PENGGALANG RAMU
PENGGALANG RAMU
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / I
Waktu : 2 x 35
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
1. Mengapresiasikan dan mengekspresikan diri melalui perilaku penggalang Ramu.
C. Sasaran
1. Melaksanakan latihan dengan rutin.
2. Mengucapkan salam Pramuka.
3. Menyebutkan macam salam pramuka.
4. Menjelaskan pengertian salam pramuka.
5. Menyebutkan kegunaan salam salam pramuka
6. Menyebutkan tanda-tanda pengenal Kepramukaan.
7. Menyebutkan kegunaan kesehatan badan.
8. Membiasakan diri untuk menabun.
9. Membiasakan diri untuk membayar uan iuran.
D. Substansi Kegiatan
- Buku absensi
- Tanda-tanda kepramukaan
- Buku tabungan
- Buku kas
E. Pelaksanaan Kegiatan
Kegiatan Awal :
1. Menyiapkan siswa dalam kegiatan.
2. Tanya jawab tentang salam pramuka, tanda – tanda kepramukaan, kegunaan kesehatan, menabung.
Kegiatan Inti :
( Pertemuan I )
1. Pembagian regu dan memilih ketua regu.
2. Menyebutkan pengertian salam pramuka.
3. Menyebutkan macam – macam salam pramuka.
4. mempresentasikan salam tongkat dengan benar.
5. Mengucapkan salam pramuka dengan benar.
( Pertemuan II )
1. Mengapresiasikan cara berpakaian yang rapi.
2. Menyebutkan tanda pengenal kepramukaan.
3. Menyebutkan manfaat dan kegunaan kegunaan kesehatan badan
4. Menyebutkan manfaat menabung.
5. Membiasakan diri menabung dengan rutin
6. Menyebutkan kegunaan iuran
7. Membiasakan diri membayar iuran rutin
Kegiatan Penutup
1. Menyimpulkan substansi kegiatan yang telah dilakukan :
- Salam Pramuka
- Macam – macam salam
- Cara berpakaian yang rapi
- Tanda-tanda pengenal kepramukaan
- Kegunaan dan manfaat kesehatan.
- Kegunaan iuran.
2. Mengevaluasi :
- Cara mengucapkan salam pramuka dengan benar.
- Tanda-tanda penenal kepramukaan
F. Waktu dan Tempat
Waktu : 2 x pertemuan
Tempat :
G. Sarana
Bendera, Tongkat, Tanda pengenal Kepramukaan, buku absensi, buku iuran.
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / I
Waktu : 2 x 35
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
2. Mengamalkan Dasa Dharma, Tri Satya, dan Pancasila dalam kehidupan sehari – hari.
C. Sasaran
1. Memahami isi Dasa Dharma, Tri Satya.
2. Menghayati isi Dasa Dharma, Tri Satya.
3. Mengamalkan isi Dasa Dharma, Tri Satya.
D. Substansi Kegiatan
- Tri Satya
- Dasa Dharma
E. Pelaksanaan Kegiatan
Kegiatan Awal :
1. Upacara Pembukaan.
2. Berdo’a bersama.
3. Penjelasan isi Tri Satya dan Dasa Dharma.
Kegiatan Inti :
1. Menghafal Tri Satya.
2. Menghafal Dasa Dharma.
Kegiatan Penutup
1. Ujian SKU No. 2
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
- Buku Saku Pramuka
- Buku SKU
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / I
Waktu : 2 x 35
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
2. Mengamalkan Dasa Dharma, Tri Satya, dan Pancasila dalam kehidupan sehari – hari.
C. Sasaran
1. Hafal Pancasila dan tahu artinya.
D. Substansi Kegiatan
- Tahu sejarah lahirnya Pancasila
- Penjabaran butir-butir pancasila
- Penucapan satu persatu butir-butir pancasila
E. Pelaksanaan Kegiatan
- Membawa buku sejarah yang bermuat sejarah Pancasila.
- Pemaparan sejarah
- Pengucapan butir-butir pancasila.
- Penghafalan butir-butir pancasila.
- Penjabaran butir-butir Pancasila.
- Pengupasan butir-butir pancasila.
- Evaluasi
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
Ruang belajar, buku sejarah, alat tulis.
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / II
Waktu : 2 x 35
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
3. Menjelaskan arti symbol-simbol dalam negara NKRI ( Bendera, lagu, lambang, dll)
C. Sasaran
1. Mengetahui sejarah lagu Indonesia Raya.
2. Mengetahui sejarah bendera Merah Putih.
3. Mengetahui lambing GP
D. Substansi Kegiatan
- Tahu arti lambing Gerakan Pramuka
- Tahu cara menggunakan Bendera Kebangsaan Indonesia, hafal lagunya.
- Tahu kapan dan dimana untuk dinyanyikan.
E. Pelaksanaan Kegiatan
- Memberi tahu arti Tunas Kelapa
- Memberi tahu sejarah Tunas Kelapa
- Memberi tahu manfaat Tunas Kelapa
- Tahu Penggunaan Bendera Merah Putih
- Tahu Cara mengibarkan Bendera Merah Putih
- Tahu dimana tempat untuk menibarkan
- Tahu cara penghormatan bendera Merah Putih
- Memberi tahu sejarah lagu kebangsaan Indonesia Raya.
- Untuk menyanyikan lagu kebangsaan
- Memberi tahu penciptanyaMenghafal lagu kebangsaan minimal 3
- Tahu tempat dimana untuk menyanyikan lau kebangsaan.
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
- Lamban Tunas Kelapa
- Bendera Merah Putih
- Kaset Lagu-lagu kebangsaan Indonesia Raya.
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester :7, / I
Waktu : 3 x Pertemuan ( 3 x 3 @ 35 menit )
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
4. Menimplementasikan kegiatan Kepramukaan dalam kehidupan sehari – hari.
C. Sasaran / Indikator
1. Bisa berbahasa Indonesia yang benar pada saat mengikuti latihan.
2. Bisa berbahasa Indonesia yang baik, sopan sesama teman, kakak pembina pada saat latihan pramuka.
3. Menyebutkan nomer gudep pangkalan tempat latihan.
4. Menjelaskan struktur organisasi pada gudep pangkalan tempat latihan.
5. Menyebutkan nama Ka. Mabigus, Kakak-kakak pembina digudep
6. Menyebutkan berapa Pa/Pi dalam gudep
7. Menjelaskan struktur organisasi gudep
8. Menjelaskan tanda-tanda pengenal / atribut yang dipakai pada seragam pramuka penggalang.
9. Menyebutkan tanda-tanda pengenal dalam gudep
10. Menyampaikan sberita secara lesan kepada kakak pembina perihal teman yang sakit tidak masuk latihan.
11. Menceritakan keterlambatan datang latihan pramuka.
D. Substansi Kegiatan
Materi Kegiatan :
- ( 8 ) Biasa berbahasa Indonesia diwaktu mengikuti pertemuan 2 penggalang.
- ( 9 ) Tahu struktur organisasi dan tanda 2 pengenal dalam gudep.
- ( 13 ) Dapat menyampaikan berita secara lisan.
E. Pelaksanaan Kegiatan
Langkah awal :
- Upacara pembukaan latihan pengalang bentuk angkare
- Petugas dari regu yang sudah ditunjuk untuk melaksanakan
Penyampaian materi :
- Secara lesan beberapa anak diajak berkomunikasi dengan mengunakan bahasa Indonesia yang baik dan benar kepada teman, kakak pembina
- Kakak pembina menyebutkan dan menjelaskan struktur orgsanisasi dan tanda pengenal dalam gudep denan gambar yang ada di gudep
- Penyampaian berita secara lesan yang benar
F. Waktu dan Tempat
Waktu : 3 x pertemuan
Tempat :
G. Sarana
- Gb. Papan struktur organisasi gudep
- Gb. Atribut penggalang
- Contoh – contoh pakaian seragam pramuka pa + pi beserta atribut yang lengkap
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / II
Waktu : 3 x Pertemuan
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
4. Mengimplementasikan kegiatan kepramukaan dalam kehidupan sehari – hari.
C. Sasaran
1. Baris – berbaris
2. Arah mata angin
3. Menggunakan kompas
4. Membuat simpul
5. Menyusuk tali
D. Substansi Kegiatan
Berbaris
Menunjuk sedikitnya 6 arah mata angin, menggunakan kompas, mambaca jam
Membuat dan menggunakan simpul mati, simpul hidup, simpul anyaman, simpul tiang, simpul pangkal, dan menyusuk tali
E. Pelaksanaan Kegiatan
Pertemuan I :
- Diawali denan bernyanyi
- Melakukan baris – berbaris satu persatu
- Melakukan baris – berbaris tiap regu
- Diakhiri dengan permainan
Pertemuan II :
- Diawali denan macam tepuk
- Menggambar arah mata angin
- Menunjukkan arah mata angin
- Menggunakan kompas
- Diakhiri denan bernyanyi bersama
Pertemuan III
- Diawali dengan permainan
- Membuat simpul – simpul
- Menggunakan ssimpul – simpul
- Diakhiri dengan bernyanyi
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
- Kompas
- Gb. Arah mata angin
- Tali
- Buku SKU
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / Ganjil
Waktu : 2 x 35 menit
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
5. Mengimplementasikan kegiatan kepramukaan sehari – hari
C. Sasaran / Indikator
- Anak didik dapat menyimpulkan keterangan untuk memperoleh pertolonan pertama pada kecelakaan ( 14 )
- Anak didik dapat melaporkannya kepada dokter, rumah sakit, pamon praja, polisi atau keluarga korban.
- Untuk anak didik putrid dapat mengatur meja makanan, atau menghidangkan minuman dan makanan kecil pada tamu ( 16 )
- Untuk anak didik putra dapat membuat 2 macam hasta karya dengan macam bahan yang berbeda
D. Substansi Kegiatan
1. Mengumpulkan seluruh peserta didik untuk ikut serta dalam memberikan bantuan saat menolong korban kecelakaan
2. Memberi tahu kepada keluarga korban, polisi atau kerumah sakit terdekat
3. Memberikan pertolongan pertama pada saat kecelakaan misalnya memberi minum air putih pada korban
4. Meletakan korban pada tempat yang aman dan nyaman
E. Pelaksanaan Kegiatan
Langkah – langkah awal :
- Membuat tandu
- Menyediakan alat-alat P3K ( obat-obatan )
- Menyediakan alat komunikasi berupa ponsel / HP
Kegiatan Inti :
- Anak didik memeragakan tentang peristiwa kecelakaan
- Sebagian/salah satu anak didik kita peragakan untuk menjadi korban dan yang lain sebaai penolongnya.
Kegiatan Penutup
- Melakukan upacara penutupan
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
- Tongkat
- Tali parmuka
- Kotak P3K
- Kain kasa
PERENCANAAN KEGIATAN
Nama Sekolah : SMP N 1 GRESIK
Pengembangan Diri : Kepramukaan
Kelas / Semester : 7 / I
Waktu : 2 x 35
A. Standart Kompetensi
Memahami dan melaksanakan syarat-syarat Pengalang Ramu.
B. Kompetensi Dasar
5. Mengimplementasikan kegiatan keagamaan dalam kehidupan sehari – hari
C. Sasaran / Indikator
1. Mengucapkan kalimat syahadat
2. Menucapkan arti kalimat syahadat
3. Menyebutkan rukun iman
4. Menyebutkan rukun islam
5. Melaksanakan sholat
6. menyebutkanrukun sholat
7. Melakukan sholat berjamaah
D. Substansi Kegiatan
Dapat mengucap kalimat syahadat dan tahu artinya.
Mengerti rukun iman dan rukun islam
Melakukan sholat berjamaah
E. Pelaksanaan Kegiatan
Pertemuan I :
1. Berdoa bersama
2. Menucapkan 2 kalimat syahadat ada 2
3. Mengucapkan kalimat syahadat bersama
4. Mengucapkan arti kalimat syahadat
5. Mengucapkan kalimat syahadat satu persatu
6. Diakhiri denan bernyanyi
Pertemuan II :
1. Bernyanyi bersama dengan bertepuk
2. Menyebutkan rukun iman
3. Menyebutkan rukun iman satu persatu
4. Menyebutkan rukun islam
5. Menghafalkan rukun islam
6. Diakhiri dengan bernyanyi bersama dan permainan
Pertemuan III
1. Bernyanyi tentang shalat 5 waktu
2. Melaksanakan sholat
3. Menyebutkan rukun sholat
4. Melakukan shalat berjamaah
5. Diakhiri dengan permainan dan do,a
F. Waktu dan Tempat
Waktu :
Tempat :
G. Sarana
- Buku SKU
- Gb. Tentang tata cara shalat
- Buku tulis
- Mukena
- Air
RELIGI JAWA
RELIGI JAWA
Orang Jawa percaya bahwa Tuhan adalah pusat alam semesta dan pusat segala kehidupan karena sebelum semuanya terjadi di dunia ini Tuhanlah yang pertama kali ada. Tuhan tidak hanya menciptakan alam semesta beserta isinya tetapi juga bertindak sebagai pengatur, karena segala sesuatunya bergerak menurut rencana dan atas ijin serta kehendak-Nya.
Pusat yang dimaksud dalam pengertian ini adalah sumber yang dapat memberikan penghidupan, keseimbangan dan kestabilan, yang dapat juga memberi kehidupan dan penghubung individu dengan dunia atas. Pandangan orang Jawa yang demikian biasa disebut Manunggaling Kawula Lan Gusti,yaitu pandangan yang beranggapan bahwa kewajiban moral manusia adalah mencapai harmoni dengan kekuatan terakhir dan pada kesatuan terakhir, yaitu manusia menyerahkan dirinya selaku kawula terhadap Gustinya.
Puncak gunung dalam kebudayaan Jawa dianggap suatu tempat yang tinggi dan paling dekat dengan dunia diatas, karena pada awalnya dipercayai bahwa roh nenek moyang tinggal di gunung-gunung.
Sebagian besar orang Jawa termasuk dalam golongan yang telah berusaha mencampurkan beberapa konsep dan cara berpikir islam, dengan pandangan asli mengenai alam kodrati (dunia ini) dan alam adikodrati (alam gaib atau supranatural).
Pandangan hidup merupakan suatu abstraksi dari pengalaman hidup. Pandangan hidup adalah sebuah pengaturan mental dari pengalaman hidup yang kemudian dapat mengembangkan suatu sikap terhadap hidup.
Ciri pandangan hidup orang Jawa realitas yang mengarah kepada pembentukan kesatuan Numinus antara alam nyata, masyarakat dan alam adikodrati yang dianggap keramat. Alam adalah ungkapan kekuasaan yang menentukan kehidupan. Orang Jawa percaya bahwa kehidupan mereka telah ada garisnya, mereka hanya menjalankan saja.
Dasar kepercayaan Jawa atau Javanisme adalah keyakinan bahwa segala sesuatu yang ada didunia ini pada hakekatnya adalah satu, atau merupakan kesatuan hidup. Javanisme memandang kehidupan manusia selalu terpaut erat dalam kosmos alam raya. Dengan demikian kehidupan manusia merupakan suatu perjalanan yang penuh dengan pengalaman-pengalaman yang religius.
Alam pikiran orang Jawa merumuskan kehidupan manusia berada dalam dua kosmos (alam) yaitu makrokosmos dan mikrokosmos.
Makrokosmos dalam pikiran orang Jawa adalah sikap dan pandangan hidup terhadap alam semesta, yang mengandung kekuatan-kekuatan supranatural (adikodrati). Tujuan utama dalam hidup adalah mencari serta menciptakan keselarasan atau keseimbangan antara kehidupan makrokosmos dan mikrokosmos.
Dalam makrokosmos pusat alam semesta adalah Tuhan. Alam semesta memiliki hirarki yang ditujukan dengan adanya jenjang alam kehidupan dan adanya tingkatan dunia yang semakin sempurna ( dunia atas - dunia manusia - dunia bawah ). Alam semesta terdiri dari empat arah utama ditambah satu pusat yaitu Tuhan yang mempersatukan dan memberi keseimbangan.
Sikap dan pandangan terhadap dunia nyata ( mikrokosmos ) adalah tercermin pada kehidupan manusia dengan lingkungannya, susunan manusia dalam masyarakat, tata kehidupan manusia sehari-hari dan segala sesuatu yang nampak oleh mata. Dalam menghadapi kehidupan manusia yang baik dan benar didunia ini tergantung pada kekuatan batin dan jiwanya.
Bagi orang Jawa dahulu, pusat dunia ini ada pada pimpinan atau raja dan keraton, Tuhan adalah pusat makrokosmos sedangkan raja dianggap perwujudan wakil Tuhan di dunia, sehingga dalam dirinya terdapat keseimbangan berbagai kekuatan dari dua alam. Jadi raja dipandang sebagai pusat komunitas di dunia seperti halnya raja menjadi mikrokosmos dari wakil Tuhan dengan keraton sebagai tempat kediaman raja. Keraton merupakan pusat keramat kerajaan dan bersemayamnya raja karena rajapun dianggap merupakan sumber kekuatan-kekuatan kosmis yang mengalir ke daerah kedaulatannya dan membawa ketentraman, keadilan dan kesuburan wilayah.
Hal hal diatas merupakan gambaran umum tentang alam pikiran serta sikap dan pandangan hidup yang dimiliki oleh orang Jawa pada jaman kerajaan. Alam pikiran ini telah berakar kuat dan menjadi landasan falsafah dari segala perwujudan yang ada dalam tata kehidupan orang Jawa.
K E J A W E N
Mari kita mengutip satu tembang Jawa
Tak uwisi gunem iki saya akhiri pembicaraan ini
Niyatku mung aweh wikan saya hanya ingin memberi tahu
Kabatinan akeh lire kabatinan banyak macamnya
Lan gawat ka liwat-liwat dan artinya sangat gawat
Mulo dipun prayitno maka itu berhati-hatilah
Ojo keliru pamilihmu Jangan kamu salah pilih
Lamun mardi kebatinan kalau belajar kebatinan
Tembang ini menggambarkan nasihat seorang tua (pinisepuh) kepada mereka yang ingin mempelajari kabatinan cara kejawen. Kiranya perlu dipahami bahwa tujuan hakiki dari kejawen adalah berusaha mendapatkan ilmu sejati untuk mencapai hidup sejati, dan berada dalam keadaan harmonis hubungan antara kawula (manusia) dan Gusti (Pencipta) ( jumbuhing kawula Gusti ) /pendekatan kepada Yang Maha Kuasa secara total.
Keadaan spiritual ini bisa dicapai oleh setiap orang yang percaya kepada Tuhan, yang mempunyai moral yang baik, bersih dan jujur. beberapa laku harus dipraktekkan dengan kesadaran dan ketetapan hati yang mantap. Pencari dan penghayat ilmu sejati diwajibkan untuk melakukan sesuatu yang berguna bagi semua orang serta melalui kebersihan hati dan tindakannya. Cipta, rasa, karsa dan karya harus baik, benar, suci dan ditujukan untuk mamayu hayuning bawono. Ati suci jumbuhing Kawulo Gusti : hati suci itu adalah hubungan yang serasi antara Kawulo dan Gusti, kejawen merupakan aset dari orang Jawa tradisional yang berusaha memahami dan mencari makna dan hakekat hidup yang mengandung nilai-nilai.
Dalam budaya jawa dikenal adanya simbolisme, yaitu suatu faham yang menggunakan lambang atau simbol untuk membimbing pemikiran manusia kearah pemahaman terhadap suatu hal secara lebih dalam. Manusia mempergunakan simbol sebagai media penghantar komunikasi antar sesama dan segala sesuatu yang dilakukan manusia merupakan perlambang dari tindakan atau bahkan karakter dari manusia itu selanjutnya. Ilmu pengetahuan adalah simbol-simbol dari Tuhan, yang diturunkan kepada manusia, dan oleh manusia simbol-simbol itu ditelaah dibuktikan dan kemudian diubah menjadi simbol-simbol yang lebih mudah difahami agar bisa diterima oleh manusia lain yang memiliki daya tangkap yang berberda-beda.
Biasanya sebutan orang Jawa adalah orang yang hidup di wilayah sebelah timur sungai Citanduy dan Cilosari. Bukan berarti wilayah di sebelah barat-nya bukan wilayah pulau Jawa. Masyarakat Jawa adalah masyarakat yang menjunjung tinggi rasa kekeluargaan dan suka bergotong royong dengan semboyannya “saiyeg saekoproyo “ yang berarti sekata satu tujuan.
Kisah suku Jawa diawali dengan kedatangan seorang satriya pinandita yang bernama Aji Saka, sampai kemudian satriya itu menulis sebuah sajak yang kemudian sajak tersebut diakui menjadi huruf jawa dan digunakan sebagai tanda dimulainya penanggalan tarikh Caka.
Kejawen adalah faham orang jawa atau aliran kepercayaan yang muncul dari masuknya berbagai macam agama ke jawa. Kejawen mengakui adanya Tuhan Gusti Allah tetapi juga mengakui mistik yang berkembang dari ajaran tasawuf agama-agama yang ada.
Tindakan tersebut dibagi tiga bagian yaitu tindakan simbolis dalam religi, tindakan simbolis dalam tradisi dan tindakan simbolis dalam seni. Tindakan simbolis dalam religi, adalah contoh kebiasaan orang Jawa yang percaya bahwa Tuhan adalah zat yang tidak mampu dijangkau oleh pikiran manusia, karenanya harus di simbolkan agar dapat di akui keberadaannya misalnya dengan menyebut Tuhan dengan Gusti Ingkang Murbheng Dumadi, Gusti Ingkang Maha Kuaos, dan sebagainya.
Tindakan simbolis dalam tradisi dimisalkan dengan adanya tradisi upacara kematian yaitu medo’akan orang yang meninggal pada tiga hari, tujuh hari, empatpuluh hari, seratus hari, satu tahun, dua tahun, tiga tahun, dan seribu harinya setelah seseorang meninggal (tahlillan). Dan tindakan simbolis dalam seni dicontohkan dengan berbagai macam warna yang terlukis pada wajah wayang kulit; warna ini menggambarkan karakter dari masing-masing tokoh dalam wayang.
Perkembangan budaya jawa yang mulai tergilas oleh perkembangan teknologi yang mempengaruhi pola pikir dan tindakan orang jawa dalam kehidupan. Maka orang mulai berfikir bagaimana bisa membuktikan hal gaib secara empiris tersebut dengan menggunakan berbagai macam metode tanpa mengindahkan unsur kesakralan. Bahkan terkadang kepercayaan itu kehilangan unsur kesakralannya karena dijadikan sebagai obyek exploitasi dan penelitian.
Kebiasaan orang Jawa yang percaya bahwa segala sesuatu adalah simbol dari hakikat kehidupan, seperti syarat sebuah rumah harus memiliki empat buah soko guru (tiang penyangga) yang melambangkan empat unsur alam yaitu tanah, air, api, dan udara, yang ke empatnya dipercaya akan memperkuat rumah baik secara fisik dan mental penghuni rumah tersebut. Namun dengan adanya teknologi konstruksi yang semakin maju, keberadaan soko guru itu tidak lagi menjadi syarat pembangunan rumah. Dengan analisa tersebut dapat diperkirakan bagaimana nantinya faham simbolisme akan bergeser dari budaya jawa. Tapi bahwa simbolisme tidak akan terpengaruh oleh kehidupan manusia tapi kehidupan manusialah yang tergantung pada simbolisme. Dan sampai kapanpun simbolisme akan terus berkembang mengikuti berputarnya sangkakala.
Mangkunegara IV (Sembah dan Budiluhur)
Mangkunegara IV memiliki empat ajaran utama yang meliputi sembah raga, sembah cipta (kalbu), sembah jiwa, dan sembah rasa.
Sembah Raga
Sembah raga ialah menyembah Tuhan dengan mengutamakan gerak laku badaniah atau amal perbuatan yang bersifat lahiriah. Cara bersucinya sama dengan sembahyang biasa, yaitu dengan mempergunakan air (wudhu). Sembah yang demikian biasa dikerjakan lima kali sehari semalam dengan mengindahkan pedoman secara tepat, tekun dan terus menerus, seperti bait berikut:
Sembah raga puniku / pakartining wong amagang laku / sesucine asarana saking warih / kang wus lumrah limang wektu / wantu wataking wawaton
Sembah raga, sebagai bagian pertama dari empat sembah yang merupakan perjalanan hidup yang panjang ditamsilkan sebagai orang yang magang laku (calon pelaku atau penempuh perjalanan hidup kerohanian), orang menjalani tahap awal kehidupan bertapa (sembah raga puniku, pakartining wong amagang laku). Sembah ini didahului dengan bersuci yang menggunakan air (sesucine asarana saking warih). Yang berlaku umum sembah raga ditunaikan sehari semalam lima kali. Atau dengan kata lain bahwa untuk menunaikan sembah ini telah ditetapkan waktu-waktunya lima kali dalam sehari semalam (kang wus lumrah limang wektu). Sembah lima waktu merupakan shalat fardlu yang wajib ditunaikan (setiap muslim) dengan memenuhi segala syarat dan rukunnya (wantu wataking wawaton). Sembah raga yang demikian ini wajib ditunaikan terus-menerus tiada henti (wantu) seumur hidup. Dengan keharusan memenuhi segala ketentuan syarat dan rukun yang wajib dipedomani (wataking wawaton). Watak suatu waton (pedoman) harus dipedomani. Tanpa mempedomani syarat dan rukun, maka sembah itu tidak sah.
Sembah raga tersebut, meskipun lebih menekankan gerak laku badaniah, namun bukan berarti mengabaikan aspek rohaniah, sebab orang yang magang laku selain ia menghadirkan seperangkat fisiknya, ia juga menghadirkan seperangkat aspek spiritualnya sehingga ia meningkat ke tahap kerohanian yang lebih tinggi.
Sembah Cipta ( Kalbu )
Sembah ini kadang-kadang disebut sembah cipta dan kadang-kadang disebut sembah kalbu, seperti terungkap pada Pupuh Gambuh bait 1 dan Pupuh Gambuh bait 11 berikut :
Samengkon sembah kalbu / yen lumintu uga dadi laku / laku agung kang kagungan narapati / patitis teteking kawruh / meruhi marang kang momong.
Apabila cipta mengandung arti gagasan, angan-angan, harapan atau keinginan yang tersimpan di dalam hati, kalbu berarti hati , maka sembah cipta di sini mengandung arti sembah kalbu atau sembah hati, bukan sembah gagasan atau angan-angan.
Apabila sembah raga menekankan penggunaan air untuk membasuh segala kotoran dan najis lahiriah, maka sembah kalbu menekankan pengekangan hawa nafsu yang dapat mengakibatkan terjadinya berbagai pelanggaran dan dosa (sucine tanpa banyu, amung nyunyuda hardaning kalbu).
Thaharah (bersuci) itu, demikian kata Al-Ghazali, ada empat tingkat.
Pertama, membersihkan hadats dan najis yang bersifat lahiriah.
Kedua, membersihkan anggota badan dari berbagai pelanggaran dan dosa.
Ketiga, membersihkan hati dari akhlak yang tercela dan budi pekerti yang hina.
Keempat, membersihkan hati nurani dari apa yang selain Allah. Dan yang keempat inilah taharah pada Nabi dan Shiddiqin.
Jika thaharah yang pertama dan kedua menurut Al-Ghazali masih menekankan bentuk lahiriah berupa hadats dan najis yang melekat di badan yang berupa pelanggaran dan dosa yang dilakukan oleh anggota tubuh. Cara membersihkannya dibasuh dengan air. Sedangkan kotoran yang kedua dibersihkan dan dibasuh tanpa air yaitu dengan menahan dan menjauhkan diri dari pelanggaran dan dosa. Thaharah yang ketiga dan keempat juga tanpa menggunakan air. Tetapi dengan membersihkan hati dari budi jahat dan mengosongkan hati dari apa saja yang selain Allah.
Sembah Jiwa
Sembah jiwa adalah sembah kepada Hyang Sukma ( Allah ) dengan mengutamakan peran jiwa. Jika sembah cipta (kalbu) mengutamakan peran kalbu, maka sembah jiwa lebih halus dan mendalam dengan menggunakan jiwa atau al-ruh. Sembah ini hendaknya diresapi secara menyeluruh tanpa henti setiap hari dan dilaksanakan dengan tekun secara terus-menerus, seperti terlihat pada bait berikut:
Samengko kang tinutur / Sembah katri kang sayekti katur / Mring Hyang Sukma suksmanen saari-ari / Arahen dipun kecakup / Sembahing jiwa sutengong
Dalam rangkaian ajaran sembah Mangkunegara IV yang telah disebut terdahulu, sembah jiwa ini menempati kedudukan yang sangat penting. Ia disebut pepuntoning laku (pokok tujuan atau akhir perjalanan suluk). Inilah akhir perjalanan hidup batiniah. Cara bersucinya tidak seperti pada sembah raga dengn air wudlu atau mandi, tidak pula seperti pada sembah kalbu dengan menundukkan hawa nafsu, tetapi dengan awas emut (selalu waspada dan ingat/dzikir kepada keadaan alam baka/langgeng), alam Ilahi.
Betapa penting dan mendalamnya sembah jiwa ini, tampak dengan jelas pada bait berikut :
Sayekti luwih perlu / ingaranan pepuntoning laku / Kalakuan kang tumrap bangsaning batin / Sucine lan awas emut / Mring alaming lama amota.
Berbeda dengan sembah raga dan sembah kalbu, ditinjau dari segi perjalanan suluk, sembah ini adalah tingkat permulaan (wong amagang laku) dan sembah yang kedua adalah tingkat lanjutan. Ditinjau dari segi tata cara pelaksanaannya, sembah yang pertama menekankan kesucian jasmaniah dengan menggunakan air dan sembah yang kedua menekankan kesucian kalbu dari pengaruh jahat hawa nafsu lalu membuangnya dan menukarnya dengan sifat utama. Sedangkan sembah ketiga menekankan pengisian seluruh aspek jiwa dengan dzikir kepada Allah seraya mengosongkannya dari apa saja yang selain Allah.
Pelaksanaan sembah jiwa ialah dengan berniat teguh di dalam hati untuk mengemaskan segenap aspek jiwa, lalu diikatnya kuat-kuat untuk diarahkan kepada tujuan yang hendak dicapai tanpa melepaskan apa yang telah dipegang pada saat itu. Dengan demikian triloka (alam semesta) tergulung menjadi satu. Begitu pula jagad besar dan jagad kecil digulungkan disatupadukan. Di situlah terlihat alam yang bersinar gemerlapan. Maka untuk menghadapi keadaan yang menggumkan itu, hendaklah perasaan hati dipertebal dan diperteguh jangan terpengaruh apa yang terjadi. Hal yang demikian itu dijelaskan Mangkunegara IV pada bait berikut:
"Ruktine ngangkah ngukud / ngiket ngruket triloka kakukud / jagad agung ginulung lan jagad alit / den kandel kumandel kulup / mring kelaping alam kono."
Sembah Rasa
Sembah rasa ini berlainan dengan sembah-sembah yang sebelumnya. Ia didasarkan kepada rasa cemas. Sembah yang keempat ini ialah sembah yang dihayati dengan merasakan intisari kehidupan makhluk semesta alam, demikian menurut Mangkunegara IV.
Jika sembah kalbu mengandung arti menyembah Tuhan dengan alat batin kalbu atau hati seperti disebutkan sebelumnya, sembah jiwa berarti menyembah Tuhan dengan alat batin jiwa atau ruh, maka sembah rasa berarti menyembah Tuhan dengan menggunakan alat batin inti ruh. Alat batin yang belakangan ini adalah alat batin yang paling dalam dan paling halus yang menurut Mangkunegara IV disebut telenging kalbu (lubuk hati yang paling dalam) atau disebut wosing jiwangga (inti ruh yang paling halus).
Dengan demikian menurut Mangkunegara IV, dalam diri manusia terdapat tiga buah alat batin yaitu, kalbu, jiwa/ruh dan inti jiwa/inti ruh (telengking kalbu atau wosing jiwangga) yang memperlihatkan susunan urutan kedalaman dan kehalusannya.
Pelaksanaan sembah rasa itu tidak lagi memerlukan petunjuk dan bimbingan guru seperti ketiga sembah sebelumnya, tetapi harus dilakukan salik sendiri dengan kekuatan batinnya, seperti diungkapkan Mangkunegara IV dalam bait berikut:
Semongko ingsun tutur / gantya sembah lingkang kaping catur / sembah rasa karasa wosing dumadi / dadi wus tanpa tuduh / mung kalawan kasing batos.
Apabila sembah jiwa dipandang sebagai sembah pada proses pencapaian tujuan akhir perjalanan suluk (pepuntoning laku), maka sembah rasa adalah sembah yang dilakukan bukan dalam perjalanan suluk itu, melainkan sembah yang dilakukan di tempat tujuan akhir suluk. Dengan kata lain, seorang salik telah tiba di tempat yang dituju. Dan di sinilah akhir perjalanan suluknya. Untuk sampai di sini, seorang salik masih tetap dibimbing gurunya seperti telah disebut di muka. Setelah ia diantarkan sampai selamat oleh gurunya untuk memasuki pintu gerbang, tempat sembah yang keempat, maka selanjutnya ia harus mandiri melakukan sembah rasa.
Pada tingkatan ini, seorang salik dapat melaksanakan sendiri sembah rasa sesuai petunjuk-petunjuk gurunya. Pada tingkat ini ia dipandang telah memiliki kematangan rohani. Oleh karena itu, ia dipandang telah cukup ahli dalam melakukan sembah dengan mempergunakan aspek-aspek batiniahnya sendiri.
Di sini, dituntut kemandirian, keberanian dan keteguhan hati seorang salik, tanpa menyandarkan kepada orang lain. Kejernihan batinlah yang menjadi modal utama. Hal ini sesuai dengan wejangan Amongraga kepada Tambangraras dalam Centini bait 156. Sembah tersebut, demikian dinyatakan Amongraga, sungguh sangat mendalam, tidak dapat diselami dengan kata-kata, tidak dapat pula dimintakan bimbingan guru. Oleh karena itu, seorang salik harus merampungkannya sendiri dengan segala ketenangan, kejernihan batin dan kecintaan yang mendalam untuk melebur diri di muara samudera luas tanpa tepi dan berjalan menuju kesempurnaan. Kesemuanya itu tergantung pada diri sendiri, seperti terlihat pada bait berikut:
Iku luwih banget gawat neki / ing rar=’]asantang keneng rinasa / tan kena ginurokake / yeku yayi dan rampung / eneng onengira kang ening / sungapan ing lautan / tanpa tepinipun / pelayaran ing kesidan / aneng sira dewe tan Iyan iku yayi eneng ening wardaya.
Content and Format of an Investigational New Drug (IND) Application
Content and Format of an Investigational New Drug (IND) Application
I. Background Information
A. Phases of a Clinical Investigation
1. Phase 1.
2. Phase 2.
3. Phase 3.
B. General Principles of the IND Submission
C. Reference to IND or Marketing Information Previously Submitted
D. FDA Administrative Actions
1. Effective date of FDA acceptance of an IND application.
2. Clinical holds and requests for modifications.
3. FDA termination of an IND.
4. Inactive status.
II. Initial IND Application: Content and Format
A. Form FDA 1571
B. Table of Contents
C. Introductory Statement and General Investigational Plan
D. Investigator’s Brochure
1. Investigator-sponsored IND.
2. University-sponsored IND.
E. Clinical Protocol(s)
1. General principles.
2. Protocol content and format.
F. Chemistry, Manufacturing and Control (CMC) Information
1. General principles.
2. CMC content and format.
3. cGMP compliance.
G. Labeling
1. IND submission requirements.
2. Investigational drug labeling requirements.
H. Pharmacology and Toxicology Information
1. General principles.
2. Content and format.
I. Previous Human Experience with the Investigational Drug
J. Additional Information
1. Drug dependence and abuse potential.
2. Radioactive drugs.
3. Pediatric studies.
4. Other information.
K. FDA-Requested Relevant Information
I. Background Information
A. Phases of a Clinical Investigation
An IND application is submitted for a specific drug substance and may incorporate multiple clinical protocols corresponding the various phases of the evaluation of its safety and effectiveness. The clinical investigation of a previously untested drug is typically divided into three phases. Although in general the phases are conducted sequentially, they may overlap. The three phases of a clinical investigation are as follows:
1. Phase 1.
Phase 1 includes the initial introduction of the investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in normal volunteer subjects or patients. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the investigational drug, but is generally in the range of 20-80.
Phase 1 studies also include studies of structure-activity relationships and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.
2. Phase 2.
Phase 2 includes the controlled clinical studies conducted to determine the common short-term side effects and risks associated with the administration of the investigational drug to patients with the disease or condition for which the drug is intended and to evaluate the effectiveness of the investigational drug when administered to such patients. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients; usually no more than several hundred subjects.
3. Phase 3.
Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the investigational drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-to-risk relationship of the drug and to provide an adequate basis for product labeling. Phase 3 studies usually include from several hundred to several thousand subjects.
B. General Principles of the IND Submission
FDA’s primary objectives in reviewing an IND are, in all phases of the clinical investigation, to assure the safety and rights of subjects; and, in Phase 2 and 3 investigations, to help assure that the quality of the respective scientific evaluation is adequate to permit an evaluation of the drug’s effectiveness and safety. Therefore, the FDA’s review of Phase 1 submissions will focus on assessing the safety of the respective investigation(s); whereas the FDA’s review of Phase 2 and 3 submissions will also include an assessment of the scientific quality of the respective investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for granting marketing approval.
The amount of information on a particular investigational drug that must be submitted in an IND application to assure the accomplishment of the above objectives depends upon such factors as the novelty of the drug, the extent to which it has been studied previously, the known or suspected risks, and the developmental phase of the drug.
The central focus of the initial IND submission should be on the general investigational plan and the protocols for specific human studies. Subsequent amendments to the IND that contain new or revised protocols should build logically on previous submissions/protocols and should be supported by additional information, including the results of animal toxicology studies or other human studies as appropriate. Annual reports to the IND should serve as the focus for reporting the status of the clinical investigations being conducted under the IND and should update the general investigational plan for the coming year.
C. Reference to IND or Marketing Information Previously Submitted
The sponsor of an IND application is not ordinarily required to resubmit information that was previously submitted to the FDA, but may incorporate the information by reference. A reference to information submitted previously must identify the file by name, reference number, volume, and page number where the information can be found. A reference to information submitted to the agency by a person other than the sponsor is required to contain a written statement that authorizes the reference and that is signed by the person who submitted the information.
D. FDA Administrative Actions
1. Effective date of FDA acceptance of an IND application. An IND goes into effect (a) thirty (30) days after the FDA receives the IND, unless the FDA notifies the sponsor that the clinical investigations described in the IND are subject to a “clinical hold”; or (b) upon earlier notification by FDA that the clinical investigation described in the IND may begin.
• FDA will notify the sponsor in writing of the date it receives the IND.
• An investigator may not administer an investigational drug to human subjects until the IND goes into effect.
2. Clinical holds and requests for modifications.
A “clinical hold” is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the clinical investigations covered under the IND.
• When a proposed study is placed on clinical hold, subjects may not be given the investigational drug.
• When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study or given the investigational drug; subjects already participating in the study should be taken off the investigational drug unless specifically permitted by the FDA to continue to receive the drug in the interest of the subjects’ safety.
• Discussion of deficiencies: Whenever the FDA concludes that deficiencies exist in a clinical investigation that may be grounds for the imposition of a clinical hold, the FDA will (unless subjects are exposed to immediate and serious risk) attempt to discuss and satisfactorily resolve the deficiencies with the sponsor before issuing the clinical hold order.
• FDA’s imposition of a clinical hold: The clinical hold order may be made by telephone or other means of rapid communication or in writing.
o The clinical hold order will identify the clinical investigation(s) under the IND to which the hold applies, and will briefly explain the basis for the action.
o Within 30 days after imposition of the clinical hold, the director of the FDA’s division with responsibility for review of the IND will provide the sponsor with a written explanation of the basis for the hold.
• Resumption of studies placed on clinical hold: A study placed on clinical hold by the FDA may not resume until such time that the sponsor has been notified by the FDA that the clinical hold has been lifted.
o Resumption of the affected clinical study (studies) will be authorized by the FDA when the sponsor corrects the deficiencies previously cited or otherwise satisfies the FDA that the study (studies) can safely proceed.
o If the sponsor of the IND that has been placed on clinical hold requests in writing that the hold be lifted and submits a complete response to the deficiencies identified in the clinical hold order, FDA shall respond in writing to the sponsor within 30 calender days of its receipt of the request and complete response.
FDA’s response will either lift or maintain the clinical hold, and will state the reasons for such determination.
Notwithstanding the 30 calendar day response time, a sponsor may not proceed with a study on which a clinical hold has been imposed until the sponsor has been notified specifically by the FDA that the hold has been lifted.
• Conversion of an IND on clinical hold to inactive status: If all clinical studies covered by an IND remain on clinical hold for 1 year or more, the IND may be placed on inactive status by the FDA.
3. FDA termination of an IND.
FDA may terminate an IND based on deficiencies in the IND or in the conduct of an investigation under the IND.
• If an IND is terminated by the FDA, the sponsor shall end all clinical studies being conducted under the IND and shall recall or otherwise provide for the disposition of all unused supplies of the investigational drug.
• Discussion of deficiencies: Unless the FDA concludes that continuation of clinical studies under the IND presents an immediate and substantial danger to the health of human subjects, a termination order shall be preceded by a proposal to terminate and an opportunity for the sponsor to respond. FDA will, in general, only initiate a termination action after first attempting to resolve the respective issues informally or, when appropriate, through the clinical hold process.
• FDA’s imposition of a termination order: If the FDA proposes to terminate an IND, it will notify the sponsor in writing and invite correction or explanation within a period of 30 calendar days.
o On such notification, the sponsor may provide a written explanation or correction or may request a conference with the FDA to provide the requested explanation or correction.
If the sponsor does not respond to such notification within the 30 calendar day period, the IND shall be terminated by the FDA.
If the sponsor responds to such notification, but the FDA does not accept the explanation or correction submitted, FDA shall inform the sponsor in writing of the reason for non-acceptance and provide the sponsor with an opportunity for a regulatory hearing before the FDA. The sponsor’s request for a regulatory hearing before the FDA must be made within 10 days of the sponsor’s receipt of the FDA’s notification of non-acceptance; otherwise the IND will be terminated by the FDA.
o Immediate termination of an IND: If at any time the FDA concludes that the initiation or continuation of clinical studies under the IND presents an immediate and substantial danger to the health of human subjects, FDA shall immediately, by written notice to the sponsor, terminate the IND.
An IND immediately terminated by the FDA due to a dangerous health consideration is subject to reinstatement only by the director of the FDA’s Division with responsibility for review of the IND; i.e., based on additional submissions to the IND that eliminate such danger.
If an IND is immediately terminated by the FDA due to a dangerous health consideration, FDA will afford the sponsor an opportunity for a regulatory hearing before the FDA.
4. Inactive status.
• An IND may be placed on inactive status by either the FDA or the sponsor if (1) no subjects are entered into clinical studies conducted under the IND for a period or 2 years or more; or (2) the IND remains on clinical hold for 1 year or more.
o If the FDA acts on its own to place an IND on inactive status, FDA shall first notify the sponsor in writing of this proposed action.
Upon receipt of such notification, the sponsor shall have 30 calendar days to respond to the FDA as to why the IND should continue to remain active.
• If an IND is placed on inactive status, all investigators shall be so notified and all stocks of the investigational drug shall be returned to the sponsor or otherwise disposed of at the request of the sponsor. (See Sponsor Responsibilities)
• Annual reports: A sponsor is not required to submit annual reports to an IND on inactive status.
• Resumption of an IND placed on inactive status: A sponsor who intends to resume clinical studies under an IND placed on inactive status shall submit a Protocol Amendment containing the proposed general investigational plan for the coming year and the respective, appropriate clinical protocol(s).
o If the Protocol Amendment relies on information previously submitted under the IND, the investigational plan for the coming year shall reference such information.
o Additional information supporting the proposed investigational plan shall be submitted in an Informational Amendment.
o Clinical studies under an IND on inactive status may only resume (1) 30 days after FDA receives the Protocol Amendment, unless the FDA notifies the sponsor that the clinical studies described in the amendment are subject to a “clinical hold”; or (2) on earlier notification by the FDA that the clinical studies described in the Protocol Amendment may begin.
• FDA termination of an IND on inactive status: An IND that remains on inactive status for 5 years or more may be terminated by the FDA.
III. Initial IND Application: Content and Format
The content and format of the IND application set forth below has been adopted from applicable FDA regulations and guidance documents and should be followed by the sponsor in the interest of fostering an efficient FDA review of the submission. It is recognized that certain redundancy exists with regard to this content and format; however such is necessary to permit adequate review of the application by multiple disciplines within the FDA (e.g., pharmacology/toxicology, clinical, chemistry, microbiology). Sponsors are expected to exercise considerable discretion, however, regarding the content of information submitted in each section; depending on the kind of drug being studied and the nature of the available information. The IND content and format requirements set forth below outline the information needed for an sponsor-investigator IND for a new molecular entity. A sponsor-investigator who desires to use, as a research tool, or evaluate an investigational new drug that is already the subject of an industry-sponsored IND or a drug that is currently approved for marketing should follow the same general format, but ordinarily may, if authorized in writing by the drug’s sponsor/manufacturer, refer to the sponsor’s IND or marketing application in providing certain technical information supporting the sponsor’s proposed clinical investigation. A sponsor-investigator who desires to use, as a research tool, or evaluate an investigational drug that is not already the subject of an industry-sponsored IND or currently approved for marketing is ordinarily required to submit all technical information supporting the IND; unless such information may be referenced from the scientific literature.
An IND application for initial submission to the FDA shall include, in the following order:
A. A completed FORM FDA 1571.
B. Table of Contents
C. Introductory Statement and General Investigational Plan
To include:
1. A brief introductory statement giving the name of the drug and all active ingredients; the drug’s pharmacological class; the structural formula of the drug (if known); the formulation of the dosage form(s) to be used; the route of administration; and the broad objectives and planned duration of the proposed clinical investigation(s).
2. A brief summary (if applicable) of previous human experience with the drug, with reference to other IND’s if pertinent, and to investigational or marketing experience in other countries that may be relevant to the safety of the proposed clinical investigations(s).
3. If the drug has been withdrawn from investigation or marketing in any country for any reason related to safety or effectiveness, identification of the respective country (countries) and the reasons for withdrawal.
4. A brief description of the overall plan for investigating the drug product for the following year. The plan should include the following:
• the rationale for the drug or the research study;
• the indication(s) to be studied;
• the general approach to be followed in evaluating the drug;
• the kinds of clinical trials to be conducted in the first year following the submission (if plans are not developed for the entire year; the sponsor should so indicate);
• the estimated number of research subjects to be given the drug in those clinical trials; and
• any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.
D. Investigator’s Brochure
An Investigator’s Brochure is not, in general, required for sponsor-investigator IND applications. However, if the University’s IND/IDE Committee has granted approval for the conduct of a multi-center (external site) clinical investigation under a University-based, sponsor-investigator IND application, an Investigator’s Brochure should be developed for dissemination to each of the involved study sites and should address the following information:
• A brief description of the active drug substance and the drug product formulation, including the structural formula of the active drug substance, if known.
• A summary of the pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.
• A summary of the pharmacokinetics and biological distribution of the drug in animals and, if known, in humans.
• A summary of information relating to the safety and effectiveness of the drug in humans obtained from prior clinical studies. (Reprints of published articles describing such studies may be appended to the Brochure if they are anticipated to be useful.)
• A description of possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or related drugs, and of precautions or special monitoring to be done as part of the investigational use of the drug.
E. Clinical Protocol(s)
There should be a separate clinical protocol for each planned clinical study of the investigational drug product. (Protocols for clinical studies of the investigational drug product not incorporated into the initial submission of the IND application should be submitted as a Protocol Amendment [see IND Amendments: Requirements and Procedures].)
1. General principles.
• Phase 1 clinical studies: In general, protocols for Phase 1 studies may be less detailed and more flexible than protocols for Phase 2 and 3 studies. Phase 1 protocols should be directed primarily at providing an outline of the clinical study (e.g., an estimate of the number of patients to be involved; a description of the safety exclusions; and a description of the dosing plan including duration, dose, or method to be used in determining the dose) and should specify in detail only those elements of the study that are critical to safety; such as necessary monitoring of vital signs and blood chemistries.
• Phase 2 and 3 clinical studies: For Phase 2 and 3 studies, detailed protocols describing all aspects of the study should be submitted.
o A protocol for a Phase 2 or 3 clinical study should be designed in such a way that, if the sponsor anticipates that some deviation from the study design may become necessary as the investigation progresses, alternatives or contingencies are built into the protocol at the outset. (E.g., a protocol for a controlled short-term study might include a plan for an early crossover of non-responders to alternative therapy.)
2. Protocol content and format.
A protocol is required to contain the following sections; with the specific elements and detail of the protocol sections reflecting the above distinctions depending on the phase of study:
• A statement of the objectives and purpose of the study.
• The name and address and a statement of the qualifications (curriculum vitae or other statement of qualifications) of each investigator; the name of each sub-investigator (e.g., health care professional or staff member, research fellow; research coordinator) working under the supervision of the investigator; the name and address of the research facilities to be used; and the name and address of each reviewing institutional review board.
• The criteria for research subject selection and for exclusion of potential research subjects, and an estimate of the number of research subjects to be studied.
• A description of the design of the study, including the kind of control group to be used, if any, and a description of the methods to be used to minimize bias on the part of the research subjects, investigators, and data analysts.
• The method for determining the dose(s) to be administered, the planned maximum dosage, and the duration of individual human subject exposure to the drug.
• A description of the observations and measurements to be made to fulfill the objectives of the protocol.
• A description of the clinical procedures, laboratory tests, or other measures to be taken to monitor the effects of the drug in human subjects and to minimize risk.
See also Good Clinical Practice (GCP) Guidelines – Clinical Study Protocol and Protocol Amendments
F. Chemistry, Manufacturing, and Control (CMC) Information
The CMC section of the IND application should include (i.e., as appropriate for the particular clinical study (studies) covered by the IND) information describing the composition, manufacture, and control of the investigational drug substance and the investigational drug product.
1. General principles.
• Although in each phase of the clinical investigation of an investigational drug sufficient information is required to be submitted to assure the proper identity, quality, purity, and strength of the drug; the amount of information needed to make that assurance will vary with the phase of the investigation, the proposed duration of the investigation, the dosage form, and the amount of information otherwise available.
• FDA recognizes that modifications to the method of preparation of the investigational drug substance and dosage form (i.e., the investigational drug product) and changes in the dosage form itself are likely to occur as the investigation progresses. Therefore, the emphasis in a Phase 1 submission should generally be placed on the identification and control of the raw materials and the new drug substance. Final specifications for the drug substance and drug product are not expected until the end of the investigational process.
• Note that the amount of information to be submitted depends also on the scope of the proposed clinical investigation. (E.g., although stability data are required in all phases of the IND to demonstrate that the new drug substance and drug product are within acceptable chemical and physical limits for the planned duration of the proposed clinical study; if very short-term studies are proposed, the supporting stability data can be correspondingly limited.)
• As drug development proceeds and as the scale or production is changed from the pilot-scale production appropriate for the limited, initial (e.g., Phase 1 and 2) clinical studies to the larger-scale production needed for expanded (i.e., Phase 3) clinical trials, the sponsor should submit Information Amendments (see IND Amendments: Requirements and Procedures) to supplement the initial information submitted on the chemistry, manufacturing, and control processes with information appropriate to the expanded scope of the investigation.
2. CMC content and format.
Reflecting the distinctions described above, and based on the phase(s) of the clinical study (studies) incorporated in the IND application, the CMC section of the application is required to address the following:
• Drug substance: A description of the active drug substance, including its physical, chemical, or biological characteristics; the name and address of the manufacturer; the general method of preparation of the drug substance; the acceptable limits and analytical methods used to assure the identity, strength, quality and purity of the drug substance; and information sufficient to support stability of the drug substance during the planned clinical studies.
o Note that reference to the current edition of the United States Pharmacopeia-National Formulary (USP-NF), if applicable, may satisfy relevant requirements.
• Drug product: A list of all components, which may include reasonable alternatives for inactive compounds, used in the manufacture of the investigational drug product, including both those components intended to appear in the drug product and those which may not appear but which are used in the manufacturing process; where applicable, the quantitative composition of investigational drug product, including any reasonable variations that may be expected during the investigational stage; the name and address of the drug product manufacturer; a brief general description of the manufacturing and packaging procedure as appropriate for the drug product; the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug product; and information sufficient to assure the drug product’s stability during the planned clinical studies.
o Note that reference to the current edition of the United States Pharmacopeia-National Formulary (USP-NF) may satisfy relevant requirements.
• Placebo: A brief general description of the composition, manufacture, and control of any placebo used in the proposed clinical study (studies).
3. cGMP compliance.
Note that strict compliance with the FDA’s current Good Manufacturing Practice (cGMP) regulations at 21 CFR Section 211 is not required for investigational drug products being used or evaluated in Phase 1 clinical studies. Rather, for Phase 1 clinical studies, the FDA will hold the sponsor of the IND application accountable for manufacturing and testing the investigational drug in accordance with the respective procedures submitted in the IND application. The manufacture of investigational drug products for use in Phase 2 and 3 clinical studies is, however, subject to full compliance with the FDA’s cGMP regulations at 21 CFR Part 211. A statement addressing whether or not the investigational drug product is being manufactured in compliance with the FDA’s cGMP regulations should be included in the CMC section of the IND application.
G. Labeling
1. IND submission requirements.
The IND application shall include a copy of all labels that will be assigned to the investigational drug product and, if applicable, all labeling to be provided to each investigator.
2. Investigational drug labeling requirements.
• The immediate package of an investigational new drug intended for human use shall be labeled with the statement “Caution: New Drug – Limited by Federal (or United States) law to investigational use.”
• The label or labeling of an investigational new drug shall not bear any statement that is false or misleading and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.
H. Pharmacology and Toxicology Information
This section of the IND application should include adequate information about non-clinical (i.e., performed in laboratory animals or in vitro) pharmacological and toxicological studies of the investigational drug; on the basis of which the sponsor has concluded that it is reasonably safe to conduct the proposed clinical study (studies) of the investigational drug product.
1. General principles.
• The kind, duration, and scope of animal and other tests required to adequately support an IND application will vary with the duration and nature of the proposed clinical studies(s). (Guidance documents are available from the FDA [see FDA Guidance Documents for Regulated Industry] that describe the ways in which these requirements may be met for various drug products.)
o As drug development proceeds, the sponsor is required to submit Informational Amendments (see IND Amendments: Requirements and Procedures), as appropriate, with additional non-clinical information pertinent to the safety of the investigational drug product.
2. Content and format.
• Qualifications of data reviewer(s): Include the identification and qualifications of the individual(s) who evaluated the results of the animal or in-vitro pharmacology/toxicology studies and concluded that it is reasonably safe to begin the proposed clinical investigation(s) of the investigational drug; and a statement of where the respective records are available for inspection.
• Pharmacology and drug disposition: Include a section describing the pharmacological effects and mechanism(s) of action of the investigational drug in animals, and information on the absorption, distribution, metabolism, and excretion of the drug, if known.
• Toxicology:
o Provide an integrated summary of the toxicological effects of the investigational drug as observed in the animal studies and in vitro. Depending on the nature of the drug and the phase of the investigation, the summary is to include the results of acute, subacute, and chronic toxicity tests; tests of the drug’s effects on reproduction and the developing fetus; any special toxicity test related to the drug’s particular mode of administration or conditions of use (e.g., inhalation, dermal, or ocular toxicology); and any in vitro studies intended to evaluate drug toxicity.
o For each non-clinical toxicology study that is intended primarily to support the safety of the proposed clinical investigation, provide a full tabulation of the respective data suitable for a detailed review.
o For each non-clinical laboratory study subject to compliance with the FDA’s Good Laboratory Practice (GLP) regulations (21 CFR Part 58) , provide a statement indicating that the study was conducted in compliance with these regulations. Alternately, specify that the non-clinical study was not conducted in compliance with the FDA’s GLP regulations and describe, in detail, all differences between the practices actually used and those required in the GLP regulations.
I. Previous Human Experience with the Investigational Drug
Include a summary of previous human experience with the investigational drug, if any, known to the sponsor. This summary is required to include the following information:
1. If the investigational drug has been investigated in humans or marketed previously, either in the United States or other countries, provide detailed information about such experience that is relevant to the safety of the proposed clinical investigation(s) or the investigation’s rationale. If the drug has been the subject of controlled clinical trials, detailed information on such trials that is relevant to an assessment of the drug’s effectiveness for the proposed investigational use(s) should also be provided. Any published material that is relevant to the safety of the proposed clinical investigation or to an assessment of the drug’s effectiveness for its proposed investigational use should be provided in full. Published material that is less directly relevant may be supplied by a bibliography.
2. If the investigational drug product is a combination of drugs previously investigated or marketed, the information required under this section should be provided for each active drug component. However, if any component in such combination is subject to an approved marketing application or is otherwise lawfully marketed in the United States, the sponsor is not required to submit published material concerning that active drug component unless such material relates directly to the proposed investigational use (including publications relevant to component-component interactions).
3. If the drug has been marketed outside the United States, incorporate a listing of the countries in which the drug has been marketed and, if applicable, identify any of these countries in which the drug has been withdrawn from marketing for reasons potentially related to safety or effectiveness.
J. Additional Information
For certain IND applications, information related to special topics, as described below, may be required. Such information, if applicable, should be incorporated under this section of the IND.
1. Drug dependence and abuse potential. If the investigational drug is a psychotropic substance or otherwise has abuse potential, describe relevant clinical studies and experience and/or relevant studies in test animals.
2. Radioactive drugs. If the investigational drug is a radioactive drug, provide sufficient data from animal or human studies to allow a reasonable calculation of radiation-absorbed dose estimates to the whole body and critical organs of human subjects. Phase 1 studies of radioactive drugs must include a clinical investigation directed at obtaining sufficient human data for direct human radiation dosimetry calculations.
3. Pediatric studies. Incorporate, if applicable, plans for assessing pediatric safety and effectiveness of the investigational drug.
4. Other information. Include, if applicable, a brief statement addressing any other information that would assist an evaluation of the proposed clinical investigations of the investigational drug with respect to their safety, or their design and respective potential as controlled clinical trials to support marketing of the drug.
K. FDA-Requested Relevant Information
If requested by the FDA (e.g., FDA comments associated with a Pre-IND meeting/assessment), include any other relevant information needed for review of the IND application.
Organizing Your Website:
Organizing Your Website:
Taking Stock of Content
The content inventory and planning process
A content inventory and analysis is an excellent way to determine what content exists on your current website, what needs to be updated, what can be removed, and what new content you need to create to meet your communications goals. After completing an inventory and analysis, it will be easier to build your new site, knowing what is needed and what is not.
While the tools and methods you use are up to you, it is often beneficial to follow the process outlined above when working with content. This is true for any website, but especially when adopting the common website structure from Harvard Web Publishing, since you will likely need to spend time organizing your content. Below are some tools and methods you may find helpful.
Step 1: Build the inventory
Begin by generating a list of all of the webpages and documents on your current website. A helpful tool to automate this process is xml-sitemaps.com. You can build the inventory by hand (you may need to in some cases described below), but this tool can save time.
1. Go to xml-sitemaps.com.
2. Enter your website URL, click “start,” and XML Sitemap will generate a list of the pages on your site for free.
3. Scroll to “download sitemap in text format” to download the list as a text (.txt) file.
4. Download the Excel content inventory template from HWP’s website.
5. Open the .txt file and copy the URLs into the content inventory template, to the “content inventory-current site” tab.
6. If your site is large, or if it is not easy to tell what the page is from the URL, you can add in the page title, and the current website section to help with navigating the spreadsheet. If a piece of content is not a webpage (such as a PDF) you can make note of this in the “format” column.
Please note: XML Sitemap will only crawl the first 500 pages of a website. Pages after 500 will not be captured. XML sitemap cannot crawl iSites. For iSites, or other sites that do not allow web crawlers, you may have to look at the folder structure of the website or click through all of the pages to manually create an inventory of the site. Harvard Web Publishing can provide assistance with the creation of a content inventory as part of Premium level service.
Step 2: Evaluate existing content
Review each page, PDF and other assets listed on the inventory. For each line in the spreadsheet, indicate the following:
1. OUCH status
O = Out-of-date. Content that is still useful and will move to the new site, but should be updated.
U = Unnecessary. Content that is not needed at all. It should not be moved to the new site.
C = Current. Content that is fine as is, up-to-date, and just needs to be moved to the new site.
H = Have to write. H will not be used on your first pass of the content inventory, so nothing on the inventory of the current site should be marked H. H will be used for the gap analysis part of the exercise below.
2. Owner: Who in your organization is responsible for writing and updating this content? This information will be helpful when you start updating content.
3. Other fields: Use the notes field to elaborate on the status of the content as needed. There is a priority field if you would like to determine what content is most important to your organization, and an audience field if your site serves multiple audiences, if you find this information helpful for your site. All of the above columns are just suggested methods – use whatever method works best for your department when evaluating your content.
Step 3: Identify gaps in content
Next, identify what content you would like to add to the new site, and begin the content plan – a roadmap for your new site.
1. Sort your content by OUCH status.
2. Copy the O and C content over to the tab titled “content plan.” The U content should be left behind since it is content you have marked for exclusion from the new site.
3. In the “content plan – new site” tab, add lines for content you would like to add to the site. Think about what kind of content you will need to add to serve your audiences and achieve your communications goals.
4. Assign all of the new content an H status, as well as an owner, and any other information you included for your current content (e.g. priority, audience).
Step 4: Map content into the new site structure
Harvard Web Publishing provides standard information architecture (IA) frameworks for academic, administrative, project, and lab/research websites. These frameworks provide common sections to help site visitors find what they need, such as Academics, Services, About, and People.
1. Refer to the Organize Your Website section on the HWP site to find a guide to using the IA for your particular site (academic, administrative, project, or lab/research).
2. Using the categories provided on the IA, start assigning new content to the appropriate section using the “new section name” column. The corresponding sections for an Academic site, for example, would be Academics, Research, People, and so on. This is where the content will reside in the new site.
3. You can also indicate the subsection at this point, or later on. To determine how to best organize the pages within a section, review HWP’s “Section Navigation Best Practice,” in the Organizing Your Website PDF.
Step 5: Gather and Manage Content
1. Connect with the owners of the website content to start collecting the content you need to have updated or written, ideally providing deadlines.
2. The content plan spreadsheet can then become a helpful way of tracking content as you add it to the new site, whether you are simply moving over content, or writing something new. You can use the “status” column in the content plan to keep track of the process in a way that works best for your organization.
3. Need help formatting your content? Be sure to visit the Create Your Content section on the HWP site for best practices and ideas for OpenScholar content types, web writing, formatting pages, and more.
4. Don’t forget, images and multimedia are content as well. Don’t wait until the last minute to include them, as finding images and compressing and uploading video can take time.
Preventing Plagiarism: Resources for Educators
Preventing Plagiarism: Resources for Educators
The most important steps in preventing plagiarism are those taken to address its causes. The strategies in this section are intended as guidelines to help you:
1) become aware of the reasons plagiarism occurs
2) identify the different forms of plagiarism
3) integrate plagiarism education and prevention techniques into your courses
Why Students Plagiarize
There are many reasons students plagiarize. Sometimes deadlines come around more quickly than expected, sometimes assignments feel overwhelming, and sometimes the boundaries of plagiarism and research just get confused. But what situations are most likely to result in plagiarism? More importantly, how can they be avoided? Learning to identify the factors that make plagiarism an attractive alternative is the best way to stop it before it starts.
Intentional Plagiarism
Just like hacking into websites, plagiarizing papers can be something of a thrill in itself. For many students it becomes a question of ingenuity: “can I sneak a plagiarized paper past my professor?” But there is usually more behind intentional plagiarism than just the thrill of deception.
• Searching vs. Researching
Today’s students learn quickly that finding and manipulating data on the internet is a valuable skill. With the wealth of information available online, the production of original analysis and interpretation may seem like “busy work” compared to finding the best or most obscure sources.
Teach your students that the real skills they need to learn are interpretation and analysis – how to process the information they find. Tell them that anyone with some basic knowledge can find information on the internet – it’s what they do with that information that is important.
• “But their words are better”
Some students might think, “Why sweat over producing an analysis that has already been done better, by someone who knows more?” Students may also be intimidated by the quality of work found online, thinking their own work cannot compare.
Tell your students that what interests you most is seeing how they understand the assigned topic, and how they develop their own style and voice. This might go a long way toward making them feel more comfortable with writing. Explain to them that you know writing is a learning process, and that you do not expect them to be as brilliant as experts who have devoted years to the subject. You may also want to let them know that their experiences and the context of your class give them a unique perspective that may give them a far more interesting angle on the issues than those of the “experts.”
• Making the Grade
Students are under enormous pressure from family, peers, and instructors to compete for scholarships, admissions, and, of course, places in the job market. They often see education as a rung in the ladder to success, and not an active process valuable in itself. Because of this, students tend to focus on the end results of their research, rather than the skills they learn in doing it.
Explain to your students that while they may be able to hide ignorance of particular facts or theories, research and writing skills make themselves very apparent to anyone evaluating them. In other words, your students’ grades won’t matter if they don’t have the skills to show for them.
Also, you may wish to emphasize improvement as a factor in grading, as this can encourage students to try developing their own abilities. This depends entirely upon your own pedagogical style, of course.
• “Everyone else is doing it”
Students often justify plagiarism by pointing out that since their peers plagiarize,
they must do the same to keep up. They feel faced with a choice: put in several hours of work and risk a mediocre grade with less time for other subjects, or do what their peers do and copy something good from the internet for an easy A with time to spare.
One of the only ways to deal with this is by catching those students who do plagiarize. It takes a great deal of the pressure off of those who want to work honestly but are afraid of falling behind their peers.
• Poor Planning
Students are not always the best judges of how much time their assignments will take. They may not be aware of the extent of work involved in a research paper, or may simply be overwhelmed by the task and put it off until the last minute, leaving them with no time for original work of their own.
Scheduling stages of progress on their papers is a very effective way to deal with this. Having them submit bibliographies, outlines, thesis statements, or drafts on specified dates before the final draft is due will give them a good idea of the amount of work involved. It will also help them organize their time and make the task seem less overwhelming.
Unintentional Plagiarism
No honest student would walk out of a neighbors’ house accidentally carrying their television. But even the most well-intentioned writers sometimes “appropriate” the work of others without proper authority. How does this happen?
• Citation Confusion
Perhaps the most common reason for inadvertent plagiarism is simply an ignorance of the proper forms of citation.
See our printable handout on how to cite sources properly.
• Plagiarism vs. Paraphrasing
Many students have trouble knowing when they are paraphrasing and when they are plagiarizing. In an effort to make their work seem “more original” by “putting things in their own words,” students may often inadvertently plagiarize by changing the original too much or, sometimes, not enough.
Doing exercises in class where you hand out paraphrased and plagiarized passages in order to discuss the differences might be very helpful. Explain that your students must retain the essential ideas of the original, but significantly change the style and grammatical structure to fit in the context of their argument.
• “I was just copying my notes”
Students often mix their own ideas and those of their sources when they take sloppy notes, creating confusion when they begin writing their papers.
It may be worthwhile to go over some note-taking methods with your students. Teaching them to document their sources using different colored pens and “post-it” tabs to mark pages, for example, will save time and keep references clear.
• “I couldn’t find the source”
Students are often sloppy about writing down the bibliographic information of their sources, leaving them unable to properly attribute information when it comes to writing the paper.
Explain how important it is to keep careful track of references during the note-taking stage. Students may be eager to focus entirely on the content of their research, and need to be told that how they handle their reference material is a significant part of the assignment. Having them turn in bibliographies before they turn in the paper itself will also encourage them to pay more attention to their sources.
• “I thought we didn’t have to quote facts”
Because the internet makes information so readily available, students may find it difficult to tell the difference between “common knowledge” they are free to use, and original ideas which are the intellectual property of others.
The easiest thing to do is teach your students the maxim, “When in doubt, cite sources.” You can also refer them to our student guide, or go over the difference between material that must be cited and material they are free to use in your class.
• Confusion about expectations
Students may not be aware of what proper research requires. They may think they are being asked simply to report critical commentary, or to “borrow” from a number of sources to show that they have “done their homework.” In either case, it becomes a problem if what they turn in tends to be predominantly the work of others.
One of the most common sources of confusion is the ambiguity of terms such as “analyze” and “discuss.” You should explain to your students that these words have specific meanings in academic discourse, and that they imply a degree of original thought that goes beyond mere “reporting.” Emphasizing your interest in their own ideas will also help them understand what you expect from them.
Cultural Perspectives on Plagiarism
Not all cultures take the same view of plagiarism. The Western notion that “ideas” can be the property of individuals may actually seem absurd to those with different views on what constitutes shared information or public discourse. Students from cultures which have a more collective sense of identity, for example, may have a difficult time understanding the distinctions some cultures draw between individual and public property. You might spend some very productive class time discussing your students’ perspectives on this issue.
Guidelines for Plagiarism Prevention
I. Explain what “plagiarism” means
Of course, most students will tell you they already know what plagiarism means. But do they really understand the difference between a legitimate paraphrase and a plagiarized one? Or between a proper citation and an improper one? Spending some time during the beginning of the course to explain plagiarism may go a long way toward preventing future problems.
You may also wish to distribute examples of plagiarism and legitimate citation, and then go over the differences together. This will clarify some of the common misconceptions about plagiarism and reduce the likelihood of “honest mistakes,” while at the same time showing how serious you are about the issue. Finally, you can direct your students to our website, where they can take a quiz on the difference between plagiarism and legitimate citation.
II. Explain what’s Wrong about Plagiarism
Without instruction, it may be hard for your students to understand the seriousness of plagiarism. Their response is often: “How can copying some words actually hurt anyone?” But the reality is that plagiarism is an act of fraud that involves both stealing (another’s intellectual property) and lying (implying that the work is one’s own). This undermines the principles of trust and respect that make education possible. But when they plagiarize, students hurt more than just their instructors and the person from whom they steal. They also hurt themselves, because they fail to acquire the research, analytic, and writing skills that they would have learned by doing the assignment honestly. Finally, plagiarism also victimizes those classmates who have legitimately earned their grades and degrees, and who will be competing with the plagiarizer for school admissions and jobs.
III. Make the Consequences Clear
Students often do not know just what they risk when they plagiarize. Begin your course by establishing a clear policy on plagiarism. Give very specific information about the penalties involved. You may want to create a specific policy for your courses in addition to your institution’s general policy. Try telling your students, for example, that any case of plagiarism will result in immediate failure of the paper, and that a second instance will result in failure of the course and possibly expulsion, will doubtless make them think twice about it. Be sure to cite your policy on any research assignments as a reminder
IV. Start off with Clear Expectations
First, let your students know you expect them to produce thoughtful, original work. Students are often under the illusion that the goal of their assignments is to collect the best information possible. Explain to them that while good research is critical, you are even more interested in their ability to transform the information they find into an original and persuasive argument than in their ability to come up with the most or best sources. The skills they learn in working to further the ideas and arguments of others are a valuable part of what they will take away from their assignments. Knowing this may help them understand the value of original work.
You may also want to establish some rules in advance: Should your students collaborate? Will you require separate “works cited” pages and bibliographies? How many sources will they be required to consult? How many sources will they have to include in their paper? Will online sources be sufficient, or would you like your students to find printed material as well? Starting off with clear guidelines will prevent most of the confusion that leads to unintentional plagiarism, and allow no excuses for the intentional kind.
V. Assign Specific Questions or Topics
Provide a list of topics or questions that you would like your students to address in their papers. The more particular the questions, the less likely that your students will find papers already written on them. If you worry that lists like this restrict your students’ creative freedom, you might want to add an option that allows your students to develop their own topics in consultation with you or a teaching assistant.
VI. Require Students to Submit Thesis Statements, Introductions, Outlines, or Drafts
One of the best ways to ensure that your students’ work is original is to check it during the process of composition. Since rough drafts, etc., are not as readily available for copying as finished papers, the simple fact that they have to submit one will encourage most of your students to produce original work. It often takes more work to forge these materials than it does to produce them originally. Also, if you have time to comment on what they submit, you can monitor how they respond to your feedback and whether their papers show the flexibility of works-in-progress.
VII. Have your students Annotate their Bibliographies
Ask your students to summarize the content and usefulness of their sources in a few sentences. Be sure to tell them that copying library abstracts or blurbs from the backs of books is not permissible. Emphasize that the annotation has to be in their own voice and words, and should specifically discuss the relevance of the source to their research. This exercise should take no time at all for students who have done their work honestly. Plagiarizers, however, will find it considerably more difficult.
VIII. Assign Oral Presentations
Have your students answer questions about the process of researching and developing their ideas. This is also an excellent opportunity to ask them specific questions about their papers, and to bring up passages that seem suspicious. Questions like “This quotation here is a little unclear. Could you tell me a little more about the article from which you got it?” can be very effective in determining how much work the student did without offending or seeming suspicious.
IX. Require Recent and Printed Sources
Most papers from online paper mills and other cheating databases are already several years old at best. Having your students integrate at least one contemporary source in their paper will keep your students up to date on the issues and help ensure legitimate research and work.
X. Assign a Paragraph on the Composition Process
If you do not have your students give oral presentations or turn in drafts during the composition process, you may want to have them submit a paragraph explaining how they arrived at their topic, how they began researching it, what criteria they used for evaluating their sources, and what they learned from the research project. This will give you an idea of how well they have comprehended the material and the degree of fluency they have in speaking about it.
XI. Encourage Concision
Students often try to “fill space” by “borrowing” material once they have finished with their own ideas. Tell your students that it is very obvious when they “pad” their papers to fill up page requirements. Encourage them to be as concise as possible, focusing on the substance of their claims rather than the length of their writing. Make sure they know the trick to writing a long research paper lies in coming up with a thesis or argument which requires the assigned number of pages to develop, and not in drawing out the points they make or citing multiple sources to prove a single idea.
Important Terms
Attribution The acknowledgement that something came from another source.
The following sentence properly attributes an idea to its original author: Jack Bauer, in his article “Twenty-Four Reasons not to Plagiarize,” maintains that cases of plagiarists being expelled by academic institutions have risen dramatically in recent years due to an increasing awareness on the part of educators.
Bibliography A list of sources used in preparing a work
Citation 1) A short, formal indication of the source of information or quoted material.
2) The act of quoting material or the material quoted.
Cite 1) to indicate a source of information or quoted material
in a short, formal note.
2) to quote
3) to ascribe something to a source
Common Information that is readily available from a number
Knowledge of sources, or so well-known that its sources do not
have to be cited.
The fact that carrots are a source of Vitamin A is common knowledge, and you could include this information in your work without attributing it to a source. However, any information regarding the effects of Vitamin A on the human body are likely to be the products of original research and would have to be cited.
Copyright A law protecting the intellectual property of individuals,
giving them exclusive rights over the distribution and
reproduction of that material.
Endnotes Notes at the end of a paper acknowledging sources and providing additional references or information.
Facts Knowledge or information based on real, observable
occurrences.
Just because something is a fact does not mean it is not the result of original thought, analysis, or research. Facts can be considered intellectual property as well. If you discover a fact that is not widely known nor readily found in several other places, you should cite the source.
Footnotes Notes at the bottom of a paper acknowledging sources or
providing additional references or information.
Fair Use The guidelines for deciding whether the use of a source is
permissible or constitutes a copyright infringement.
Intellectual A product of the intellect, such as an expressed idea or
Property concept, that has commercial value
Notation The form of a citation; the system by which one refers
to cited sources.
Original 1) Not derived from anything else, new and unique
2) Markedly departing from previous practice
3) The first, preceding all others in time
4) The source from which copies are made
Paraphrase A restatement of a text or passage in other words
It is extremely important to note that changing a few words
from an original source does NOT qualify as paraphrasing. A paraphrase must make significant changes in the style and voice of the original while retaining the essential ideas. If you change the ideas, then you are not paraphrasing – you are misrepresenting the ideas of the original, which could lead to serious trouble. (see examples in the students preventing page….)
Peer Review Turnitin.com’s teaching tool that allows students to anonymously review the work of their peers. This gives students a chance to build critical skills while helping them to see the strengths and weaknesses of their own writing.
Plagiarism The reproduction or appropriation of someone else’s work without proper attribution; passing off as one’s own the work of someone else
Public Domain The absence of copyright protection; belonging to the public so that anyone may copy or borrow from it.
See our section on What is public domain?
Quotation Using words from another source
Self-plagiarism Copying material you have previously produced and passing it off as a new production. This can potentially violate copyright protection, if the work has been published, and is banned by most academic policies.
0 komentar: