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TEMPLE UNIVERSITYA Commonwealth University

Institutional Review BoardMedical Intervention Committee

Student Faculty Conference Center3340 North Broad Street – Suite 304Philadelphia, Pennsylvania, 19140(215)707-8757 Fax: (215)707-8387e-mail: [email protected]

MEMORANDUM

TO: TUHS RESEARCH COMMUNITY INVOLVED IN HUMAN SUBJECTS RESEARCH

FROM: CHAD PETTENGILL, IRB DIRECTOR

SUBJECT: REVISED GUIDELINES FOR SUBMITTING HUMAN SUBJECTS PROTOCOLS

DATE: January 1, 2008~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~The code of Federal Regulations defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge”. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. Other criteria, which may be of use in determining whether a planned activity is research, include:

1. The collection of data with the intent to report it in scientific publications;

2. Use of a standard procedure or medication if it is influenced by any consideration other than the direct welfare of the patient, even if both therapies seem equal to the physician in charge (e.g. a selection between different though widely accepted therapies according to a predetermined plan such as randomization); and

3. Use of experimental drugs or devices.

Innovative or newly introduced therapies or procedures do not require IRB approval except when they involve “research” activities (e.g., the systematic collection of data with the intent to evaluate the effectiveness of the therapy, use of an experimental drug or device, or use of any procedure such as randomization which is not done solely for the benefit of the subject). When such therapies or procedures involve research, a protocol for their use must be reviewed by the IRB.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

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Institutional Review Board Guidelines

Enclosed are the revised guidelines for the submission of human subjects protocols. Please familiarize yourselves with these instructions, since it will save you time in the long run. The Committee will not hesitate to return protocols that do not conform to these guidelines. Research protocols involving human subjects fall into one of three categories described below. Investigators may request an expedited review or an exemption under the guidelines. However, the IRB Chair in accordance with all relevant federal regulations shall determine the level of review required by the Committee. If you have any questions about the status of your project, please call me at 2-8757.

1. Full Committee Review (follow the attached instructions)

2. Expedited Review – Generally protocols that involve no more than minimal risk include those where only drawing blood is required (under certain restrictions), using physical sensors, and observing moderate exercise. (The Code of Federal Regulations definition is, "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 102i}). Only one copy of the protocol and consent form need be submitted. While the review process is expedited, the investigator should be aware that the protocol and consent form submitted must be complete in every detail. Consequently, the same level of information required for a full committee review must be submitted.

3. Exempt - Protocols involving the use of existing data, documents, records, or pathological specimens, or using educational tests or survey procedures with questionnaires may be exempt from compliance with Department of Health and Human Services (DHHS) requirements. A memorandum explaining the project is all that needs to be submitted. Investigators should know that to qualify as an exempt protocol all data or specimens must be in existence at the time the data collection starts. If there is a need to collect additional data or specimens at some time in the future, the protocol will not be eligible for exempt status.

If your protocol requires full review by the Institutional Review Board you must submit 30 copies of your protocol collated in this order:

1. The COMPLETED Request for Protocol Review Page including all necessary signatures (a blank is included in this package)2. IRB Narrative Description of the protocol – in Temple University format3. Informed Consent, on appropriate letterhead – in Temple University format.

Additionally; 1. Four (4) copies of the full protocol2. Four (4) copies of the Investigator’s Brochure or Device Description.3. One (1) copy of the Investigator Drug Data Sheet (IDDS) if applicable4. One (1) copy of the completed FDA form 1572, if applicable5. One (1) copy of the grant or award application, if applicable

At the time of final approval of the protocol and consent two (2) final originals of the consent will be required for stamping by the IRB.Pettengill/HSC\CommitteeAdministration\Instructionss

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Protocol submission dates - Please note these dates carefully listed on the following link:

http://www.temple.edu/research/regaffairs/irb/index.html#meet

Deadlines for submission are two (2) weeks prior to the meeting date:

If your protocol includes radiation exposure that is required only because of the subject’s participation in the study, you must also have the project approved by the Medical Radiation Subcommittee (MRC). Radiation exposure that is “standard of care” does not require MRC approval. However, all radiation exposure required by the study should be included in the protocol and the investigator should explain why each exposure is considered standard of care. If in its deliberations the committee determines that MRC approval is needed, a Certification of Approval cannot be issued until approval from MRC is received.

If your protocol uses an investigational biologic, drug, or device, or a new indication or dosage for a previously approved drug or biologic, then you must apply for an IND# (Investigational New Drug) or an IDE# (Investigational Device Exemption). The pharmaceutical company usually provides this number for you. Your protocol can be reviewed before the number is obtained but cannot be finally approved until the number is issued. An INVESTIGATIONAL DRUG DATA SHEET must be filed with the TUH Pharmacy (sent to the attention of Adrienne Au, Pharm.D, Investigational Pharmacy.)

Additionally a copy of the INVESTIGATIONAL DRUG DATA SHEET, a copy of the full protocol, and a copy of the Investigator’s Brochure need to be submitted to the Investigational Pharmacy.

If a pharmaceutical company sponsors your research, then you also must submit two copies of the investigator's drug brochure and the full company protocol in addition to the protocol summary.

If your research involves a contract with a third party, the contract must be submitted to Ms. Arleen Wallen – Clinical Trials Office, HSC. Temple has developed a Standard Clinical Trials Agreement for research protocols. If this standard contract is used, then approval can be obtained much more expeditiously. Copies of this agreement (hard copy or on disk) are available from the Sponsored Projects Office. Please note that subject recruitment and enrollment cannot begin until there is a signed agreement between the sponsor and Temple University.


http://www.temple.edu/research/regaffairs/irb/index.html#meet


Instructions for Submitting Protocols for Expedited or Full Committee Review

PROJECT PROTOCOL Complete the Request for Protocol Review cover sheet. (Copy attached)

Cover Sheet Section

Specific Instructions for Completion

Title The title on this sheet MUST be the same as the title on the Informed Consent document.

Principal Investigator All fields must be completed including email address, fax and telephone numbers.

Research Coordinator

This individual must be identified. If the research coordinator is unknown at the time of submission, please indicate this.

Co-Investigators

Include all coinvestigators involved with the study. For company-sponsored trials, anyone listed on the FDA 1572 form should be added. Use additional pages if necessary. Remember, each coinvestigator must sign the second page of the cover sheet.

Protocol Data

Funding

Identifying the source of funding is important as it affects elements of the consent form including the confidentiality statement (who will have access to information) and the Injury Statement (where will care be provided and who will assume the cost of care).

Study LocationIf this is not a Temple University site, please provide documentation that the other institution approves of the research. In some cases protocols will need to be submitted to that institution’s IRB.

Number of Subjects at

Temple

This is the total number of subjects you intend to enroll. If control patients are utilized within the protocol, you must state the number of subjects and the number of controls. Once a study receives IRB approval, this number cannot be exceeded without submitting a protocol amendment.

Males/Females

Please provide a number for males and females you intend to enroll. You should estimate the distribution based on the observed enrollment from similar studies, or visits to your particular practice. If males or females are excluded from participation based on study eligibility criteria, the reason for the exclusion should be explained in the protocol.. If controls are used within the protocol, you must state the number of males and females.

Age Range Age range for subjects that will be studied at Temple. If the lower age limit is less than 18 years, parental consent and child assent forms may be required.

IND/IDEThe drug or device manufacturer will usually supply this number. Studies that involve the “off-label” use of an approved drug may require an investigator-sponsored IND. Please contact the IRB office for additional information.

Multicenter Indicate the approximate number of centers involved in the study.

Investigational Drug Data Sheet

An INVESTIGATIONAL DRUG DATA SHEET must be filed with the TUH Investigational Pharmacy if non-marketed drugs are being used. A full copy of the protocol and a copy of the Investigational Brochure must be submitted.

Radiation/IBC Institutional

Biosafety Committee

All studies that require radiation exposure as part of the study must be submitted to the Medical Radiation Committee. Full IRB approval cannot be given without approval from the MRC. IBC approval is necessary for some protocols prior to IRB approval. Please check with the committee.

Signature Page Make sure that the principal investigator, all coinvestigators and appropriate department chairs sign where indicated.



The format outlined below must be followed when preparing your proposal for submission to the IRB.

1. STUDY TITLE

2. OBJECTIVES

Enumerate the primary and secondary objectives of the study.

3. BACKGROUND

Give a brief overview the current state of the scientific literature in the area of your proposed investigation. This section should be relatively brief, but should include sufficient detail for the committee to understand the rationale for conducting the study and the scientific significance of the proposed protocol.

4. ELIGIBILITY CRITERIA

Describe the methods and criteria by which subjects will be selected and/or excluded from the study. The criteria should be specific. If the study requires “normal renal function” this should be defined as “a serum creatinine <1.5 mg/dL” for example. It should be clear how the study population will be identified (e.g. referrals, medical records, all patients presenting to the emergency department). The manner in which you will attempt to recruit appropriate numbers of women and minorities should be identified. If women (including pregnant women) or minorities are not included, then you must state why.

5. TREATMENT PLAN

The treatment plan should provide specific details as to what will be required of the patient who agrees to enroll in the study. The investigator should identify those drugs, devices, or procedures that are experimental, and those that are approved or standard of care. It is useful to present the study requirements in the order in which the subject will experience them. The committee often finds a flow sheet or table; describing study visits to be useful for longer or more complex studies. Once a patient is identified as a potential study subject the treatment plan should reflect:

a. Indication of whether this is an inpatient or outpatient study.b. When informed consent will be obtained and who will obtain it.c. If multiple treatment groups are being compared, how will subjects be assigned to

these groups? Are the chances of assignment to each treatment group equal? If not, why is an unbalanced design being used?

d. Will subjects need to withdraw from current therapies to be included in the trial? If there is a washout period, this is considered part of the study and must be included in the protocol and consent form.

e. A description of the study article.Pettengill/HSC\CommitteeAdministration\Instructionss

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i. For drugs include the generic and trade names, dosage, frequency of administration, route of administration and, expected duration of administration.

ii. For devices include the determination of whether the device is a significant risk device or a non-significant risk device.

f. A description of all study-related procedures including clinical and laboratory testing, number and frequency of follow-up visits, and any surveys or diaries that will be required of the subject. Please specifically comment on the number of times blood will be drawn, how much blood will be drawn each time and what it will be used for and the total amount of blood that will be required as part of the study. Similar detail should be provided for any ionizing radiation exposure required by the study.

g. The frequency and method of follow-up.h. A description of what study related costs would be assumed by the sponsor and

those that will be the responsibility of the subject.i. A description of who will be responsible for care of subjects before, during, and

after the intervention is complete.

6. RISKS

Describe the risks related to the subject’s participation in the research. These include, but are not limited to:

a. Risks associated with withdrawing active treatment of a condition in order to qualify for the study.

b. Drug side effects, as well as discomforts, and inconveniences associated with medication administration.

c. Risks associated with device implantation or device failure. d. Risks of required study procedures, even if these procedures are approved or

standard of care.e. Risks of blood sampling.f. Risks of exposure to ionizing radiation.g. Inconveniences related to the number or duration of study visits.h. Inconveniences related to completion of surveys or subject diaries.i. Risks associated with failure to maintain patient confidentiality. This is especially

important for studies that involve genetic testing.j. Any psychological or emotional harm that may occur as a result of study

participation.

For each of the risks identified, the investigator should explain how these risks have been minimized. Methods to minimize risks include, but are not limited to: subject selection (i.e. inclusion/exclusion criteria); investigator training; the specific monitoring plans and follow-up of subjects; use of an internal or external data safety monitoring board (DSMB).

7. BENEFITSPettengill/HSC\CommitteeAdministration\Instructionss

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Describe the benefits that could reasonably be expected by the subject’s participation in the study. If there are no direct benefits to the subject state this. Remember, monetary or other compensation for participating in a study is not considered a study benefit. Briefly discuss the potential benefits as they relate to the risks associated with the study.

8. ALTERNATIVE TREATMENTS

Disclosure of appropriate alternative procedures or treatments that might be advantageous to subjects. If the drug or device being investigated is available without participating in the study this should be stated here. For some studies doing nothing or “comfort care” may be an alternative. Examples of alternative therapy should be given. Just including a statement that “other treatments for my condition are available and will be discussed by my doctor” is unacceptable.

9. DATA COLLECTION AND STATISTICS

The investigator should indicate:a. The primary statistical endpointb. The statistical method to be used to evaluate the endpointc. The power of the study to detect a difference in the endpoint based on the specified

sample size

Examples of an acceptable statistical section are:1. The primary objective of the present study is to compare the control arm and the

study arm with respect to the actuarial survival rate.2. The log-rank test will be used to evaluate the above endpoint.3. This study has an 80% chance of detecting a 15% improvement in actuarial 3 year

survival rate, based on the proposed sample size of 50 patients.

Include copies of the all the data collection forms to be used, including those of the study sponsor. For internally funded studies, the investigator should develop and submit data collection forms. This is to assure that the information or study results being sought are study related and in compliance with institutional and HIPAA standards.

10. MEDICAL RADIATION SUBCOMMITTEE/INSTITUTION BIOLOGIC COMMITTEE APPROVAL

This is required whenever radiation exposure is being undertaken primarily in the interest of research and would not be part of the usual clinical management of the patient. On the cover sheet indicate one of the following: the approval number; pending; or not applicable. IBC approval is necessary for some protocols prior to IRB approval. Please check with the committee.

11. IND/IDE NUMBER; INVESTIGATIONAL DRUG DATA SHEET



The Investigational New Drug or and Investigational Device Exemption number assigned by the FDA must be provided. If an FDA approved drug or device is being used in a manner for which it does not have FDA approval, an IND or IDE may be required. Please contact the IRB office for guidance in this situation. Also remember to complete and file an Investigational Drug Data Sheet with the Department of Pharmacy at Temple University Hospital.

12. BIBLIOGRAPHY

List any citations to the scientific literature made in any of the above sections.

INFORMED CONSENT

The consent form must be typed. The first page of the consent form must be on original departmental letterhead

The first page must include the following:1. Project title, which should be exactly the same as the protocol title.2. Investigator(s)'s name(s), position(s) and affiliation(s)3. Patient’s name and ID # below the title4. IRB Protocol number must be included. A line stating “IRB Protocol # ____.” The number

will be assigned by the IRB when protocols are received and the PI will be notified of this number in a letter stating the status of the review.

5. There should be a brief, one sentence statement indicating whether Temple University is being compensated for performing this study, select appropriate:Temple University is receiving monetary compensation for performing this study OR Temple University is not being compensated for performing this study.

6. There should be a brief one sentence statement indicating who is the sponsor of the study. Select as appropriate or amend as necessary: This study is sponsored by: Company Name, Agency Name, other appropriate I.D. or this study is sponsored internally by: Department Name or other appropriate I.D.

Other requirements:

1. Project title must be printed on the signature page.2. Leave an inch and a half by two-inch (1.5” x 2”) space on every page for the IRB

approval stamp.3. The use of “you” is preferred in the consent form, as it has been found that it makes it

easier for the individual who is obtaining informed consent. The use of the person (“I” or preferably, “you”) must be consistent throughout the consent form until the patient reaches the final statement and signature section. The person can then be switched to “I”.

4. The pages of the consent form should be numbered.



5. Except for the signature page, each page should have a place for the subject to initial and date the informed consent document.

The Informed Consent must be written in language that non-medical persons can easily understand. It is suggested that the consent form be at the eighth grade reading level or lower. Most word processing programs will determine the reading level as part of the spell check function. (You may have to go into the “Options” portion of the program to set this up.)

Each of the following sections should be included in the consent form.

1. PURPOSE OF THE STUDY

A brief description of the study and its rationale (Why is this study important? What deficiencies exist with current drugs or devices? What new information is to be learned from this study?). There must be a statement that the study involves research. A statement as to why the subject is being considered for the study should be included. (e.g. You are being asked to join in this research study because you have high cholesterol that that did not come down after changing your diet.). The purpose of the study should be stated clearly in one or two sentences. (e.g. The aim of this study is to see how well an experimental drug lowers cholesterol compared to usual therapy.)

2. DESCRIPTION OF THE PROJECT Include a description of the project and the required study procedures. This description should follow the logical sequence for a subject who would complete the entire trial. It should be clear to the patient if the study is an inpatient or outpatient study or if there are both inpatient and outpatient components. The consent form should state the total number of subjects that will be enrolled at Temple. For multicenter studies, the total number of centers and total number of subjects should be identified.

The consent form should clearly state the duration of subject’s involvement in the study and total number of study-related visits. The reason for each of the study-related visits should be explained. For studies that involve multiple visits or are of long duration providing a table that outlines the visits and study procedures for each visit is useful and encouraged by the committee.

The intervention (i.e. drug, device, or procedure) that is experimental should be made clear. If the study has a comparison group (placebo or active treatment) these should also be included and the chances of receiving each treatment should be disclosed to the subject. Approved interventions that are required for the study should also be included in the description of the project. For example, in a study of a new asthma drug, the drug itself would be experimental. Pulmonary function testing may be required for the study, but are not experimental. Even so, the pulmonary function tests would be included in the project description. If blood sampling is necessary be sure to include the number of times blood sampling is required, the amount of blood drawn each time and why this blood is needed, and the total amount of blood that is required by the study. The amount of blood to be drawn should be explained in lay language (e.g. teaspoonfuls, tablespoonfuls, cupfuls). The investigator should take care to insure that the consent form explains aspects of the study that would not generally be understood by the layperson. These include:



1. Explanation of treatment assignment procedures (e.g. you will have an equal chance of receiving the study drug or placebo)

2. Explanation of terms such as "random", (like a flip of a coin (for two groups) or a roll of the dice (for three or more groups), "double-blind"(neither you nor your physician will know.....), and "placebo" (an inactive substance).

3. Explanations of any tests or procedures required by the study.

3. DESCRIPTION OF ANY FORSEEABLE RISKS OR DISCOMFORT TO THE SUBJECT

Risks associated with clinical research trials include physical and non-physical risks. The investigator is reminded to consider both types of risk when developing the informed consent document. Examples of non-physical risk include psychological harm or distress (as might be experienced in completing surveys if the requested information is upsetting or if the surveys are lengthy); threats to insurability; failure to maintain patient confidentiality; economic harm due to loss of work for study visits; legal harm as might occur in studies of drug or sexual abuse. Genetic research studies might uncover information that could be distressing to siblings or other family members. Risks that are commonly encountered are described below.

a. Known risks or side effects of the study article (drug or device)b. Risks of procedures required by the study (even if not experimental).c. Risks of radiation exposure. (Contact the Medical Radiation Committee for guidance)d. Risks of blood sampling. (Pain, small risk of bleeding or bruising at the puncture site,

temporary lightheadedness or fainting, and infection at the puncture site).e. Consideration of risks for pregnant women, if it pertains to the study. The following

statement should be included exactly as written:“Since there may be unknown risks to pregnant women and their unborn child, if I am nursing, pregnant or planning to become pregnant, I will not be allowed to participate in the study. I confirm to the best of my knowledge that I am not pregnant and if I become pregnant during the course of the study, I must notify my physician immediately.”

f. Risks to others not involved in the study. For example potential risks associated with live virus vaccines to family members, sexual partners of subjects taking certain study medications.

g. That not all risks of a treatment are known (especially important in new drug or device studies).

4. DESCRIPTION OF BENEFITS

The informed consent document should describe the benefits that can reasonably be expected from the subject’s participation in the trial. Subjects might expect a direct benefit from certain treatments and access to therapies that might not otherwise be available to them. Generally these benefits cannot be guaranteed. Some benefit might ensue from the testing required by the protocol that might provide information relevant to the care of the patient. The investigator is reminded that payment for participation in research is not a benefit, but should be discussed in the “Compensation Statement”.

5. ALTERNATIVE PROCEDURESPettengill/HSC\CommitteeAdministration\Instructionss

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Briefly discuss the alternative therapies available to the subject. If the study does not involve a treatment, the alternative would be to not participate (i.e. not complete the survey, not provide a blood or urine sample). Examples of alternative treatments include accepted surgical or medical procedures; other investigational interventions; no treatment; or comfort care.

6. CONFIDENTIALITY STATEMENT

The purpose of the confidentiality statement is to inform the subject about the agencies and organizations that will have access to their study data. All studies conducted by Temple University faculty, staff, and students are subject to review by the Temple University’s Institutional Review Board, Office for Human Research Protections (OHRP). In addition, studies funded by outside agencies (NIH, NCI) generally require access to individual patient data. Studies sponsored by pharmaceutical companies seeking data for approval of a new drug or device will usually provide some guidance as to who will have access to the data. A template for our “Standard Confidentiality Statement is given below.

All documents and information pertaining to this research study will be kept confidential in accordance with all applicable federal, state, and local laws and regulations. I understand that medical records and data generated by the study may be reviewed by Temple University's Institutional Review Board, the Office for Human Research Protections (OHRP) the study sponsor, (insert name), [include any Clinical Research Organizations that may have access to the data], and the United States Food and Drug Administration (FDA) [only for studies that will submit data to the FDA for a new drug approval] to assure proper conduct of the study and compliance with federal regulations. [Occasionally data will also be sent to regulatory agencies of foreign governments seeking approval of a drug in that country]. I understand that the results of this study may be published. If any data is published, I will not be identified by name.

7. VOLUNTARY PARTICIPATION STATEMENT

The voluntary participation statement must be included exactly as given below. Consequences of the subject’s decision to discontinue participation in the study should be explained as well as any procedures required for orderly termination from the study.

I understand that my participation in this study is entirely voluntary, and that refusal to participate will involve no penalty or loss of benefits to me. I may discontinue my participation at any time without penalty or loss of benefits.

8. COMPENSATION STATEMENT

The compensation statement explains the manner and the timing of compensation for the subject’s time spent in study-related activities. One of the two statements below should be included.

I understand that I will receive no compensation for this studyOR



I understand that I will receive ________ for participating in this study. (Details should be discussed, e.g. timing of payments and pro-rating arrangements if the subject does not complete the study)

9. INSTITUTIONAL CONTACT

The subject must be informed of who to contact for additional information for their research rights and must be provided a number that is available 24 hours a day, seven days a week to contact the principal investigator regarding research related injuries. Suggested statements are given below.

If I have any questions about my rights as a research subject, I may contact the Institutional Review Board Coordinator, Richard Throm at (215) 707-8757.

If I have any questions about research-related injuries, I may contact (name and telephone number of principal investigator)

10. STANDARD INJURY STATEMENT

For research involving more than minimal risk, an explanation of whether any compensation is available if injury occurs, whether any medical treatments are available and what they consist of. Three templates for the standard injury statement are suggested below. The Institutional Review Board looks carefully at statements that appear to abridge a research subject’s right to treatment in the event of a study-related injury. Phrasings such as “if you correctly followed all of the study procedures” or “if your study physician administered the drug in the right way” are strongly discouraged. The injury statement used in the informed consent document must conform to the language in the contract with the sponsoring agency.

For studies funded by an outside agency:

I understand that if I sustain an injury as a result of participation in this study, only physicians' fees and medical expenses not covered by my medical and hospital coverage or other third party coverage will be paid at no cost to me (may include name of sponsor). I understand that financial compensation for such injuries is not available. I understand that I have not waived any of the legal rights that I would otherwise have as a participant in an investigational study.

For studies funded through the NIH or from Department funds:

I understand that if I sustain an injury as a result of participation in this study, only physicians' fees and medical expenses at Temple University Hospital not covered by my medical and hospital coverage or other third party coverage will be paid at no cost to me. I understand that financial compensation for such injuries is not available. I understand that I have not waived any of the legal rights that I would otherwise have as a participant in an investigational study.

In unusual circumstances, subjects may be expected to assume responsibility for injuries resulting from their participation in a study.



I understand that if I sustain an injury as a result of participation in this study, the physicians' fees and medical expenses that result will be billed to my insurance company or me in the usual manner. I understand that financial compensation for such injuries is not available. I understand that I have not waived any of the legal rights that I would otherwise have as a participant in an investigational study.

11. COSTS STATEMENT

The subject must be informed of any additional costs that may result from their participation in the research project. They should be informed if they would be required to pay for parking or transportation to the study site. Examples of cost statements are given below.

I understand that the study drug/device, physicians' fees and tests required by the study will be provided at no cost to me.

ORI understand that the study drug/device, physicians' fees and tests required by the study will be billed to me in the usual manner. If the device is a Class A, experimental device, it may not be paid for by the insurers.

12. TERMINATION STATEMENT

A statement should be included that the investigator can terminate the subject’s participation without regard to the subject’s consent. The anticipated circumstances under which this might occur should be included (e.g. failure to take study medications as prescribed or missing scheduled study visits).

13. STATEMENT OF SIGNIFICANT NEW FINDINGS

When appropriate, the investigator should include a statement that significant new findings that may relate to a subject’s continued willingness to participate in a study will be communicated with the subject. This is most likely to be needed in large, multicenter studies or long-term follow-up studies where additional risks have been identified.

Example statement:You will be informed in a timely manner of any new information regarding this study that may have an affect on your willingness to participate, continue your participation, or after your participation that may have an affect on your future medical care. You may be asked to sign a revised informed consent that contains this new information.

14. FINAL STATEMENT AND SIGNATURE

This study has been explained to me, I have read the consent form and I agree to participate. I have been given a copy of this consent form. Include signature lines for both the participant and the Principal Investigator. A signature for a witness is not required, but may be useful in certain circumstances.



When the study is approved, the consent form will be stamped on each page with the IRB stamp and returned to you to copy and use. All study participants must sign a copy of the consent form that has the date stamp on it.

THE POST REVIEW PROCESS

Your protocol will be reviewed by the Committee and classified as follows:

1. APPROVED

2. CONDITIONALLY APPROVED

3. DEFERRED

You will receive a letter from the IRB Office informing you of the status and detailing any revisions recommended by the Committee.

1. APPROVALIf your protocol is approved, you will receive a Certification of Approval. The final approved informed consent will be stamped and returned to you with the Certificate of Approval. Only a copy of the stamped informed consent form may be used and is only valid for one year from the date stamped on the consent form.

2. CONDITIONAL APPROVALWhen you have addressed all of the recommended revisions, and they are approved, you will be sent a letter and a Certification of Approval. Once the Approval is received you may begin the study.

3. DEFERREDYour protocol will be deferred if the Committee has serious concerns about the scientific merit or design of your project. You will be expected to make the recommended revisions and submit 30 copies of the corrected versions of the protocol and consent form to the full Committee for re-review.

RECERTIFICATION

According to FDA regulations, all protocols must be reviewed at least on an annual basis. Two or three months before the anniversary date of your protocol approval you will receive a REQUEST FOR RECERTIFICATION (a yellow form, copy attached). In order to have your protocol recertified you must:

a. On page 1, indicate the status of your protocol, and sign the form. Complete page 2.

b. On page 3, provide a list of patients seen since the last approval, indicating any adverse events that have occurred

c. Attach two clean, newly printed informed consent forms on departmental letterhead, EVEN IF IT HAS NOT CHANGED. Old copies of this form will not be accepted



or stamped and therefore will delay your recertification process. Please be sure to provide the protocol # under the title on the first page.

d. Provide a summary of any recent literature, findings, or other relevant information, especially about risks associated with the research (this is a new requirement mandated by the Office for the Protection from Research Risks, effective April, 1995)

If possible, your reapproval request will be assigned to the committee member who reviewed the study initially, and he/she will present it to the full committee for approval. If your protocol is still in progress and is recertified for one more year, a blue Recertification of Approval will be issued. This form is VERY IMPORTANT - it authorizes continuation of the research study for one more year. The Informed consent will be date stamped and returned with the Recertification of Approval form, and only copies of the current date- stamped form may be issued to subjects. The informed consent is good for only one year until the current recertification expires.

It is most important that you return the yellow Request for Recertification form by the deadline date in order to allow time for copying and distribution to the appropriate committee members. If you do not return the form by the deadline, you will receive one reminder letter giving you until the anniversary date of your initial approval to respond, and if there is still no response the protocol approval will be withdrawn. This action is mandated by federal regulations.

AMENDMENTS AND MINOR CHANGES

Any amendments or changes to the contract, protocol or informed consent must be submitted to the IRB for approval whether you or the sponsor originates them. If the modified informed consent form is approved, it will be date stamped and returned to you. This form is good only until the renewal date for recertification.

AUDITS OF PROTOCOLS

The IRB is responsible for monitoring compliance with OPRR and FDA regulations related to studies involving human subjects and for ensuring that protocols are conducted as approved by the IRB. Therefore, the IRB Coordinator may review the files of subjects enrolled in the study. The IRB Coordinator will notify you the day prior to an inspection and you will be expected to make the patient records available.

IRB FEES

1. FEE POLICY

A fee is applied for IRB review to all but the following sponsored activities:Pettengill/HSC\CommitteeAdministration\Instructionss

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1. Government agency funded projects (federal, state, city);

2. Internally funded projects;

3. Projects originally reviewed prior to November 1, 1996.

Refer to item 3 for the IRB Fee Schedule.

2. IRB PROCEDURES

Investigators are to ensure that the following procedures are followed:

1. The investigator is to notify the external sponsor, prior to submission of the protocol to the IRB, that the IRB charges a fee for its services. The investigator is to provide the name and phone number of the contact for the sponsor to the Office of the Vice President of Research.

2. The Office of the Vice President for Research will discuss with the sponsor whether the IRB fee should be billed separately or added into the budget with the sponsor. 3. The IRB fee will be assessed whether the protocol is approved or not, and whether or not any patients are enrolled. Future year charges will be assessed at the time of subsequent IRB review(s).

4. At the Sponsor’s request, a single IRB Fee may be assessed for multi-year projects at the time the agreement is ratified or when the notification of a grant award is received. In many instances the sponsor may wish to pay a one-time single IRB fee for the project to the University. This would be preferable and more cost effective.

5. The IRB fee will be excluded from the direct cost base to calculate the applicable indirect cost rate.

6. The Department of an investigator submitting the protocol is to be responsible for any uncollected IRB funds.

3. FEE SCHEDULE

The following IRB fee schedule is applicable to projects reviewed after October 31, 1996:



IRB REVIEW IRBAPPLICATION REQUIRED FEE TYPE__________________________________________________

New Submission Full CommitteeNew Submission ExpeditedAnnual Review Full CommitteeAnnual Review ExpeditedSubstantive Amendment* Full CommitteeSubstantive Amendment* Expedited

*No IRB fee is charged for technical amendments


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