existing means "on the shelf" at the time of approval. No materials will be collected once approval has been given. In addition, this material could have been collected for research purposes, per OHRP (10/18/01).
**Examples of publicly available information: driver's license and court records.
CATEGORY 5 – Demonstration Projects 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
CATEGORY 6 - Agricultural Research Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if 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 Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
v If this research qualifies for exempt status do not complete this form. Complete EXEMPT form.
Does this research qualify for expedited review?
v The following types of research may be reviewed by the BC IRB under an expedited review procedure (45 CFR 46.110 and 21 CFR 56.110). These research activities present no more than minimal risk to human subjects and involve only procedures listed in one or more of the following categories.
CATEGORY 1. Clinical studies of drugs and medical devices. Only when: a) Research on drugs for which an investigational new drug [IND] application is not required (21 CFR Part 312). or b) Research on medical devices for which: i) an investigational device exemption application [IDE] is not required (21 CFR Part 812); or ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
CATEGORY 2. Blood Samples. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or b) from other adults and children* considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
CATEGORY 3. Prospective Specimen Collections Prospective collection of biological specimens for research purposes by noninvasive means.
CATEGORY 4. Routine Noninvasive Procedures Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.
CATEGORY 5. Data Collected for Non-Research Purposes Research involving materials (data, documents, records, or specimens) that have been, or will be, collected solely for non-research purposes such as medical treatment or diagnosis.
CATEGORY 6. Voice, Video, Digital, Image Recordings Collection of data from voice, video, digital, or image recordings made for research purposes.
CATEGORY 7. Group or Behavior Characteristics Research on individual or group characteristics or behavior.
CATEGORY 8. Previously Approved Research Continuing review of research previously approved by the convened IRB
a.) where (i) the research is permanently closed to enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
b.) where no subjects have been enrolled and no additional risks have been identified; or
c.) where the remaining research activities are limited to data analysis.
CATEGORY 9. Previously Approved Research not using an IND or IDE. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
v If this research qualifies for expedited status do not complete this form. Complete EXPEDITED form.
/ Boston College Institutional Review BoardOffice for Human Research Participant Protection
AddressLower Campus Office Building Carney Hall 116551
Phone: 617-552-4778
FAX: 617-552-69810948
0
APPLICATION FOR FULL REVIEW OF
RESEARCH PROPOSAL INVOLVING HUMAN SUBJECTSPARTICIPANTS
(Cells will expand as needed)
DATENew [ ] / Resubmission [ ]
Principal Investigator
(Last, First, Credentials)
Investigator Rank (e.g., Professor, Graduate Student)
Faculty/Staff Sponsor Advisor (if appropriate)
Department or School and
BC Campus Address
Interoffice Address (or home address)
______
Telephone Number
E-mail address
Title of Project (If there is a sponsor, title must match the sponsored title)
Source of Funding
/ ( ) University( ) External (identify source and grant number)
*Wait until you have been notified that your project will be funded before submitting protocol application to the IRB. Submit documentation of funding status with protocol application.
*If federally funded, submit copy of the grant application to the IRB
( ) None
Please see Page 2 for the justification for expedited review or exempt status for your research.
Your signature below indicates that you accept responsibility and have followed the ethical guidelines set forth by the Belmont Report, Declaration of Helsinki, the Nuremberg Code, or the Ethical Principles of the your discipline American Psychological Association in developing the research described.
Signature of Principal Investigator Date
YourMy signature below affirms that a scientific review of this research has been conducted, and represents your my approval of the research.
Signature of Dept Chair or Dean Date
YourMy signature below affirms that a youI have reviewed this application and that youI will oversee the project in its entirety, including any final or termination report.
Signature of Faculty Advisor Date
Note: If you will be working with data that has been collected anonymously or data that is publicly available, please first review the Exemption Categories to see if your research qualifies for exempt status. If you think your research qualifies for exempt status, please complete the Exemption FormApplication for Exempt Status instead of the BC IRB protocol application.
IRB Review CategoryREVIEW:
1. Does your research qualify for expeditedExpedited Categories or full Committee review?
*Research must present no more than minimal risk to human participants in order to qualify for expedited review. Minimal risk means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR 46.102)
[ ] Full Committee Review [ ] Expedited Review
Justification for Exempt Status or Expedited Review