Human Subjects Committee
Operations and Procedures
Review Schedule | Commencement of Research | Recruitment of Subjects | Compensation | Submission Process | Help With Process | Approval Process | Committee Actions | Amendments | Continuing Reviews | Unanticipated Events | Record Keeping | Policy and Procedure Handbook
Exempt and expedited level projects and most amendments and continuing reviews are reviewed weekly by the chair of the HSC. Applications must be received by 5:00 p.m. on Monday in order to be reviewed that week. To help speed up the review process submit your initial application electronically to the Human Subject’s Office, Human Subjects Committee. The administrator will review the application electronically highlight suggestions made to the application and any other alterations that may have been needed. Then electronically return the application to the researcher for approval of the changes. After the changes have been completed and authorized, a hard copy of the application with original signatures is to be submitted to the office, Lindenwood Hall, 326.
The Committee meets monthly to review those projects requiring full review, normally on the third Friday of each month. Applications must be received by 5:00 p.m. on the first Friday of the month, in order to be reviewed by the full committee on the third Friday. There are some exceptions to these schedules and researchers are urged to contact the Human Subjects Committeeat (219) 981-5646, for the current schedule. Investigators should allow sufficient time for review prior to the beginning date of the project. While projects are reviewed frequently, the entire process can take up to 4 weeks. Projects that require full Committee review may take longer.
If it is determined your application requires full review and it has been submitted after the stated date, it will be held for the next month's meeting.
Investigators are reminded that research may not begin (i.e., data may not be collected) until and unless they receive final written approval from the HSC. This includes any and all contacts with human subjects (or work with documents on, or from, human subjects) and any and all categories of research. This restriction applies not only to the initial application, but also to any amendments. Investigators may not institute changes to their research prior to receipt of written approval for the change. The regulations governing research involving human subjects and our Letter of Assurance with the federal government preclude the granting of retroactive approval.
Subjects should not be recruited in any manner before HSC approval is received. Any documents recruiting subjects must be submitted to the Committee with the application. This includes: fliers, e-mails, letters, newspaper and other media advertisements. Offers of compensation must not be in print larger than that used in the document generally. Nor can any other benefits be over-emphasized. Refer to the Recruitment Policy below.
The Committee considers recruitment of subjects to be all procedures that take place from the first contact with a potential subject to the point when they enroll in a study or return a completed survey. This includes follow-up contacts, or "nudges", used as reminders to complete mail, e-mail, or telephone surveys.
Following are polices regarding advertising that may be used, be it paper or oral, and the number of follow-up contacts that will be allowed. Any deviations to these policies must be submitted with justification for the need and are subject to review by the full committee.
Direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study, is not in and of itself, an objectionable practice. Direct advertising includes, but is not necessarily limited to: newspaper, radio, bulletin boards, posters, and flyers that are intended for prospective subjects. Also included are "dear doctor" letters when soliciting for study subjects. Not included are: (1) news stories and (2) publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.
The HSC considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the HSC as part of the package for initial review. When the investigator decides at a later date to advertise for subjects, the advertising requires an amendment to the ongoing study. If such advertisements are easily compared to the approved consent document, the HSC chair, or other designated HSC member, may review and approve the advertising document by expedited procedures. If the HSC reviewer has doubts, or other complicating issues are involved, the advertising will be reviewed at a convened meeting of the HSC.
The HSC reviews advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol. This is especially critical when a study may involve subjects who are likely to be vulnerable to undue influence.
When direct advertising is to be used, the HSC will review the information contained in the advertisement and the mode of its communication to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol. The HSC will review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects.
When advertisements are to be taped for broadcast, the HSC will review the final audio/video tape. The HSC may review and approve the wording of the advertisement prior to taping. The review of the final taped message prepared from HSC approved text may be accomplished through expedited procedures. The HSC cautions investigators to obtain HSC approval of message text prior to taping, in order to avoid having to re-tape because of a finding of inappropriate wording.
For clinical studies, no claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Such representation would not only be misleading to subjects but would also be a violation of federal regulations concerning the promotion of investigational drugs.
Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational. A phrase such as "receive new treatments" leads study subjects to believe they will be receiving newly improved products of proven worth.
Advertisements should not promise "free medical treatment," when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid by such means as larger or bold type.
Generally, any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in advertisements. It should be noted, however, that the HSC does not require inclusion of all of the listed items.
- The name and address of the investigator and/or research facility
- The condition under study and/or the purpose of the research;
- In summary form, the criteria that will be used to determine eligibility for the study;
- A brief list of participation benefits, if any (e.g., a no-cost health examination)
- The time or other commitment required of the subjects; and
- The location of the research and the person or office to contact for further information.
Often, the first contact a prospective study subject makes is with a receptionist who follows a script to determine basic eligibility for the specific study. The HSC will assure the procedures followed adequately protect the rights and welfare of prospective subjects. In some cases, personal and sensitive information is gathered about the individual. The HSC should have assurance that the information will be appropriately handled. A simple statement such as "confidentiality will be maintained" does not adequately inform the HSC of the procedures that will be used.
Examples of issues that should be reviewed: What happens to personal information if the caller ends the interview or simply hangs up? Are the data gathered by a marketing company? If so, are names, etc. sold to others? Are names of non-eligible's maintained in case they would qualify for another study? Are paper copies of records shredded or are readable copies put out as trash? The acceptability of the procedures would depend on the sensitivity of the data gathered, including personal, medical and financial information.
The Committee will generally allow 5 contacts with potential subjects in mail,e-mail, or telephone surveys.
- Pre-contact postcard/letter
- Information sheet and survey
- Follow-up postcard/letter
- Second mailing of survey
- Telephone contact
After the telephone contact (actually speaking with a person, as opposed to leaving a message), any further contact would be with stipulations such as the caller verbally agrees to be re-contacted in a couple of weeks by a postcard reminder if the survey is not returned. The potential subject must explicitly agree to any further follow-up. For example, in the telephone contact, when the potential subject has agreed to have another survey sent, the researcher could ask: "Could we call you again in 2-3 weeks to remind you to return the survey?" or "Could we send you a card in 2-3weeks to remind you to return the survey?" Anytime a referral to amore appropriate potential subject is made, then the recruitment procedure can go back to item one and start over.
All possible follow-up procedures must be approved by the HSC first. Procedures requested outside of this policy will be evaluated on a case by case basis.
It is not uncommon for subjects to be paid for their participation in research. Payment to research subjects for participation in studies is not considered a benefit, it is a recruitment incentive. Financial incentives are often used when health or other benefits to subjects are remote or non-existent. The amount and schedule of all payments should be presented to the HSC at the time of initial review. The HSC will review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence.
Any credit for payment should accrue as the study progresses and not be contingent upon the subject completing the entire study. Unless it creates undue inconvenience or a coercive practice, payment to subjects who withdraw from the study may be made at the time they would have completed the study (or completed a phase of the study) had they not withdrawn. For example, in a study lasting only a few days, it is permissible to use a single payment date at the end of the study; even for subjects who have withdrawn before that date.
While the entire payment should not be contingent upon completion of the entire study; payment of a small proportion as an incentive for completion of the study is acceptable, providing that such incentive is not coercive. The HSC will determine that the amount paid as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn. All information concerning payment, including the amount and schedule of payment(s), should be set forth in the informed consent document.
All IU Northwest investigators must submit an application detailing the involvement of human subjects in the research project. All documents must be typed or prepared legibly on a current edition of the forms as they appear on this site or they will be returned to the investigator. Some applications will require a sponsor. See the "Researcher Responsibility " section for details and requirements. If the sponsor is from another campus, the review must take place on that campus.
Requests for approval to use human subjects should be submitted to the IU Northwest Human Subjects Committee Office, TH F04, on the appropriate forms. The forms must be completed according to the instructions provided.
The application for approval from the HSC includes the required submission of a Summary Safeguard Statement in which the investigator sets forth answers to specific questions about his/her proposed research. Investigators may not submit a protocol or proposal in lieu of the Summary Safeguard Statement. The Committee will process only those applications that include a properly completed Summary Safeguard Statement; incomplete applications will be returned to the investigator. Applications must be submitted on versions of the forms that are no older than one year prior to the date of submission. A copy of the application packet can be downloaded from this web site.
In order for applications to be reviewed in a timely manner the Committee must be able to understand the purpose of the project, what the procedures are, and how human subjects are involved (i.e., what the subjects will be asked to do or will have done to them). Investigators are cautioned to avoid using discipline specific jargon, both in the description of the project and in the consent form. For projects being conducted where instruments and consent forms will be in a foreign language, two copies of the materials must be submitted; the foreign language version and an English translation. Investigators are urged to carefully follow the directions and to pay close attention to the quality of the consent statements and the clarity of the application in general.
The initial application is to be submitted electronically to the Human Subject’s Office, Human Subjects Committee. The administrator will review the application electronically highlight suggestions made to the application and any other alterations that may have been needed. Then electronically return the application to the researcher for approval of the changes. After the changes have been completed and authorized, a hard copy of the application with original signatures is to be submitted to the office, Tamarack Hall room F04.
Contact the Human Subjects Committee at (219) 981-5646 for help with the process.
In its review of protocols, the Committee determines that the following requirements have been satisfied:
- Risks to the subjects are minimized.
- Risks to the subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
- Selection of subjects is equitable.
- Informed consent meets the requirements of the federal regulations and provision is made to obtain an informed consent from each subject or the subject's legally authorized representative.
- The research plan makes adequate provision to ensure the safety of subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Studies are rarely disapproved by the Committee. However, many studies require additional information for adequate review. Occasionally, the Committee requests investigators to revise their procedures. Examples of common problems causing delays in the review and approval process are:
- Failure to use a current application form.
- Failure to complete the Documentation of Review and Approval page completely (dates, address, signatures, etc.).
- Failure to complete each section of the Summary Safeguard Statement in a legible and comprehensible manner (making it impossible for the Committee to understand the research project and what subjects will be asked to do or have done to them).
- Failure to provide additional materials as directed in the instructions.
- Lack of acknowledgment of risk, although some element of risk is clearly present.
- Lack of, or lack of an adequate, informed consent statement (containing all relevant information in language comprehensible to the prospective subject population).
- Lack of screening of subjects to make certain they are not unduly at risk.
- Need for the Committee to ascertain risk through consulting experts.
- Unacceptable risk involved. (These are generally few in number and, typically, can be modified to meet concerns of the Committee.)
When approval is granted, the investigator will be sent a copy of the Documentation of Review and Approval with the Chairperson's signature and date. This page, along with a cover letter, will be sent to the address provided by the investigator.
The review committee may take one of four actions in regard to proposed protocols and consent forms:
- Final Approval - The PI may commence the research only after receiving written approval indicated by a signed copy of the "Documentation of Review and Approval" with a cover letter outlining the additional responsibilities for conducting research at IUN.
- Provisional Approval - The PI must respond in writing to provisions requested by the board and receive final approval prior to initiating the research.
- Tabled - Deferred for reconsideration at a subsequent meeting after PI has responded to modifications requested by the board.
- Denied - The PI will be notified in writing of reasons for disapproval.
Upon completion of the review, the investigator will receive a written response from the IRB shortly after the meeting. Any questions raised by the committee must be responded to in writing within sixty (60) days (provisionally approved or tabled studies). No work may be initiated until written final approval is received from the IRB.
Investigators are required to report any proposed changes to their research study via a Study Amendment Form (one copy). Investigators must report any changes whatsoever, regardless of the level of the original review and regardless of their assessment of the importance of the change. Reference the original title of the study, the principal investigator, and the protocol number. Any changes to the title or the investigator should be described in section 1. If the investigator's appointment does not carry an approved rank code, then both the investigator and the sponsor must sign the form. Amendments involving minor changes that pose no more than minimal risk to subjects will be reviewed on an expedited basis according to the weekly review schedule. Amendments involving more than minor changes or involving changes that pose more than minimal risk will be reviewed by the full Committee, at its next scheduled monthly meeting. Investigators are reminded that changes may not be implemented until final written approval is received from the Committee. A copy of the Amendment form can be downloaded from this web site.
Approval will be granted for up to one year. Studies (except exempt level) that continue for longer than the approval period must apply for an updated approval before the end of the approval period. The investigator will be notified by the chair of the Human Subjects Committee when it is time to apply for an updated approval. If the initial application indicates less than a one-year period, the investigator will receive a form to indicate whether the project has been completed or is continuing. Studies that initially received full Committee review will continue to receive full review for the duration of the project, unless the scope of the study changes such that it would qualify for a lower level of review. Studies that continue to recruit subjects beyond the initial approval period will need to submit consent forms/information sheets for reapproval and updated stamps. A copy of the continuing review form may be obtained from the HSC office in Academic Affairs. A copy of the Continuing Review form can be downloaded from this web site.
Investigators of exempt level projects are required to notify the HSC when their project is completed. About one month after the indicated ending date, the HSC will send a notice to the investigator asking about the status of the project. The form should be completed and returned to the office for processing by the office staff. Studies that continue to recruit subjects beyond the initial approval period will need to submit consent forms/information sheets for reapproval and updated stamps.
If a study is terminated by the investigator, it may be reactivated within 60 days without having to submit a complete application to the HSC as a new study. If it is beyond the 60 days, or a significant number of changes have been made, a new application will be required.
Any unanticipated event associated with a study must be reported to the HSC within 3 working days after the incident. The report should be in letter format which contains the following:
- Study number and title to which the incident relates.
- Description of the incident.
- Principal investigator's assessment of the incident, outlining any changes and the significance/relevance to the study, e.g., changes in risk/benefit ratio.
- Any changes that need to be made to the consent statement, plus the revised form.
- Identification of the principal investigator and the principal investigator's signature.
The Committee maintains the following files:
- Federal regulations and communications, as well as University memoranda, and letters of assurance.
- Minutes of the HSC meetings.
- Original protocols and copies of memoranda sent to, and received from, investigators.
- Protocols not yet reviewed.
- Protocols from which approval has been withheld and for which suitable remedial action has not yet been taken.
All protocols are kept for three years after completion of the research, and then are destroyed.
To obtain a PDF copy of the above operations and procedures plus other valuable information click here to retrieve the Policy and Procedure Handbook.